Initial trial data for their COVID-19 vaccine in 5-11 year olds have been submitted to the U.S. Food and Drug Administration by top vaccine makers.
Pfizer Inc and BioNTech SE said on Tuesday that they have submitted the data and are now making a formal request to U.S. regulators for emergency use in the coming weeks, Reuters reported.
Earlier, the U.S. Food and Drug Administration had said that it would look to complete its data review for this age group as quickly as possible.
The exercise if expected to be completed in a matter of weeks rather than months, the agency said earlier this month. That could mean an authorization of the shot for children by the end of October, sources have told Reuters.
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The companies, however, have yet to start the official process for authorization, which could slow the decision. According to the Wall Street Journal, the FDA may not make its decision until sometime between Halloween and Thanksgiving, citing a person familiar with the matter.
A Pfizer spokesperson said the company expects to start and complete its application very soon.
A decision on the vaccine's use in younger children is eagerly awaited by millions of Americans as coronavirus infections have soared in children to the highest point in early September, according to data from the American Academy of Pediatrics.
The vaccine, which is already authorized for 12 to 15-year- olds 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 companies said on Sept. 20. read more
The Pfizer-BioNTech vaccine was authorized for the 12-15 age group roughly a month after the companies filed for authorization. If the same timeline is followed for this application, younger children could start receiving their shots as soon as late October.
A rapid authorization could help mitigate a potential surge of cases this fall, with schools already open nationwide.
While kids are less susceptible to severe COVID-19, they can spread the virus to others, including vulnerable populations that are more at risk of severe illness.
The companies said they plan to submit the data to the European Medicines Agency and other regulatory authorities. They also plan to submit data from the full late-stage trial for scientific peer-reviewed publication.
FDA Reserves Comments
The FDA was not immediately available to comment.
Data from the companies' trial showed the two-shot vaccine generated an immune response in children that matched what was previously observed in 16-to-25 year olds. The safety profile was also comparable to the older age group, Pfizer said.
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.
Moderna's COVID-19 vaccine is not yet authorized for use in adolescents in the United States, while it has gained authorization for that age group in Europe.
Both the Pfizer and Moderna vaccines have been linked by regulators to rare cases of heart inflammation in adolescents and young adults, particularly young men. Pfizer said no instances of heart inflammation were seen in the trial participants.