The vaccine Pandemrix, (According to GSK, some 30 million doses of the vaccine were administered across Europe and 800 people, mostly children, developed narcolepsy) will be added to the national stockpile.The vaccine will not be available commercially; it will be placed in the U.S. government’s emergency stockpile, FDA said.
FDA site: GSK Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted with ASO3.
VLA comment: This newly approved “Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted is like Pandemrix, (Pandemrix, which has not been approved in the United States). It is also made by GSK and is almost identical in structure and has just been approved for our national stockpile. This vaccine contains the adjuvant ASO3 (contains Squalene) and (polysorbate 80) for use on the American people under Emergency Use Authorization*, so you won’t know what’s coming! Generally unknown, In June 23, 2011 the FDA approved Novartis FLUAD Influenza vaccine which contains a similiar adjuvant- MF596 (contains Squalene) and (polysorbate 80).
While GSK has acknowledged an association between the vaccine and the narcolepsy cases, it has said there is insufficient evidence to prove the adjuvant (ASO3) was to blame. Scientists believe AS03 may be the culprit in the narcolepsy cases though they have yet to decipher the precise nature of the association. Read article…
GKS: The vaccine will be supplied in a kit consisting of one package containing 50 multidose vials of H5N1 antigen and two packages each containing 25 multidose vials of AS03 adjuvant. Since, as stated in your November 11, 2013, submission, you do not intend to market this product for commercial distribution. (Stockpiling for emergency authorization use). “Supporting the U.S. Government’s capability to help protect Americans against pandemics ranks among GSK’s most important U.S. public-health responsibilities,” said Bruce Innis, Vice President of Vaccines Development for GSK. “H5N1-related illness has thus far been rare, but life-threatening when it has occurred”.
GSK will make this vaccine available in the U.S. only if directed to by the Biomedical Advanced Development and Research Authority (BARDA) in the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response. The GSK H5N1 pandemic influenza vaccine programme has been supported by a development contract (HHSO100200700029C) from BARDA. GSK’s Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, has also received marketing authorisation in Europe and Canada under the brand names, Pumarix™ and Arepanrix™ H5N1, respectively. Read more…
Pumarix: Glaxo’s super-charged product is the first to show it can confer protection in the event of a pandemic. European regulators have approved it under the brand name Pumarix (contains Squalene) and (polysorbate 80)
Division of Chemical, Biological, Radiological and Nuclear Medical Countermeasures (CBRN MCM)
Stockpiling Lifesaving MCMs
The Division of CBRN MCMs is responsible for developing and establishing stockpiles of lifesaving vaccines, drugs, and diagnostics against CBRN threats. The Project BioShield Act of 2004 established the Special Reserve Fund (SRF), a one-time appropriation of $5.6 billion (2004 – 2013) to accelerate the research, development and acquisition of MCMs against CBRN threat agents. Eight Project BioShield programs have led to the acquisition of MCMs for the Strategic National Stockpile (SNS). These include an anthrax vaccine for post-exposure prophylaxis, anthrax therapeutics, a novel smallpox vaccine, a smallpox antiviral drug, a botulinum antitoxin, and radiation countermeasures. Read more…
MUST READ…Bioshield Annual Report (2012)
*Emergency Use Authorization for Medical Counter-measures– Section 4 of the Act allows the HHSSecretary to issue an Emergency Use Authorization (EUA) after an emergency has been declared by the Secretary as described in the “Statutory Authority”section found on page 7. The EUA declaration justifies the use of a FDA-approved, licensed, or cleared product for an unapproved indication or an unapproved product for an indication over a specified period of time during the emergency.