The FDA said children that are part of the clinical trials ‘should be monitored for at least two months for side effects.’
Pfizer and BioTech might soon be applying for emergency use approvals (EUA) for its vaccine to be administered to children who are between the ages of 5-11 years. According to recent news reports, the US Food and Drug Administration (FDA) might be inclined to authorise them as well. The approvals might come as soon as October.
Recently, the Pfizer vaccine was approved by the FDA as the first COVID-19 vaccine in the US. It is not sold and administered under the name Comirnaty. The vaccine is effective in preventing COVID-19 in people who are 16 years and older. It is available via EUA for children who are 12-15 years and as a third dose (aka booster shot) for certain people who are immunocompromised.
Reuters reported that the FDA said children that are part of the clinical trials “should be monitored for at least two months for side effects.”
There is speculation that the FDA will make its decision based on the results, within three weeks after Pfizer submits it EUA request.
Such emergency authorization requires companies to submit two months of safety data on trial participants, versus six months required for full licensure.
The vaccine chief Dr Peter Marks told The Associated Press that he is “very, very hopeful” that vaccinations for 5-11 year olds will be underway by the end of this year as Pfizer is expected to submit its results by the end of September.
During an online town hall meeting, Anthony Fauci, the chief medical adviser to President Joe Biden and director of the National Institute of Allergy and Infectious Diseases, said that Pfizer’s vaccine could be available for children by October. The approval for Moderna’s vaccine could come by November as it will take about three weeks longer to collect and analyze data for ages 5-11.
Pfizer’s German partner BioNTech told weekly Der Spiegel Friday that it was on track “in the coming weeks” to seek approval of the companies’ COVID-19 vaccine for 5 to 11 year-olds. Moderna, which makes a second US vaccine, told investors this week to expect its data on that age group by year’s end. Both companies also are testing their vaccines down to age 6 months, but those results will come later.
The FDA recently released a statement talking about the approval process and the use of vaccines for kids. They said. “Children are not small adults – and issues that may be addressed in pediatric vaccine trials can include whether there is a need for different doses or different strength formulations of vaccines already used for adults.”
The statement states that since young children are still growing and developing, it is important for clinical trials to evaluate the safety and immune response to a COVID-19 vaccine.
With inputs from agencies