Covid-19: Pfizer asks US regulator to authorise fourth vaccine dose for over 65s

Pfizer and BioNTech have applied to the US Food and Drug Administration for emergency use authorisation for a fourth dose of its mRNA vaccine against covid-19 for adults aged 65 and older. The companies said that the additional dose reduced the rates of infection and severe illness in older adults. In a press release they said that they were seeking the new approval for adults over 65 who had received an initial booster of any of the authorised or approved covid-19 vaccines. Pfizer-BioNTech said that the request was based on “two real-world data sets from Israel analyzed at a time when the Omicron variant was widely circulating. These data showed evidence that an additional mRNA booster increases immunogenicity and lowers rates of confirmed infections and severe illness.” The companies said that an analysis of Israeli Ministry of Health records was conducted on over 1.1 million adults aged 60 and over who had no known history of SARS-CoV-2 infection and were eligible for a fourth vaccine dose. They wrote, “These data showed rates of confirmed infections were two times lower and rates of severe illness were four times lower among individuals who received an additional booster dose of the Pfizer-BioNTech covid-19 vaccine administered at least four months after an initial booster (third) dose compared to those who received only one booster dose.”