ICAN
attorneys and research staff watch every meeting of the FDA’s Vaccines
and Related Biological Products Advisory Committee (VRBPAC) and the
CDC’s Advisory Committee on Immunization Practices (ACIP). What is seen
over the course of many meetings are the patterns and methods by which
these agencies rig the approval process to achieve pre-determined
outcomes. Now VRBPAC and ACIP are gearing up to pre-approve all future
COVID-19 shots, regardless of formulation, with no additional clinical
trials!
After VRBPAC’s April 6, 2022 meeting, ICAN, through its attorneys, wrote a letter
to FDA Commissioner Robert Califf, the members of VRBPAC, and the
Senators and Representatives responsible for the FDA’s budget,
explaining our concerns in detail.
To
summarize, VRBPAC appears to be following the same plan it follows for
the flu vaccine every year and we know how well that works. Each year,
they engage in “the flu strain selection process”
and agree on the strains that will be included in the flu vaccine that
year. Vaccine manufacturers love this because they can create a single
flu vaccine and sell it worldwide. Most importantly, however, they can
then skip the regulatory review process because these new formulations
are automatically deemed safe and effective since they are “biologically
similar” to previous versions of the flu vaccine.
The problem from a public health perspective is that this process does not work. As ICAN has noted previously, at best, FDA’s own data show flu vaccine effectiveness in the previous season was between 8% and 14%. Evidence from an influenza outbreak at a large university campus showed flu vaccine effectiveness was zero.
What
does all of this have to do with COVID-19 shots? The White House, FDA,
and CDC have come up with a disturbing plan: they are proposing to take
the flu strain selection process (that does not work) and apply it to
future COVID-19 shots!
What
this means is that each year, FDA/VRBPAC and CDC/ACIP (under the
direction of the WHO) will engage in an elaborate performance of
“COVID-19 variant selection.” They will potentially choose between 1 and
4 strains to put into the COVID-19 shots (for example, combining spike
proteins from Wuhan, Beta, Delta, and Omicron variants in a single
shot). The worst part? They will argue that this new formulation is
biologically similar to previous COVID-19 shots, and therefore they will
not require pharmaceutical companies to conduct any new clinical
trials.
ICAN is already fighting back, and you can also take action. You can join us in pushing back before VRBPAC and ACIP
meet again in June regarding this proposal by contacting your elected
officials today to tell them to reject this dangerous proposal and hold
the FDA and CDC accountable if they do succeed. ICAN also intends to
legally challenge this proposal if it is adopted but let’s hope that
won’t be necessary.
***
Employment Opportunity: A
law firm that regularly represents ICAN has an opening for (i) an
attorney with litigation and/or civil rights experience, and (ii) an
attorney with vaccine or other personal injury related claims. If
interested, please send a resume, a short cover letter, and 2-4 writing
samples to jenna@icandecide.org.
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