U.S. regulators on June 17 authorized two COVID-19 vaccines for young children.
The U.S. Food and Drug Administration (FDA) granted emergency authorization for the Moderna and Pfizer COVID-19 vaccines for children as young as 6 months old.
Previously, only children 5 and up could get the Pfizer vaccine, and only people 18 and older could get Moderna's jab.
"We know that many parents, caregivers and clinicians have been anxiously awaiting today's authorizations. We're acutely aware of the importance of having vaccines available for our youngest children. And as we've seen with the older age groups, we expect that the vaccines for younger children will provide protection for the most severe outcomes of COVID-19, such as hospitalization and death," Dr. Robert Califf, the FDA's commissioner, told reporters on a call.
About 19.5 million children under 5 reside in the United States, according to Census Bureau estimates.
Estimates from clinical trials the companies ran pegged the efficacy of Moderna's vaccine against infection at 50.6 percent for children 6 months through 23 months of age and 36.8 percent for children aged 2 to 5, and the efficacy of Pfizer's vaccine was estimated at 80.3 percent across the age groups.
For young children, the Moderna immunogenicity measurements were based on just 490 children and the Pfizer immunogenicity measurements were based on just 220 children. The efficacy estimates were based on 4,100 Moderna volunteers and 992 Pfizer participants who received the vaccines.
The FDA said in its new statement that Pfizer's estimate "was determined not to be reliable due to the low number of COVID-19 cases that occurred in study participants."
No estimates were possible for protection against severe illness—which is the primary reason officials say to get vaccinated because the protection has waned considerably as new virus variants emerge—because of the low numbers of severe cases among vaccinated and unvaccinated volunteers.
“As with all vaccines for any population, when authorizing COVID-19 vaccines intended for pediatric age groups, the FDA ensures that our evaluation and analysis of the data is rigorous and thorough,” Dr. Peter Marks, a top official at the FDA, said in a statement.
Authorization has a lower evidentiary bar than approval, and is only possible because U.S. authorities have maintained a COVID-19 emergency designation despite cases, hospitalizations, and deaths linked to the disease plunging since the metrics hit fresh peaks in January.
Some outside experts have questioned the data from the trials.
"From an efficacy standpoint, it makes absolutely no sense to approve these products," Brian Hooker, chief scientific officer for Children's Health Defense, told The Epoch Times before the authorization.
Others agreed with authorizations, asserting the data indicated sufficient protection.
"Although the Moderna vaccine was not as effective, it is likely as effective as the vaccines are for Omicron (2-dose) for adults. Both vaccines increase antibodies which likely indicates a deeper T/B cell response being generated," Dr. Monica Gandhi, a professor of medicine at the University of California, San Francisco, told The Epoch Times in an email. T and B cells are thought to protect against severe illness.
The Centers for Disease Control and Prevention (CDC) is meeting with its vaccine advisory panel on Friday and Saturday to discuss the data. The panel will decide whether to advise the CDC to say young kids should, or may, get the vaccines. The panel could also recommend the vaccines should only be administered to kids with serious health problems, like diabetes.
CDC Director Rochelle Walensky then makes the final decision.