(edited for copyright purposes proud patriot Moderator Democratic Underground)
U.S. could potentially use controversial adjuvants in swine flu vaccine
BY LJ ANDERSON
Posted: 10/13/2009 08:09:34 PM PDT
Updated: 10/14/2009 01:13:45 PM PDT
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Maine physician Meryl Nass, MD, has written widely on the use of vaccines. "If novel adjuvants do get added (in the U.S.) — only if conditions change — it would preclude the quick licensure process that took place for the licensed H1N1 vaccines. Recipients would need to sign an informed consent for an experimental product," said Nass. "I do not believe they would be 'secretly' added."
The World Health Organization has tried to allay concerns about the vaccine and states that clinical trials suggest this vaccine is as safe as the seasonal influenza vaccines, and that most countries have vaccine monitoring systems in place. Without specifically addressing the use of adjuvants, WHO states that any vaccine side effects are expected to be of short-term duration, such as injection site soreness, swelling and redness, and possibly, headache, fever and muscle aches. However, WHO also has a disclaimer that "even very large clinical trials will not be able to identify possible rare events that can occur when pandemic vaccines are administered to many millions of people."
With a pivotal and profitable role played by the pharmaceutical industry in vaccine production, Nass suggests that there is a lack of "unconflicted data" available about adjuvants. "Nearly all of the MF59 (adjuvant) data were derived from the manufacturer of MF59, for example," said Nass. "It is more the lack of reliable data, and gives the impression that something is being hidden. Those of us who are familiar with the subject are concerned that if these adjuvants were used en masse, we would face some bad outcomes. The FDA has been sitting on them for 10 years, and usually, that means that the FDA is aware of significant problems."
Nass testified before Congress in 2001 that the FDA needed to make a decision on the safety of adjuvants, so manufacturers could know whether they could include them in vaccines or not. "It seems that the FDA and the manufacturers have been waiting for a pandemic to solve the problem for them," said Nass. "It was going to be avian flu — an adjuvanted vaccine for H5N1 avian flu was approved in many countries, but the disease never spread person to person. Then swine flu came along, and Glaxo and Novartis got another bite at the cherry. You see, once these adjuvants get into licensed products in the U.S., they will become part of all sorts of novel vaccines for cancer and non-infectious diseases, whose antigens are waiting in the wings."
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http://www.mercurynews.com/ci_13555627?source=most_emailed&nclick_check=1