Pharmaceutical

H1N1 vaccine coming at pivotal time

“We are now in a position never before experienced in the history of influenza,” said Dr. Margaret Hamburg, Commissioner of Food and Drugs, in a letter to health care providers about the safety and availability of the 2009 H1N1 influenza vaccine. Just as a new and serious virus is spreading widely around the country, causing hospitalizations and deaths, a vaccine is becoming available to help prevent infection and protect the public.”

More than 41 million doses of the 2009 H1N1 vaccine have been allocated to the United States for distribution, with more coming available daily. But a gap still remains between demand for the vaccine and the current available supply. The letter does not address if or when the demand will be met.

However, the fact that any vaccines are available at all is positive, says Hamburg. Her letter states that is the first time in history a vaccine has been available at the time that an influenza pandemic has struck. “We are not cutting any corners,” Hamburg said. “Just as for the seasonal influenza vaccine, no lot of the 2009 H1N1 vaccine can be used until it has been carefully evaluated and released as sterile and potent by both the manufacturer and the FDA.

The FDA and other agencies are also investigating any possible serious adverse events associated with the vaccine, and is urging consumers and health care providers to report any adverse effects believed to be linked to the vaccine to the Vaccine Adverse Event Reporting System at vaers.hhs.gov/index. More information is available at www.flu.gov.

“It is likely that most families in the United States will be touched by H1N1 influenza this year. Fortunately, many will experience mild illness. Others will endure unspeakable tragedy. The benefits of preventing serious consequences from infection with the 2009 H1N1 influenza virus far outweigh the risks associated with vaccination,” Hamburg said. “All Americans, and especially pregnant women and others at high risk of severe influenza infection, should seriously consider the recommendation for vaccination to help protect themselves and their loved ones.”