US FDA approves four vaccines for 2009 H1N1 influenza virus
21 September 2009
The US Food and Drug Administration (FDA) has announced 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, MD. "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 US 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).
Bookmark this page