Pfizer on Friday asked the FDA for an amendment to its emergency use authorization of its Covid-19 vaccine to expand its use in people ages 12-15 in the United States.
(CNN) — Pfizer on Friday asked the FDA for an amendment to its emergency use authorization of its Covid-19 vaccine to expand its use in people ages 12-15 in the United States. “It’s highly likely” that the FDA will allow the expansion and could act “relatively quickly,” the acting chairman of an FDA vaccine advisory committee said. “It’s highly likely, if the data submitted support it,” said Dr. Arnold Monto, a professor of epidemiology at the University of Michigan who is serving as acting chairman of the advisory committee for its review of the Covid-19 vaccines. “I think it could be done relatively quickly.” The pharmaceutical company said in a statement it will seek similar rulings by other authorities around the world in coming days. “These requests are based on data from the pivotal Phase 3 trial in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, which demonstrated 100 percent efficacy and robust antibody response after vaccination with the COVID-19 Vaccine,” Pfizer said in a statement. The FDA currently allows the vaccine’s use in people 16 and up. The FDA likely won’t ask the committee Monto chairs — the Vaccines and Related Biological Products Advisory Committee — to meet to discuss expanding the use of Pfizer’s vaccine, he said. “They’re not going to have advisories every time they tweak things,” Monto said. The other two Covid-19 vaccines — made by Moderna and Johnson & Johnson — are authorized for emergency use in people age 18 and older. Meanwhile, as the country races against Covid-19 variants, more than 1 in 4 adults are now fully vaccinated. While more than 66 million people have received two doses, more than a third of Americans — or 112 million — have received at least one dose, according to data published Thursday by the US Centers for Disease Control and Prevention. Officials and experts hope to get Americans vaccinated quickly as lockdown fatigue takes its toll and many people are letting down their guard just as more transmissible, and perhaps more deadly, variants of the virus become dominant. In that effort, all 50 states have committed to opening vaccinations to all Americans 16 and up by April 19. “It’s almost a race between getting people vaccinated and this surge that seems to want to increase,” Dr. Anthony Fauci said earlier this week, noting Europe is experiencing a spike much like the one experts worry about for the US. The US added 79,878 new cases Thursday, the highest since March 24.
