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Pfizer and BioNTech announced Thursday that the companies' COVID-19 had received emergency use authorization (EUA) from the Food and Drug Administration (FDA) for individuals 16 years of age and older.
The dose is to be administered at least six months following completion of the primary series and is the same formulation and dosage strength as the doses in the primary series.
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The move marks the first EUA for a COVID-19 vaccine booster in that age group.
"Today’s decision by the FDA to further expand the Emergency Use Authorization of a booster dose of our COVID-19 vaccine is a critical milestone as we continue to stay vigilant in addressing the virus," Pfizer CEO Albert Bourla said in a statement. "While new variants, including omicron, emerge across the globe, we believe that the best way to minimize the spread of COVID-19 and any future variants is getting all eligible people fully vaccinated with the first two dose series and a booster dose as recommended."
Dr. Manjul Shukla transfers Pfizer COVID-19 vaccine into a syringe, Thursday, Dec. 2, 2021, at a mobile vaccination clinic in Worcester, Mass. (AP Photo/Steven Senne)
"The booster vaccination increases the level of immunity and dramatically improves protection against COVID-19 in all age groups studied so far," BioNTech CEO and co-founder Ugur Sahin said. "In the current situation, it is important to offer everyone a booster, particularly against the background of the newly emerging variants such as omicron."
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In November, the FDA authorized a booster dose of the Pfizer-BioNTech COVID-19 vaccine for emergency use after completion of a primary series in individuals 18 and older.
"Authorizing the use of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccine for individuals 18 years of age and older helps to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalization and death," acting FDA Commissioner Janet Woodcock said in a Nov. 19 statement.
Woodcock said Thursday that vaccination remains the best method for fighting COVID-19.
"Vaccination and getting a booster when eligible, along with other preventive measures like masking and avoiding large crowds and poorly ventilated spaces, remain our most effective methods for fighting COVID-19," she said"As people gather indoors with family and friends for the holidays, we can’t let up on all the preventive public health measures that we have been taking during the pandemic. With both the delta and omicron variants continuing to spread, vaccination remains the best protection against COVID-19."
Pfizer and BioNTech said the companies plan to submit a Biologics License Application (BLA) for approval of booster doses of their COVID-19 vaccine in individuals 16 and older, including efficacy and safety data from a Phase 3 trial. The data showed that a 30-micrometer booster dose administered to more than 10,000 individuals 16 and older who had previously received the Pfizer-BioNTech primary two-dose series "demonstrated a relative vaccine efficacy of 95% when compared to those who did not receive a booster."
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"These are the first efficacy data disclosed from any randomized, controlled COVID-19 vaccine booster trial," the release noted. "The adverse event profile was generally consistent with other clinical safety data for the vaccine, with a favorable safety profile."