Children’s Health Defense (CHD) is raising significant concerns based on the briefing released for the U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee meeting Thursday, Dec. 10, to review the Pfizer coronavirus vaccine BNT162b2.
Less than 2.1 percent of the safety study cohort had been followed for over three months as of the Nov. 14 cutoff date. This is inadequate to determine any long-term effects of the vaccine. If the manufacturers allow vaccination of the placebo group after six months, 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 percent and 1.8 percent of the study cohort included patients 75 years old and over with pre-existing medical conditions, for the vaccinated and the placebo groups, respectively. There were only 41 total African Americans over age 75 in both arms of the Pfizer vaccine study. 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 percent (two-sided 95 percent confidence interval of -13.1 percent to 100.0 percent)….” 100 percent 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. 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.