FDA panel recommends H5N1 vaccine
The H5N1 monovalent vaccine was designated to be used in the national stockpile, where it is to be reserved for use in an emergency in case of an H5N1 pandemic or outbreak. The FDA Vaccines and Related Biological Products Advisory Committee voted 14-0 that clinical trials proved its immunogenicity and safety profile, according to InternalMedicineNews.com.
The U.S. government contracted biopharmaceutical GlaxoSmithKline to develop the drug for the national stockpile. GSK said it has no plans to market the drug, currently known as Q-Pan H5N1.
The vaccine has been proposed to be indicated for those 18 or older. It is administered in two doses given approximately 21 days apart. GSK is also conducting studies to determine whether children aged 17 months or older should be approved to receive the vaccine, InternalMedicineNews.com reports.
Q-Pan H5N1 has already been licensed in 30 countries, including those in the European Union and Australia. It is currently being reviewed for licensure in Canada.
The advisory board's vote is not binding, but the FDA usually follows its recommendations. Board panelists have to be cleared of potential conflicts of interest.