The White House said it expects its COVID-19 vaccination rollout for children under 5 years of age to start on June 21, in the event of a swift approval from the U.S. Food and Drug Administration (FDA).
Ashish Jha, the White House COVID-19 response coordinator, on Thursday walked reporters through a hypothetical timeline of how things may play out within the next month regarding the vaccines for the young cohort, but pointed out he is not there to “pre-judge” the outcome of the vaccine vetting process.
“I’m not here to pre-judge the outcome of the process, but the administration is hard at work planning all sorts of scenarios based on whatever the outcome is from the process that’s playing out,” Jha said. “We’ve been working very closely with states, local health departments, pediatricians, family physicians, other health care providers, and pharmacies to get ready.”
He said that “if and when” the FDA authorizes the vaccine, the administration will “move from planning to execution.”
“FDA authorization will allow us to start shipping doses. These doses are specifically formulated for these young kids. These doses will be shipped to thousands of sites across the country,” he said.
He said that the FDA’s independent advisory panel, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), is set to meet June 14–15 to discuss requests for emergency use authorizations from Pfizer-BioNTech and Moderna for their COVID-19 vaccines for children.
“We expect FDA to make its decision soon thereafter. Once FDA authorized—if they have authorized vaccines, we can begin shipping,” Jha continued. “We expect some of the shipments to start arriving to in their destinations over that long weekend. Remember Monday is an important federal holiday and many doctors’ offices may be closed. And we can’t ship vaccines until FDA has authorized these vaccines. And vaccination can’t start until CDC has issued its recommendations.
“So we expect that vaccination will begin in earnest as early as Tuesday, June 21, and really roll on throughout that week. It will take some time to ramp up the program and for vaccines to be more widely available.”
He noted that the White House expects that “within weeks” every parent who wants to vaccinate their children in the under-6 age group will be able to get an appointment, and that the administration will “make sure that supply is always meeting demand.”
Those under age 5 comprise the only age group not eligible for any COVID-19 vaccination in the United States. There are about 18 million children under age 5 in the country.
“We have plenty of supply of both Pfizer and Moderna vaccines to start our vaccination program, and we are going to make 10 million doses available to states, pharmacies, and community health centers and federal entities to order initially,” Jha said.
He said that while parents may be frustrated at what appears to be a delayed timeline for obtaining FDA authorization, it was important to get things right.
Jha’s statements come a day after Pfizer-BioNTech announced it has submitted its request to the FDA for emergency use authorization (EUA) for its vaccine for children aged 6 months to under 5 years old.
VRBPAC is set to discuss the EUA for the Pfizer-BioNTech vaccine, as well as Moderna’s COVID-19 vaccine for children aged 6 months through 5 years of age, on June 15.
A poll from the Kaiser Family Foundation in April found that just one in five parents of those under age 5—or 18 percent—would be “eager to vaccinate their child and say they will do so right away once a COVID-19 vaccine is authorized for their age group.”
The vaccines from Pfizer-BioNTech and Moderna are both based on mRNA technology. The COVID-19 vaccines from these companies have been linked with heart inflammation, including myocarditis and pericarditis, in age groups older than 5, and more so in young men. A small number of deaths due to heart inflammation after the COVID-19 vaccine have been reported.
Vaccine manufacturers are immune from liability for any adverse reactions—unless there’s “willful misconduct” involved. Vaccine providers are required to report any serious adverse effects or vaccination administration errors to VAERS, hosted by the U.S. Department of Health and Human Services. The federal government has a countermeasures program that can compensate eligible persons who suffer serious injury from approved vaccines. But the burden of proof may be challenging.
Zachary Stieber contributed to this report.