Children’s Health Defense (CHD) raised significant concerns based on the briefing released for the FDA’s Vaccines and Related Biological Products Advisory Committee meeting on Dec. 10, to review the Pfizer coronavirus vaccine BNT162b2.
Less than 2.1% of the safety study cohort had been followed for over three months as of the November 14th cutoff date (page 30). This is inadequate to determine any long-term effects of the vaccine. If the manufacturers allow vaccination of the placebo group after 6 months (page 17), longer follow up of these early cohorts will be lost. Manufacturers bear no liability for any adverse events under the Prep Act.
Only 2.1% and 1.8% of the study cohort included patients 75 years old and over with pre-existing medical conditions, for the vaccinated and the placebo groups, respectively (page 22). There were only 41 total African Americans over age 75 in both arms of the Pfizer vaccine study (page 21). These are insufficient samples on which to base broad recommendations for these very important and vulnerable segments of the population.
The change in the age groupings from 18-55 and 65-85 in Phase 1/2 to 12-15, 16-55 and >55 years of age in Expanded Phase 2/3, has limited the assessment of safety and efficacy in elderly, frail populations by combining working age, community-living empty-nesters and seniors with an older, sicker population. In the Phase 2/3 portion, ” In participants … 75 years of age and older …, efficacy of COVID-19 mRNA Vaccine BNT162b2 was … 100% (two-sided 95% confidence interval of -13.1% to 100.0%)….” 100% efficacy means that they had no COVID-19 cases in the oldest group that received the vaccine; but the confidence interval is statistically meaningless.
Also, the initial Phase 2 portion of the trial, which looked at blood immune responses to vaccination, included a maximum of 22 people over age 68 in the 65-85-year-old group. It showed that older adults did not have noteworthy immune responses until after the second vaccination (page 27). With less robust immune responses in the elderly, extensive follow up on titers and how long they last is needed.
Children’s Health Defense is calling for further intense study overall, particularly for the elderly residential population and Blacks, before EUA of the Pfizer coronavirus vaccine.