The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Pfizer and BioNTech’s Covid-19 vaccine booster dose for people aged 65 years and above.
The booster dose is also intended for people aged 18 to 64 years at increased risk of severe Covid-19, as well as for people whose regular institutional or occupational exposure to SARS-CoV-2 places them at an increased risk of serious complications of the infection, including severe disease.
Administered at a minimum of six months following inoculation with the two-dose regimen, the booster shot will have the same formulation and dosage strength as the initial series vaccines.
The latest authorisation is based on the totality of scientific data submitted by Pfizer and BioNTech, which was analysed by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the FDA.
The evidence included results from the Pfizer-BioNTech clinical programme assessing the safety, tolerability and immunogenicity of the booster shot.
According to the results, the booster shot induced substantially increased neutralising antibody titers against the wild type SARS-CoV-2 virus and the Beta and Delta variants when compared to the levels reported after the initial series.
Furthermore, a mild-to-moderate reactogenicity profile was observed within seven days after the booster while the incidence of reactions was in line with or lower than after the second vaccine dose.
The adverse event profile of the booster was similar to other clinical safety data for the shot.
BioNTech CEO and co-founder Ugur Sahin said: “Today’s emergency use authorization is supported by clinical data underlining that a booster induces a strong immune response against tested variants of concern and can address a current public health need.
“We and our collaboration partner have submitted booster data to other regulatory agencies around the world.”
Last month, the FDA revised EUA for the Pfizer-BioNTech’s Covid-19 vaccine to enable the use of a third dose in some immunocompromised people.
Separately, Pfizer and BioNTech intend to extend their agreement with the US Government by delivering an additional 500 million doses of the vaccine at a not-for-profit price for donation to low and lower-middle-income nations and the organisations that support them.
The latest agreement takes the number of doses to be supplied to the government for donation to these countries to a total of one billion.