It is possible that the company's application will be submitted by Tuesday.
Pfizer data suggests that the vaccine, which is given to younger children at one-tenth of the adult dose, is safe and causes an immune response. Pfizer reported last year that the two-dose shot was less effective in preventing COVID-19 among children aged 2-5 years. To counter this, regulators encouraged Pfizer to add another dose to the study. This is in the belief that an additional dose will increase the vaccine's effectiveness in the same way booster doses in adults.
The Food and Drug Administration wants the company to submit its application using the two-dose data in February. Once it has data from the third dose study, it will return for additional authorization. If the FDA and Centers for Disease Control and Prevention approve the shots, young children may be vaccinated up to a month earlier than previously estimated.
To discuss sensitive regulatory issues, the person spoke under anonymity. According to the person, the decrease in effectiveness of the two dose vaccine was not surprising given the recent emergence of COVID-19's highly transmissible Omicron variant. The ability to give young children a two-dose shot sooner would allow them to get stronger protection with a third dose.
This would be a welcome development for parents of young children as it is the last age group to receive COVID-19 shots.
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While young children are less likely to get COVID-19 than adults, the number of cases has risen in this age group due to the increase in cases from the Omicron variant. The majority of cases and deaths are among older adults, particularly those who have not been vaccinated.
The Biden administration has made it a priority to speed up the approval of vaccines for children against COVID-19 for over a year. They believe they are crucial to reopening schools and keeping them open, and to free parents from child care responsibilities that could prevent them from returning to work.
U.S. regulators approved vaccines for children aged 5-12 in November. However, the uptake of shots was slower than officials expected.
Pfizer's primary series of drugs is given three weeks apart. The administration of the third dose to young children is currently being investigated. It should be administered at least two months following the first dose.
The Washington Post first reported news of the regulatory review.
