A bipartisan coalition in Congress has sent a letter to the Food and Drug Administration (FDA) asking the agency about the status of its authorization for COVID vaccines for kids below 12 years old.
Led by Rep. Ro Khanna and Rep. Katie Porter of California, the lawmakers said that the rise in pediatric cases have been "alarming for parents" as children in the ages of 2 to 11 years old are attending schools and daycare sessions while vaccine continues to be unavailable for this age group.
One of the key questions the lawmakers asked from the FDA was about the length of time it will take for the agency to review the data expected from vaccine makers like Pfizer and Moderna. The representatives also want to know if the studies by these pharmaceutical companies include "recommended childhood vaccination schedules for non-COVID illnesses" and if this will impact safe vaccine distribution. The lawmakers want the FDA to provide them a briefing.
It comes as the FDA has asked Pfizer and Moderna to enroll more children in their vaccine trials for 5 to 11 years old, which will essentially delay the release of their trials' findings. Before this request to increase the number of participants, both vaccine makers have expressed that the results should be ready by September.
On August 12, the American Academy of Pediatrics learned that pediatric cases made up 14.4 percent of all COVID-cases in recent months. The experts also found out that the number of cases in schools is gradually increasing as in-person classes have resumed all over the country.
FDA Full Approval for Pfizer
On Monday, August 23, the FDA announced that Pfizer had received the first full approval for the COVID-19 vaccine, which will be commercially known as Comirnaty. This vaccine will be eligible for individuals 16 years old and older.
Pfizer's vaccine for individuals ages 12 to 15 will continue with an emergency use authorization (EUA) while administering a third dose or booster shot for immunocompromised individuals is also still under EUA.
As a commercially viable vaccine, Comirnaty will carry the same formulation as the Pfizer vaccine with EUA, which has been administered to individuals in two doses in a span of three weeks.
Pfizer said that it will still require a longer duration for follow-up studies on the vaccine's safety and effectiveness for children below 16 years old before full approval. Together with the Centers for Disease Control and Prevention (CDC), the FDA said that it would continue to conduct safety monitoring of the vaccine outcomes, especially for covid vaccines for kids.
No Cominarty for Younger Children
Meanwhile, Pfizer's phase one trial for the COVID vaccine for kids below 12 years old comprised a lower dose. While adults and teens received 30 micrograms of the vaccine, kids in the ages of 5 to 11 years old will be given ten micrograms, and it's three micrograms for kids below five years old until six months.
According to the company's researchers, low doses in smaller bodies will mean fewer side effects. In the trials among adolescents, the researchers have also learned that children develop side effects more frequently than adults because of their immune systems.
With Comirnaty ready for commercial use, FDA commissioner Janet Woodcock warned that the vaccines must never be given to children under 12 since there are no proper dose recommendations or complete data from the pharmaceutical company's trials.
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