FDA to Discuss Child COVID-19 Vaccine in June; Moderna, Pfizer Request Emergency Use Authorization


Leonel Campos, 6, receives a COVID-19 vaccine at Arturo Velasquez Institute in Chicago on Nov. 12, 2021. (Scott Olson/Getty Images)

The Epoch Times

By Naveen Athrappully

The U.S. Food and Drug Administration (FDA) has announced tentative June dates for the meeting of its advisory committee to discuss authorizing COVID-19 vaccines for young children below the age of five years.

FDA has set aside June 8, 21, and 22 for virtual meetings of its Vaccines and Related Biological Products Advisory Committee. The agency will discuss updates on Moderna’s and Pfizer’s requests for Emergency Use Authorization (EUA) for their COVID-19 vaccines targeting “younger populations,” FDA said in an April 29 news release.

At present, children aged 5 years and older can be vaccinated in the United States, leaving 18 million children below the age of five who are not approved for a COVID-19 vaccine.

“The agency is committed to a thorough and transparent process that considers the input of our independent advisors and provides insight into our review of the COVID-19 vaccines,” said Peter Marks, M.D., Ph.D., director of the Center for Biologics Evaluation and Research. “We intend to move quickly with any authorizations that are appropriate once our work is completed.”

The FDA announcement comes after Moderna asked the agency to grant an EUA for its COVID-19 vaccine for children as young as six months old.

The EUA submission is for two COVID-19 doses of 25 micrograms each for those in the age groups six months to 2 years and 2 years to 6 years. However, in the case of Moderna, vaccine efficacy for the six month-to-2 years group was only 51 percent, with the other group showing an efficacy rate of just 37 percent.

“As the company has acknowledged, they still need to submit additional data to complete its request,” an FDA spokesperson previously told The Epoch Times. “FDA cannot reach a decision on any vaccine without a completed EUA request, which allows us to do a thorough review, which includes, among other things, a comprehensive review of all of the adverse events and replication of the key analyses.”

Vaccinating children against COVID-19 is a hotly debated topic, with some strongly arguing against it as the demographic is the least impacted by the pandemic.

Natural immunity provides a much more durable and broader protection for children than vaccines, Dr. Liz Mumper, a pediatrician and former medical director of the Autism Research Institute, said in an interview with non-profit organization Children’s Health Defense.

If a child contracts COVID-19, they not only don’t need the vaccine but also might be at higher risk of adverse effects if they are subjected to them, the doctor warned.

“If kids don’t need the vaccines, we do not want to give them the vaccines because we do not have long-term studies on the side effects, and the short-term information we have is actually quite a bit concerning to me,” Mumper said. The interview host pointed out that the COVID-19 survival rate in childhood is 99.98 percent.