Pfizer and BioNTech announced Tuesday that they applied for U.S. Food and Drug Administration Emergency Use Authorization for a fourth dose of their COVID-19 vaccine for seniors age 65 and older.
According to a press release from Pfizer, the submission was based off “real-world safety and efficacy data from Israel,” and data showed that confirmed infection rates were two times lower for those who received the second booster dose. Rates of severe illness were four times lower.
As of March 13, people age 65 and older did not account for most COVID-19 illnesses in the U.S., according to Centers for Disease Control and Prevention data.
By January of this year, the FDA had given full approval to Pfizer’s initial two-dose COVID-19 vaccine sequence, as well as third booster doses for children as young as 12 and third initial sequence doses for immunocompromised people. Those immunocompromised people have already been able to get a fourth dose as their booster shot.
Pfizer and BioNTech’s data regarding another booster dose was collected during the omicron variant surge, which began in November of last year and lasted through the holiday season.
“An analysis of Israeli Ministry of Health records was conducted for over 1.1 million adults 60 years of age and older who had no known history of SARS-CoV-2 infection and were eligible for an additional [booster],” said Pfizer. The fourth vaccine booster doses were administered at least four months after an initial booster dose.
Results “from an ongoing, open-label, non-randomized clinical trial in healthcare workers 18 years of age and older at a single study center in Israel,” who had received third booster doses were also included. Out of 154 who received a fourth booster dose, “neutralizing antibody titers increased approximately 7-fold to 8-fold at two and three weeks after the additional booster,” according to Pfizer. Additionally, there was an 8-fold and 10-fold increase in neutralizing antibody titers against the Omicron variant at one and two weeks after the additional booster dose.
No safety concerns were revealed by the study.
According to the CDC, close to 67% of people age 65 and older in the U.S. have already received a third booster dose of a COVID-19 shot. Close to 89% had received two doses and more than 95% had received at least one dose.
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