Kids ages 12 and up can get vaccinated with Pfizer’s COVID-19 shot in the U.S. But what about those under 12? Will they be able to return to the classroom this fall confident in their immune protection against the Delta variant?
Here’s an anticipated pediatric timeline for clinical trials and potential authorization for the three vaccines allowed for U.S. adults and one that has high hopes for authorization.
Pfizer’s COVID-19 vaccine is still the only shot authorized for kids ages 12 to 15, with FDA authorizing it in May.
The company is evaluating its two-dose strategy in three additional groups of children: age 6 months to under 2 years, ages 2 to under 5 years, and ages 5 to 11 years. Those ages 5 to 11 will receive a 10-mcg dose, while those age 5 and under will receive a 3-mcg dose. The dose for those age 12 and up is 30 mcg.
A Pfizer spokesperson told MedPage Today via email that the company expects “a potential pivotal readout for children between the ages of 5 and 11 sometime in September.”
Pending data demonstrating safety and immunogenicity, “and in agreement with regulators, we could potentially submit for a U.S. EUA [emergency use authorization] shortly after that in September,” the spokesperson said.
Data for children ages 2 to under 5 “could arrive soon after that,” the spokesperson added.
For children ages 6 months to under 2 years, the spokesperson said, “we could potentially have a safety and immunogenicity readout that would provide the [necessary] data … sometime in October/November, followed by a potential submission to the U.S. FDA for an EUA once agreed upon with regulators shortly thereafter.”
Moderna reported top-line data on kids ages 12 to 17 from its TeenCOVE study in late May, showing vaccine efficacy of 100%, with no cases of the disease in the fully vaccinated group.
The vaccine was also 93% effective when looking at milder disease 14 days after the first dose, given that the incidence rate of COVID is lower in adolescents.
Moderna filed for an EUA in this population in mid-June.
The 100-mcg dose used in the TeenCOVE study is the same as the dose used in adults.
Initially, its two-dose regimen will test either 50 mcg or 100 mcg in 2- to 12-year-olds, while those under 2 will get 25, 50, or 100 mcg. This will guide dosing selection for the second part of the study.
As of press time, Moderna had not returned a request for comment on the company’s anticipated trial readouts and FDA authorization timelines.
Johnson & Johnson
Johnson & Johnson announced in early April that it started dosing adolescents in its ongoing phase IIa trial, noting it would begin with “a small number” of those ages 16 to 17.
Reports from early July note that a company official said a trial in kids ages 12 to 17 is planned to begin this fall. Pending results from that study, the company could initiate a trial in kids ages 2 to 11, as well as one in those under 2.
In an emailed statement, Johnson & Johnson confirmed to MedPage Today that adolescent trials are still underway, and that the “phase 3 trials are planned but have not yet started recruiting.” J&J also plans to “conduct studies in lower age groups if initial data show an acceptable safety profile.”
The statement also said the company “will be moving forward with future adolescent clinical trials in countries where a COVID-19 vaccine is not widely available and are in discussions with regulators and partners regarding the timing of these trials.”
In mid-June, Novavax announced top-line results from its 30,000-patient PREVENT-19 trial conducted in the U.S. & Mexico, showing an overall efficacy of about 90%, with 100% efficacy against moderate and severe disease.
At that time, the company said it plans to file for an EUA in adults in the third quarter of this year.
The company announced in May that it would expand the PREVENT-19 trial to include adolescents ages 12 to 17.
As of press time, Novavax has not returned a request for comment as to the status of any additional pediatric trials or FDA authorization timelines.