Pfizer expects results on clinical trials for kids between the ages of five to 11 in September, with data for children between the ages of two to five expected soon afterwards. Data on children younger than that may take as long as November, the company told NBC.
Moderna expects a similar timeline, with Dr. Buddy Creech, one of the main researchers for the Moderna KidCOVE clinical trials, telling NBC that "there is still a lot of work left to be done" concerning children five years old and younger.
The vaccinations for children are the next step in fighting the continuing coronavirus pandemic as children are becoming one of the main groups affected by the virus as many adults are already vaccinated and coronavirus restrictions are being lifted in many countries.
In Israel, the recent outbreak of the Delta variant of the coronavirus was largely sparked by outbreaks caused by children breaking quarantine at schools. The outbreak has been affecting vaccinated Israelis as well, with about half of those infected on Wednesday being already vaccinated or recovered patients.
Of the 5,600 people actively infected with the novel coronavirus as of Thursday, 45.2% (about 2,530 people) were under the age of 20, although only 1.1% of patients in serious condition were in the same age range.
Unlike the vaccines for adults, it may be easier for vaccinations for children to get full approval, not just emergency approval, as the FDA will be provided with four to six months of safety follow-up data. A Biologics License Application (BLA) requires six months of follow-up data.
Pfizer-BioNTech and Moderna have already applied for BLA approval for their vaccines for adults 18 and older. The FDA official told NBC that the agency's highest priority is fully approving vaccinations for adults.
The granting of full approval may help convince those who are still wary about the vaccine to receive the shot as it will be granted after a more robust process.
A BLA differs from the Emergency Use Authorization (EUA) the vaccines currently have for adults, in that a BLA requires that a product be demonstrated to be "safe, pure and potent," while a EUA requires that it be "reasonable to believe" that the product is effective and has known and potential benefits that outweigh the known and potential risks. EUAs also only last as long as the emergency which prompted their need.
The EUAs issued for coronavirus vaccines have been held to a higher standard than other emergency approvals, including full-scale clinical trials which have not been required in other emergency approvals, according to an article by professors of law from Standford University, Villanova University and the University of Akron.