FDA
Approves Four Vaccines for 2009 H1N1 Influenza (Swine Flu) Virus
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The U.S. Food and Drug Administration
announced on September 15, 2009 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. Following
is the text of the FDA announcement: |
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FDA
Approves Vaccines for 2009
H1N1 Influenza Virus Approval
Provides Important Tool
to Fight Pandemic 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 (see information on H1N1 flu). 9/16/09 Source
US
Food and Drug Administration. FDA Approves Vaccines for 2009 H1N1 Influenza Virus.
Press Release. September 15, 2009. 
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