FDA approves swine flu vaccines

Consumer Reports News: September 15, 2009 06:50 PM

The Food and Drug Administration approved swine  (H1N1) flu vaccines today from four of the five manufacturers contracted to produce them, including CSL Limited, MedImmune LLC, Novartis Vaccines and Diagnostics Limited, and Sanofi Pasteur. The FDA says that the vaccines will be distributed nationally within the next four weeks, as initial supplies become available. GlaxoSmithKline's vaccine is still awaiting approval.

“The H1N1 vaccines approved today undergo the same rigorous FDA manufacturing oversight, product quality testing, and lot release procedures that apply to seasonal influenza vaccines,” said FDA acting chief scientist Jesse Goodman, M.D., in a statement. The swine flu vaccines are all made using the same methods used to produce annual seasonal flu vaccines, which the FDA describes as having a long record for safety.

Preliminary clinical trial data suggest that a single dose produces a robust immune response in most healthy adults within 8 to 10 days. Additional results will determine the optimal dose in children.

The most common side effect of the swine flu shot is soreness at the injection site. Other side effects may include mild fever, body aches, and fatigue. The most common side effects of the nasal spray include runny nose or nasal congestion, as well as a sore throat in adults and fever in children 2 to 6 years old.

Anyone who has severe or life-threatening allergies to chicken eggs should not be vaccinated, according to the FDA.

Who needs it?
Swine flu doesn’t appear to spread easily to people over age 65, possibly because many have immunity from exposure to a similar strain decades ago. The Centers for Disease Control and Prevention has developed a list of people who should get vaccinated first. They are:

  •     Pregnant women.
  •     People who live with or care for infants under 6 months.
  •     Health-care and emergency medical workers.
  •     Children and adults between 6 months and 24 years old.
  •     People age 25 to 64 years old with underlying health conditions or compromised immune systems.

Other patients can ask their doctor for the vaccine, and doctors can give it to them. But our consultants say that you should wait until supplies have reached high-risk people first. People who have already had a confirmed case should ask their doctor if they need the vaccine, since the previous exposure may offer some protection.

The new expectation that adults will need just one shot is welcome news. Just a quarter of the planned 195 million doses of the swine flu vaccine are expected to arrive in October. That can be spread across a wider swath of the population if adults can skip a second dose. And they’ll have immunity more quickly, according to the HHS trial.

Seasonal flu vaccine available now
While the swine flu vaccine is expected to dominate the flu season, the seasonal flu is still expected to circulate. In a typical year it kills 36,000 people and hospitalizes 200,000. It’s best to get your shot early so you have immunity whenever it rolls around.

We recommend it for:
  •     Anyone who wants to avoid getting the flu.
  •     All adults 50 and older.
  •     All children 6 months to 18 years.
  •     Pregnant women.
  •     Anyone with asthma, emphysema, chronic bronchitis, or heart, lung, kidney, or sickle-cell disease.
  •     People with impaired immunity and their household members.
  •     People who live with or care for infants under 6 months old.
  •     Health-care and emergency medical workers.
Kevin McCarthy, associate editor

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