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The emergency authorizations of Pfizer’s and Moderna’s bivalent COVID-19 boosters are based on preliminary test results from only eight mice, and that data hasn’t even been made public.
Story at a glance:
- The emergency authorizations of Pfizer’s and Moderna’s bivalent COVID-19 boosters are based on preliminary test results from a grand total of eight mice, and that data hasn’t even been made public.
- Based on the antibody response in eight mice, the Biden administration has ordered 171 million doses of the two boosters.
- A reanalysis of data from the Pfizer and Moderna COVID-19 vaccine trials found that combined, the jabs were associated with a risk increase of serious adverse events of special interest at a rate of 12.5 per 10,000 vaccinated. Meanwhile, the risk reduction for COVID-19 hospitalization was only 2.3 per 10,000 participants for Pfizer and 6.4 per 10,000 for Moderna.
- According to a recent risk-benefit analysis of a third booster for university students, for each COVID-19 hospitalization prevented, the booster will cause 18 to 98 serious adverse events.
- A number of top officials with the U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC) and the National Institutes of Health reportedly have serious concerns about the direction we’re going in, yet are too afraid to speak out or push back.
On Aug. 31, the FDA authorized the reformulated COVID-19 bivalent booster shots by Moderna and Pfizer — all without the required convening of its Vaccines and Related Biological Products Advisory Committee (VRBPAC), which would typically discuss or vote on the authorization or approval of a new vaccine.
Instead, the FDA pushed the matter before the CDC’s Advisory Committee on Immunization Practices, or ACIP.
ACIP met for eight hours on Sept. 1 and authorized the untested boosters 13-to-1.
CDC director Dr. Rochelle Walensky endorsed the recommendation later that evening.
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