bcgauspohl
Active member
SUMMARY REPORT of the NATIONAL BIODEFENSE SCIENCE BOARD (NBSD)
H1N1 TELECONFERENCE
July 17, 2009
Dr. Grabenstein invited Dr. Robin Robinson from the Biological Advanced Research and Development Authority (BARDA) to update the Board on the events of the last month since the Bethesda meeting on June 18, 2009. Dr. Robinson said that all five manufacturers the Department contracted with have begun to produce the H1N1 vaccine at commercial-scale. Eighteen million doses have already been produced (assuming 15 mcg antigen per dose). The Department has contracted for a total of 193 million doses. Virus yields are toward the lower end of the expected range, roughly 1.4 doses per egg.
Commercial-scale production of the live attenuated vaccine experienced low yields with initial lots, but they are now using a second seed strain, yielding 2 logs higher. With that higher yield of virus titer than normally seen, the number of doses available would be limited by the ability to fill sprayers; with more bulk virus available than can be filled (at 10e7 pfu per dose) at present. Dr. Robinson stated that they are looking with other manufacturers at other sites within the U.S. to fill the sprayers, and are also looking at alternative ways of delivering the flu-mist-like product from the sprayer.
Regarding adjuvants, Dr. Robinson said that there have not been changes in the schedule or in the amount produced. The Department has contracted for enough adjuvant for 119 million doses of vaccine.
In order to have the monovalent unadjuvanted H1N1 vaccine available by September 15, the Department would have to make a decision by August 15, to direct the manufacturers to formulate the bulk antigen into usable product and fill containers. By August 15, roughly 60 to 80 million doses of bulk antigen (assuming 15 mcg/dose) should be available. The first clinical studies with the companies are starting next week. The Board will not know until September whether or not the 15 microgram dose is immunogenic.
Dr. Dretchen asked if the Centers for Disease Control and Prevention (CDC) might encourage administration of the vaccine in school settings. CAPT Fiore from the CDC said that there are no formal efforts for providing novel H1N1 in school settings, and that the CDC does encourage vaccinations in school settings. Dr. Grabenstein indicated that the PIWG report says that HHS should consider recommending school-based immunization delivery for children.
Dr. Robinson noted that if one assumes a 15 mcg dose at 0.5 ml, the vaccine could be available by September 15. The Food and Drug Administration (FDA) is still in the process of deliberating whether the vaccine would be licensed at the standard dose, 15 mcg with a strain change, based on previous years. Dr. Pavia pointed out that the FDA has not indicated that they would license the vaccine at the existing dose based on the strain change, and it was reconfirmed that this topic was within the purview of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). Dr. Gellin asked if the Board should go forward with the vaccine, in the absence of data, and do what is done for seasonal vaccine. Given the uncertainties, Dr. Gellin further asked what would be the Board’s assessment of how much vaccine should be bottled on August 15. It was reconfirmed by Dr. Robinson that on August 15th, ~60 million bulk antigen would be available for use, and that approximately 30 days will be needed for fill-to-finish to have a complete product available for distribution.
http://www.hhs.gov/aspr/conferences/nbsb/nbsb-mtgsum-090717.pdf
H1N1 COUNTERMEASURES STRATEGY AND DECISIONMAKING:
REPORT WITH RECOMMENDATIONS FROM THE NATIONAL BIODEFENSE SCIENCE BOARD FOR THE SECRETARY U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
JULY 17, 2009
The National Biodefense Science Board held an urgent public teleconference on July 17, 2009, to consider and discuss the Report from the Pandemic Influenza Working Group of the NBSB. Following discussion by the members and public, the NBSB voted on, and unanimously approved the ‘H1N1 Countermeasures Strategy and Decision Making: Report with Recommendations,’ to the Secretary of HHS for prompt action, with timingappropriate to the current pandemic situation.
In brief, the key findings of the meeting and subsequent deliberations include the following:
H1N1 Vaccine
*Based on available data, the NBSB recommends that HHS set a goal of having several tens of millions of doses of unadjuvanted monovalent A/H1N1 vaccine available for clinical use not later than September 15, 2009. To achieve this, HHS should pursue a simplified testing program to achieve that goal. Additional studies may be appropriate for additional supplies in subsequent months, but time of availability seems to be the dominant criterion for vaccine decision making.
*Decades of experience with A/H1N1 influenza viruses provide a basis for selecting initial antigen quantities and dosing. If the US goal is vaccine availability on the shelf in September 2009, 15‐mcg unadjuvanted subunit vaccine and live attenuatedintranasal vaccine for children may be a rational approach.
*If the second wave is delayed or production is slower than expected, mix‐and‐match studies of vaccine plus separate adjuvant may yield information that may stretch the available vaccine supply.
http://www.hhs.gov/aspr/conferences/nbsb/nbsb-panflurecs-090720.pdf
*CLARIFICATION* -- THIS IS THE United States PANDEMIC H1N1 VIRUS VACCINE PLAN (see below)
This is the Pandemic H1N1 strain they are discussing. If you go to my previous 4 posts and click on the official US government website links and read them thoroughly you will see this and also notice all the "little" details they seem to gloss over. This is all official and for public viewing. They want to start mass H1N1 vaccinations of US citizens on TUESDAY SEPTEMBER 15, 2009. The H1N1 vaccine supply already exist, they are just waiting for the "official" green light (nothing disasterous in the 3 week clinical trials) to execute the start date.
They (the National Biosafety Science Board, NBSB) will meet again FRIDAY AUGUST 14th from 12:00 to 2:00 PM EDT in Washington, DC to update the H1N1 situation (vaccine trial results) and accordingly amend future measures.
http://www.hhs.gov/aspr/conferences/nbsb/090814-nbsb-meeting.html
For further information click on the upcoming US Pandemic H1N1 Vaccination Plan regarding NBSB, BARDA, and US Project Bioshield :
http://www.hhs.gov/aspr/barda/bioshield/index.html
http://www.hhs.gov/aspr/barda/index.html
http://www.hhs.gov/aspr/conferences/nbsb/nbsb-mtgsum-090717.pdf
http://www.hhs.gov/aspr/conferences/nbsb/nbsb-panflurecs-090720.pdf
bcgauspohl
H1N1 TELECONFERENCE
July 17, 2009
Dr. Grabenstein invited Dr. Robin Robinson from the Biological Advanced Research and Development Authority (BARDA) to update the Board on the events of the last month since the Bethesda meeting on June 18, 2009. Dr. Robinson said that all five manufacturers the Department contracted with have begun to produce the H1N1 vaccine at commercial-scale. Eighteen million doses have already been produced (assuming 15 mcg antigen per dose). The Department has contracted for a total of 193 million doses. Virus yields are toward the lower end of the expected range, roughly 1.4 doses per egg.
Commercial-scale production of the live attenuated vaccine experienced low yields with initial lots, but they are now using a second seed strain, yielding 2 logs higher. With that higher yield of virus titer than normally seen, the number of doses available would be limited by the ability to fill sprayers; with more bulk virus available than can be filled (at 10e7 pfu per dose) at present. Dr. Robinson stated that they are looking with other manufacturers at other sites within the U.S. to fill the sprayers, and are also looking at alternative ways of delivering the flu-mist-like product from the sprayer.
Regarding adjuvants, Dr. Robinson said that there have not been changes in the schedule or in the amount produced. The Department has contracted for enough adjuvant for 119 million doses of vaccine.
In order to have the monovalent unadjuvanted H1N1 vaccine available by September 15, the Department would have to make a decision by August 15, to direct the manufacturers to formulate the bulk antigen into usable product and fill containers. By August 15, roughly 60 to 80 million doses of bulk antigen (assuming 15 mcg/dose) should be available. The first clinical studies with the companies are starting next week. The Board will not know until September whether or not the 15 microgram dose is immunogenic.
Dr. Dretchen asked if the Centers for Disease Control and Prevention (CDC) might encourage administration of the vaccine in school settings. CAPT Fiore from the CDC said that there are no formal efforts for providing novel H1N1 in school settings, and that the CDC does encourage vaccinations in school settings. Dr. Grabenstein indicated that the PIWG report says that HHS should consider recommending school-based immunization delivery for children.
Dr. Robinson noted that if one assumes a 15 mcg dose at 0.5 ml, the vaccine could be available by September 15. The Food and Drug Administration (FDA) is still in the process of deliberating whether the vaccine would be licensed at the standard dose, 15 mcg with a strain change, based on previous years. Dr. Pavia pointed out that the FDA has not indicated that they would license the vaccine at the existing dose based on the strain change, and it was reconfirmed that this topic was within the purview of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). Dr. Gellin asked if the Board should go forward with the vaccine, in the absence of data, and do what is done for seasonal vaccine. Given the uncertainties, Dr. Gellin further asked what would be the Board’s assessment of how much vaccine should be bottled on August 15. It was reconfirmed by Dr. Robinson that on August 15th, ~60 million bulk antigen would be available for use, and that approximately 30 days will be needed for fill-to-finish to have a complete product available for distribution.
http://www.hhs.gov/aspr/conferences/nbsb/nbsb-mtgsum-090717.pdf
H1N1 COUNTERMEASURES STRATEGY AND DECISIONMAKING:
REPORT WITH RECOMMENDATIONS FROM THE NATIONAL BIODEFENSE SCIENCE BOARD FOR THE SECRETARY U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
JULY 17, 2009
The National Biodefense Science Board held an urgent public teleconference on July 17, 2009, to consider and discuss the Report from the Pandemic Influenza Working Group of the NBSB. Following discussion by the members and public, the NBSB voted on, and unanimously approved the ‘H1N1 Countermeasures Strategy and Decision Making: Report with Recommendations,’ to the Secretary of HHS for prompt action, with timingappropriate to the current pandemic situation.
In brief, the key findings of the meeting and subsequent deliberations include the following:
H1N1 Vaccine
*Based on available data, the NBSB recommends that HHS set a goal of having several tens of millions of doses of unadjuvanted monovalent A/H1N1 vaccine available for clinical use not later than September 15, 2009. To achieve this, HHS should pursue a simplified testing program to achieve that goal. Additional studies may be appropriate for additional supplies in subsequent months, but time of availability seems to be the dominant criterion for vaccine decision making.
*Decades of experience with A/H1N1 influenza viruses provide a basis for selecting initial antigen quantities and dosing. If the US goal is vaccine availability on the shelf in September 2009, 15‐mcg unadjuvanted subunit vaccine and live attenuatedintranasal vaccine for children may be a rational approach.
*If the second wave is delayed or production is slower than expected, mix‐and‐match studies of vaccine plus separate adjuvant may yield information that may stretch the available vaccine supply.
http://www.hhs.gov/aspr/conferences/nbsb/nbsb-panflurecs-090720.pdf
*CLARIFICATION* -- THIS IS THE United States PANDEMIC H1N1 VIRUS VACCINE PLAN (see below)
This is the Pandemic H1N1 strain they are discussing. If you go to my previous 4 posts and click on the official US government website links and read them thoroughly you will see this and also notice all the "little" details they seem to gloss over. This is all official and for public viewing. They want to start mass H1N1 vaccinations of US citizens on TUESDAY SEPTEMBER 15, 2009. The H1N1 vaccine supply already exist, they are just waiting for the "official" green light (nothing disasterous in the 3 week clinical trials) to execute the start date.
They (the National Biosafety Science Board, NBSB) will meet again FRIDAY AUGUST 14th from 12:00 to 2:00 PM EDT in Washington, DC to update the H1N1 situation (vaccine trial results) and accordingly amend future measures.
http://www.hhs.gov/aspr/conferences/nbsb/090814-nbsb-meeting.html
For further information click on the upcoming US Pandemic H1N1 Vaccination Plan regarding NBSB, BARDA, and US Project Bioshield :
http://www.hhs.gov/aspr/barda/bioshield/index.html
http://www.hhs.gov/aspr/barda/index.html
http://www.hhs.gov/aspr/conferences/nbsb/nbsb-mtgsum-090717.pdf
http://www.hhs.gov/aspr/conferences/nbsb/nbsb-panflurecs-090720.pdf
bcgauspohl