Vaccine Investigations.....Raw Data Thread

[ztsmom]

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

I am new here, but I have been following the pandemic and vaccine production for the past few months. I do not have a scientific background, but would like to share some information that I have found.

The Biomedical Advanced Research Development Agency (BARDA), under Health and Human Services, is responsible for procurement of vaccines. Their websites can be found at https://www.medicalcountermeasures.gov/BARDA/BARDA.aspx and http://www.hhs.gov/aspr/barda/. They purchased antigen and adjuvant separately. If an emergency use authorization (EUA) for adjuvants is granted, only then will the US government administer adjuvanted vaccines. At that point, they will mix antigen and adjuvant in vaccines. However, I believe the public will be given fair warning if such a situation comes about. EUAs have been publicized for other pandemic products, such as tests. However, if the public is concerned about the use of adjuvants, they must be vigilant about informing themselves, watch for public meeting notices, and express their opinions, ask questions, and/or raise concerns at or via those meetings.

In my opinion, the US government has been transparent in its vaccination campaign. The National Biodefense Science Board (NBSB) report that is referenced in this thread is one of several invaluable resources that the government has provided to provided transparency in the development and rollout of a vaccination campaign for pandemic H1N1. The general pandemic flu plan developed in 2005, with sections that address vaccine policy, can be found at http://www.hhs.gov/pandemicflu/plan/

In addition, you can comb through http://www.flu.gov for vaccine information, as well as http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm150305.htm to learn about the FDA approval process for H1N1 vaccines.

Admittedly, finding a way through the labyrinth of agencies, pages of information, and links is daunting. However, the information about pandemic flu vaccines is available to those who are willing to look for it.

To address your question about the GSK vaccine, BARDA ordered separate antigen and adjuvant from GSK. I believe that at this time, GSK's vaccine has not yet been approved by the FDA. BARDA has documented the following information at https://www.medicalcountermeasures.gov/BARDA/MCM/panflu/factsheet.aspx

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

Manufacturer: Bulk Vaccine Antigen; Oil-In-Water Bulk Adjuvant
Novartis: $150 million; $139 million
GlaxoSmithKline: $ 38 million; $144 million
Sanofi Pasteur: $191 million; [$0]
CSL Biotherapies: $180 million; [$0]
MedImmune: $ 90 million; [$0]
Total: $649 million; $283 million


Orders for Bulk Supply of H1N1 Influenza Vaccine Antigen and Adjuvant: July 9, 2009

Manufacturer: Bulk Vaccine Antigen; Bulk Virus Concentrate/FFF; Oil-In-Water Bulk Adjuvant
Sanofi Pasteur: $61,425,000; 0; 0
GSK: $0; 0; $71,400,000
Novartis: $346,334,450; 0; $343,810,470
CSL: $0; 0; 0
MedImmune: $0; $61,008,000; 0
Total: $407,759,450; $61,008,000; $415,210,470


HHS orders an additional 56 million doses of vaccine: September 21, 2009

Manufacturer: Total Cost
MedImmune: $295,660,000
Sanofi Pasteur: $143,483,025
Total: $438,143,025

 

[ztsmom]

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

I would also like to add another helpful document. The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) held a meeting in late July to discuss the H1N1 vaccine. The transcript can be found at http://www.fda.gov/downloads/Adviso...ogicalProductsAdvisoryCommittee/UCM175998.pdf.

 

[Commonground]

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

Thanks ztsmom. You have been very helpful.

 

[Commonground]

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

Monday, 26 October 2009

Experience of GSK's H1N1 adjuvanted vaccine, Pandemrix™, and preliminary paediatric results

GlaxoSmithKline (GSK) announced that more than 150,000 people have received GSK's pandemic H1N1 vaccine, Pandemrix™, as part of Government initiated vaccination programmes across Europe which commenced last week. Additionally, over 2,000 people have received Pandemrix in clinical trials which are ongoing. To date, data have demonstrated that the H1N1 adjuvanted vaccine has a similar tolerability profile to GSK's previously EMEA approved H5N1 adjuvanted vaccine. The immune response elicited by Pandemrix has previously been reported in a limited number of adults demonstrating over 98% of the subjects exceeded the immunogenicity criteria as defined by international licensing authorities for a pandemic influenza vaccine. The adjuvant system in GSK's influenza vaccine has already been tested in more than 41,000 people in GSK's influenza programmes including the H5N1, the H1N1 and candidate adjuvanted seasonal flu vaccines.

Preliminary paediatric results
Also announced today are preliminary results from the first paediatric clinical trial assessing use of Pandemrix. The trial in children aged 6 to 36 months, which is ongoing, shows that after a first dose of adjuvanted vaccine, a strong response was demonstrated which exceeds the immunogenicity criteria as defined by international licensing authorities for a pandemic influenza vaccine. As planned, the vaccine in this trial contains a half dose of H1N1 antigen (1.9 µg) and a half dose of adjuvant, as compared to the adult vaccine.



"These results in young children provide clinically relevant information as they show the ability of the vaccine to induce a very high immune response suggestive of early protection after one dose, in a population where it is known to be difficult to raise such an immune response." said Jéan Stephenne, President GlaxoSmithKline Biologicals. "GSK is sharing these preliminary data with public health officials and organisations who will consider these results as they continue their efforts to develop the most effective strategies for providing protection against the H1N1 virus. GSK also expects to have data in the elderly shortly."



This paediatric trial, which is taking place in Spain, involves 200 children aged 6 to 36 months, and has been designed to evaluate the tolerability and immunogenicity of Pandemrix.



A planned interim analysis was performed on the first 51 children recruited in this trial. These first results with Pandemrix in a paediatric population show that a high immune response was elicited 21 days after one single administration of vaccine. In 100% of the children receiving the adjuvanted vaccine a response above the regulatory threshold of 1:40 seroprotection was elicited, which is considered indicative of protection in adults. The level of immune response according to the above mentioned threshold was identical between children in different age groups when the data were stratified (6 - 11 months, 12 - 23 months and 24 - 35 months). The tolerability of the vaccine in this trial has been shown to be similar to that in the H5N1 clinical trial programme. Once the trial is completed, regulatory authorities will review the data set and may then consider changes to the label which currently indicates a two dose schedule for the paediatric population.



These results differ from the recently publicised data1 on an unadjuvanted H1N1 pandemic vaccine which, when used in children, demonstrated that 50% of children aged 6 to 35 months met the seroprotection benchmark set by regulatory agencies. In general, seasonal influenza vaccines, which are unadjuvanted, elicit a lower immune response and reduced efficacy in young children compared to adults. Further results on the H1N1 clinical trials will follow as the data become available.



Supplies have been provided to governments, with more than 10 million doses already having been shipped. Shipments are continuing and GSK anticipates increasing the amount being shipped to governments in the coming weeks as additional manufacturing regulatory approvals are received.



Further information on GSK's development of a vaccine to protect against pandemic (H1N1) 2009, including explanation of the vaccine development process and background information on adjuvants is available on: http://www.gsk.com/media/pandemic-flu.htm
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.


http://www.pharmanews.eu/gsk/361-ex...-pandemrix-and-preliminary-paediatric-results