UNITED STATES: Pfizer/BioNTech submitted initial trial data to the Food and Drug Administration (FDA) to clear its COVID-19 vaccine for use in children aged 5 to 11, officials announced Tuesday.
The FDA is expected to take at least several weeks to analyze data collected in a trial that included more than 2,000 children before it would grant emergency use authorization.
“The FDA takes very seriously the importance of getting vaccines, shown to be safe and effective in children,” Dr Anthony Fauci, the nation’s leading infectious disease expert, told MSNBC’s “Morning Joe” show. “I would imagine in the next few weeks they will examine that data and hopefully give the O.K. so we can start vaccinating children hopefully by the end of October.”
Coronavirus infections have seen a spike among children, hitting their highest point in early September, according to data from the American Academy of Pediatrics.
The vaccine, which is already authorized in teens aged 12 to 15 and fully approved for ages 16 and up, induced a strong immune response in the target age group in a 2,268-participant clinical trial, the company said on Sept. 20.
The children in Pfizer’s trial were given two smaller doses of the vaccine than those given to those 12 and older, the company said. The vaccine caused similar side effects to those seen in people aged 16 to 25 and adults, which have included arm soreness and fatigue.
A formal submission to request emergency use authorization of Pfizer’s vaccine is expected to follow in the coming weeks, officials said in a release.
The Pfizer vaccine is the only COVID-19 vaccine available to Americans under 18. The drugmakers are also testing the vaccine in children aged 2-to-5 and those aged 6 months-to-2 years, with data expected in the fourth quarter.
In June, Moderna submitted data to the FDA to use its vaccine among adolescents aged 12 to 17, however, it has gained authorization for that age group in Europe. Johnson & Johnson is conducting clinical trials of its one-dose vaccine in younger recipients.