The US Food and Drug Administration (FDA) has expanded authorisation for the Pfizer-BioNTech Covid-19 vaccine (BNT162b2) to include adolescents who are 12-15 years of age.
The FDA said it had amended the original emergency use authorisation (EUA) that was issued on 11 December 2020 to permit administration in individuals 16 years of age and older.
Acting FDA Commissioner Janet Woodcock said it was a significant step in the fight against the coronavirus pandemic.
“Today’s action allows for a younger population to be protected from Covid-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our Covid-19 vaccine emergency use authorizations,” commented Woodcock.
According to the FDA, the available safety data to support the expanded authorisation for BNT162b2, included 2,260 participants aged 12 through 15 years old enrolled in an ongoing randomised, placebo-controlled clinical trial in the US. Of these, 1,131 adolescent participants received the vaccine and 1,129 received a placebo. Over half of the participants were followed after their second dose for at least two months for safety reasons.
The FDA said that the side effects in adolescents receiving BNT162b2 were consistent with those reported in clinical trial participants aged 16 years and older.
Last week, Pfizer reported strong first-quarter results and issued an upbeat outlook. The US pharmaceutical giant raised its revenue guidance for 2021 to $70.5-$72.5bn versus its previous $59.4-$61.4bn estimate, with most of the increase due to higher-than-expected sales from BNT162b2, which it developed in partnership with German biotechnology firm BioNTech.
Yesterday, BioNTech was similarly boosted by robust results and guidance. It has set a target for full-year manufacturing capacity of BNT162b2 of at least 3 billion doses in 2021 and expects to exceed 3 billion in 2022.
While Pfizer shares are only modestly higher since the beginning of 2020, BioNTech’s stock has surged by about 400% during that time.