BioNTech/Pfizer in the US: Vaccine approval for infants pending

BioNTech and Pfizer have applied for approval of their corona vaccine for children under the age of five in the United States. If approved by the FDA, babies as young as six months could receive a dose of the vaccine.

The German company BioNTech and its US partner Pfizer have applied for emergency approval of their corona vaccine for children under five in the United States. Pfizer said the relevant data had been sent to the US Food and Drug Administration (FDA). The application should be completed in the coming days.

The emergency approval should apply to children from six months. It would be the first available vaccine for this age group in the United States. BioNTech/Pfizer preparation for children from the age of five has already been approved in the USA.

FDA had requested a speedy application

If the FDA approves, children as young as six months could receive a vaccine dose that contains one-tenth the active ingredient in an adult dose. In an extraordinary step, the authority asked the companies BioNTech and Pfizer to submit the application earlier than the companies had planned.

“Having a safe and effective vaccine available for children in this age group is a priority for the agency and we are committed to a timely review of the data the agency has requested from Pfizer in light of the recent omicron case spike.” communicated to the FDA.

Probably three cans necessary

It is still unclear how many syringes of the vaccine are needed. Data on a third dose, administered at least eight weeks after the second dose, is expected and submitted to the FDA in the coming months, Pfizer said. Two-shot tests had proved strong enough for babies but not for preschoolers.

Ultimately, it is believed that three doses of the vaccine for the age group are required to achieve a high level of protection against current and potential future variants. However, the FDA may consider allowing two doses for now and possibly a third syringe later.