FDA Explains Why It Authorized Pfizer's COVID-19 Vaccine

Despite reassurances about its safety, many people remain skeptical about the COVID-19 vaccine and indicate that they may not be willing to receive it. The FDA announced that it has granted an Emergency Use Authorization (EUA) for Pfizer-BioNTech's COVID-19 vaccine — and it also explained why it granted the EUA.

According to the FDA, it has determined that Pfizer's COVID-vaccine meets 'the statutory criteria for issuance of an EUA.' The agency evaluated data on the vaccine and found 'clear evidence' that it may be effective at protecting the public against the novel coronavirus.

Likewise, the agency says that there's also evidence that the possible benefits of getting this vaccine outweigh the possible risks, ultimately stating that it 'can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information.'

Put simply, Pfizer's product is an mRNA vaccine that teaches the body's immune system to defend against the SARS-CoV-2 virus. The FDA notes that it has not approved the vaccine — rather, it has granted an Emergency Use Authorization, which is something the FDA can do in emergency situations such as the pandemic.

Among other things, the FDA explains the process that led to the authorization:

In determining whether to issue an EUA for a product, the FDA evaluates the available evidence and assesses any known or potential risks and any known or potential benefits, and if the benefit-risk assessment is favorable, the product is made available during the emergency. Once a manufacturer submits an EUA request for a COVID-19 vaccine to the FDA, the agency then evaluates the request and determines whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to the FDA.

The FDA notes that the safety data on Pfizer's vaccine indicated multiple possible side effects that 'typically lasted several days,' among them pain where the vaccine is injected, as well as headache, tiredness, chills, muscle pain, fever, and joint pain. The side effects were more common after receiving the second vaccine dose.

The FDA's full announcement, including details on the safety data and testing, can be found here.