Pfizer and BioNTech are expected to seek authorization from the FDA for their COVID-19 shot for children younger than 5 as early as Feb. 8, which could make it the first vaccine available for the age group by the end of February, The Washington Post reported Jan. 31.
People familiar with the situation told the Post that a two-dose regimen would likely become available by the end of February for the age group while the drugmakers continue to analyze data on a three-dose regimen. Had the companies waited for data on a third shot, the vaccine would not have been available for young children until at least late March.
"We know that two doses isn't enough, and we get that," a person familiar with the situation who spoke on the condition of anonymity told the news outlet. "The idea is, let's go ahead and start the review of two doses. If the data holds up in the submission, you could start kids on their primary baselines months earlier than if you don't do anything until the third-dose data comes in."
Pfizer-BioNTech in December announced two doses of the vaccine in 2- to 4-year-olds did not generate an immune response comparable to what is generated in teens and adults. However, the two-dose regimen did trigger a protective immune response in children 6 months to 2 years. These findings prompted the drugmakers to add a third shot to the trial. The companies are expected to provide updated data when they submit their authorization request to the FDA.
Two more COVID-19 vaccine updates:
1. Moderna's COVID-19 vaccine became the second to gain full regulatory approval in the U.S. from the FDA Jan. 31. The vaccine will be marketed under the brand name Spikevax. The FDA granted full approval to Pfizer's vaccine Aug. 31, 2021.
2. Novavax on Jan. 31 announced it has officially submitted an emergency use authorization request to the FDA for its protein-based coronavirus vaccine, which is different from the mRNA technology in Pfizer and Moderna's vaccines.