Covid-19 Vaccine Usage Permission Seeked by Pfizer and BioNTech

Pfizer and BioNTech have announced the start of a rolling proposal to modify the Covid-19 vaccine’s emergency use authorisation (EUA) to include children aged six months to four years. The action comes in response to a request from the US Food and Drug Administration (FDA). The businesses expect to finish the EUA application soon, with permission to use the first two 3g doses of a proposed three-dose vaccine regimen.

In addition, data on the third vaccine dosage, given at least eight weeks after the second dose, is expected in the coming months. This information will be given to the regulatory body in order to support a potential change to the EUA. The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will have a virtual meeting on February 15 to review the EUA request for vaccination use in children of this age range. If approved, the vaccine might be the first to be made available to children under the age of five.

As hospitalizations of children under the age of five due to Covid-19 have risen, our common goal with the FDA is to prepare for future variant spikes and provide parents with an alternative to help safeguard their children against this virus,” stated Pfizer chairman and CEO Albert Bourla. Pfizer and BioNTech current proposal is based on the full of evidence on the vaccine’s safety, immunogenicity, tolerability, and available efficacy in two doses.

The businesses plan to submit this information to the European Medicines Agency (EMA) as well as other regulatory bodies throughout the world. The businesses are still supplying the vaccine to the US government under a supply arrangement that runs until April. In addition, in the event that the FDA amends the EUA, Pfizer and BioNTech intend to provide enough supply of the 3g dose to accommodate demand.