FDA to Docs—"H1N1 Vaccine Is Safe"
Provider Letter Outlines How Swine Flu Vaccine Safety Is Assured
Nov 11, 2009
To prepare healthcare providers for when patients ask about safety of the new H1N1 (swine flu) vaccine, the Commissioner of the US Food and Drug Administration sent out an informational letter November 10, 2009.
Dr. Margaret Hamburg, the Commissioner, emphasized the vaccine is not entirely new at all. She explained the process.
First, scientists grew the virus in the lab, and modified it so it would be attenuated. In the attenuated form, it is not possible to spread from person to person. These virus samples became seeds for manufacturers to grow and package for distribution to the public. The seeds were sent in May, 2009.
Then the manufacturers simply used the same factories, equipment and processes they use for every year’s regular flu vaccine. The attenuated virus is grown in specially produced eggs. The product is harvested from the eggs and processed for distribution.
The FDA inspects these factories at least yearly. The FDA tests both factories that make vaccine for injection and those for nasal mist.
Determining How Much Vaccine Is Needed
Scientists from England, Japan, Australia, and other countries developed tests to assure that each dose of vaccine had enough attenuated virus to do the job, to get an adequate immune response from the vaccinated person.
Selection of Manufacturers
Companies applied to be licensed by the FDA to manufacture the vaccine. Four were selected, based on the past performance and apparent ability to rapidly and smoothly produce the large quantities needed.
Close Timing
If the H1N1 virus had been isolated a few months earlier, the strain would have been included in the routine annual 2009 flu vaccine. So, while the virus strain is new, the vaccine production is the same as today’s annual flu vaccine.
Continuous Monitoring
Every lot of H1N1 2009 vaccine is tested. Each lot needs to be potent and sterile. Tests are done both by the manufacturer and the FDA.
Dr. Hamburg closed with this realistic remark:
- “It is likely that most families in the United States will be touched by H1N1 influenza this year... 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.”
Other Information from the FDA
In other bulletins, the FDA pointed out that the H1N1 vaccine is monovalent (only one virus strain), and no adjuvant is used (no additional agents in the vaccine, although some vaccines do have a preservative).
Watch Out for Fraud
Anyone selling a product that claims to prevent or treat H1N1 (swine) flu, other than a product approved by the FDA, is operating outside the law, according to Dr. Hamburg. Some of the products are dangerous. Others are just rip-offs. One product was represented as Tamiflu, an antibiotic approved for use to treat flu. On examination, it was found to contain talc and acetaminophen (e.g., Tylenol) and nothing else.
A Widget For You
To help the public avoid fraud, bloggers and website owners can put a widget on their site. It will provide the latest information about products.
Unified Web Site
A US government-wide site provides the latest information about H1N1 in the United States.
Analysis of Risk
A non-government analysis suggests the risk of Paralysis attributed to flu vaccine is almost nil.
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