Pfizer Seeks Full FDA Approval for their Vaccine

Pfizer and its vaccine partner BioNTech have just submitted an application for full approval of their vaccine from the Food and Drug Administration. This makes Pfizer the first covid-19 vaccine that is requesting full FDA approval. Currently, Pfizer, Moderna, and Johnson & Johnson vaccines are cleared for use under the FDA’s emergency use authorization. The EUA is a less rigorous approval method to aid response to the pandemic, and why the vaccine is being distributed.

With Pfizer seeking approval, this means that the company believes the benefits outweigh the known risks of the vaccine. If granted with approval, it will only be FDA-approved for those who are 16 and older. The age group 12-15 that Pfizer is running a trial on will still fall under the EUA. The Pfizer vaccine is 95% effective against COVID-19. This is the highest efficacy amongst all vaccines authorized.

Source: NPR