Vaccine Investigations.....Raw Data Thread

[Commonground]

Re: Vaccine Orders -

Re: Vaccine Orders -

APPENDIX B
H1N1 COUNTERMEASURES STRATEGY AND
DECISION-MAKING FORUM
DETAILED REPORT
PANDEMIC INFLUENZA WORKING GROUP (PIWG)
NATIONAL BIODEFENSE SCIENCE BOARD
JULY 2009

Update: Domestic and International Surveillance Update and Plans?CAPT Anthony Fiore, M.D., M.P.H., CDC
excerpt:

CDC is working to increase funding for reporting and field staff. It faces challenges in obtaining representative samples of the virus from other countries. In countries with less surveillance in place, CDC faces challenges in interpreting the data it receives.

What U.S. program captures severe pneumonia cases?

CAPT Fiore: The Emerging Infections Program (EIP). We have good surveillance of hospitalization. In the early weeks of the outbreak, there were few cases of influenza in the States where we had surveillance projects. I think that?s changing as we get EIP data. We reinstated that and increased its funding. The new National Vaccine Surveillance Network also has that capability.

[Unidentified]: You need to get surveillance on teens and young adults.

CAPT Fiore: The EIP will be useful there.

Mr. Ferguson: We?ve considered that. The 1957 pandemic was truly novel, and it is similar to novel H1N1. Age-specific attack rates vary by pandemic. Attack rates could be two to three times higher than seasonal influenza. Even a bad year of seasonal influenza has only a 10% attack rate, and it?s concentrated in kids and the elderly. I think we should be planning for an event three times as bad as a bad seasonal influenza year in terms of clinical disease.

Terry Adirim, M.D., M.P.H.: Has there been any thought about triggers for de-escalation of mitigation strategies?

Dr. Robinson: Part of our planning has been to include exit ramps. The next one would be in September. On the basis of clinical data and surveillance, would we buy more antigen and adjuvant?

Dr. Pavia: After this meeting, you should look more closely at CAPT Fiore?s data to determine the likelihood of an exit point at which we don?t vaccinate. But that?s not terribly relevant right now.

James James. M.D., Dr.P.H., M.H.A.: Considering the wave nature of pandemics, when you model, how do you handle background immunity or herd immunity? How does that translate into vaccine-sparing policies?

Mr. Ferguson: It?s relatively easy with models; they allow for different susceptibility for different age groups and can take into account background immunity. With an epidemic, we run various scenarios and evaluate what the current situation implies about immunity in the fall. However, we need more data to validate those projections. We could have 3 million to 20 million people infected by September. We need serologic data to resolve some questions.

Fred Hayden, M.D.: How do existing population susceptibility patterns affect your projections of background immunity? If you look at age patterns using attack rates to date, if there were no changes in viral antigenicity and given background immunity, could there be less impact?

Mr. Ferguson: How much seasonal influenza spread impedes the spread of the pandemic and how much background immunity slows spread are difficult to untangle. Looking at South America, if only a small percentage is infected by September, we could see explosive spread in September. That should be a planning assumption. If later data show that lots of people are already infected, that could affect decision-making.

Dr. Hayden: Is there a drift variant of H3N2?

Dr. Katz: We don?t have data, but I have heard that the WHO Collaborating Centers are looking at it and characterizing strains of H3N2.

Dr. Modlin: Children have higher attack rates, and some of the most serious disease is occurring in young children, including those zero to six months old. That group is not currently targeted for vaccine. That group is difficult to surveil and has a high rate of respiratory disease. They will not have maternal antibodies. We should think about surveillance in this special population, because we may recommend extending vaccine to the very young.

Dr. Pavia: The National Vaccine Surveillance Network might capture that, and there may be some surveillance in certain cities. I don?t expect us to answer all the questions we?ve raised. We should be thinking about which of those questions will influence decision-makers, such as severity of disease and age-specific risk groups.

Dr. Lambert commented that the lessons learned from NIH?s H5N1 influenza vaccine clinical trials were enormous.

http://www.hhs.gov/aspr/conferences/nbsb/nbsb-h1n1forum-sum-090617.pdf

 

[Commonground]

Re: Vaccine Orders -

Re: Vaccine Orders -

APPENDIX B
H1N1 COUNTERMEASURES STRATEGY AND
DECISION-MAKING FORUM
DETAILED REPORT
PANDEMIC INFLUENZA WORKING GROUP (PIWG)
NATIONAL BIODEFENSE SCIENCE BOARD
JULY 2009

excerpt:
Discussion
Dr. Pavia: We probably have a vaccine, and we think we want to use it. So, we need to identify the target groups, priorities, doses, how it will be administered, contraindications, coadministration with seasonal vaccine, etc. I want to hear from the other Federal advisory groups: What information do you need to make a decision? Do you have that information? How can we inform the decision process?

Dr. Neuzil: At ACIP, we?re 15 members, selected for our diverse expertise and representation, and we make recommendations to the director of CDC and to the HHS Assistant Secretary for Health. Our charter addresses vaccine licensed for the civilian population and maybe also for vaccines that are not yet licensed. So that?s why it?s important to understand if the H1N1 vaccine will be licensed or not. Under what circumstances does ACIP make decisions on unlicensed vaccines? Who decides what we should address? It?s in our charge to make recommendations on current seasonal vaccine, and we have. Nothing that I?ve heard so far would make me reassess our recommendation for the 2009?2010 seasonal vaccine. It?s important to understand that despite logistical and communication challenges of coadministration or sequential vaccine, nothing makes me think that the benefit for seasonal vaccine is not there.

Dr. Pavia: Have we set a goal? Reduce the number of deaths? Minimize disruption? Who sets that goal?

CAPT Fiore: The overarching goal so far has been to reduce deaths, hospitalization, and complications of seasonal influenza, and I expect the goal will be the same for pandemic influenza. We have relatively few deaths now, so we may need to reassess and look at severe illness and hospitalization or societal disruption. I think ACIP would contribute to goal-setting.
Also, as influenza vaccination progresses, we?ve expanded the groups for whom we recommend vaccines greatly in the past 10 years; now, 84% of people are affected by annual influenza vaccine recommendations. ACIP goes beyond listed indications, e.g., recommending that pregnant women get influenza vaccine. It is an unusual Federal advisory group. It has ongoing work groups that meet throughout the year, including one on H1N1. The groups have other liaisons and ad hoc experts. ACIP has made decisions despite gaps in data by relying on expertise, and the group is comfortable talking in public forum about its concerns.

Dr. Schonberger: Who deals with questions related to what?s available when? If you treated the new pandemic virus-related antigen like regular seasonal vaccine?15 mcg, no adjuvant, injected?and used it under an EUA, that could be ready quickly (without doing formal, time-consuming, clinical trials). But the lines that the manufacturers are pursuing mean there will be delays. Who evaluates that issue? If we decide to do clinical trials on adjuvants, that?s a decision that leads to a later vaccine.

Dr. Pavia: If we leave aside the question of adjuvants, I?m uncomfortable making a decision about using one dose for all. We need at least some dose-response studies.

Dr. Edwards: I think Dr. Schonberger makes sense. We may have to decide whether we will go forward with just a few answers, otherwise it may be too late and we?ll be spending money on vaccine we may not need. We need to find out quickly what happens with one dose. I?m worried that the trials will miss the mark.

Dr. Schonberger: Maybe there?s a precedent. In 1977, we did not call it a pandemic; we just slipped the antigen into the regular seasonal vaccine.

Dr. Dowdle: There was small, simple field trial, but no consideration of a new subtype, and it was very quietly done.

Dr. Quinnan: Dr. Treanor gave data on clinical trials in 1977 from the Russian influenza vaccine that showed very good responses in people who had been alive in 1957. However, that data reflects responses of people who had had multiple natural exposures to H1N1 strains that were nearly identical to the 1977 H1N1 strain. It is important to recognize that similar, very potent responses were observed in the same age groups among people vaccinated in 1976 with the A/New Jersey H1N1 strain, since that strain was very different from the strains that circulated prior to 1957. Those results indicate that we should see the same degree of cross strain priming in people vaccinated now with the novel H1N1 strain based on prior exposure to previously circulating H1N1 viruses. Moreover, the cross priming should be evident in people who were alive before 1957 and in people who have been exposed to circulating H1N1 strains over the past 30 years.

Dr. Murphy: Some respond well to one dose per data on the 1976 trials?about 8090%.
Despite the uncertainty about the number of doses and ability to respond, I think we can make a decision early.

Dr. Pavia: That?s all good for people over 50, but that?s not the target group.

Dr. Murphy: The viruses circulating in the 1940s and 1950s were priming the population for the virus that circulated in the 1980s. Everybody over a certain age has H1N1 priming.

Dr. Field: This is politically sensitive. Is there a procedure for getting public input and perceptions?

CAPT Fiore: We have one public member [on ACIP] and we have public comment time during meetings. Also, CDC sponsors public engagement.

Dr. Redd: The public engagement process is good for value decisions but not for technical decisions.

Dr. Gellin: We went through the prioritization process for pandemic influenza planning. There is a way to formalize the input, and we see it as a data point.

Dr. Modlin: I?m a veteran of the swine influenza outbreak. We studied the vaccine at Boston?s children?s hospital and we found the vaccine poorly immunogenic in children, even at two doses.

Dr. Meltzer: In terms of setting a goal, keep in mind that the valuation of a vaccine changes, and you can?t transfer that value to others. I don?t think seasonal vaccine valuations are comparable in the public?s mind to H1N1. As for the data we need to make decisions, e.g., the case-fatality rate, I don?t think it?s that simple. Public comment is important, but people say one thing and do another. Whether to use one or two doses is important for logistics, etc., but to the public it?s a side issue. Regarding the decision process, you need to get down to a few key points. There will never be enough data, but if you start too early, you will be back in 1976.


Dr. Neuzil: We need to focus on what we have to decide now?can there be vaccine ready for what we are seeing??not the decision that people start a vaccination program. We need to make decisions that prepare us for action in September. This issue is important, but we don?t know where we?ll be in September.


Dr. Robinson: If we started making vaccine on August 15, we could have around 60 million doses by September 15, or, at best, 20% more. That would be an unadjuvanted, 15-mcg formula.

Dr. Pavia: So the data we have is that vaccines are being manufactured and the next question is the formulation?whether we use adjuvant or not. Do we have enough data to decide that?


Dr. Modlin: I think we should act on these assumptions today:

. We will see H1N1 infection this fall.
. We will likely have a narrow window in which to make decisions.
. We have good reasons to believe that illness could come early (based on biology
and epidemiology).
. We expect high attack rates in certain age groups.
. The disease will be at least as virulent as seasonal influenza.
. We anticipate considerable morbidity and mortality.

To act on those assumptions, we need some simple information that could come from simple studies in small numbers of patients about safety and immunogenicity of an unadjuvanted dose, perhaps at 15 mcg. Parallel studies could be undertaken of adjuvanted vaccine, and I think the manufacturers are going that way. We need to know the effect of coadministration with seasonal vaccine, both simultaneous and sequential, because we?re not sure what will be available when and we have concerns about a blunting effect. We need to know the effect on special populations. I think we agree children are the highest priority because they are at high risk and because of their role in transmitting disease in the community. We should think more about conducting limited studies in infants up to 6 months; that?s difficult, but they may be at highest risk. If we see hospitalization and death in this group and we have no EUA for a vaccine, that would be a mistake.

Dr. Pavia: I think Dr. Modlin has brought great clarity to the discussion. So, if we agree on those key assumptions, let?s look at the clinical trials planned and the timelines. The questions are addressed, but the timelines may be slow. Someone needs to look at the timelines critically and figure out how to get that information much faster.

Dr. Modlin: We need to be prepared to pull the trigger based on limited data.

Dr. Meltzer: I think Dr. Neuzil put it well: What?s the decision we need to make today? Dr. Modlin identified the tests we need to get the data for September or later. Have we decided how many doses to buy or when? If that?s still open, it?s relatively easy to solve the other questions. You have the stock, do you use it?

Dr. Pavia: I think the decision to purchase has been made.

Dr. Robinson: We are doing it in a stepwise approach. If we have the appropriations, we will buy more.

Dr. Pavia: So now we?re talking about go or no-go. We can get data and decide later whether vaccine is licensed or used under an EUA. Is time more important than licensure status?

Stephen Cantrill, M.D.: We have not decided to go with a vaccine program, but we have to bring in State and local partners. They can?t ramp up in two weeks. Our thinking process has to be shared. At the least we need to put them on notice about what could happen.

Dr. Gellin: Yes?they are not all present, but I think they know the calendar is coming. CDC is engaging with States, talking about the assumptions. They know they need to get contracts in place, etc. We are focusing on vaccine mostly, but we recognize the importance of implementation. What?s the earliest we can protect people? The formulations for earliest, single-dose protection coincide with the easiest administration route.

Dr. Pavia: It sounds like we want the minimum data set to learn if one-dose antigen-only vaccine could be available.

[Unidentified]: Only if those data are available by August 15.

Dr. Innis: If you need vaccine in September, you must decide now on the basis of existing data. There?s no way you?ll have information in August so that Dr. Robinson can get product for distribution in September. Is that crazy? I don?t think so. We have learned a lot about adjuvanted H5N1 vaccines;, GSK has limited safety and immunogenicity data for children and the profile is similar to that in adults. We know you can give children as young as 3 years of age low doses of antigen and fractionated doses of adjuvant and they respond. You can create immunological memory, so that with a second dose or perhaps upon exposure to virus, they fire up an intense anamnestic response. To be prepared for September, you have to decide now, and you have to consider whether parents will want to have their children vaccinated with the products you make available. When Dr. Modlin tested vaccine in little kids in 1976, it didn?t? work well.

Dr. Modlin: I agree. I think we?re being too timid about adjuvants. I?m reassured by the European data, although I?m concerned about the lack of data in young children. Our most important responsibility is providing a vaccine that is effective and safe. We need adjuvant early, so we need to study adjuvants in parallel in all age groups. That?s a high priority.

Dr. Belshe: It?s not unreasonable to pick a default dose?say, 15 mcg with no adjuvant?and use it for adults. For children, we could use live vaccine and we know the dose. For those not eligible, we could study alternatives. That approach gets you a long way. CDC showed that if you vaccinate 70% of kids with live attenuated vaccine, you reduce community burden by 99%. We should consider more creative use of two vaccine types.

Dr. Robinson: I agree with the use of the FluMist product, but the manufacturer has a small capacity. They are struggling to get enough. They expect to have about 6.4 million doses by the end of August. The limitations are not in the capacity to produce the bulk product but are inherent in the production of the delivery device.

Dr. Belshe: You could use live vaccine as drops. NIH has conducted several studies with drops.

Dr. Tsai: Novartis? adjuvant has been studied in children. One study in Finland included children 6?36 months, and it found that a single dose led to seroprotective responses to the H3N2 strain. Some adults responded similarly to adjuvanted H9N2 vaccine. There is evidence that in people naive to antigen, the adjuvant promotes good response after one dose.

Dr. Pavia: In closing, I want to summarize what I?ve heard today. We have some assumptions we?re getting comfortable with:

. There will be significant disease this fall, mild to moderate at least. . We are not locking into a vaccination program, but we need to work on our
assumptions. . Children are likely to be heavily affected and also an amplifier of disease. . A late decision and late vaccine may be worse than no vaccine. Some options
may lead to a safe vaccine at a point when it?s useless. We must abandon that approach and move back to an early vaccine strategy. . Some decisions will be made with limited data and some with no data.



http://www.hhs.gov/aspr/conferences/nbsb/nbsb-h1n1forum-sum-090617.pdf

 

[Commonground]

Re: Vaccine Orders -

Re: Vaccine Orders -

HHS 2009 H1N1 Vaccine Development Activities
Excerpt


HHS Contracting Activities

Since 2004, HHS has contracted with manufacturers that currently hold U.S. licenses for flu vaccine as part of the National Strategy for Pandemic Influenza. In May 2009, HHS issued new orders on these contracts to produce a bulk supply of vaccine antigen and adjuvant and to produce pilot (also called investigational) lots of a 2009 H1N1 vaccine. Most will be stored in bulk, and a small amount will be prepared as vaccine for use in clinical studies to evaluate vaccine safety and the dosage required for a protective effect. This research will include studies with adjuvant to determine its safety and the effect it would have on the immune system?s response.


Orders for Bulk Supply of H1N1 Influenza Vaccine Antigen and Adjuvant: May 22, 2009

<table style="border: medium none ; width: 6.2in; border-collapse: collapse;" border="1" cellpadding="0" cellspacing="0" width="595"> <tbody><tr> <td style="border: 1pt solid windowtext; padding: 0in 5.4pt; background: navy none repeat scroll 0% 0%; width: 2.05in; -moz-background-clip: border; -moz-background-origin: padding; -moz-background-inline-policy: continuous; color: White;" valign="top" width="197">

[FONT=&quot]Manufacturer[/FONT]​

</td> <td style="border-style: solid solid solid none; border-color: windowtext windowtext windowtext -moz-use-text-color; border-width: 1pt 1pt 1pt medium; padding: 0in 5.4pt; background: navy none repeat scroll 0% 0%; width: 2.05in; -moz-background-clip: border; -moz-background-origin: padding; -moz-background-inline-policy: continuous; color: White;" valign="top" width="197">

[FONT=&quot]Bulk Vaccine Antigen[/FONT]​

</td> <td style="border-style: solid solid solid none; border-color: windowtext windowtext windowtext -moz-use-text-color; border-width: 1pt 1pt 1pt medium; padding: 0in 5.4pt; background: navy none repeat scroll 0% 0%; width: 2.1in; -moz-background-clip: border; -moz-background-origin: padding; -moz-background-inline-policy: continuous; color: White;" valign="top" width="202">

[FONT=&quot]Oil-In-Water Bulk Adjuvant[/FONT]​

</td> </tr> <tr> <td style="border-style: none solid solid; border-color: -moz-use-text-color windowtext windowtext; border-width: medium 1pt 1pt; padding: 0in 5.4pt; width: 2.05in;" valign="top" width="197"> [FONT=&quot]Novartis[/FONT]
</td> <td style="border-style: none solid solid none; border-color: -moz-use-text-color windowtext windowtext -moz-use-text-color; border-width: medium 1pt 1pt medium; padding: 0in 5.4pt; width: 2.05in;" valign="top" width="197"> [FONT=&quot]$150 million[/FONT]
</td> <td style="border-style: none solid solid none; border-color: -moz-use-text-color windowtext windowtext -moz-use-text-color; border-width: medium 1pt 1pt medium; padding: 0in 5.4pt; width: 2.1in;" valign="top" width="202"> [FONT=&quot]$139 million[/FONT]
</td> </tr> <tr> <td style="border-style: none solid solid; border-color: -moz-use-text-color windowtext windowtext; border-width: medium 1pt 1pt; padding: 0in 5.4pt; background: rgb(243, 251, 255) none repeat scroll 0% 0%; width: 2.05in; -moz-background-clip: border; -moz-background-origin: padding; -moz-background-inline-policy: continuous;" valign="top" width="197"> [FONT=&quot]GlaxoSmithKline[/FONT]
</td> <td style="border-style: none solid solid none; border-color: -moz-use-text-color windowtext windowtext -moz-use-text-color; border-width: medium 1pt 1pt medium; padding: 0in 5.4pt; background: rgb(243, 251, 255) none repeat scroll 0% 0%; width: 2.05in; -moz-background-clip: border; -moz-background-origin: padding; -moz-background-inline-policy: continuous;" valign="top" width="197"> [FONT=&quot]$ 38 million[/FONT]
</td> <td style="border-style: none solid solid none; border-color: -moz-use-text-color windowtext windowtext -moz-use-text-color; border-width: medium 1pt 1pt medium; padding: 0in 5.4pt; background: rgb(243, 251, 255) none repeat scroll 0% 0%; width: 2.1in; -moz-background-clip: border; -moz-background-origin: padding; -moz-background-inline-policy: continuous;" valign="top" width="202"> [FONT=&quot]$144 million[/FONT]
</td> </tr> <tr> <td style="border-style: none solid solid; border-color: -moz-use-text-color windowtext windowtext; border-width: medium 1pt 1pt; padding: 0in 5.4pt; width: 2.05in;" valign="top" width="197"> [FONT=&quot]Sanofi[/FONT][FONT=&quot] Pasteur[/FONT]
</td> <td style="border-style: none solid solid none; border-color: -moz-use-text-color windowtext windowtext -moz-use-text-color; border-width: medium 1pt 1pt medium; padding: 0in 5.4pt; width: 2.05in;" valign="top" width="197"> [FONT=&quot]$191 million[/FONT]
</td> <td style="border-style: none solid solid none; border-color: -moz-use-text-color windowtext windowtext -moz-use-text-color; border-width: medium 1pt 1pt medium; padding: 0in 5.4pt; width: 2.1in;" valign="top" width="202"> [FONT=&quot] [/FONT]
</td> </tr> <tr> <td style="border-style: none solid solid; border-color: -moz-use-text-color windowtext windowtext; border-width: medium 1pt 1pt; padding: 0in 5.4pt; background: rgb(243, 251, 255) none repeat scroll 0% 0%; width: 2.05in; -moz-background-clip: border; -moz-background-origin: padding; -moz-background-inline-policy: continuous;" valign="top" width="197"> [FONT=&quot]CSL Biotherapies[/FONT]
</td> <td style="border-style: none solid solid none; border-color: -moz-use-text-color windowtext windowtext -moz-use-text-color; border-width: medium 1pt 1pt medium; padding: 0in 5.4pt; background: rgb(243, 251, 255) none repeat scroll 0% 0%; width: 2.05in; -moz-background-clip: border; -moz-background-origin: padding; -moz-background-inline-policy: continuous;" valign="top" width="197"> [FONT=&quot]$180 million[/FONT]
</td> <td style="border-style: none solid solid none; border-color: -moz-use-text-color windowtext windowtext -moz-use-text-color; border-width: medium 1pt 1pt medium; padding: 0in 5.4pt; background: rgb(243, 251, 255) none repeat scroll 0% 0%; width: 2.1in; -moz-background-clip: border; -moz-background-origin: padding; -moz-background-inline-policy: continuous;" valign="top" width="202"> [FONT=&quot] [/FONT]
</td> </tr> <tr> <td style="border-style: none solid solid; border-color: -moz-use-text-color windowtext windowtext; border-width: medium 1pt 1pt; padding: 0in 5.4pt; width: 2.05in;" valign="top" width="197"> [FONT=&quot]MedImmune[/FONT][FONT=&quot][/FONT]
</td> <td style="border-style: none solid solid none; border-color: -moz-use-text-color windowtext windowtext -moz-use-text-color; border-width: medium 1pt 1pt medium; padding: 0in 5.4pt; width: 2.05in;" valign="top" width="197"> [FONT=&quot]$ 90 million[/FONT]
</td> <td style="border-style: none solid solid none; border-color: -moz-use-text-color windowtext windowtext -moz-use-text-color; border-width: medium 1pt 1pt medium; padding: 0in 5.4pt; width: 2.1in;" valign="top" width="202"> [FONT=&quot] [/FONT]
</td> </tr> <tr> <td style="border-style: none solid solid; border-color: -moz-use-text-color windowtext windowtext; border-width: medium 1pt 1pt; padding: 0in 5.4pt; background: rgb(243, 251, 255) none repeat scroll 0% 0%; width: 2.05in; -moz-background-clip: border; -moz-background-origin: padding; -moz-background-inline-policy: continuous;" valign="top" width="197"> [FONT=&quot]Total[/FONT]
</td> <td style="border-style: none solid solid none; border-color: -moz-use-text-color windowtext windowtext -moz-use-text-color; border-width: medium 1pt 1pt medium; padding: 0in 5.4pt; background: rgb(243, 251, 255) none repeat scroll 0% 0%; width: 2.05in; -moz-background-clip: border; -moz-background-origin: padding; -moz-background-inline-policy: continuous;" valign="top" width="197"> [FONT=&quot]$649 million[/FONT]
</td> <td style="border-style: none solid solid none; border-color: -moz-use-text-color windowtext windowtext -moz-use-text-color; border-width: medium 1pt 1pt medium; padding: 0in 5.4pt; background: rgb(243, 251, 255) none repeat scroll 0% 0%; width: 2.1in; -moz-background-clip: border; -moz-background-origin: padding; -moz-background-inline-policy: continuous;" valign="top" width="202"> [FONT=&quot]$283 million[/FONT]
</td> </tr> </tbody></table>
Orders for Bulk Supply of H1N1 Influenza Vaccine Antigen and Adjuvant: July 9, 2009

<table style="border: medium none ; width: 6.25in; border-collapse: collapse;" border="1" cellpadding="0" cellspacing="0" width="600"> <tbody><tr> <td style="border: 1pt solid windowtext; padding: 0in 5.4pt; background: navy none repeat scroll 0% 0%; width: 99pt; -moz-background-clip: border; -moz-background-origin: padding; -moz-background-inline-policy: continuous;" valign="top" width="132">

[FONT=&quot]Manufacturer[/FONT][FONT=&quot][/FONT]​

</td> <td style="border-style: solid solid solid none; border-color: windowtext windowtext windowtext -moz-use-text-color; border-width: 1pt 1pt 1pt medium; padding: 0in 5.4pt; background: navy none repeat scroll 0% 0%; width: 135pt; -moz-background-clip: border; -moz-background-origin: padding; -moz-background-inline-policy: continuous;" valign="top" width="180">

[FONT=&quot]Bulk Vaccine Antigen[/FONT][FONT=&quot][/FONT]​

</td> <td style="border-style: solid solid solid none; border-color: windowtext windowtext windowtext -moz-use-text-color; border-width: 1pt 1pt 1pt medium; padding: 0in 5.4pt; background: navy none repeat scroll 0% 0%; width: 117pt; -moz-background-clip: border; -moz-background-origin: padding; -moz-background-inline-policy: continuous;" valign="top" width="156">

[FONT=&quot]Bulk Virus Concentrate/FFF[/FONT]​

</td> <td style="border-style: solid solid solid none; border-color: windowtext windowtext windowtext -moz-use-text-color; border-width: 1pt 1pt 1pt medium; padding: 0in 5.4pt; background: navy none repeat scroll 0% 0%; width: 99pt; -moz-background-clip: border; -moz-background-origin: padding; -moz-background-inline-policy: continuous;" valign="top" width="132">

[FONT=&quot]Oil-In-Water Bulk Adjuvant[/FONT][FONT=&quot][/FONT]​

</td> </tr> <tr> <td style="border-style: none solid solid; border-color: -moz-use-text-color windowtext windowtext; border-width: medium 1pt 1pt; padding: 0in 5.4pt; width: 99pt;" valign="top" width="132"> [FONT=&quot]Sanofi[/FONT][FONT=&quot] Pasteur[/FONT]
</td> <td style="border-style: none solid solid none; border-color: -moz-use-text-color windowtext windowtext -moz-use-text-color; border-width: medium 1pt 1pt medium; padding: 0in 5.4pt; width: 135pt;" valign="top" width="180"> [FONT=&quot]$61,425,000[/FONT]
</td> <td style="border-style: none solid solid none; border-color: -moz-use-text-color windowtext windowtext -moz-use-text-color; border-width: medium 1pt 1pt medium; padding: 0in; width: 117pt;" valign="top" width="156"> [FONT=&quot]0[/FONT]
</td> <td style="border-style: none solid solid none; border-color: -moz-use-text-color windowtext windowtext -moz-use-text-color; border-width: medium 1pt 1pt medium; padding: 0in 5.4pt; width: 99pt;" valign="top" width="132"> [FONT=&quot]0[/FONT]
</td> </tr> <tr> <td style="border-style: none solid solid; border-color: -moz-use-text-color windowtext windowtext; border-width: medium 1pt 1pt; padding: 0in 5.4pt; background: rgb(243, 251, 255) none repeat scroll 0% 0%; width: 99pt; -moz-background-clip: border; -moz-background-origin: padding; -moz-background-inline-policy: continuous;" valign="top" width="132"> [FONT=&quot]GSK[/FONT]
</td> <td style="border-style: none solid solid none; border-color: -moz-use-text-color windowtext windowtext -moz-use-text-color; border-width: medium 1pt 1pt medium; padding: 0in 5.4pt; background: rgb(243, 251, 255) none repeat scroll 0% 0%; width: 135pt; -moz-background-clip: border; -moz-background-origin: padding; -moz-background-inline-policy: continuous;" valign="top" width="180"> [FONT=&quot]$0[/FONT]
</td> <td style="border-style: none solid solid none; border-color: -moz-use-text-color windowtext windowtext -moz-use-text-color; border-width: medium 1pt 1pt medium; padding: 0in; background: rgb(243, 251, 255) none repeat scroll 0% 0%; width: 117pt; -moz-background-clip: border; -moz-background-origin: padding; -moz-background-inline-policy: continuous;" valign="top" width="156"> [FONT=&quot]0[/FONT]
</td> <td style="border-style: none solid solid none; border-color: -moz-use-text-color windowtext windowtext -moz-use-text-color; border-width: medium 1pt 1pt medium; padding: 0in 5.4pt; background: rgb(243, 251, 255) none repeat scroll 0% 0%; width: 99pt; -moz-background-clip: border; -moz-background-origin: padding; -moz-background-inline-policy: continuous;" valign="top" width="132"> [FONT=&quot]$71,400,000[/FONT]
</td> </tr> <tr> <td style="border-style: none solid solid; border-color: -moz-use-text-color windowtext windowtext; border-width: medium 1pt 1pt; padding: 0in 5.4pt; width: 99pt;" valign="top" width="132"> [FONT=&quot]Novartis[/FONT]
</td> <td style="border-style: none solid solid none; border-color: -moz-use-text-color windowtext windowtext -moz-use-text-color; border-width: medium 1pt 1pt medium; padding: 0in 5.4pt; width: 135pt;" valign="top" width="180"> [FONT=&quot]$346,334,450[/FONT]
</td> <td style="border-style: none solid solid none; border-color: -moz-use-text-color windowtext windowtext -moz-use-text-color; border-width: medium 1pt 1pt medium; padding: 0in; width: 117pt;" valign="top" width="156"> [FONT=&quot]0[/FONT]
</td> <td style="border-style: none solid solid none; border-color: -moz-use-text-color windowtext windowtext -moz-use-text-color; border-width: medium 1pt 1pt medium; padding: 0in 5.4pt; width: 99pt;" valign="top" width="132"> [FONT=&quot]$343,810,470[/FONT]
</td> </tr> <tr> <td style="border-style: none solid solid; border-color: -moz-use-text-color windowtext windowtext; border-width: medium 1pt 1pt; padding: 0in 5.4pt; background: rgb(243, 251, 255) none repeat scroll 0% 0%; width: 99pt; -moz-background-clip: border; -moz-background-origin: padding; -moz-background-inline-policy: continuous;" valign="top" width="132"> [FONT=&quot]CSL[/FONT]
</td> <td style="border-style: none solid solid none; border-color: -moz-use-text-color windowtext windowtext -moz-use-text-color; border-width: medium 1pt 1pt medium; padding: 0in 5.4pt; background: rgb(243, 251, 255) none repeat scroll 0% 0%; width: 135pt; -moz-background-clip: border; -moz-background-origin: padding; -moz-background-inline-policy: continuous;" valign="top" width="180"> [FONT=&quot]$0[/FONT]
</td> <td style="border-style: none solid solid none; border-color: -moz-use-text-color windowtext windowtext -moz-use-text-color; border-width: medium 1pt 1pt medium; padding: 0in; background: rgb(243, 251, 255) none repeat scroll 0% 0%; width: 117pt; -moz-background-clip: border; -moz-background-origin: padding; -moz-background-inline-policy: continuous;" valign="top" width="156"> [FONT=&quot]0[/FONT]
</td> <td style="border-style: none solid solid none; border-color: -moz-use-text-color windowtext windowtext -moz-use-text-color; border-width: medium 1pt 1pt medium; padding: 0in 5.4pt; background: rgb(243, 251, 255) none repeat scroll 0% 0%; width: 99pt; -moz-background-clip: border; -moz-background-origin: padding; -moz-background-inline-policy: continuous;" valign="top" width="132"> [FONT=&quot]0[/FONT]
</td> </tr> <tr> <td style="border-style: none solid solid; border-color: -moz-use-text-color windowtext windowtext; border-width: medium 1pt 1pt; padding: 0in 5.4pt; width: 99pt;" valign="top" width="132"> [FONT=&quot]MedImmune[/FONT][FONT=&quot][/FONT]
</td> <td style="border-style: none solid solid none; border-color: -moz-use-text-color windowtext windowtext -moz-use-text-color; border-width: medium 1pt 1pt medium; padding: 0in 5.4pt; width: 135pt;" valign="top" width="180"> [FONT=&quot]$0[/FONT]
</td> <td style="border-style: none solid solid none; border-color: -moz-use-text-color windowtext windowtext -moz-use-text-color; border-width: medium 1pt 1pt medium; padding: 0in; width: 117pt;" valign="top" width="156"> [FONT=&quot]$61,008,000[/FONT]
</td> <td style="border-style: none solid solid none; border-color: -moz-use-text-color windowtext windowtext -moz-use-text-color; border-width: medium 1pt 1pt medium; padding: 0in 5.4pt; width: 99pt;" valign="top" width="132"> [FONT=&quot]0[/FONT]
</td> </tr> <tr> <td style="border-style: none solid solid; border-color: -moz-use-text-color windowtext windowtext; border-width: medium 1pt 1pt; padding: 0in 5.4pt; background: rgb(243, 251, 255) none repeat scroll 0% 0%; width: 99pt; -moz-background-clip: border; -moz-background-origin: padding; -moz-background-inline-policy: continuous;" valign="top" width="132"> [FONT=&quot]Total[/FONT][FONT=&quot][/FONT]
</td> <td style="border-style: none solid solid none; border-color: -moz-use-text-color windowtext windowtext -moz-use-text-color; border-width: medium 1pt 1pt medium; padding: 0in 5.4pt; background: rgb(243, 251, 255) none repeat scroll 0% 0%; width: 135pt; -moz-background-clip: border; -moz-background-origin: padding; -moz-background-inline-policy: continuous;" valign="top" width="180"> [FONT=&quot]$407,759,450[/FONT][FONT=&quot][/FONT]
</td> <td style="border-style: none solid solid none; border-color: -moz-use-text-color windowtext windowtext -moz-use-text-color; border-width: medium 1pt 1pt medium; padding: 0in; background: rgb(243, 251, 255) none repeat scroll 0% 0%; width: 117pt; -moz-background-clip: border; -moz-background-origin: padding; -moz-background-inline-policy: continuous;" valign="top" width="156"> [FONT=&quot]$61,008,000[/FONT][FONT=&quot][/FONT]
</td> <td style="border-style: none solid solid none; border-color: -moz-use-text-color windowtext windowtext -moz-use-text-color; border-width: medium 1pt 1pt medium; padding: 0in 5.4pt; background: rgb(243, 251, 255) none repeat scroll 0% 0%; width: 99pt; -moz-background-clip: border; -moz-background-origin: padding; -moz-background-inline-policy: continuous;" valign="top" width="132"> [FONT=&quot]$415,210,470[/FONT][FONT=&quot][/FONT]
</td> </tr> </tbody></table>
HHS orders an additional 56 million doses of vaccine: September 21, 2009

The U.S. Department of Health and Human Services ordered an additional 56 million doses of vaccine for the 2009 H1N1 flu from MedImmune and Sanofi Pasteur. HHS used approximately $438 million in existing funds for the purchase. The additional vaccine purchase will help to ensure that anyone who wants a vaccine will be able to obtain one when the vaccine becomes available. The Advisory Committee on Immunization Practices recommended that five groups of people receive the vaccine as soon as it is available (embed link http://www.flu.gov/individualfamily/vaccination/index.html). The 2009 H1N1 flu vaccine will be available beginning in October and throughout the flu season.


https://www.medicalcountermeasures.gov/BARDA/MCM/panflu/factsheet.aspx

 

[Commonground]

Re: Vaccine Orders -

Re: Vaccine Orders -

Posting some articles that I have included in a future analysis.

Sanofi CEO says H1N1 vaccine en route early

by Ransdell Pierson

Last Updated: 2009-09-29 15:21:26 -0400 (Reuters Health)

* Sanofi CEO says vaccine shipments began Tuesday

* Says first shipment about "a couple of weeks" early

* MedImmune says 5 million doses of its vaccine delivered

* U.S. says early clinical data hastens vaccine delivery

NEW YORK (Reuters) - The chief executive officer of Sanofi-Aventis SA said on Tuesday his company has begun U.S. shipments of its H1N1 swine flu vaccine ahead of schedule.

"The first truck left today," Chris Viehbacher said in an interview. "So we're actually ahead of schedule, probably a couple of weeks."

Swine flu was declared a pandemic in June and is spreading widely in most of the United States.
-snip-

Sanofi-Aventis, which has a contract to provide 75.3 million doses of its H1N1 vaccine to the U.S. government, is making all of its product at a new plant in Swiftwater, Pennsylvania.

Sanofi-Aventis said its first shipment is headed to a designated government distributor, but the Paris-based company declined to provide the location or other details.

The government hopes by the end of the year to acquire a total of 250 million doses from Sanofi and four other vaccine makers -- the MedImmune division of AstraZeneca Plc, Australia's CSL Ltd, GlaxoSmithKline Plc and Novartis AG.

U.S. SAYS ALL VACCINE MAKERS AHEAD OF SCHEDULE

Gretchen Michael, a spokeswoman for the U.S. Department of Health and Human Services on Tuesday said all five vaccine makers are ahead of schedule because the government gave them an early go-ahead to fill their vials and nasal sprayers.

"Everybody is ahead in production and scheduling deliveries because we got clinical data on the vaccines earlier than we expected," and were therefore able to authorize completion of the production process, she said.

Although the government is providing the vaccine free of charge, stores, doctors and some insurance companies are likely to charge for administering it.

MedImmune on Tuesday said it had delivered 5 million does of its nasally inhaled H1N1 vaccine in the past week to McKesson Corp, which the U.S. government has designated to distribute vaccines made by all five companies.

McKesson is distributing the vaccine through 90,000 sites across the United States. Each state will get allocations based on population. Doctor's offices, clinics, hospitals, retailers and employers can also place orders.

MedImmune said it has already made enough vaccine to fulfill its government contract for 40 million doses. Its product is approved for people aged 2-49, but not recommended for those with certain underlying health problems, or who have a high risk of becoming severely ill if infected with the flu.

Sanofi is working around the clock to fulfill its larger contract, with 2,000 employees involved in production.

Viehbacher said the vaccine is being delivered ahead of schedule because the U.S. Food and Drug Administration approved its new Pennsylvania facility "on a timely basis" and because the plant has produced good "yields" of the vaccine. The vaccine is grown in chicken eggs.

"We're using something like 300,000 eggs a day to produce the vaccine, (from) farms that are all dedicated to this," Viehbacher said.

An older Sanofi-Aventis plant in Swiftwater, meanwhile, is producing supplies of seasonal flu vaccine, that will be available separately to patients, Viehbacher said.

Such regular flu shots are given each year to protect against strains of influenza most likely to appear and infect people in the fall and winter months.

Viehbacher said no other company currently makes influenza vaccines in the United States, although Swiss drugmaker Novartis has plans to build such a plant in North Carolina in coming years.
http://www.sleepreviewmag.com/reuters_article.asp?id=20090929inds015.html


Sanofi Pasteur Receives A(H1N1) Vaccine Order from U.S. Government
May 26, 2009
Sanofi Pasteur received a $190 million order from the U.S. Department of Health and Human Services (HHS) to begin production of a vaccine to help protect against the A(H1N1) flu virus.

This order was issued under an existing pandemic stockpile contract between Sanofi Pasteur and the U.S. government that allows HHS to purchase vaccines for viruses with pandemic potential.

The HHS order provides for the production of the bulk vaccine and related activities. The dosage requirements for the new vaccine are yet to be determined and will be based on clinical trials, which could begin as early as August. Final formulation, filling and distribution of the vaccine have not been established yet.

"This initial order for A(H1N1) vaccine under our existing contract is part of a major effort by Sanofi Pasteur to support global public health efforts to prepare the world for the possibility of an influenza pandemic," said Wayne Pisano, president and chief executive officer of Sanofi Pasteur. "Production of a new vaccine is not a simple task and there are a number of necessary and complex steps that must be taken before a vaccine can be made available to the public, but we have experience on our side. Previously, we developed and licensed the first pre-pandemic vaccine for H5N1 and we look forward to further demonstrating our experience and expertise in vaccine development as we prepare for this new threat from A(H1N1)."

Sanofi Pasteur is waiting to receive the seed virus to be used for vaccine production from the U.S. Centers for Disease Control and Prevention (CDC). The company will then begin development efforts to prepare a working seed for vaccine production. Sanofi Pasteur is prepared to begin commercial scale production in June following FDA certification of the working seed. The company currently estimates it will have the first bulk concentrate vaccine in a few months.

Production of the A(H1N1) vaccine will initially occur in Sanofi Pasteur's recently licensed flu vaccine production facility in Swiftwater PA. Once ongoing seasonal flu production is finished in the second facility in Swiftwater, the A(H1N1) vaccine will be produced in both Swiftwater facilities.
http://www.contractpharma.com/news/...s_a(h1n1)_vaccine_order_from_u.s._government_




2nd UPDATE:Sanofi-Aventis Shipping H1N1 Vaccine To US Government Tuesday


(Adds shipping status of Novartis vaccine in seventh paragraph and details about McKesson's role in distribution in eighth paragraph.)

By Peter Loftus

Of DOW JONES NEWSWIRES

Sanofi-Aventis SA (SNY) said it delivered its first shipment of swine-flu vaccine to the U.S. government Tuesday, ahead of schedule, according to a spokeswoman.

The company cautioned that the shots may not become immediately available for administration because they will have to work their way through government distribution channels.

"It's a tremendous milestone and one that we're pleased to reach in a timely manner," said Donna Cary, spokeswoman for Sanofi Pasteur, the vaccines unit of the Paris-based drug giant.

Last week, the director of the U.S. Centers for Disease Control and Prevention said the first doses of an H1N1 vaccine should become available by about Oct. 6.

Sanofi has contracted with the U.S. government to supply a total of 75.3 million doses of its H1N1 vaccine, manufactured at a plant in Swiftwater, Pa. Other manufacturers also have supply contracts with the U.S., including GlaxoSmithKline PLC (GSK) and AstraZeneca PLC (AZN).

AstraZeneca's MedImmune unit began moving its H1N1 vaccine from its distribution center to U.S. regional distribution centers a week ago, said spokeswoman Karen Lancaster. She said it was up to the government to determine when the doses would become available.

Novartis AG (NVS) began shipping its H1N1 vaccine for distribution in the U.S. on Sunday, a spokesman said.

Drug distributor McKesson Corp. (MCK) is handling the distribution of the vaccines under a contract with the U.S. government.

Cary said Sanofi's U.S. contract had called for an initial delivery by Oct. 15. She didn't specify how many doses were being shipped Tuesday.

-snip-

(Mimosa Spencer in Paris contributed to this article.)

-By Peter Loftus, Dow Jones Newswires; 215-656-8289; peter.loftus@dowjones.com

(END) Dow Jones Newswires
09-29-091644ET
Copyright (c) 2009 Dow Jones & Company, Inc.
http://www.nasdaq.com/aspx/company-...hipping-h1n1-vaccine-to-us-government-tuesday

GlaxoSmithKline update: Government orders for pandemic (H1N1) 2009 vaccine

Issued: Tuesday 04 August 2009, London UK

GSK is committed to supporting governments and health authorities around the world respond to the pandemic (H1N1) 2009 influenza strain.

On the 22nd July, the company confirmed that it had contracts in place to supply 195 million doses of its pandemic (H1N1) 2009 adjuvanted influenza vaccine and had a variety of agreements in place with the US Government to supply pandemic products worth $250 million. Since that date, nine government contracts have been signed for a further 96 million doses of the vaccine. This now brings the total number of doses ordered for GSK?s adjuvanted vaccine to 291 million. Discussions continue with governments for further supplies of the vaccine.

First supplies of the vaccine will be available to governments from September onwards, with shipments expected in the second half of 2009 and early 2010. The exact pace of delivery will be dependent on capacity and the yield of the influenza strain.

To ensure that the vaccine is available to developing nations, and subject to the yield and existing contractual commitments, GSK has allocated 20% of production at its Canadian manufacturing site to developing countries from early September onwards. Included within this capacity is GSK?s proposed donation of 50 million doses of the H1N1 vaccine to the WHO. Ongoing discussions with developing country governments may well lead to an increase in the percentage of output supplied to developing countries. GSK is operating a tiered-pricing policy for its vaccine, based on World Bank classification of countries and GAVI eligibility.

About the pandemic (H1N1) 2009 vaccine

Following more than ten years of investment in research and development of pandemic influenza vaccines, and the successful registration of its pre-pandemic H5N1 vaccine, the company is making rapid progress to produce the Pandemic (H1N1) 2009 adjuvanted influenza vaccine.

The vaccine will comprise antigen of the recently isolated Pandemic (H1N1) 2009 influenza strain and also contain GSK's proprietary adjuvant system AS03. An adjuvant system can be added to the antigen at time of administration. In clinical studies using the H5N1 influenza strain, an adjuvanted formulation has been shown to stimulate a higher immune response while using a smaller amount of antigen as compared to a formulation without adjuvant. The adjuvant system therefore helps to increase the number of vaccine doses that can be produced.1 In addition, in clinical studies with the H5N1 influenza strain, the adjuvanted vaccine demonstrated the potential to provide protection even if the influenza strain drifts (changes slightly).2,3

http://www.gsk.com/media/pressreleases/2009/2009_pressrelease_10081.htm

September 25, 2009

Novartis Vaccines? Focetria?, the Novartis Influenza A(H1N1) 2009 monovalent vaccine, received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA). The positive opinion clears the way for European Union approval in all 27 Member States as well as in Iceland and Norway.

Focetria, which includes the adjuvant MF59?, can elicit protective antibody levels with a lower dose, just 7.5 micrograms of viral antigen versus 15 micrograms in non-adjuvanted vaccines, potentially resulting in greater vaccine supply.

The CHMP opinion follows the September 15 US Food and Drug Administration (FDA) approval of the Novartis Fluvirin Influenza (A)H1N1 2009 monovalent vaccine.

Novartis already started first deliveries of pandemic vaccines under quarantine to governments in Europe ? just 3 months after WHO declaration of the pandemic ? despite the initially low yields with the current production seed strain provided by the World Health Organization (WHO). Novartis also plans to begin delivery of its Fluvirin A(H1N1) monovalent vaccine to the U.S. market by early October.

We recently received a need seed strain from the WHO and are working diligently to improve the yields, while continuing with the production process, to make as much vaccine available as quickly as possible.
http://www.novartis.com/newsroom/swine-flu/

FDA Approves H1N1 Vaccines, Paving Way For Large-Scale U.S. Vaccination Campaign
17 Sep 2009
HHS Secretary Kathleen Sebelius announced Tuesday during a House Energy and Commerce Committee hearing that H1N1 (swine flu) vaccines produced by four manufacturers -- CSL Ltd., Novartis, Sanofi-Pasteur and Medimmune -- had won FDA approval, paving the way for a large-scale U.S. vaccination campaign, the Wall Street Journal reports. The application for GlaxoSmithKline PLC's vaccine is still being considered (Dooren/Favole, 9/15).

According to CQ HealthBeat, HHS anticipates having some supplies of H1N1 vaccine ready as early as October 5 (Attias, 9/15), but "[t]he bulk of vaccine will start arriving Oct. 15, and Sebelius said it should be available at 90,000 sites around the country," the Associated Press/TIME reports. "'We will have enough vaccine available for everyone' eventually, Sebelius said - everyone who wants it, that is," writes AP/TIME. The U.S. government currently has contracts to buy 195 million doses of the H1N1 vaccine, but will buy more if demand is high, Seblieus explained (Neergaard, 9/15).

The large-scale vaccination campaign, scheduled to begin in mid-October, will first target those at greatest risk from H1N1, including health care workers, pregnant women and young people ages 6 months to 24 years. Reuters writes: "H1N1 vaccines will be free, Sebelius said, but some healthcare providers may charge an administration fee. The federal government is planning to spend about $1.4 billion for states and hospitals to prepare for the virus, she added" (Heavey, 9/15).

-snip-
http://www.medicalnewstoday.com/articles/164256.php

 

[Commonground]

Re: Vaccine Investigations.....Raw Data Thread

See this thread for Summaries on each vaccine derived from these threads:

http://www.flutrackers.com/forum/showthread.php?p=302429&posted=1#post302429

 

[Commonground]

Re: Vaccine Investigations.....Raw Data Thread

2009-10-06 07:18:02 -

* 27 million doses shipped to US market by Novartis - providing
more seasonal flu vaccine earlier than in any previous year

* Shipments completed ahead of normal seasonal vaccine delivery
schedules to allow for earlier vaccination

* First shipments of A(H1N1) vaccine delivered to US government
less than four months after the pandemic declaration by the WHO

Basel, October 6, 2009 - Novartis announced today that the company
has completed its entire shipment of seasonal influenza vaccine to
the United States for the 2009/2010 season. As previously
anticipated, the company delivered 27 million doses of Fluvirin?
influenza virus vaccine, which has been approved by the U.S. Food and
Drug Administration (FDA). Novartis completed this season's shipment
earlier than in previous years, in anticipation of demand for earlier
vaccination with seasonal influenza vaccine created by the current
global A(H1N1) influenza pandemic.

"Novartis is pleased to have delivered more seasonal influenza
vaccine to the US market by the end of September than we have in any
previous year allowing more people to get their vaccine early in the
season," said Andrin Oswald, CEO of Novartis Vaccines and
Diagnostics. "We are relieved to have been able to complete our
deliveries ahead of schedule despite the challenging task to produce
large quantities of A(H1N1) pandemic vaccines at the same time. We
hope that the early delivery of our Fluvirin vaccine will help
physicians and public health officials better prepare for the
upcoming flu season and balance the needs for pandemic and seasonal
vaccination."

On September 27, Novartis also began shipments of the first doses of
its influenza A(H1N1) 2009 monovalent vaccine[1] to the United
States. The early shipment is the first of an accelerated effort to
provide as much A(H1N1) vaccine as soon as possible, despite the low
yield seen with the initial production seed strain provided by the
World Health Organization. Production has switched to a new higher
yielding seed strain which will allow deliveries of higher volumes
later in the year.

Novartis Influenza A(H1N1) 2009 monovalent vaccine was approved by
the FDA on September 15, 2009. The A(H1N1) vaccine is an inactivated
subunit vaccine approved for active immunization of persons 4 years
of age and older, including patients with underlying chronic medical
conditions. The US Department of Health and Human Services (HHS)
awarded Novartis two contracts totaling USD 979 million for purchase
of H1N1 bulk vaccine and the Novartis proprietary MF59 adjuvant.

The Novartis seasonal influenza vaccine, Fluvirin is indicated for
patients 4 years and older. Fluvirin vaccine contains antigens to the
three influenza virus strains for this year's vaccine recommended by
the World Health Organization (WHO) in January 2009:

* A/Brisbane/59/2007, IVR-148 (H1N1)
* A/Uruguay/716/2007, NYMC X-175C (H3N2) (an
A/Brisbane/10/2007-like virus)
* B/Brisbane/60/2008[2]

About seasonal influenza
Seasonal influenza is a highly communicable, acute viral infection
that predominantly attacks the respiratory tract and sometimes the
lungs. It can cause mild to severe illness and can lead to death[3].

The number of people in the U.S. who die every year from the flu is
similar to the more than 40,000 people in the U.S. estimated to die
from breast cancer every year[4] and about half of the estimated
70,000 people who die annually of diabetes and its complications[5].
During the 2007-2008 influenza season, 83 children were reported to
have died of influenza-related causes[6]. Of the 63 whose vaccination
status was known, 58 (92 percent) were not vaccinated according to
recommendations[7]. Final numbers for the 2008-2009 flu season are
not yet available.

Influenza vaccination is one of the most effective public health
interventions ever implemented, sparing millions of people from
complications of the infectious disease. Use of currently available
seasonal flu vaccines has been calculated to save more than 8 million
lives annually; translating to one person saved every five
seconds[8].

ACIP recommends seasonal influenza vaccinations as the principal
method of preventing seasonal influenza. The vaccine is recommended
for those at greatest risk for serious complications, including:

* Children between 6 months and 18 years of age
* Pregnant women
* People 50 years of age and older
* People of any age with certain chronic health conditions, such as
asthma, diabetes or heart disease
* People in nursing homes and other long-term care facilities,
* Household contacts of person at high risk for complications from
influenza,
* Household contacts and out-of-home caregivers of children less
than 6 months of age
* Healthcare workers[9]

Important safety information
As is the case with most drugs and vaccines, there is a chance that a
serious allergic reaction, serious illness or even death could occur
as a result of vaccination with Fluvirin vaccine. The most common
side effect of vaccination with Fluvirin influenza virus vaccine is
soreness at the injection site. Less common side effects include
fever, malaise, myalgia and allergic reactions. Fluvirin vaccine
should not be administered to anyone with a history of
hypersensitivity to any component of the vaccine, including eggs, egg
products or thimerosal. Generally, persons should not be vaccinated
during an acute febrile illness. Vaccination should be delayed in
persons with an active, unstable neurological disorder, but should be
considered when the disorder has been stabilized. The occurrence of
any neurological symptoms or signs following administration of any
vaccine is a contraindication to further use. Fluvirin vaccine is not
indicated for use in children under four years of age. Persons should
consult with their healthcare providers if they are pregnant and/or
are taking other medications. Fluvirin vaccine may not protect 100%
of individuals who are susceptible to influenza. Before administering
Fluvirin vaccine, please see full prescribing information.

Important Safety Information for US Market
Adverse reaction information is based on studies conducted with
seasonal trivalent Influenza Virus Vaccine manufactured by Novartis
(Fluvirin). The most frequently reported adverse reactions are mild
hypersensitivity reactions (such as rash), local reactions at the
injection site, and influenza-like symptoms. For patients who have
experienced Guillain-Barr? syndrome within 6 weeks of receipt of
prior influenza vaccine, the decision to administer Influenza A
(H1N1) 2009 Monovalent Vaccine should be based on careful
consideration of the potential benefits and risks. Immunocompromised
persons may have a reduced immune response to Influenza A (H1N1) 2009
monovalent vaccine.

Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "hope," "will," or similar
expressions, or by express or implied discussions potential future
deliveries of influenza vaccines, or regarding potential future
revenues from influenza vaccines. You should not place undue reliance
on these statements. Such forward-looking statements reflect the
current views of management regarding future events, and involve
known and unknown risks, uncertainties and other factors that may
cause actual results to be materially different from any future
results, performance or achievements expressed or implied by such
statements. There can be no guarantee that Novartis will successfully
meet its delivery obligations for its influenza vaccines. Neither
can there be any guarantee that Novartis' influenza vaccines will
achieve any particular levels of revenue in the future. In
particular, management's expectations regarding Novartis' influenza
vaccines could be affected by, among other things, unexpected
regulatory actions or delays or government regulation generally;
unexpected manufacturing difficulties or delays, including unexpected
difficulties with our flu cell culture manufacturing facility and
processes; unexpected clinical trial results, including unexpected
new clinical data and unexpected additional analysis of existing
clinical data; the company's ability to obtain or maintain patent or
other proprietary intellectual property protection; competition in
general; government, industry and general public pricing pressures;
the impact that the foregoing factors could have on the values
attributed to the Novartis Group's assets and liabilities as recorded
in the Group's consolidated balance sheet, and other risks and
factors referred to in Novartis AG's current Form 20-F on file with
the US Securities and Exchange Commission. Should one or more of
these risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially from
those anticipated, believed, estimated or expected. Novartis is
providing the information in this press release as of this date and
does not undertake any obligation to update any forward-looking
statements contained in this press release as a result of new
information, future events or otherwise.

About Novartis
Novartis Vaccines and Diagnostics is a division of Novartis focused
on the development of preventive treatments. The division has two
businesses: Novartis Vaccines and Novartis Diagnostics. Novartis
Vaccines is the world's fifth-largest vaccines manufacturer and
second-largest supplier of flu vaccines in the US. The division's
products also include meningococcal, pediatric and travel vaccines.
Novartis Diagnostics prevents the spread of infections through the
development and marketing of innovative technologies that enable
early detection of pathogens to protect the world's blood supply and
prevent the spread of infectious diseases.

Novartis provides healthcare solutions that address the evolving
needs of patients and societies. Focused solely on healthcare,
Novartis offers a diversified portfolio to best meet these needs:
innovative medicines, cost-saving generic pharmaceuticals, preventive
vaccines, diagnostic tools and consumer health products. Novartis is
the only company with leading positions in each of these areas. In
2008, the Group's continuing operations achieved net sales of USD
41.5 billion and net income of USD 8.2 billion. Approximately USD 7.2
billion was invested in R&D activities throughout the Group.
Headquartered in Basel, Switzerland, Novartis Group companies employ
approximately 99,000 full-time-equivalent associates and operate in
more than 140 countries around the world. For more information,
please visit www.novartis.com.

http://www.pr-inside.com/novartis-completes-shipment-of-us-supply-r1513527.htm

 

[Commonground]

Re: Vaccine Investigations.....Raw Data Thread

Merck & Co., Inc. Obtains Exclusive U.S. Marketing Rights for AFLURIA(R), Seasonal Influenza Vaccine from CSL Biotherapies

Merck and Co
MRK | 9/28/2009 8:11:00 AM
WHITEHOUSE STATION, N.J., Sep 28, 2009 (BUSINESS WIRE) --

Merck & Co., Inc. announced today that the Company has entered into an exclusive agreement with CSL Biotherapies, a subsidiary of CSL Limited, to market and distribute AFLURIA(R) (Influenza Virus Vaccine), CSL's seasonal influenza (flu) vaccine, in the U.S., for the 2010/2011-2015/2016 flu seasons. CSL and Merck have been partners in vaccine development and marketing since 1980.



Under the terms of the agreement, Merck will assume responsibility for all aspects of commercialization of AFLURIA in the U.S. CSL will supply AFLURIA to Merck and will retain responsibility for marketing the vaccine outside the U.S. Specific financial details of the agreement were not disclosed.



AFLURIA was approved by the U.S. Food and Drug Administration (FDA) in September 2007. It is indicated for the active immunization of persons age 18 years and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine. This indication is based on immune response elicited by AFLURIA, and there have been no controlled trials demonstrating a decrease in influenza disease after vaccination with AFLURIA.


"Adult vaccines are an integral part of preventive healthcare and continue to be a strong focus for Merck," said Margaret G. McGlynn, president, Merck Vaccines and Infectious Diseases. "AFLURIA is an important addition to our robust adult vaccine portfolio and provides an opportunity for us to help address the public health need for flu vaccination in the U.S."



With the addition of seasonal flu vaccine, Merck will market eight of the 10 vaccines on the recommended immunization schedule for adults in the U.S.



CSL Biotherapies recently announced that the FDA licensed a new vaccine filling and packaging facility in Kankakee, Illinois. The facility includes a high-speed, single-dose vaccine syringe filling line and will primarily provide filling and packaging services for influenza vaccine supply to the U.S. market.



About Influenza
The flu is a contagious respiratory illness caused by influenza viruses. According to the U.S. Centers for Disease Control and Prevention, on average, 5 percent to 20 percent of the population gets the flu every year in the U.S. Everyone is at risk for the flu, but some people, such as older people and people with certain health conditions, are at high risk for serious flu complications. In the U.S., annual epidemics of influenza occur typically during the late fall through early spring seasons.



Important safety information about AFLURIA

AFLURIA should not be administered to individuals with hypersensitivity to eggs or chicken protein or other components of AFLURIA, or to anyone who has had a life-threatening reaction to previous influenza vaccination.



The most common injection-site adverse reactions were tenderness, pain, redness and swelling. The most common systemic adverse reactions were headache, malaise and muscle aches.



Immunocompromised persons may have a diminished immune response to AFLURIA. If Guillain-Barre syndrome has occurred within six weeks of receipt of prior influenza vaccine, the decision to give AFLURIA should be based on careful consideration of the potential benefits and risks.



In four clinical studies, 343 subjects 65 years of age and older received AFLURIA. Hemagglutination-inhibiting (HI) antibody responses in geriatric subjects were lower after administration of AFLURIA in comparison to younger adult subjects. Adverse event rates were generally similar in frequency to those reported in subjects 18 years of age to less than 65 years of age, although some differences were observed.
Vaccination with AFLURIA may not protect all individuals.



About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.



Forward-looking statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the risk factors and cautionary statements in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2008, and in any risk factors or cautionary statements contained in the Company's periodic reports on Form 10-Q or current reports on Form 8-K, which the Company incorporates by reference.



Prescribing information for AFLURIA(R) is attached.



CSL(TM) Influenza Virus Vaccine Package insert for the 2009-2010 Influenza Season STN BL 125254/118
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use AFLURIA(R) safely and effectively. See full prescribing information for AFLURIA(R).
AFLURIA(R), Influenza Virus Vaccine
Suspension for Intramuscular Injection
2009-2010 Formula
Initial U.S. Approval: 2007
----------------------------INDICATIONS AND USAGE-----------------------------
-- AFLURIA(R) is an inactivated influenza virus vaccine indicated for active immunization of persons ages 18 years and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine. (1)
-- This indication is based on the immune response elicited by AFLURIA(R); there have been no controlled clinical studies demonstrating a decrease in influenza disease after vaccination with AFLURIA(R). (14)
-------------------------DOSAGE AND ADMINISTRATION----------------------
-- A single 0.5 mL dose for intramuscular injection. (2)
------------------------DOSAGE FORMS AND STRENGTHS---------------------
AFLURIA(R), a sterile suspension for intramuscular injection, is supplied in two presentations:
-- 0.5 mL preservative-free, single-dose, pre-filled syringe. (3)
-- 5 mL multi-dose vial containing ten doses. Thimerosal, a mercury derivative, is added as a preservative; each 0.5 mL dose contains 24.5 micrograms (mcg) of mercury. (3)
Each 0.5 mL dose contains 15 mcg of influenza virus hemagglutinin (HA) from each of the three strains: A/Brisbane/59/2007, IVR-148 (H1N1), A/Uruguay/716/2007, NYMC X-175C (H3N2) (an A/Brisbane/10/2007-like strain), and B/Brisbane/60/2008. (3, 11)
-----------------------------CONTRAINDICATIONS----------------------------
-- Hypersensitivity to eggs or chicken protein, neomycin, or polymyxin, or life-threatening reaction to previous influenza vaccination. (4)
------------------------WARNINGS AND PRECAUTIONS--------------------
-- If Guillain-Barre Syndrome (GBS) has occurred within 6 weeks of previous influenza vaccination, the decision to give AFLURIA(R) should be based on careful consideration of the potential benefits and risks. (5.1)
-- Immunocompromised persons may have a diminished immune response to AFLURIA(R). (5.2)
------------------------------ADVERSE REACTIONS----------------------------
The most common (greater-than or equal to 10%) local (injection-site) adverse reactions were tenderness, pain, redness, and swelling. The most common (greater-than or equal to 10%) systemic adverse reactions were headache, malaise, and muscle aches. (6)
To report SUSPECTED ADVERSE REACTIONS, contact CSL Biotherapies at 1-888-435-8633 or VAERS at 1-800-822-7967 and www.vaers.hhs.gov.
------------------------------DRUG INTERACTIONS----------------------------
-- Do not mix with any other vaccine in the same syringe or vial. (7.1)
-- Immunosuppressive therapies may diminish the immune response to AFLURIA(R). (7.2)
-----------------------USE IN SPECIFIC POPULATIONS---------------------
-- Safety and effectiveness of AFLURIA(R) have not been established in pregnant women or nursing mothers and in the pediatric population. (8.1, 8.3, 8.4)
-- Antibody responses were lower in geriatric subjects than in younger subjects. (8.5)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 06/2009



-snip-


http://www.stockhouse.com/News/USReleasesDetail.aspx?n=7465190

 

[Commonground]

Re: Vaccine Investigations.....Raw Data Thread

18 May: GlaxoSmithKline:
first contracts for a prepandemic vaccine

GSK announced at the end of last week that it had received orders from various governments keen to
stockpile a pre-pandemic vaccine with a view to using it against Mexican (swine) flu.
These stockpiles will be used once the WHO identifies the exact viral strain concerned. The vaccine will
be produced in addition to the usual seasonal vaccine. The first batches will be available 4-6 months after
the WHO has revealed the details of the strain and providing that the vaccine has been approved by
health regulators. This approval should be obtained quickly as GSK managed to have a mock-up dossier
for an avian flu pandemic vaccine approved in Europe (unlike sanofi-aventis which failed in this task).
The new vaccine will include GSK?s AS03 adjuvant. Adjuvants are one of GSK? strengths, with GSK
having already demonstrated the appeal of incorporating an adjuvant in the avian flu vaccine, as a means
of significantly increasing production.
The group?s press release mentioned that several governments were interested un the H1N1 vaccine.
GSK expects to deliver 60 million doses of its adjuvanted H1N1 candidate and has signed an agreement
with the Finnish government to supply 5.3 million doses.
GSK also mentioned the Belgian government?s intention to purchase 12.6 million doses and the French
government?s plans to buy 50 million. As a result, pre-pandemic vaccine sales are set to rise significantly
in 2009 relative to the ?66m booked in 2008 (and compared with ?215m for the seasonal flu vaccine).
For the flu vaccine franchise as a whole, we are forecasting sales of ?370m for 2009 and ?420m in 2010,
versus ?281m in 2008

http://www.google.com/url?sa=t&sour...EVPxcYQy9HK43CSmg&sig2=duhWt81jaYARDvfw70AFig

 

[Commonground]

Re: Vaccine Investigations.....Raw Data Thread

From Post #24:

GlaxoSmithKline update: Government orders for pandemic (H1N1) 2009 vaccine

Issued: Tuesday 04 August 2009, London UK

GSK is committed to supporting governments and health authorities around the world respond to the pandemic (H1N1) 2009 influenza strain.

On the 22nd July, the company confirmed that it had contracts in place to supply 195 million doses of its pandemic (H1N1) 2009 adjuvanted influenza vaccine and had a variety of agreements in place with the US Government to supply pandemic products worth $250 million.

 

[Commonground]

Re: Vaccine Investigations.....Raw Data Thread

For Immediate Release
Thursday, October 8, 2009

[SIZE=+1]NIAID Announces Vaccine Adjuvant Discovery Contracts [/SIZE]

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, today awarded six new research contracts to discover and characterize novel adjuvants, substances that can be added to vaccines to enhance the protective immune response they induce.

"The goal of these awards is to find safe new adjuvants that will boost the effectiveness of vaccines," says NIAID Director Anthony S. Fauci, M.D. "Adjuvants can be used not only to enhance the immune response to a vaccine and thereby offer better protection but also to extend the vaccine supply if needed, enabling more people to be vaccinated with fewer doses."

Currently, the only vaccine adjuvant approved for use in the United States is an aluminum mixture known as alum.

NIAID has awarded a total of approximately $60 million over five years for these contracts. The awardees will identify novel compounds with the potential to be vaccine adjuvants. All compounds will be tested in animal models and human cells to determine how well they stimulate the immune response. The investigators also will examine and describe the cellular reactions the compounds induce.
"The goal of these awards is not only to identify new adjuvant candidates but also to describe how these candidates work," says Helen Quill, Ph.D., chief of NIAID?s basic immunology research branch. "We would hope that these adjuvant candidates will become part of a robust pipeline leading to the development of many different vaccines."

The awardees of the adjuvant contracts will work to identify and characterize novel adjuvants that trigger receptors of the inborn, or innate, immune system. These receptors recognize and bind small molecules that are unique to harmful microorganisms. Binding stimulates an immediate innate immune response, a broadly protective reaction. The innate immune response also is required for the development of the highly specific antibody and T-cell responses that characterize long-term immunity.

The investigators also will seek to identify the cellular receptor for each of the novel adjuvant candidates, determine how it triggers the innate immune response, and then make changes to the adjuvant to improve its ability to induce the innate immune response. Although a number of innate immune receptors already have been described, many more likely exist and are expected to be uncovered in the course of these projects.

"The award of these contracts is an integral part of NIAID's long-range plan to expand the adjuvant pipeline" says Daniel Rotrosen, M.D., director of NIAID's Division of Allergy, Immunology, and Transplantation, which oversees these awards. ?A first round of NIAID contracts, awarded in 2003, limited the discovery of novel adjuvants to those that stimulated the only group of innate immune receptors known at the time. With this second round of awards, we intend to increase the number of adjuvant candidates by expanding the research scope to include all known innate immune receptors."

The institutions receiving contracts for 2009 are

• James R. Baker, Jr., M.D., University of Michigan, Ann Arbor
• Dennis A. Carson, M.D., Moores Cancer Center, University of California San Diego, La Jolla
• Sunil A. David, M.D., Ph.D., University of Kansas, Lawrence
• Michael J. Gale, Jr., Ph.D., University of Washington School of Medicine, Seattle
• David A. Johnson, Ph.D., Corixa Corporation (now part of GlaxoSmithKline Biologicals), Hamilton, Mont.
• Peter Palese, Ph.D., Mount Sinai School of Medicine, New York City

NIAID conducts and supports research ? at NIH, throughout the United States, and worldwide ? to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.
The National Institutes of Health (NIH) ? The Nation's Medical Research Agency ? includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

http://www.nih.gov/news/health/oct2009/niaid-08.htm

 

[Commonground]

Re: Vaccine Investigations.....Raw Data Thread

Also, see this thread:

http://www.flutrackers.com/forum/showthread.php?p=298967

 

[Blue]

Re: Vaccine Investigations.....Raw Data Thread

Just what the anti vaccine crowd needed to hear...

Many antivaccine website sites have led the gullible to believe that adjuvants
such as squalene are already in use secretly.

I wonder if the govt knows or cares that these folks are very vocal, and are
influencing many who are on the fence about the swine flu vaccine. I am
afraid that there are even professional nurses, and students of nursing that
are posting this information as if it were fact.

It would be helpful if a trusted spokesperson would come forward and talk
to the public about transparency. Talk honestly about adjuvants, and notify
us if they are going to be used, and why it is necesary BEFORE any decision is
made.

I hope that any govt official that has anything to do with these decisions is
reading this. You need to talk to the public about the decision made to protect
manufactures from liability due to vaccine injury. You need to explain who made
this decision, and why it was necessary. And you need to tell us what recourse
there will be if there are any adverse effects from the new vaccine. This is necessary
to build the trust that CDC and other govt agencies seem to assume is already there.
I have heard enough to know that it is NOT there. Why do you think that only 40%
of HCP having been vaccinating with seasonal flu vaccine? You need to do a better
job of reaching out and establishing trust because right now we really need you to
do this. Can you step up to the plate, and give the country the guidance that it
needs during this public health emergency?

http://allnurses.com/pandemic-flu-forum/would-you-accept-412057.html

http://allnurses.com/nursing-news/survey-87-favor-428384.html

Just like angry kids, when you tell them that they have to do something, some
are now going to refuse the vaccine, just because the state or the facilty is
mandating it.

http://allnurses.com/nursing-news/nurses-file-lawsuit-428297.html

 

[Commonground]

Re: Vaccine Investigations.....Raw Data Thread

I'm just trying to find out exactly what is in the vaccine that GlaxoSmithKline will be providing in the contract that they just received. They were the last company to get a contract. I just want to know what their product is, that's all.

 

[Blue]

Re: Vaccine Investigations.....Raw Data Thread

I'm just trying to find out exactly what is in the vaccine that GlaxoSmithKline will be providing in the contract that they just received. They were the last company to get a contract. I just want to know what their product is, that's all.

Me too.

Sorry for the rant, Commonground.

 

[Commonground]

Re: Vaccine Investigations.....Raw Data Thread

Sorry Snowy, it's not so "loud and clear to me".

The only product they have been describing does contain them. So, I searched everywhere, and can't seem to find exactly what it is - that the Gov't just purchased with them.

 

[Commonground]

Re: Vaccine Investigations.....Raw Data Thread

Snowy, can you copy the link?

 

[Commonground]

Re: Vaccine Investigations.....Raw Data Thread

Post #22:

Dr. Schonberger: Who deals with questions related to what?s available when? If you treated the new pandemic virus-related antigen like regular seasonal vaccine?15 mcg, no adjuvant, injected?and used it under an EUA, that could be ready quickly (without doing formal, time-consuming, clinical trials). But the lines that the manufacturers are pursuing mean there will be delays. Who evaluates that issue? If we decide to do clinical trials on adjuvants, that?s a decision that leads to a later vaccine.

Dr. Pavia: If we leave aside the question of adjuvants, I?m uncomfortable making a decision about using one dose for all. We need at least some dose-response studies.

Dr. Edwards: I think Dr. Schonberger makes sense. We may have to decide whether we will go forward with just a few answers, otherwise it may be too late and we?ll be spending money on vaccine we may not need. We need to find out quickly what happens with one dose. I?m worried that the trials will miss the mark.

Dr. Schonberger: Maybe there?s a precedent. In 1977, we did not call it a pandemic; we just slipped the antigen into the regular seasonal vaccine.

Dr. Dowdle: There was small, simple field trial, but no consideration of a new subtype, and it was very quietly done.

 

[Treyfish]

Re: Vaccine Investigations.....Raw Data Thread

Washington state says they are willing to accept higher levels of mercury than normal, to accomodate for shortages

Washington State OKs mercury in swine flu vaccine
<HR style="COLOR: #cccccc; BACKGROUND-COLOR: #cccccc" SIZE=1><!-- / icon and title --><!-- message -->Last updated September 24, 2009 1:37 p.m. PT


THE ASSOCIATED PRESS
<!--BEGIN ARTICLE-->OLYMPIA, Wash. -- The state Health Department will allow more mercury than usual in some of the swine flu vaccine to make sure shots are available to pregnant women and children under three.
The department says mercury-free swine flu vaccine may not always be in stock, so it wants to give people the choice of using vaccine with the mercury preservative called thimerosal. While thimerosal is believed to be safe, most vaccines for children under six are thimerosal-free.
The suspension of the mercury limit announced Thursday lasts six months and applies only to the swine flu vaccine expected to become available in October.:tiphat:http://www.seattlepi.com/local/6420a...u_vaccine.html

 

[Treyfish]

Re: Vaccine Investigations.....Raw Data Thread

National Institute of Allergy and
Infectious Diseases (NIAID)
http://www.niaid.nih.gov

FOR IMMEDIATE RELEASE
Thursday, October 8, 2009

Media Contact: <Name>
<?XML:NAMESPACE PREFIX = SKYPE /><SKYPE:SPAN class=skype_v3_tb_injection id=softomate_v3_highlight_0 title=Call this phone number in United States of America with Skype: +13014021663 mode=".compat" skypeid="0" skypeaction="call" nof="" isfax="" freecall="" fwidth=".w16" type=".flex" path="file://C:/DOCUME~1/Tom/LOCALS~1/Temp/__SkypeIEToolbar_Cache/e70d95847a8f5723cfca6b3fd9946506/static/" durex2="%DADDYHEIGHT%" durex="%DADDYWIDTH%" context="(301) 402-1663"><SKYPE:SPAN class=skype_v3_tb_imgA id=skype_v3_tb_droppart_0 title="Skype actions" style="BACKGROUND-IMAGE: url(file://C:/DOCUME~1/Tom/LOCALS~1/Temp/__SkypeIEToolbar_Cache/e70d95847a8f5723cfca6b3fd9946506/static/inactive_a.compat.flex.w16.gif)" skypeid="0" skypeaction="drop" skypesms="0"><SKYPE:SPAN class=skype_v3_tb_imgFlag id=skype_v3_tb_img_f0 style="BACKGROUND-IMAGE: url(file://C:/DOCUME~1/Tom/LOCALS~1/Temp/__SkypeIEToolbar_Cache/e70d95847a8f5723cfca6b3fd9946506/static/famfamfam/US.gif)"></SKYPE:SPAN></SKYPE:SPAN><SKYPE:SPAN class=skype_v3_tb_imgS id=skype_v3_tb_img_s0 style="BACKGROUND-IMAGE: url(file://C:/DOCUME~1/Tom/LOCALS~1/Temp/__SkypeIEToolbar_Cache/e70d95847a8f5723cfca6b3fd9946506/static/inactive_s.flex.compat.gif)"></SKYPE:SPAN><SKYPE:SPAN class=skype_v3_tb_injectionIn id=skype_v3_tb_text0 style="BACKGROUND-IMAGE: url(file://C:/DOCUME~1/Tom/LOCALS~1/Temp/__SkypeIEToolbar_Cache/e70d95847a8f5723cfca6b3fd9946506/static/inactive_m.compat.gif)"><SKYPE:SPAN class=skype_v3_tb_innerText id=skype_v3_tb_innerText0 style="BACKGROUND-IMAGE: url(file://C:/DOCUME~1/Tom/LOCALS~1/Temp/__SkypeIEToolbar_Cache/e70d95847a8f5723cfca6b3fd9946506/static/inactive_m.compat.gif)"> (301) 402-1663 </SKYPE:SPAN></SKYPE:SPAN><SKYPE:SPAN class=skype_v3_tb_imgR id=skype_v3_tb_img_r0 style="BACKGROUND-IMAGE: url(file://C:/DOCUME~1/Tom/LOCALS~1/Temp/__SkypeIEToolbar_Cache/e70d95847a8f5723cfca6b3fd9946506/static/inactive_r.compat.gif)"></SKYPE:SPAN></SKYPE:SPAN> <SKYPE:SPAN class=skype_v3_tb_injection_print id=softomate_v3_print_0 context="">(301) 402-1663</SKYPE:SPAN>
niaidnews@niaid.nih.gov

NIAID Announces Vaccine Adjuvant
Discovery Contracts

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has awarded six new research contracts to discover and characterize novel adjuvants, substances that can be added to vaccines to enhance the protective immune response they induce.

?The goal of these awards is to find safe new adjuvants that will boost the effectiveness of vaccines,? says NIAID Director Anthony S. Fauci, M.D. ?Adjuvants can be used not only to enhance the immune response to a vaccine and thereby offer better protection but also to extend the vaccine supply if needed, enabling more people to be vaccinated with fewer doses.?

Currently, the only vaccine adjuvant approved for use in the United States is an aluminum mixture known as alum.

NIAID has awarded a total of approximately $60 million over five years for these contracts. The awardees will identify novel compounds with the potential to be vaccine adjuvants. All compounds will be tested in animal models and human cells to determine how well they stimulate the immune response. The investigators also will examine and describe the cellular reactions the compounds induce.

?The goal of these awards is not only to identify new adjuvant candidates but also to describe how these candidates work,? says Helen Quill, Ph.D., chief of NIAID?s basic immunology research branch. ?We would hope that these adjuvant candidates will become part of a robust pipeline leading to the development of many different vaccines.?

The awardees of the adjuvant contracts will work to identify and characterize novel adjuvants that trigger receptors of the inborn, or innate, immune system. These receptors recognize and bind small molecules that are unique to harmful microorganisms. Binding stimulates an immediate innate immune response, a broadly protective reaction. The innate immune response also is required for the development of the highly specific antibody and T-cell responses that characterize long-term immunity.

The investigators also will seek to identify the cellular receptor for each of the novel adjuvant candidates, determine how it triggers the innate immune response, and then make changes to the adjuvant to improve its ability to induce the innate immune response. Although a number of innate immune receptors already have been described, many more likely exist and are expected to be uncovered in the course of these projects.

?The award of these contracts is an integral part of NIAID?s long-range plan to expand the adjuvant pipeline,? says Daniel Rotrosen, M.D., director of NIAID?s Division of Allergy, Immunology, and Transplantation, which oversees these awards. ?A first round of NIAID contracts, awarded in 2003, limited the discovery of novel adjuvants to those that stimulated the only group of innate immune receptors known at the time. With this second round of awards, we intend to increase the number of adjuvant candidates by expanding the research scope to include all known innate immune receptors.?

The institutions receiving contracts for 2009 are:

James R. Baker, Jr., M.D., University of Michigan, Ann Arbor
Dennis A. Carson, M.D., Moores Cancer Center, University of California San Diego, La Jolla
Sunil A. David, M.D., Ph.D., University of Kansas, Lawrence
Michael J. Gale, Jr., Ph.D., University of Washington School of Medicine, Seattle
David A. Johnson, Ph.D., Corixa Corporation (now part of GlaxoSmithKline Biologicals), Hamilton, Mont.
Peter Palese, Ph.D., Mount Sinai School of Medicine, New York City

NIAID conducts and supports research?at NIH, throughout the United States, and worldwide?to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.

The National Institutes of Health (NIH)?The Nation's Medical Research Agency?includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.
_________________:tiphat:Mneeagle

 

[Commonground]

Re: Vaccine Investigations.....Raw Data Thread

GlaxoSmithKline.

FDA NEWS RELEASE
For Immediate Release: Sept. 15, 2009
-- The U.S. Food and Drug Administration announced today that it has approved four vaccines against the 2009 H1N1 influenza virus.

-- The vaccines are made by CSL Limited, MedImmune LLC, Novartis Vaccines and Diagnostics Limited, and sanofi pasteur Inc.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm182399.htm

FDA Approves H1N1 Vaccines, Paving Way For Large-Scale U.S. Vaccination Campaign
17 Sep 2009
HHS Secretary Kathleen Sebelius announced Tuesday during a House Energy and Commerce Committee hearing that H1N1 (swine flu) vaccines produced by four manufacturers -- CSL Ltd., Novartis, Sanofi-Pasteur and Medimmune -- had won FDA approval, paving the way for a large-scale U.S. vaccination campaign, the Wall Street Journal reports. The application for GlaxoSmithKline PLC's vaccine is still being considered (Dooren/Favole, 9/15).

http://www.medicalnewstoday.com/articles/164256.php

But...on September 29th, we get five companies....hmmmm.....

U.S. SAYS ALL VACCINE MAKERS AHEAD OF SCHEDULE

Gretchen Michael, a spokeswoman for the U.S. Department of Health and Human Services on Tuesday said all five vaccine makers are ahead of schedule because the government gave them an early go-ahead to fill their vials and nasal sprayers.

http://www.sleepreviewmag.com/reuters_article.asp?id=20090929inds015.html

On October 6th, we have this announcement:

Government Orders Additional 149 Million H1N1 Vaccines from GlaxoSmithKline (GSK)

GlaxoSmithKline plc (NYSE:GSK) announced Tuesday that it received an additional 22 orders, or 149 million doses, of the 2009 H1N1 flu vaccine from the government. The additional orders bring the total to 440 million doses of GSK's vaccine as discussions continue with governments for further supplies.

http://www.tmcnet.com/usubmit/2009/10/06/4408678.htm

I'm still trying to find out if there has been a new vaccine made by GlaxoSmithKline. So I went to the FDA News archives. Here:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm

No announcement of a new vaccine. Some announcements on "Strategic Plan For Risk Communication, and issuance of a Draft Guidance on Risk Evaluation and Risk Mitigation...but no new vaccine.

So I am forced to go back to my only data on the product. Which is this, located in this thread:

The vaccine will comprise antigen of the recently isolated Pandemic (H1N1) 2009 influenza strain and also contain GSK's proprietary adjuvant system AS03. An adjuvant system can be added to the antigen at time of administration. In clinical studies using the H5N1 influenza strain, an adjuvanted formulation has been shown to stimulate a higher immune response while using a smaller amount of antigen as compared to a formulation without adjuvant. The adjuvant system therefore helps to increase the number of vaccine doses that can be produced.1 In addition, in clinical studies with the H5N1 influenza strain, the adjuvanted vaccine demonstrated the potential to provide protection even if the influenza strain drifts (changes slightly).2,3

http://www.gsk.com/media/pressreleases/2009/2009_pressrelease_10081.htm

So my bottom line is, yes, they are ordering vaccine with an adjuvant. I only want full disclosure, to all the everyday people out there -- so that they can make a decision - as to what they want to do.