WASHINGTON, Sept. 15 /PRNewswire-USNewswire/ -- 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
"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
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
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).
Media Inquiries: Pat El-Hinnawy, 301-796-4763,
Peper Long, 301-796-4671, email@example.com
Consumer Inquiries: 1-888-INFO-FDA
SOURCE U.S. Food and Drug Administration
Pat El-Hinnawy, +1-301-796-4763, firstname.lastname@example.org, or Peper
Long, +1-301-796-4671, email@example.com, both of the U.S. Food and Drug