by Lynn Shapiro
, Writer | September 16, 2009
The FDA, on Tuesday, approved swine flu vaccines from Sanofi-Aventis, Novartis, CLS and AstraZeneca's MedImmune division.
Kathleen Sebelius, Secretary of Health, said there would be enough vaccine for every American who wanted it, especially because one shot--rather than the two shots officials expected people would need--did the trick.
The vaccine produced what officials called a "robust response" in healthy individuals after eight to 10 days. The swift response time is another good piece of news the government didn't expect.
Until last week, CDC officials were saying it would take a full month until people got full protection against the virus. Since the shots won't be distributed until mid-October when flu season starts, waiting one week instead of three for immunity could forestall a pandemic.
No Adjuvant Needed
About 300 million Americans are expected to take the swine flu shot, although some people, including some health care workers, say they will refuse to take a drug that was approved at such breakneck speed. Clinical trials of the vaccine didn't start until August, they contend.
Officials counter that because the vaccine contains inactivated virus, it is impossible to become infected with the 2009 H1N1 influenza virus by receiving the vaccine. What's more, the vaccine contains no thimerosal, a preservative, or adjuvant--a substance added to some vaccines to improve the body's response. While vaccines with adjuvants are approved in Europe, no vaccines using adjuvants are approved in the U.S.
Officials had believed they might need to use adjuvants in the H1N1 vaccine to boost its effectiveness. Another good piece of news is that they don't.
The government plans to distribute $1.4 billion to hospitals and to states to prepare for a possible flu outbreak. It will also spearhead a nationwide vaccination effort starting in mid-October. Officials say pregnant women and young people from six months to 24 years are at the highest risk and will be among the first to be vaccinated. The inoculations are free but some health care providers might charge a nominal fee for service.
Pregnant Women at Risk for Severe Illness
Trials are underway for children and also for pregnant women. "Women are at higher risk of developing severe illness if they become infected with influenza virus while pregnant, which is why they are strongly encouraged to receive the seasonal influenza vaccine every year," says Dr. Anthony Fauci, director, National Institute of Allergy and Infectious Diseases, at the NIH.
He notes "data indicate that pregnant women are at higher risk for complications from the 2009 H1N1 influenza virus as well, so this trial will provide critical information for public health planning." Other trials for pregnant women are in the offing.
Meanwhile, all 50 states report H1N1 activity. The Southeast, Alaska, Arizona, Oklahoma and Maryland are most affected. Flu is mostly confined to young children and young adults there.
Sources: FDA, CDC, NIH,