Yale docs: Vaccine for under 12s not in cards by September; Pfizer booster trials to begin
A Yale expert leading the investigation of use of the Moderna vaccine for children younger than 12 predicts those shots will not be available before the start of the school year, while another Yale investigator noted the medical school would soon begin a Pfizer booster trial.
“Before the schools open, I don’t believe we will have a vaccine for children under 12,” Dr. Inci
Yildirim said.
Yildirim’s comments were provided in response to questions and through an email from Colleen Moriarty, associate director of media relations for Yale School of Medicine, who identified Yildirim as a pediatric infectious diseases specialist who leads Yale’s investigation of the Moderna vaccine in children.
The amount of time before vaccines are available for those younger than 12 depends upon whether the Food and Drug Administration decides to evaluate it for Emergency Use Authorization or full licensure, according to Yildirim.
“It is possible that before the end of 2021 or early 2022, they may have emergency use authorization for those under 12,” she said. “It all depends on the public emergency impact.”
Full licensure would push that time frame even further out. With EUAs, the FDA can begin evaluating trial data when there is just two months of follow-up with participants, according to the federal agency’s website.
But full licensure requires the trials to be completed, Yildirim said. That will take roughly ten more months, she said.
Yale’s Pfizer trial also remains ongoing, with children under age five still enrolling, according to comment from principal investigator Dr. Onyema Ogbuagu, also provided by Moriarty, who noted there are about 120 sites holding the trials.
Ogbuagu, an infectious diseases specialist and associate professor of medicine, said Yale will soon begin a Pfizer booster trial.
Such trials are already underway elsewhere. They mark the company’s efforts “to stay ahead of the virus causing COVID-19 and circulating mutations,” according to a July 8 statement from Pfizer.
“Pfizer and BioNTech have seen encouraging data in the ongoing booster trial of a third dose of the current BNT162b2 vaccine,” according to Pfizer. “The first batch of the mRNA for the trial has already been manufactured. The Companies anticipate the clinical studies to begin in August, subject to regulatory approvals.”
Neither Ogbuagu nor Yildirim was available for a phone interview.
Fall classes
The news about vaccines for children younger than 12 may come as a disappointment to parents and school administrators, and leaves uncertainty around what guidelines districts will need to follow come fall.
Jody Goeler, superintendent of Hamden Public Schools, said he had hoped a vaccine would be available for all students by the start of the school year.
“But I also understand that those who determine when a vaccine is safe need the time to do that, so I certainly respect and appreciate the due diligence that our medical research professionals … are giving to this,” he said.
Goeler is anticipating further guidance from the state on issues such as masks mandates, he said, adding that the district would “(continue) to work with our public health officials locally and statewide and continue to assess where we are with this pandemic and the Delta variant.”
Meanwhile, the town’s schools are preparing to maintain certain efforts aimed at preventing the spread of COVID-19, such as increased ventilation, according to Goeler. He also expects to relax others – he said social distancing still will take place, but maintaining three feet of space as rather than six.
“The most important thing is getting all of our children into school at the end of August safely, and for the full school year,” he said.
The state departments of Education and Public Health are working to create forthcoming fall guidance for schools, according Peter Yazbak, spokesman for the education department.
“As a mitigation strategy, mask wearing inside school buildings is supported by the Governor’s Executive Order as binding rules at this time,” he wrote.
But whether masks will be mandatory throughout fall remains in question. The order from Gov. Ned Lamont that requires them to be worn in certain spaces, including school buildings, is set to expire Sept. 30.
What will happen afterward remains unclear.
“The current order remains in effect until at least September 30,” David Bednarz, a spokesman for Lamont, said via email. “Beyond that, we don’t have any more updates at this time.”
The more people get vaccinated, the better it will be for schools, officials say.
“Our children benefit most from in-person learning, and our priority of a safe return to in-person instruction this fall can be accomplished by achieving and maintaining high vaccination coverage in schools,” Yazbak said via email. “Getting vaccinated remains the leading public health prevention strategy to protect against COVID-19 and is the best tool we have to make sure that the school year is free from interruption and disruption from outbreaks and the resulting need for students or teachers to quarantine.”
He said state agencies will continue efforts to offer on-site vaccination clinics at schools for eligible age groups.
Goeler shared similar thoughts about the importance of vaccinations.
“Every bit of evidence that I’ve seen and heard … suggests strongly that everybody who can be vaccinated, should be,” he said, later adding, “What I would love to see is everyone from 12 to 112 get vaccinated. That would be a game changer for our country, and for our state and our community.”