On Friday, May 7, Pfizer and its partner BioNTech filed an application seeking full approval from the United States Food and Drug Administration (FDA) for its COVID-19 vaccine for patients age 16 and up. Pfizer is the first COVID-19 vaccine producer to do so. Full approval would allow Pfizer to market and distribute its vaccine without seeking a new emergency authorization. It would also represent an official acknowledgment from the FDA that the benefits of the vaccine outweigh any risks. The full approval process is likely to take several months.
The FDA originally granted Pfizer emergency use authorization (EUA) in December, 2020. This EUA allows for distribution and use of the vaccine even though it is not fully approved, in order to accelerate the response to the ongoing COVID-19 pandemic. However, this EUA only lasts as long as the public health emergency lasts, and Pfizer hopes to market and distribute its vaccine on a long term basis.
The provisional nature of Pfizer’s COVID-19 vaccine (and the other vaccines approved to date) has also led to legal challenges. On the one hand, no federal government agency has said employers cannot mandate vaccination simply because the vaccines are only approved for emergency use. On the other hand, as previously reported here, at least one case has been filed in federal court, arguing that employers cannot require vaccinations that are only approved under an EUA. If the FDA grants Pfizer full approval of its COVID-19 vaccine, this issue will be moot, and employees will no longer be able to challenge employer authority to mandate the vaccine on this basis.
In a move that may help schools reopen and, thus, employees without reliable child care, return to work, the FDA also recently expanded Pfizer’s EUA to include adolescents ages 12 through 15. This could pave the way for businesses to re-open more aggressively in the coming months.