The FDA's authorization for a 4th COVID-19 vaccine is based on an Israeli study that says… exactly the opposite.
The strangest thing happened yesterday (March 29, 2022).
The FDA issued its authorization to administer a second booster dose for older and immunocompromised individuals , in which they state, without a blink of an eye, that: "a second booster… improves protection against severe COVID-19".
How do they know, you ask? Well, the only scientific reference they bring in their News Release  to support this straightforward claim is a recent Israeli study by Sheba Medical Center  that did not provide the proclaimed supporting results. In fact, this study (published on March 16, 2022, in the New England Journal of Medicine) did not address severe illness or older/immunocompromised populations, and its findings were used by its authors to conclude that the second booster (i.e., the fourth vaccination) "may have only marginal benefits" .
In practice, the vaccine efficacy against infections in this study ranged from 11% to 30%, for Moderna's and Pfizer's vaccines, respectively, and it was statistically insignificant for both vaccines. The reported efficacy against symptomatic disease (not severe illness!) was a little higher, but still much below the minimum required efficacy  (between 31% to 43% for Moderna and Pfizer, respectively), and still not statistically significant, as far as I can tell (the authors do not provide significance scores for symptomatic disease, but the study's supplementary material exposes an overlap between the confidence intervals of the booster group and the control group).
Indeed, the FDA states that "the evidence considered for authorization of a second booster dose… included… additional information on effectiveness submitted by the companies", but this information is not shared with us in this News Release.
So, in the meantime, considering (a) the insignificant results of the scientific study that is brought by the FDA, (b) the massive evidence regarding the failure of the vaccines to prevent COVID-19 infections [4-9] (especially today, following the outbreak of the Omicron variant), and (c) the ever-increasing and authenticated reports that the vaccines may trigger serious events, including immunological, cardiovascular, and neurological reactions [10, 11], I urge the scientific/medical community to question the FDA decision, and to reconsider the balance between the benefits and the risks of the novel, mRNA vaccines against COVID-19.
1. FDA, Coronavirus (COVID-19) Update: FDA Authorizes Second Booster Dose of Two COVID-19 Vaccines for Older and Immunocompromised Individuals. 2022, U.S. Food and Drug Administration, News Release from: March 29, 2022. Last retrieved on March 30, 2022 from: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-second-booster-dose-two-covid-19-vaccines-older-and.
2. Regev-Yochay, G., et al., Efficacy of a Fourth Dose of Covid-19 mRNA Vaccine against Omicron. New England Journal of Medicine, 2022.
3. WHO, Vaccine efficacy, effectiveness and protection. 2021, World Health Organization (WHO). Last retrieved on March 31, 2022 from: https://www.who.int/news-room/feature-stories/detail/vaccine-efficacy-effectiveness-and-protection.
4. Brown, C.M., et al., Outbreak of SARS-CoV-2 infections, including COVID-19 vaccine breakthrough infections, associated with large public gatherings—Barnstable County, Massachusetts, July 2021. Morbidity and Mortality Weekly Report, 2021. 70(31): p. 1059.
5. CDC, V.B.C.I.T., COVID-19 Vaccine Breakthrough Infections Reported to CDC—United States, January 1–April 30, 2021. Morbidity and Mortality Weekly Report, 2021. 70(21): p. 792.
6. Servellita, V., et al., Predominance of antibody-resistant SARS-CoV-2 variants in vaccine breakthrough cases from the San Francisco Bay Area, California. medRxiv, 2021.
7. Chemaitelly, H., et al., Waning of BNT162b2 vaccine protection against SARS-CoV-2 infection in Qatar. medRxiv, 2021: p. 2021.08.25.21262584.
8. Mizrahi, B., et al., Correlation of SARS-CoV-2 breakthrough infections to time-from-vaccine; Preliminary study. medRxiv, 2021.
9. Doshi, P., Does the FDA think these data justify the first full approval of a covid-19 vaccine? 2021, The British Medical Journal (BMJ) Opinion. Last retrieved on September 12, 2021, from: https://blogs.bmj.com/bmj/2021/08/23/does-the-fda-think-these-data-justify-the-first-full-approval-of-a-covid-19-vaccine/?fbclid=IwAR0SLXO2N-vHI-6pOSsNBj0o4dRKMDgR70iYd2Qlqm2ZcaYgHZMCQkPKzs8.
10. McLachlan, S., et al., Analysis of COVID-19 vaccine death reports from the Vaccine Adverse Events Reporting System (VAERS) Database Interim: Results and Analysis. 2021.
11. Rose, J., A Report on the US Vaccine Adverse Events Reporting System (VAERS) of the COVID-1 9 Messenger Ribonucleic Acid (mRNA) Biologicals. Science, Public Health Policy, and The Law, 2021. 2: p. 59-80.
Screenshot from Regev-Yochay et al., 2022, New England Journal of Medicine, 2022