CDC's ACIP Committee Regarding Pfizer
Vaccine Boosters
Last Friday’s meeting of the FDA’s Vaccines and Related Biological
Products Advisory Committee, regarding boosters for the Pfizer/BioNTech
vaccine, resulted in recommending authorization of boosters for those 65
years of age and older, along with those individuals who are at high
risk for severe COVID-19. After the formal vote, a poll was taken, and
the committee unanimously agreed this recommendation should be extended
to healthcare workers and those who are high-risk of occupational
exposure to SARS-CoV-2. Thus, initially the committee focused on
vaccinated individuals who are biologically high-risk of developing
severe COVID-19, but finally, also recommended boosters for those at
high-risk of SARS-CoV-2 exposure. However, the degree of exposure is
like being pregnant you either are exposed or you are not.
During a raging pandemic, action is needed NOW, we do not have the
luxury of waiting for the results of randomized controlled trials.
I would like to encourage the committee to broaden the FDA’s
recommendations. The following should be considered:
First, at least one FDA committee member indicated the main goal was to
prevent severe disease, which is defined as hospitalizations or death.
However, this ignores the lasting and debilitating effects of
Long-COVID, which can afflict 10 to 30% of those with even mild to
moderate infections and poses a significant risk to our population.
Second, Dr. Alroy-Preis, Israel’s Director of Public Health Services,
testified that the Pfizer booster created a 10-fold increase in
protection in 40- to 60-year-olds. With the disease profile of Delta
markedly shifting to younger age groups, providing boosters to a wider
range of individuals would be good public health policy.
Finally, in the United States, over 386 million doses of vaccines have
been administered, with an extraordinarily good safety record. The FDA
Committee had concerns regarding myocarditis in the young. However, this
is a rare event, occurring in approximately 1 in 5,000 young individuals
and as stated by Dr. Alroy-Preis, 95% of these cases were not severe.
There is a much higher incidence of myocarditis in those who contract
COVID-19.
In view of the above, I would recommend reconsideration of offering
Pfizer boosters to all who are 16 years of age or older; or at least
offering boosters to those who are 30 years of age or older, plus all
individuals who are at risk of SARS-CoV-2 exposure.
As a side note, we encourage the flu vaccine to be taken by all, not
just those at high risk of severe disease or disease acquisition, we
need to be consistent with our messaging.
Dr Kevin Kavanagh
Health Watch USAsm
Download Expanded Written Comment:
https://www.healthwatchusa.org/HWUSA-Presentations-Community/PDF-Downloads/20210922-The_CDC_ACIP_Written-Comment-3.pdf
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