Combating Omicron Requires 4th mRNA Vaccination

New York-based Pfizer Inc. and BioNTech SE recently announced the companies had submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of an additional (4th) booster dose adults 65 years of age and older who have received an initial (3rd) booster of any of the authorized or approved COVID-19 vaccines.

As of March 16, 2022, the Pfizer-BioNTech COVID-19 Vaccine is currently authorized as a single booster dose administered at least five months after completion of a primary two-dose series of the Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® to individuals 12 years of age and older. 

Emerging evidence, including data from Kaiser Permanente Southern California, suggests that effectiveness against symptomatic COVID-19 and severe disease caused by Omicron wanes 3 to 6 months after receiving an initial Pfizer-BioNTech COVID-19 Vaccine booster (third) dose.

Thus, additional booster doses may be needed to ensure individuals remain adequately protected, stated the press release.

The submission to the FDA includes real-world data from Israel analyzed when the initial Omicron variant (BA.1) was widely circulating.

A recent analysis of Israeli Ministry of Health records confirmed infections were two times lower and rates of severe illness were four times lower among individuals who received an additional booster dose of the Pfizer-BioNTech COVID-19 Vaccine administered at least four months after an initial booster (third) dose compared to those who received only one booster dose.

The Israeli COVID-19 dashboard reflects a declining number of Breakthrough Cases, hospitalizations, and deaths following the SARS-CoV-2 virus Omicron variant peak.

This data may not include current Omicron sublineage findings.

Haaretz reported on March 16, 2022, the Health Ministry confirmed cases of a combination of the BA.1 (omicron) and infectious BA.2 variants in Israel.

In the U.S., the CDC's NowCast reporting system indicates the BA.2 variant now accounts for 23% of SARS-CoV-2 infections.

Note: This press release was edited for clarity and curated for mobile readers.