Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced that they plan to extend their rolling submission to the U.S. Food and Drug Administration (FDA) for amending emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine to include children between 6 months and 4 years.
Shares of Pfizer and BioNTech fell 1.7% and 5%, respectively, on NYSE at the time of writing.
While the trial on children is ongoing, data is being pooled in fast as the Omicron-variant has been affecting this age group at a higher rate and is causing infection and illness. The data is being shared with the FDA on an ongoing basis.
The key reason for the delay is that Pfizer and BioNTech seek to wait for the three-dose data, as they believe it will provide better protection to children. The data is expected to be available by early April.
In December 2021, the companies had announced plans to evaluate a third 3 µg dose at least two months after the second dose of the two-dose series in this age group.
The companies also mentioned that the independent Data Monitoring Committee supports the continuation of the trial and believes that the data collected to date indicate the vaccine is well tolerated and supports a potential three-dose regimen.
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