FDA gives expanded EUA for Pfizer-BioNTech Covid-19 vaccine booster dose

The expanded EUA allows the administration of booster dose to individuals of 18 years of age and older who have received primary dosages.

With the same dosage strength as the primary series, the booster dose is approved to be administered after minimum six months of receiving the primary doses.

Pfizer chairman and CEO Albert Bourla said: “With boosters, more adults will now have the opportunity to help preserve a high-level of protection against this disease.

“We are grateful to the FDA for their rigorous review, and the action taken today that we hope will help accelerate our path out of this pandemic.”

The expanded authorisation follows October announcement of results from a Phase III Covid-19 booster dose trial that showed individuals who were given a  booster dose, following the completion of Pfizer-BioNTech primary two-dose series, had relative vaccine efficacy of 95% compared with people who were not given a booster dose.

Commenting on the latest development, BioNTech CEO and co-founder Ugur Sahin added: “Today’s FDA decision is supported by clinical data showing robust immune responses following a booster dose of our vaccine, exceeding what has been seen even after the completion of the highly-effective two-dose primary schedule.”

“These data suggest a booster dose of our vaccine has the potential to maintain a high-level of protection against tested variants, including Delta.”

Under their existing supply agreement with the US government through April 2022, Pfizer and BioNTech will supply Covid-19 vaccine, including booster doses.

The US FDA previously authorised Pfizer-BioNTech Covid-19 vaccine booster for emergency use in persons of 65 years of age and older, persons between the age of 18 and 64 years at high risk of severe Covid-19, and persons aged between 18 and 64 years with frequent occupational exposure to SARS-CoV-2.

It was also authorised by the agency for emergency use in eligible individuals who received primary vaccination with other authorised Covid-19 vaccines.