Pfizer and BioNTech said Tuesday that they had submitted data to the US Food and Drug Administration for emergency use permission of its COVID-19 vaccine for children aged six months to 4 years.
The firms added that data on a third dosage of the vaccine for children under the age of five would be available in the coming months, completing the authorization of what is likely to be a three-dose vaccination series for the youngest age group.
The FDA said Tuesday that a committee that advises the agency will meet on Feb. 15 to debate whether to approve Pfizer’s COVID-19 vaccination for children under five. Following the FDA’s approval, a group that advises the US Centers for Disease Control and Prevention meets to examine whether a vaccination series should be recommended. Parents of newborns and preschoolers will be allowed to begin the process of vaccinating their children against COVID-19 if the CDC adopts the recommendation.
COVID-19 vaccination is already available to children aged five and higher.
While two doses of the vaccine were proven successful in children aged six months to 2 years in a prior study, two injections failed to produce a robust immune response in children aged 2 to 4 years. As a result, the firm began testing a three-dose vaccination for youngsters under five. However, while regulators await evidence to license three doses of the vaccine (data not expected until this spring), public health experts are working to have two doses approved so that younger children can be fully immunized sooner.
Pfizer’s vaccination for children under the age of five is three micrograms in size, or one-tenth the size of the company’s vaccine for adults. In addition, the vaccination is one-third the size of an adult vaccine for children aged 5 to 11.
Pfizer claimed in December that there were no safety issues in the trial for children under the age of five. However, the business will submit the data to the FDA for approval of the three doses if three doses of the vaccine for children are efficacious.
Given the two-dose vaccination series’ glitch among 2 to 4-year-olds, Pfizer’s FDA submission came a bit sooner than public health authorities had anticipated. However, it represents the significant incidence of COVID-19 instances in children caused by the omicron variation and worries about long-term COVID and multi-inflammatory syndrome in young children.