FDA Expected to OK Pfizer Vaccine for Teens Within Week
WASHINGTON (AP) — The U.S. Food and Drug Administration is expected to authorize Pfizer’s COVID-19 vaccine for youngsters ages 12 to 15 by next week, according to a federal official and a person familiar with the process, setting up shots for many before the beginning of the next school year.
The announcement is set to come a month after the company found that its shot, which is already authorized for those age 16 and older, also provided protection for the younger group.
The federal official, speaking on the condition of anonymity to preview the FDA’s action, said the agency was expected to expand its emergency use authorization for Pfizer’s two-dose vaccine by early next week, and perhaps even sooner. The person familiar with the process, who spoke on condition of anonymity to discuss internal matters, confirmed the timeline and added that it is expected that the FDA will approve Pfizer’s use by even younger children sometime this fall.
The FDA action will be followed by a meeting of a federal vaccine advisory committee to discuss whether to recommend the shot for 12- to 15-year-olds. Shots could begin after the Centers for Disease Control and Prevention adopts the committee’s recommendation. Those steps could be completed in a matter of days.
The New York Times first reported on the expected timing for the authorization.
Pfizer in late March released preliminary results from a vaccine study of 2,260 U.S. volunteers ages 12 to 15, showing there were no cases of COVID-19 among fully vaccinated adolescents compared with 18 among those given dummy shots.
Kids had side effects similar to young adults, the company said. The main side effects are pain, fever, chills and fatigue, particularly after the second dose. The study will continue to track participants for two years for more information about long-term protection and safety.
Pfizer isn’t the only company seeking to lower the age limit for its vaccine. Results also are expected by the middle of this year from a U.S. study of Moderna’s vaccine in 12- to 17-year-olds.
But in a sign that the findings were promising, the FDA already allowed both companies to begin U.S. studies in children 11 and younger, working their way to as young as 6 months old.
More than 131 million doses of Pfizer’s vaccine have already been administered in the U.S., where demand for vaccines among adults has dramatically slowed in recent weeks.
While younger people are at dramatically lower risk of serious side effects from COVID-19, they have made up a larger share of new virus cases as a majority of U.S. adults have been at least partially vaccinated and as higher-risk activities like indoor dining and contact sports have resumed in most of the country. Officials hope that extending vaccinations to teens will further accelerate the nation’s reduced virus caseload and allow schools to reopen with minimal disruptions this fall.
The U.S. has ordered at least 300 million doses of the Pfizer shot by the end of July, enough to protect 150 million people.
Lemire reported from New York.
In The News
Over the last two weeks, China and the U.S. have made dueling comments about whether Taiwan should be admitted to this year's World Health Assembly, the meeting where priorities and policies of the World Health Organization are set, which will be held later this month. U.S.... Read More
WASHINGTON (AP) — U.S. restaurants and stores are rapidly raising pay in an urgent effort to attract more applicants and keep up with a flood of customers as the pandemic eases. McDonald's, Sheetz and Chipotle are just some of the latest companies to follow Amazon, Walmart ... Read More
The Centers for Disease Control and Prevention issued new guidance that people who are fully vaccinated against COVID-19 can safely resume life without any restrictions. "The science is clear: if you are fully vaccinated, you are protected, and you can start doing the things that you... Read More
WASHINGTON -- Infectious disease experts urged Congress Wednesday to move quickly to vaccinate Americans before the COVID-19 virus mutates to become more dangerous. Without fast action to create herd immunity, emerging virus strains could make current vaccines less effective, experts told the House Science, Space and... Read More
The White House is stepping up its efforts to encourage the parents of adolescents age 12-15 to get their kids vaccinated against COVID-19.Earlier this week, the Food and Drug Administration expanded the emergency use authorization for the Pfizer BioN-Tech vaccine to include individuals ages 12-15. On... Read More
Researchers from Emory University are working on a National Institutes of Health-supported project to develop a sensor capable of detecting COVID-19 in the air, called Rolosense. “It’s tricky to anticipate what the real-world implementation will be of this technology, but we anticipate this will fill a... Read More