Pfizer Inc and BioNTech SE released preliminary trial data for their COVID-19 vaccine in children aged 5 to 11 years old on Tuesday and said they would file a formal request for emergency use to US regulators in the following weeks.
The US Food and Drug Administration announced earlier this month that it would try to finish its data evaluation for this age group as soon as possible, presumably in weeks rather than months. According to Reuters, this could suggest that the shot for youngsters will be approved by the end of October.
However, the corporations have yet to begin the formal authorization process, which might delay the decision. The FDA may not make a decision until somewhere between Halloween and Thanksgiving, according to the Wall Street Journal, citing a source familiar with the situation.
According to a Pfizer spokeswoman, the company plans to begin and complete its application as soon as possible.
Millions of Americans are waiting for a decision on whether the vaccine should be used in younger children, as coronavirus infections in children reached an all-time high in early September, according to data from the American Academy of Pediatrics.
In a 2,268-person clinical trial, the vaccine, which is already approved for 12 to 15-year-olds and completely approved for ages 16 and up, generated a significant immune response in the target age group, the firms reported on Sept. 20.
A month after the firms petitioned for approval, the Pfizer-BioNTech vaccine was approved for the 12-15 age range. If the same schedule is followed for this application, younger children could begin receiving shots as early as late October.
With schools already open across the country, a quick approval could help prevent a potential influx of cases this fall. While children are less sensitive to severe COVID-19, they can disseminate the virus to others, including vulnerable populations.
The companies intend to submit the data to the European Medicines Agency and other regulatory bodies, according to the companies. They also intend to submit data from the entire late-stage experiment for publication in a professional peer-reviewed journal.
The FDA did not respond to a request for comment right away. The two-shot vaccine elicited an immunological response in youngsters that mirrored what had previously been seen in 16-to-25-year-olds, according to data from the firms’ experiment. According to Pfizer, the safety profile was comparable to that of the older age group.
The vaccine is also being tested in children aged 2 to 5 years old and those aged 6 months to 2 years old, with results due in the fourth quarter.
The COVID-19 vaccine from Moderna is not yet approved for use in adolescents in the United States, but it has been approved for that age group in Europe.
Regulators have connected the Pfizer and Moderna vaccines to rare incidences of heart inflammation in adolescents and young adults, particularly young males. The trial participants showed no signs of heart irritation, according to Pfizer.