New Bird Flu Virus Vaccine

By twin votes of 14-0, the panel agreed that the immunogenicity and the safety of the vaccine, made in Quebec by GlaxoSmithKline, were enough to meet licensing standards under accelerated approval regulations. Flu experts have been watching the H5N1 avian flu for years, fearing it might mutate in a way that would allow it to spread as easily among humans as it does among domestic and wild fowl. Currently, the virus only rarely infects humans but when it does, it is highly dangerous. As of Aug. 10, according to the World Health Organization, there have been 608 cases since 2003 -- 359 of which ended in death. The Q-Pan H5N1 vaccine, developed under contract with the Department of Health and Human Services, consists of a monovalent, inactivated, split A/H5N1 influenza virus antigen and Glaxo's AS03 adjuvant. In clinical trials, the most common adverse events were injection site pain and swelling, muscle aches, headache, fatigue, joint pain, shivering and sweating, according to briefing documents prepared by FDA staff reviewers. The rates of those events were increased compared with unadjuvanted H5N1 antigen or saline placebo. On the other hand, antibody responses to the vaccine were better than for unadjuvanted H5N1 antigen.

People do not realize how important it is to have a deep understanding on their health. Especially since it is flu season, we should all be very cautious about who and what we are around. It can affect the world population, especially since this particular disease is being carried by birds. And with the problem now with population, it would just be another nuisance.