WASHINGTON – The US Food and Drug Administration is expected to approve Pfizer’s COVID-19 vaccine for teens 12-15 years old by next week next school year.
The announcement is to be made one month after the company has determined that its shot, which is already approved for people aged 16 and over, also offers protection for the younger group.
Speaking on condition of anonymity to preview the FDA’s actions, the federal official said the agency was expected to renew its emergency approval for Pfizer’s two-dose vaccine early next week and possibly even sooner. The person familiar with the process, who spoke on condition of anonymity to discuss internal matters, confirmed the schedule, adding that the FDA is expected to approve the use of Pfizer by even younger children this fall.
The FDA action will be followed by a federal vaccine advisory board meeting to discuss whether the shot is recommended for 12-15 year olds. Recordings could begin after the Centers for Disease Control and Prevention accepts the committee’s recommendation. These steps could be completed in a few days.
The New York Times reported for the first time on the expected time of approval.
In late March, Pfizer released preliminary results of a vaccine study of 2,260 US volunteers, ages 12-15, which found no cases of COVID-19 occurred in fully vaccinated teenagers, compared to 18 with dummy shots.
Children had side effects similar to those of young adults, the company said. The main side effects are pain, fever, chills, and fatigue, especially after the second dose. The study will follow participants for two years for more information on long-term protection and safety.
Pfizer isn’t the only company trying to lower the age limit on its vaccine. Results of a US study of Moderna’s vaccine in 12 to 17 year olds are also expected by mid-year.
As a sign that the results were promising, the FDA has already allowed both companies to begin US studies with children aged 11 and under, ranging up to 6 months of age.
More than 131 million doses of Pfizer vaccine have been administered in the US, where adult vaccine demand has slowed dramatically in recent weeks.
While younger people have a dramatically lower risk of serious side effects from COVID-19, they have made a greater proportion of new virus cases because the majority of adults in the US have been at least partially vaccinated and higher-risk activities such as indoor eating and contact sports are resumed in most of the country. Officials hope that expanding vaccinations to teenagers will further accelerate the country’s decreased viral loads and allow schools to reopen in the fall with minimal disruption.
The US has ordered at least 300 million doses of Pfizer by the end of July, enough to protect 150 million people.
Lemire reported from New York.
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