The Food and Drug Administration may extend the use of Pfizer-BioNTech’s Covid-19 vaccine to children aged 6 months to 5 years by the end of February, a person with knowledge of the plan said. said.
Federal regulators want to start looking at two-dose vaccine data for this age group while the companies continue to collect data on a potential three-dose regimen, the person said.
In December, Pfizer said it was testing a third dose of the vaccine in an ongoing trial of young children after it found that the two-dose regimen does not produce a strong enough immune response in some children.
The FDA is expected to eventually register three doses for children under the age of 5, but regulators believe that two doses in the meantime will provide enough – although less than ideal – protection against the complication. omicrons, personally said.
The news was first reported by washington articles.
The FDA’s plan could help parents who want to get their kids vaccinated.
According to the Centers for Disease Control and Prevention, Omicron accounts for virtually all new Covid cases in the United States. New variants available leading to a significant spike in child cases.
Children under the age of 5 are the only group in the United States that is not authorized to receive the Covid vaccine. Pfizer’s vaccine has been delete for children under 5 years oldwhile Moderna and Johnson & Johnson’s vaccines are approved for use in adults.
Pfizer has yet to submit to the FDA for approval of the vaccine for children under the age of 5, the company said in a statement Monday. “We are continuing to collect and analyze data from both and three doses in our youth group,” the company said.
However, two people familiar with the plans said the submission is expected to happen this week, possibly as early as Tuesday.
According to NBC News, there are an estimated 19.5 million children under the age of 5 in the US and Puerto Rico.
Pfizer tested 3 microgram doses for the age group. Children aged 5 to 11 were allowed to receive a dose of 10 micrograms, while everyone 12 years of age and older received a dose of 30 micrograms.
Heidi Przybyla contribute.
https://www.nbcnews.com/health/health-news/covid-vaccine-pfizer-shot-kids-5-available-end-february-rcna14347 Pfizer shot for kids under 5 could be out at the end of February