Tell the FDA and CDC to Request Further IOM Study of Vaccine AERs!

Many vaccines are developed via government/industry “partnerships.” Post-approval, the government often refuses to study vaccines’ long-term safety record. Perhaps this is due to the government’s significant financial and political investment in these dangerous drugs.

It is irresponsible for the FDA and CDC to freely permit mass vaccination—especially with unapproved, foreign drugs—without careful analysis of side affects and serious adverse events. It’s vital that the short and long-term impact of vaccines, particularly those mandated for K-12 and college students, be carefully studied by an independent, nongovernmental body.

Tell the FDA and CDC to ask that the IOM to study all vaccine AERs, particularly those stemming from Bexsero.

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Stephen Ostroff

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Dear [Decision Maker],

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I'm writing to ask CDC and FDA officials to request that the Institute of Medicine analyze all adverse event reports (AERs) for vaccines, and particularly of the Bexsero vaccine.

Recently, I learned that due to a limited outbreak of meningitis B, Princeton University plans to recommend that all undergraduates and all graduate studies students who live in dormitories, as well as various "other members of the University community" (about 8,000 in total) receive the Bexsero vaccine.

Although approved in Australia and Europe, Bexsero was rejected by the UK's Joint Committee on Vaccination and Immunisation (JCVI) and has not yet been approved by the FDA for sale in the United States. Further, it's my understanding that FDA approval has been delayed, as Novartis and FDA couldn't agree on a "reliable surrogate for efficacy" for mandatory Phase III studies. I find it extremely alarming that such a crucial outcome would even be open to debate!

The studies of Bexsero that I am familiar with do not inspire confidence: one study found that Bexsero increased rates of fevers in the infants (there were 3,630 infants studied). While a second study involving 1,200 patients found that there was no increased rate of fever, it was also an open label study, which left it wide upon to both unconscious bias and willful manipulation.

I understand that the Princeton outbreak may seem like an urgent health event that demands immediate and extreme response. However, the Princeton outbreak is not an epidemic, as only seven students have been infected, everyone has recovered, and the disease is not expected to spread off-campus.

More to the point, it is irresponsible for government organizations to freely permit mass vaccination -- especially with unapproved, foreign drugs -- without careful analysis of side effects and serious adverse events. It's vital for the short and long-term impact of vaccines, particularly those mandated for K-12 and college students, be carefully studied by an independent, nongovernmental body.

Sincerely,
[Your Name]
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