Top Democrat Asks for FDA Briefing on COVID-19 Vaccines for Young Children

U.S. drug regulators should not delay in authorizing COVID-19 vaccines for young children, a top Democrat said on April 25.

Rep. Jim Clyburn (D-S.C.) asked Food and Drug Administration (FDA) Commissioner Robert Califf whether reports that the FDA is considering postponing a decision on whether to clear Moderna’s jab so that it can be reviewed at the same time as Pfizer’s shot are accurate.

Moderna officials recently announced results of a trial for its vaccine for children aged 6 months to 4 years and said it would apply to the FDA for emergency authorization by the end of April. Pfizer expects to have data ready for a request for its shot for the same age group in June.

“Recent reports indicate that FDA is considering postponing its decision on whether to authorize Moderna’s vaccine for young children until early summer, so that it can be evaluated—and potentially authorized—at the same time as Pfizer’s vaccine,” Clyburn wrote to Califf. He noted that Dr. Anthony Fauci, the chief medical adviser to President Joe Biden, told CNN in a recent interview that authorizing the products at the same time would help avoid “confus[ing] people.”

“Such a decision could delay the potential authorization and administration of the Moderna vaccine by several weeks,” Clyburn said. He asked for a briefing on the vaccines for young kids by May 9 on “whether these recent reports are accurate and, if so, the scientific basis and any other rationale for such a delay.”

An FDA spokeswoman acknowledged receipt of the letter but declined to comment further, saying the agency would respond directly to Clyburn, the House majority whip and the chairman of the House Select Subcommittee on the Coronavirus Crisis.

The coronavirus, also known as SARS-CoV-2 or the CCP (Chinese Communist Party) virus, causes COVID-19.

The House established the panel early in the pandemic, charging it with examining how taxpayer funds were being used, the development of vaccines and treatments, and other issues related to the pandemic.

All Americans 5 and older can currently get Pfizer’s vaccine and all Americans 18 and older can get Moderna’s vaccine.

Some parents and advocacy groups have been pressuring the FDA to expand authorization for one or both of the shots to children as young as 6 months old, claiming the kids need protection against severe COVID-19.

“Once FDA is in receipt of one or more submission for emergency use authorization of COVID vaccines for these younger pediatric age groups, we will work diligently to review the data, to independently verify the analyses, and to bring those data to our advisory committees for discussion and consideration for regulatory action,” Dr. Dorian Fink an FDA official, said during a virtual meeting on April 20 after listing to some of the parents.

Data from the pandemic show children, particularly healthy ones, are at little risk of contracting any symptoms from COVID, much less severe ones.

Those zero to 4 have had 2.3 million cases in the United States since the start of the pandemic, according to federal statistics, but just 468 deaths.

Some experts have cautioned against rushing authorization for young children, noting the data.

The FDA appeared poised to authorize Pfizer’s shot for the age group in February but abruptly announced a delay on the decision until more data were gathered. Updated results from a Pfizer-run trial are expected soon, and Pfizer’s CEO Albert Bourla said on a podcast that he hoped authorization would happen in June.

Moderna in March announced its trial for young children reached its primary endpoint, which was the triggering of an immune response similar to that seen in older groups. The company portrayed the results as positive despite a substandard protection against infection, and no outcome being available for shielding against severe illness. A number of experts told The Epoch Times that the results mean the FDA should not authorize the jab.

From The Epoch Times