A Top Lawmaker Wants a Briefing on COVID-19 Vaccines for Young Kids
Separately, the FDA approved the first COVID-19 treatment for kids under 12 on Monday.
Over two years into the pandemic, a top House lawmaker wants to know more about when young kids will be eligible to receive coronavirus vaccines.
Rep. James Clyburn, D-S.C., is requesting a briefing by early next month on the status of the vaccines for children under age five. The Food and Drug Administration issued the first emergency use authorization for COVID-19 vaccines in December 2020 and since then vaccines have been authorized for kids as young as five. However, the youngest kids still are not eligible to receive vaccines, which leaves them more at risk and puts additional stress on parents and those involved in childcare.
“White House Chief Science Adviser Dr. Anthony Fauci recently indicated that FDA is weighing whether to consider authorization of both the Moderna and Pfizer vaccine candidates at the same time—rather than considering them separately—so as not to ‘confuse people’ with a staggered rollout of two vaccines with different dosing regimens, potentially with varying degrees of efficacy,” wrote Clyburn, chairman of the House Select Subcommittee on the Coronavirus Crisis, to Dr. Robert M. Califf, FDA commissioner, on Monday.
“Such a decision could delay the potential authorization and administration of the Moderna vaccine by several weeks,” the lawmaker added.
Moderna plans to formally apply for emergency use authorization for its two-dose regime for kids under the age of six by the end of the month; meanwhile, Pfizer/BioNTech will most likely request authorization for their three-dose vaccine series for kids under five in June, according to a Politico article from April 21 that was cited in the letter.
“The staff briefing, which is requested by May 9, 2022, should provide information on whether these recent reports are accurate and, if so, the scientific basis and any other rationale for such a delay,” wrote Clyburn.
When asked for comment, Abby Capobianco, FDA press officer, told Government Executive on Tuesday, “The FDA will respond directly to the letter.”
The Centers for Disease Control and Prevention released data last month showing that during the wave of the Omicron variant in late December 2021, infants and children in the United States (newborn to four years old) were hospitalized at about five times the rate of the peak of the Delta variant over the summer. Also, infants (under six months) had the highest hospitalization rates, “but indicators of severity (e.g., respiratory support) did not differ by age group,” said the agency.
Despite the fact that vaccines for young kids aren’t a possibility right now, on Monday the FDA approved the first COVID-19 treatment for kids under 12.
“As COVID-19 can cause severe illness in children, some of whom do not currently have a vaccination option, there continues to be a need for safe and effective COVID-19 treatment options for this population,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, in a statement. “Today’s approval of the first COVID-19 therapeutic for this population demonstrates the agency’s commitment to that need.”