Pfizer, BioNTech seek EUA for fourth COVID vax dose

March 16, 2022

Pfizer and BioNTech are asking the U.S. FDA for Emergency Use Authorization of an additional booster dose in adults 65 and older.

With their application, the companies included two real-world data sets collected at the time when the omicron variant was circulating in Israel. Results were consistent among both and showed that an additional mRNA booster increased protection and lowered infection rate and severe illness.

Researchers have looked at Israel for data on the efficacy of extra boosters, as the country’s Ministry of Health was among the first to offer a fourth shot to older individuals.

Although general results have been mixed, in their submission to the FDA, the companies included large-observational studies that also demonstrate a correlation between the fourth jab and reduced infection severity.

The Pfizer-BioNTech COVID-19 jab, based on BioNTech’s proprietary mRNA technology, was developed by both companies. We first heard of their partnership back in March of 2020, and despite some challenges the two have faced together — like hackers tapping into their data later that year — 329 million Pfizer-BioNTech vaccine doses have been administered in the U.S. alone.

More recently, the two announced they would begin trials for a new omicron-specific COVID-19 vaccine.