Finally, Pfizer has submitted the request to FDA to grant emergency use status to their vaccine for children. Here’s everything you should know about the vaccine.
Pfizer’s vaccine for children can enter the market anytime soon.(Courtesy of Ascannio)
Pfizer has submitted a request to the U.S. Food and Drug Administration to grant Emergency Use Authorization to its two-dose COVID-19 vaccine for children aged 6 months to 5 years. The submission comes after the FDA’s request to Pfizer. The FDA will hold an advisory committee meeting on February 15 to discuss the application.
Pfizer’s COVID-19 vaccine has been granted full approval from the FDA for its two-dose regimen in adults, including a third dose in people aged 12 and older. The company also holds emergency authorization for the use of the vaccine for children ages 5 and older in the U.S.
The approval of the emergency use of the vaccine for children of age 6 months and up has been magnified by the surge of COVID-19 cases from Omicron. Some studies have shown that infection in children from Omicron is more dangerous and requires hospitalization compared to previous variants.
Why do We Need a Vaccine for Children?
“The need for a safe and effective vaccine for our youngest children is significant, particularly given the rapid spread of the omicron variant, the notable rise in the number of hospitalizations in young children with severe disease, and the possibility that future variants could cause severe disease in those who are unvaccinated,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research in a press release.
If the FDA grants authorization, parents will have the opportunity to begin the two-dose regimen in young children. According to Pfizer, data on the third dose in this age group is still being collected and is pending submission to the FDA in the upcoming months. There are no safety concerns in using the vaccine for children. The FDA stated that they intend to make background material available to the public, including the meeting agenda and committee roster.
“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, which the agency asked Pfizer to submit in light of the recent Omicron surge. Furthermore, children are not small adults. Because they’re still growing and developing, it’s critical that these vaccines are evaluated in well-designed and well-conducted clinical trials,” said Acting FDA Commissioner Janet Woodcock, M.D.
In December 2021, Pfizer reported disappointing results across several phases of their clinical trial in 4,500 children under 12 years, stating that although the vaccine for children had a positive effect on the immune response of those aged 6 months to 24 months, the results were not replicated for those between the ages of 2 and 5. However, Pfizer is hopeful that administering a third dose in this age group, given at least two months after the initial series, will allow the vaccine to meet its immunogenicity endpoint.
“As hospitalizations of children under 5 due to COVID-19 have soared, our mutual goal with the FDA is to prepare for future variant surges and provide parents with an option to help protect their children from this virus,” said Pfizer CEO Albert Bourla in a statement. “Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants.”
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