Pfizer and BioNTech Submit EUA for Additional Booster Dose of COVID-19 Vaccine for Older Adults

Pfizer Inc and BioNTech have submitted an application to the FDA for Emergency Use Authorization (EUA) for an additional fourth booster dose of their COVID-19 vaccine for adults 65 years of age and older who received an initial booster of any of the authorized or approved COVID-19 vaccines.

The application follows the results of a pair of real-world Israeli data sets that were conducted during the timeframe in which the Omicron variant was spreading widely. Both data sets indicate that an additional mRNA booster increased immunogenicity and lowered rates of confirmed infections and severe illness, according to Pfizer and BioNTech.

An analysis of Israeli Ministry of Health records was conducted in more than 1.1 million adults 60 years of age and older with no known history of COVID-19 infection and who were eligible for a fourth dose of the vaccine. The data showed rates of confirmed infections were 2 times lower and rates of severe illness were 4 times lower among those who received a fourth booster dose of the Pfizer-BioNTech vaccine administered at least 4 months after the third booster dose compared to those who received only 1 booster dose.

Further, the EUA included results from an ongoing, open-label, non-randomized clinical trial conducted in health care workers 18 years of age and older at a single study center in Israel who were vaccinated with 3 doses of the Pfizer-BioNTech vaccine. Among 154 out of 700 individuals who received a fourth booster dose at least 4 months following the initial (third) booster, neutralizing antibody titers increased approximately 7- to 8-fold at 2 and 3 weeks following the fourth booster dose compared to 5 months after the third booster dose.

The investigators also found an 8- and 10-fold increase in neutralizing antibody titers against the Omicron variant (B.1.1.529) at 1 and 2 weeks following the additional (fourth) booster dose, respectively, compared to 5 months after the initial (third) booster.

Earlier this week, Pfizer CEO Albert Bourla said he expected people to need a fourth dose of the vaccine to prevent another wave of COVID-19 in an interview with Face the Nation.

”It is necessary a fourth booster, right now; the protection we are getting from the third is good enough; it is actually quite good for hospitalizations and deaths; it’s not that good against infections,” Bourla said during interview.

A Delta and Omicron hybrid variant was identified earlier this week called Delta 21J/AY.4-Omicron 21K/BA.1, which has been referred to as “Deltacron,” a recombinant virus because it contains genes from both variants. The variant appears to be the most contagious strain thus far, and some medical experts have called it as contagious as the measles.

Reference

Pfizer and BioNTech Submit for U.S. Emergency Use Authorization of an Additional Booster Dose of their COVID-19 Vaccine for Older Adults. Pfizer Inc. [news release]. March 15, 2022. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-us-emergency-use-authorization