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 USA^sm
 
Download Expanded Written Comment: https://www.healthwatchusa.org/HWUSA-Presentations-Community/PDF-Downloads/20210922-The_CDC_ACIP_Written-Comment-3.pdf