UPDATE: FDA Sends Letter To Doctors On H1N1 Vaccine Safety
11 November 2009 - 10:44AM
Dow Jones News
U.S. Food and Drug Administration Commissioner Margaret Hamburg
on Tuesday sent a letter to doctors explaining the manufacturing
process of the H1N1 flu vaccine as part of an effort to address
concerns some people have about the safety of the new swine-flu
vaccine.
While many Americans want the vaccine and haven't been able to
get it yet amid an ongoing shortage, several polls suggest up to
half of Americans have no plans to be vaccinated. There is also
anecdotal evidence that some doctors are advising patients to skip
the vaccine until more is know about its safety.
In 1976, more than 40 million Americans were vaccinated with a
different swine-flu vaccine and there were several hundred reports
of Guillain-Barre Syndrome, a serious neurological disorder. While
it isn't clear if the vaccine caused the illnesses, federal health
officials are aware of the concerns and will be studying whether
there are increased reports of GBS and other side effects from this
year's H1N1 vaccine.
Hamburg said so far there have been no reports of serious side
effects from on-going clinical studies of the vaccine. More than
3,600 patients are enrolled in studies that are being overseen by
the National Institutes of Health.
In the letter, Hamburg explained that the H1N1 vaccine is being
made by the same companies in the same manner the seasonal vaccine
is made. The composition of the seasonal flu vaccine changes almost
every year, and the FDA typically signs off on those strain changes
without requiring human clinical studies.
The U.S. Centers for Disease Control and Prevention and the
World Health Organization routinely monitor influenza viruses and
report on which strains are predominant.
U.S. health officials use that information to pick the three
strains that are most likely to offer protection against dominant
strains of influenza expected to be circulating during the upcoming
seasonal flu season. More than 10,000 viruses can cause the
flu.
The three strains included in influenza vaccines are grown in
chicken eggs. It takes about eight months for the entire
influenza-vaccine production process to be completed, meaning
manufacturers usually start making one part of the vaccine in
January in order for the finished product to start being shipped in
late August.
Because the H1N1 virus wasn't discovered until April it was too
late to include it as one of the strains in the seasonal vaccine so
the U.S. asked five companies to make a separate H1N1 vaccine. The
companies are: Novartis AG (NVS); Sanofi-Aventis SA (SNY, SAN.FR);
CSL Ltd. (CSL.AU); GlaxoSmithKline PLC (GSK, GSK.LN); and
MedImmune, which is a unit of AstraZeneca PLC (AZN, AZN.LN).
The FDA approved Glaxo's vaccine on Tuesday.
"The benefits of preventing serious consequences from infection
with the 2009 H1N1 influenza virus far outweigh the risks
associated with vaccination," Hamburg wrote in the letter. "All
Americans, and especially pregnant women and others at high risk of
severe influenza infection, should seriously consider the
recommendation for vaccination to help protect themselves and their
loved ones."
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com
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