Pfizer and BioNTech Covid-19 Vaccine gets FDA approval to be used as a booster dose
Pfizer and BioNTech today announced that the U.S. Food and Drug Administration (FDA) has expanded the emergency use authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine to include individuals 18 years of age and older.
“As we near the two-year mark in our fight against COVID-19, we have reached another critical milestone with the expanded authorization of a booster dose of our COVID-19 vaccine in individuals 18 years and older,”Albert Bourla, Chairman and Chief Executive Officer, Pfizer
He continues, “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.”
“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,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “These data suggest a booster dose of our vaccine has the potential to maintain a high level of protection against tested variants, including Delta.”
The firms, last month, announced that the people who previously received the primary jabs of the Pfizer-BioNTech vaccine demonstrated a relative vaccine efficacy of 95% after getting booster shots than those who did not receive a booster.
The booster dose is to be administered at least six months after completion of the first two jabs and is the same dosage strength as the doses in the primary series.