COVID-19 vaccination for children ages 6 months to under five years–the only age group yet to be eligible for vaccination–is expected to get underway on June 21, White House COVID-19 response coordinator Ashish Jha said in a press briefing Thursday.
The Food and Drug Administration is now reviewing data from Moderna and Pfizer-BioNTech on their respective vaccines for the young age group. The agency will convene its panel of independent expert advisors to review the data on June 15 and vote on whether the vaccines should be granted emergency use authorization.
If the panel votes in favor of authorization, the FDA will likely grant authorization quickly. After that, federal vaccine supplies will start being sent to the states for distribution. Before they can be distributed, however, the Centers for Disease Control and Prevention must have its own advisory group to review and vote on the recommendations. The recommendation will be finalized by Rochelle Walensky, Director of the CDC.
There are approximately 18 million children in the US under 5, and the federal government has “plenty of supply of both Pfizer and Moderna vaccines” for the age group, Jha said. Starting Friday, states can begin placing orders from an initial supply of 10 million doses. To prepare for the rollout of the vaccine, the Biden administration has been working with state and local health departments, family doctors, pediatricians, pharmacists, and other health care providers.
“We expect that the vast majority of these kids will be vaccinated by their primary care providers,” Jha said. The administration wants states to prioritise distribution to areas serving high-risk children in difficult-to-reach locations and sites capable of handling large numbers of children like children’s hospitals. Officials encourage states to open vaccination centers outside of working hours in order to make it easier to immunize their children.
Rollout and questions
Jha was careful to note that the administration is not trying to “prejudge the outcome of the process,” but it is preparing for all scenarios. The administration expects the FDA to decide quickly after the advisory meeting on June 15, which is a Wednesday. Due to the federal holiday of Juneteenth, the following weekend will be a three-day long weekend. Jha stated that if all goes according to plan, some shipments will arrive at their destinations over the long weekend.
Given that the CDC will still need to sign off on use and that many doctors’ offices will be closed for the holiday, “we expect that vaccinations will begin in earnest as early as Tuesday, June 21 and really roll on throughout that week,” he said. He cautioned that it would take time to scale up the program and make vaccines more widely accessible. “
The long wait for vaccines for the youngest children during the two-and-a-half-year pandemic has been excruciating for many parents, particularly as cases are again on the rise and many areas have pulled back health precautions. The FDA’s slow approach to Moderna’s vaccine has also been criticized by parents and lawmakers. In April, Politico reported that the FDA was considering delaying Moderna’s review to wait for data from Pfizer and BioNTech. Since then, the FDA has repeatedly denied any intentional delay.
Moderna requested FDA authorization on April 28 and finished submitting its vaccine data to the regulator on May 9. However, FDA advisors will review that data while reviewing information on the Pfizer-BioNTech vaccine, which was fully submitted on June 1.
In the press briefing Thursday, Jha was asked again about the apparent delay of Moderna’s review. He said that the FDA determines the timeline based upon how fast it can review all data. He said that while we all want to move quickly, we also want to do it right. “That has to be priority number one, and that’s what the FDA has been focusing on. “