Children aged from six months to five years may get their dose of the COVID-19 vaccine by the end of February this year, a person with knowledge of the plan said. Pfizer-BioNTech filed a submission for emergency use authorization to the Food and Drug Administration (FDA) for the COVID-19 vaccine designed for children aged six months to five years.
The FDA plans to begin reviewing the data on the two doses of the vaccine for the mentioned age group while Pfizer-BioNTech will gather data on a potential third dose. The agency will announce an advisory committee meeting on February 15 to discuss an emergency use authorization request.
"Having a safe and effective vaccine available for children in this age group is a priority for the agency, and we're committed to a timely review of the data," said acting FDA Commissioner Janet Woodcock.
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Clinical trial results
As per clinical trials last fall, findings revealed that the low doses of the vaccine provided immune protection in children up to two years. However, it failed to offer more vital resistant protection for kids aged two to five. In December, the companies announced that its clinical trials would include a third dose, which would cause a delay in the submission to the FDA.
The emergency use authorization may grant children the two-dose regimen. Eventually, children at the age of two to five would receive a third shot if clinical trial results would find it compelling.
Pfizer studied three microgram doses for the six-month to five-year age group. Older kids aged five to 11 can receive ten microgram doses, while children aged 12 and up can get 30 microgram doses.
NBC, however, reported that FDA is eventually expected to allow the three doses for kids below five years old. The report indicated the FDA regulators believed that two doses should provide enough protection, "though less than ideal" defense against the omicron variant.
Meanwhile, Pfizer announced Monday that they have not yet filed a submission to the FDA to allow its vaccine to children below five years old.
Collection and analyzing data from both two and three doses "in our younger age cohort is ongoing," Pfizer said. A reliable source said that the submission is expected this week, the NBC article revealed.
Protection against Omicron variant
According to the Centers for Disease Control and Prevention, the COVID-19 Omicron variant accounts for virtually all new COVID-19 cases in the US. It has also led to a significant increase in pediatric patients.
Only children age five and below are not allowed to receive COVID-19 vaccination, as authorities only allowed the vaccine of children aged five and up. Moderna and Johnson and Johnson are allowed in adults.
NBC News data estimated that there are 19.5 million children under the age of five in the US and Puerto Rico alone.
