FDA Approves Vaccines for 2009 H1N1 Influenza Virus
The U.S. Food and Drug Administration announced today that it has
approved four vaccines against the 2009 H1N1 influenza virus. The
vaccines will be distributed nationally after the initial lots become
available, which is expected within the next four weeks.
"Today's approval is good news for our nation's response
to the 2009 H1N1 influenza virus," said Commissioner of Food and Drugs
Margaret A. Hamburg, M.D. "This vaccine will help protect individuals
from serious illness and death from influenza."
The vaccines are made by CSL Limited, MedImmune LLC,
Novartis Vaccines and Diagnostics Limited, and sanofi pasteur Inc. All
four firms manufacture the H1N1 vaccines using the same processes,
which have a long record of producing safe seasonal influenza vaccines.
"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
Jesse Goodman, M.D., FDA acting chief scientist.
Based on preliminary data from adults participating in
multiple clinical studies, the 2009 H1N1 vaccines induce a robust
immune response in most healthy adults eight to 10 days after a single
dose, as occurs with the seasonal influenza vaccine.
Clinical studies under way will provide additional
information about the optimal dose in children. The recommendations for
dosing will be updated if indicated by findings from those studies. The
findings are expected in the near future.
As with the seasonal influenza vaccines, the 2009 H1N1
vaccines are being produced in formulations that contain thimerosal, a
mercury-containing preservative, and in formulations that do not
contain thimerosal.
People with severe or life-threatening allergies to
chicken eggs, or to any other substance in the vaccine, should not be
vaccinated.
In the ongoing clinical studies, the vaccines have been
well tolerated. Potential side effects of the H1N1 vaccines are
expected to be similar to those 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 the inoculation.
For the nasal spray vaccine, the most common side effects include runny
nose or nasal congestion for all ages, sore throats in adults, and --
in children 2 to 6 years old -- fever.
As with any medical product, unexpected or rare serious
adverse events may occur. The FDA is working closely with governmental
and nongovernmental organizations to enhance the capacity for adverse
event monitoring, information sharing and analysis during and after the
2009 H1N1 vaccination program. In the U.S. Department of Health and
Human Services, these agencies include the Centers for Disease Control
and Prevention.