Pfizer COVID-19 Vaccine Receives Emergency Use Authorization

December 14, 2020 – The U.S. FDA has granted Emergency Use Authorization (EUA) to a vaccine from Pfizer and BioNTech to prevent COVID-19 caused by the SARS-CoV-2 virus in individuals who are at least 16 years old. The vaccine is the first product to receive an EUA to prevent COVID-19.

Authorization was granted based on clinical studies in which the vaccine was found to be 95% effective in preventing COVID-19.

An EUA does not represent full FDA approval for the vaccine. It is instead a mechanism through which the FDA can allow the use of unapproved medical products in an emergency when there are no adequate, approved, and available alternatives. Based on the currently available scientific evidence, the FDA has determined that the potential benefits of the Pfizer COVID-19 vaccine outweigh the potential risks.

Pfizer has submitted a pharmacovigilance plan to the FDA to monitor the safety of the vaccine. The plan includes longer-term safety follow up for participants enrolled in ongoing clinical trials, and other activities aimed at monitoring the safety profile of the vaccine.

Under the current recommended dosing, patients must receive two doses of the vaccine spaced several weeks apart for full efficacy. Pfizer began shipping the vaccine shortly after issuance of the EUA, and vaccination of select populations – including frontline healthcare workers – began on December 14.

Because supplies of the vaccine are limited, it is currently being distributed and administered in phases according to guidelines from the U.S. Centers for Disease Control and Prevention (CDC). Distribution and administration are being managed by state and local healthcare agencies. Early recipients of the vaccine are expected to consist of frontline healthcare workers and long-term care facility residents. COVID-19 vaccination is not expected to be available to the general population until spring of 2021 at the earliest.

Currently, the federal government is covering the medication costs for the Pfizer/BioNTech vaccine. Under the Affordable Care Act (ACA), the vaccine is considered preventive care and must be covered at a $0 copayment under the medical and/or prescription benefit for members of ACA plans that are required to provide preventive care vaccine coverage. Plan sponsors are expected to cover the administration costs of the vaccine, which have been set by the U.S. government at $16.94 for the first dose and $28.39 for the second.