U.S. FDA May Clear COVID-19 Vaccine for Children Based on Two Months of Safety Data

(Reuters) – U.S. health regulators have said children participating in clinical trials testing COVID-19 vaccines should be monitored for at least two months for side effects, suggesting the agency is considering a faster route for authorize the vaccine for emergency use only with full approval.

The U.S. Food and Drug Administration said on Friday it was looking to complete the data review as quickly as possible, likely within weeks rather than months.

The FDA last month granted full approval for use of Pfizer Inc’s vaccine in people over 16 years of age based on a six-month follow-up from the trial. The shot was cleared in December for emergency use based on a shorter two-month follow-up.

The agency is under pressure to approve a vaccine for children under 12 amid an increase in infections fueled by the spread of the Delta coronavirus variant, which has disrupted the reopening of schools.

Pfizer and its partner BioNTech SE as well as Moderna Inc are rushing to submit clinical data for regulatory approval for their vaccines for children under 12 years of age.

Pfizer / BioNTech’s vaccine is currently licensed for children aged 12 to 15 in the United States.

Pfizer said it plans to report the data needed for approval in children aged five and 11 within the month and could potentially submit an emergency use request shortly thereafter. The drugmaker said data for children aged two and under five could arrive soon after.

For children between six months and two years old, Pfizer said it may have safety and immunogenicity data as early as October or November.

Moderna said on Thursday that he had fully enrolled participants in a trial testing his injection in children six to 11 years old and that he was still conducting dose selection studies for younger age groups.

(Reporting by Manojna Maddipatla in Bengaluru and Mike Erman in Maplewood, New Jersey)