FDA Gives the Nod to H1N1 Flu Vaccines

September 16, 2009

On Sept 15, 2009, the FDA approved 4 vaccines against the H1N1 influenza virus. Distribution of the vaccine to about 90,000 sites across the United States will begin in mid October.


On Sept 15, 2009, the FDA approved 4 vaccines against the H1N1 influenza virus. Distribution of the vaccine to about 90,000 sites across the United States will begin in mid October.

According to the CDC, the groups recommended to receive the H1N1 flu vaccine first are •Pregnant women.
•People who live with or care for children younger than 6 months.
•Health care workers and emergency medical personnel.
•All persons aged 6 months to 24 years.
•Persons aged 25 through 64 who have health conditions associated with a high risk of influenza-related complications.

In the event of limited vaccine availability, priority for vaccination should be given to the first 3 groups listed above and the following persons:
•Children aged 6 months to 4 years.
•Children and adolescents aged 5 to 18 years with health conditions associated with a high risk of influenza-related complications.

According to preliminary data, the 2009 H1N1 vaccines induce a robust immune response in most healthy adults 8 to 10 days after a single dose. Studies are currently under way to determine the optimal dosing schedule in children.

The vaccines have been well tolerated in clinical trials. The safety profile of the H1N1 vaccines is expected to be similar to that of seasonal flu vaccines.

For the injected vaccine, the most common side effect is soreness at the injection site. Other side effects may include mild fever, body aches, and fatigue for a few days after vaccination. For the nasal spray vaccine, the most common side effects are rhinorrhea or nasal congestion for all ages, pharyngitis in adults, and-in children 2 to 6 years old-fever.

The CDC and FDA will closely monitor the safety of the 2009 H1N1 influenza vaccine. Health care providers are asked to report serious adverse reactions to the Vaccine Adverse Event Reporting System (VAERS). A report can be filed at the VAERS Web www.vaers.hhs.gov or by calling 1-800-822-7967.

Persons with severe or life-threatening allergies to chicken eggs, or to any other substance in the vaccine, should not be vaccinated.

The manufacturers of the H1N1 vaccines-CSL Ltd, MedImmune, Novartis AG, and Sanofi-Aventis SA-used the same processes that produce the seasonal influenza vaccine, which has a long safety record.