An FDA Press Release today notes that vaccines made by MedImmune (the nasal spray attenuated live virus vaccine) and killed vaccines from CSL (Commonwealth Scientific Laboratories, Australia), Novartis and Sanofi Pasteur have been approved for use (licensed).
These are the vaccines made without novel adjuvants. Based on FDA’s statement that, “All four firms manufacture the H1N1 vaccines using the same processes, which have a long record of producing safe seasonal influenza vaccines,” none will use cell-culture techniques. (Novartis has developed a cell-culture H1N1 vaccine also, which has apparently not been approved at this time.)
The vaccines have interim information on adverse effects. Novartis’ package insert states that the adverse event information provided is a copy of that used for its seasonal flu vaccine, Fluvirin. CSL’s package insert says the same: “Adverse reactions information is based on studies conducted with seasonal trivalent influenza virus vaccine, Afluria.” Sanofi’s package insert also says this. The NEJM provides some early information from clinical trials.
Vaccine will be available in multi-dose vials with thimerosal (25 mcg/dose) and single dose vials without much thimerosal (actually, 1 mcg/dose) for children and pregnant women. Vaccine will be free; there may be an administration fee charged.
“FDA and CDC will closely monitor the safety of the Influenza A (H1N1) 2009 vaccines… Efforts are underway to establish a robust network to share information in real-time. The network will build on the well established Vaccine Adverse Event Reporting System and Vaccine Safety Datalink by integrating capabilities from the Department of Defense, the Department of Veterans Affairs, the Center for Medicare and Medicaid Services, State, Territorial, Tribal, and local public health and medical, and private sector healthcare entities. FDA is also engaged with international regulatory partners on pharmacovigilance planning efforts.
The purpose of the collaborations is to improve our ability to identify adverse events following receipt of the 2009 H1N1 monovalent vaccines and rapidly evaluate them to determine their significance.”
The 1976 swine flu vaccine was also made using standard techniques and no novel adjuvants. Guillain Barre Syndrome occurred after vaccination, during a specified window of time, at about 8 times the baseline rate.
Improving vaccine safety monitoring is very important for understanding the safety profile of all vaccines. Hopefully the systems put in place to monitor this vaccine will be used for all new vaccines, as well as those already licensed…since there has been virtually no active surveillance performed after vaccines are licensed. Such systems will help answer many questions about the benefits and risks of all vaccines.