The U.S. Congress is calling for the coronavirus management plan to deliberate on the timeline for the approval and release of vaccines for children under 5 years old.
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According to the
Centers for Disease Control and Prevention, three in four children were showing signs of COVID-19 infection as of February. Now, the United States Congress is calling on key stakeholders of the coronavirus management plan to deliberate on the timeline for the approval and release of vaccines for children under 5 years old.
In a letter to U.S. Food and Drug Administration commissioner Dr. Robert M. Califf, Congressman James E. Clyburn, the chairman of the Select Subcommittee on the Coronavirus Crisis, highlighted the importance of having a vaccine available for young children. He says that while the risk of contracting the virus is lower in kids than adults, around 1.5% of positive cases end up in hospitalizations. When the Omicron variant cases surged, children under 5 years were five times more prone to being hospitalized than the recorded peak numbers with the Delta variant.
As of this writing, the FDA is looking into two types of vaccines possible for the under 5 age group: Pfizer‘s three-dose candidate and Moderna’s two-dose product.
Moderna is reportedly preparing to apply for emergency use authorization by the end of April. However, talks that the FDA will not take action until Pfizer is ready with their own product, which is likely to happen around June, are causing Congress concern.
This is after Dr. Anthony Fauci, chief science adviser for the White House, said that the FDA wants to consider both EUAs together when both are filed instead of evaluating them separately in order to avoid “confusion” with the different dosage requirements and reactions to the two vaccines.
“Such a decision could delay the potential authorization and administration of the Moderna vaccine by several weeks....I write today to request a staff briefing on the status of coronavirus vaccine candidates for young children,” Clyburn said.
The committee is asking the FDA to attend a staff briefing on May 9, 2022, to discuss concerns about the delay and the scientific rationale for the decision.
Moderna‘s COVID-19 vaccine appears to be the most ideal for the under 5 group after demonstrating zero incidents of severe disease, hospitalizations or death in the Phase II/III KidCOVE trial. If Moderna is given the go-ahead with its EUA early, it will be the only vaccine for COVID-19 available for this age range. If the FDA does confirm plans to wait it out until Pfizer is ready, any vaccine for kids of this age might not be available until early summer.
As for Pfizer’s vaccine candidate, the biopharma revealed in March that it was only 12% effective versus the Omicron variant among 5 to 11-year-olds, which could explain why it is delaying its application for the younger age group.
In the same letter, Clyburn told the FDA that it is well within its responsibility to conduct a full and complete investigation of the matter, including all activities and communications related to the health crisis. The FDA has yet to comment on the request.
