Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have filed an application to the FDA for Emergency Use Authorization (EUA) for an additional COVID-19 vaccine booster dose in adults 65 years of age and older.
The two companies submitted two real-world data sets from Israel while the omicron variant was widespread.
Pfizer notes that an additional dose of the BNT162b2 vaccine enhanced protection against infections and severe illness.
One dataset involved patient records from the Israeli Ministry of Health involving more than 1.1 million adults at least 60 years old with no known prior COVID-19 infection eligible for a fourth dose booster. That data suggested that individuals receiving an additional dose were half as likely to be infected and had one-fourth the risk of contracting severe illness than those who had received a single booster.
The companies also submitted data from an ongoing, open-label, non-randomized study focused on healthcare workers in Israel at least 18 years old. Participants in that study had received at least three doses of the BNT162b2 vaccine. A total of 154 out of the 700 participants received a fourth dose four months or more after the first booster.
Neutralizing antibody titers from recipients of a fourth dose increased between roughly seven- and eightfold at two and three weeks compared to those who received three doses. Investigators drew blood from the remaining participants five months after receiving the third dose.
The companies said the recent data indicated no new safety concerns.
Moderna (NSDQ:MRNA) has also signaled that it will seek authorization for a fourth dose of COVID-19 vaccine as well.