FDA grants EUA to Pfizer-BioNTech Covid-19 booster shot for older population

EUA. Emergency Use Authorization. If this vaccine is approved why would the boosters require emergency use authorization?

A third vaccine dose is intended for people at high risk and those prone to institutional or occupational exposure to the virus.

Pharmaceutical Technology

FDA approves Pfizer Covid vaccine booster shot for older population

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.

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