Pfizer and BioNTech Ask Federal Regulators to Authorize Booster Shot For 18 and Older
On Nov. 9, Pfizer and BioNTech asked federal regulators to authorize their coronavirus booster shot for those 18 and older. On Oct. 20, the FDA announced it had taken action to expand the use of a booster dose for COVID-19 vaccines in certain populations, including the use of each of the available COVID-19 vaccines as a heterologous booster dose.
A press release states that “Pfizer Inc. and BioNTech SE today announced they have submitted a request to amend the U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for a booster dose of their COVID-19 vaccine to include all individuals 18 years of age and older. The amendment request is based on results from a Phase 3 randomized, controlled trial evaluating the efficacy and safety of a 30-µg booster dose of the vaccine, which enrolled more than 10,000 participants during a period when the Delta variant was the prevalent strain.”
Further, “A booster dose of the Pfizer-BioNTech COVID-19 Vaccine is currently authorized by the FDA for emergency use after completion of a primary series in individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19, and individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2, as well as eligible individuals who have completed primary vaccination with a different authorized COVID19 vaccine. Booster eligibility and schedule are based on the labeling information of the vaccine used for the primary series.”
“Data from the Phase 3 booster trial have been shared with the European Medicines Agency (EMA) and other regulatory authorities,” the release continues. “A booster dose of the vaccine is approved in the European Union and authorized/approved in other countries for individuals 18 years of age and older based on previously submitted safety, tolerability and immunogenicity data, with recommendations for populations varying based on local health authority guidance.”
An article from The New York Times by Sharon LaFraniere states that “For younger, healthy people, the benefits of a booster injection will be marginal, according to Dr. Eric Rubin, a member of the F.D.A.’s advisory panel and an adjunct professor of immunology at the Harvard T. H. Chan School of Public Health.”
LaFraniere writes that “Even so, some leading experts argue that the case for booster shots has grown stronger. Dr. Nahid Bhadelia, director of Boston University Center for Emerging Infectious Diseases Policy and Research, said that ‘there’s some stronger data’ now than there was in September, when the F.D.A. advisory committee rejected Pfizer’s initial request.”
“She added, ‘I think that the boosters now seem to look like they may help prevent severe disease for a lot more people than we thought previously,’” LaFraniere reports.
LaFraniere adds that, “Moderna could follow with a request much like Pfizer’s. But winning authorization may be more complicated because of concerns about rare cases of myocarditis, especially in men under the age of 30 who have received two doses of Moderna’s vaccine. Similar concerns have been raised about the Pfizer-BioNTech vaccine, but to a lesser extent.”
