Pfizer-BioNTech seeks EUA for fourth-dose COVID-19 vaccine for older adults
Pfizer-BioNTech seeks EUA for fourth-dose COVID-19 vaccine for older adults

Pfizer-BioNTech seeks EUA for fourth-dose COVID-19 vaccine for older adults

March 17, 2022

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Pfizer and BioNTech announced this week that they are seeking an FDA emergency use permit for an additional booster dose of their COVID-19 vaccine for older adults.

The companies have submitted an application for EUA for adults aged 65 or older who have already received a booster dose of any approved COVID-19 vaccine.


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Their submission was based on data from Israel, which showed that an additional dose of the vaccine increases immunogenicity, lowers the number of confirmed infections and lowers the number of serious diseases, according to a press release.

An analysis by the Israeli Ministry of Health of more than 1.1 million adults aged 60 years or older with no history of COVID-19 showed a reduced infection rate and serious illness after another booster. The incidence of confirmed infections was twice lower and the incidence of serious illness was four times lower among individuals who received the extra shot at least 4 months after a third dose compared to those who received only one booster dose.

An ongoing trial evaluating healthcare professionals aged 18 years or older who had received three doses of the vaccine showed that a fourth dose was safe and enhanced antibody levels similar to levels observed after a third dose, although companies noted that it did not appear to be someone more effective in preventing infection with omicron variant. The results were published in That New England Journal of Medicine on Wednesday.

According to the companies, none of the investigations generated any new security issues.

References:

Regev-Yochay G, et al. N Engl J Med. 2022; doi: 10.1056 / NEJMc2202542.

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