U.S. Food and Drug Administration
Moderna says its COVID-19 shot works in kids as young as 12
Moderna said Tuesday its COVID-19 vaccine strongly protects kids as young as 12, a step that could put the shot on track to become the second option for that age group in the U.S.
With global vaccine supplies still tight, much of the world is struggling to vaccinate adults in the quest to end the pandemic. But earlier this month, the U.S. and Canada authorized another vaccine — the shot made by Pfizer and BioNTech — to be used starting at age 12.
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Moderna aims to be next in line, saying it will submit its teen data to the U.S. Food and Drug Administration and other global regulators early next month.
The company studied more than 3,700 12- to 17-year-olds. Preliminary findings showed the vaccine triggered the same signs of immune protection in kids as it does in adults, and the same kind of temporary side effects such as sore arms, headache and fatigue.
There were no COVID-19 diagnoses in those given two doses of the Moderna vaccine compared with four cases among kids given dummy shots. In a press release, the company also said the vaccine appeared 93% effective two weeks after the first dose.
While children are far less likely than adults to get seriously ill from COVID-19, they represent about 14% of the nation’s coronavirus cases. At least 316 have died in the U.S. alone, according to a tally by the American Academy of Pediatrics.
Read: EU commission greenlights Moderna’s COVID-19 vaccine
With plenty of vaccine supply in the U.S., younger teens flocked to get Pfizer’s shot in the days after FDA opened it to them, part of a push to get as many kids vaccinated as possible before the next school year.
Both Pfizer and Moderna have begun testing in even younger children, from age 11 down to 6-month-old babies. This testing is more complex: Teens receive the same dose as adults, but researchers are testing smaller doses in younger children. Experts hope to see some results in the fall.
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FDA expected to OK Pfizer vaccine for teens within week
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.
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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.
Read Also: Pfizer says its COVID-19 vaccine protects younger teens
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.
Read Also: Hong Kong halts use of Pfizer vaccine, cites defective lids
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.
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