According to a federal official and a source familiar with the procedure, the US Food and Drug Administration is likely to approve Pfizer’s COVID-19 vaccine for children aged 12 to 15 by next week, allowing many to get vaccines before the start of the next school year.
The announcement comes a month after the organisation discovered that its shot, which is already approved for those aged 16 and up, still offered security for the younger generation.
The federal official, who spoke on the condition of anonymity to preview the FDA’s decision, stated that the department planned to extend its emergency usage permit for Pfizer’s two-dose vaccine by early next week, if not sooner. The timeframe was verified by a source familiar with the procedure, who spoke on the condition of anonymity to discuss internal issues, and it is estimated that the FDA will allow Pfizer’s use of even younger children sometime this fall.
The FDA action would be accompanied by a meeting of a federal vaccine advisory committee to determine whether the shot should be recommended for children aged 12 to 15. After the Centers for Disease Control and Prevention accepts the committee’s decision, vaccinations could begin. Those measures should be completed within a few days.
The planned timeline for the authorization was first mentioned by the New York Times.
Pfizer published preliminary findings from a vaccination survey of 2,260 US volunteers aged 12 to 15 in late March, revealing that there were no cases of COVID-19 among fully vaccinated teenagers relative to 18 among those offered dummy shots.
According to the company, children experienced side effects comparable to young adults. Pressure, fever, chills, and fatigue are the most common side effects, particularly after the second dose. The research will continue to follow participants for the next two years in order to gather more knowledge about long-term protection and safety.
Pfizer isn’t the only organisation attempting to reduce the age requirement for the vaccine. A review of Moderna’s vaccine in 12- to 17-year-olds in the United States is also scheduled to produce results by the middle of this year.
However, as an indication that the results were positive, the FDA has now approved both firms to begin U.S. trials in children 11 and younger, with the aim of eventually reaching children as young as 6 months old.
More than 131 million doses of Pfizer’s vaccine have since been distributed in the United States, where adult vaccine production has slowed sharply in recent weeks.
Although younger people are at somewhat lower risk of severe COVID-19 side effects, they have made up a greater share of recent virus cases since the majority of U.S. adults have been at least partly vaccinated and higher-risk practises such as indoor dining and contact sports have resumed in the majority of the population. Officials hope that expanding vaccines to teenagers would hasten the nation’s virus caseload reduction and enable schools to reopen with limited disturbances this fall.
The United States has requested at least 300 million doses of the Pfizer vaccine by the end of July, which is enough to cover 150 million citizens.
