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.
Vaccines against three
seasonal virus strains are already available and should be used
(see information
on the seasonal flu). However, they do not protect against the
2009 H1N1 virus.
U.S. Food and
Drug Administration
http://www.fda.gov/
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