The two firms developing a prominent COVID-19 vaccine solution are preparing to request authorization from the U.S. Food and Drug Administration for emergency use of their preventative measure, with their application scheduled for submission today [Update: Pfizer has verified the application was filed as anticipated on Friday afternoon]. Pfizer and BioNTech, who announced earlier this week that their vaccine demonstrated 95% efficacy according to Phase 3 clinical trial results, are requesting emergency authorization in the United States, alongside applications in Australia, Canada, Europe, Japan, and the United Kingdom, indicating a potential start for vaccine administration to “high-risk groups” before the month’s end.

The FDA’s EUA pathway enables pharmaceutical companies to pursue accelerated approval when exceptional conditions are present, as is the situation with the ongoing pandemic. EUAs still necessitate the submission of comprehensive supporting data and safety information, but the review process is expedited compared to the standard, formal, and long-term approval procedures generally applied to new medications and therapies before widespread use.

The vaccine being developed by Pfizer and BioNTech utilizes mRNA technology, which essentially delivers instructions to a recipient’s body on how to generate specific proteins that hinder the SARS-CoV-19 virus (the virus responsible for COVID-19) from attaching to cells. A Phase 3 clinical trial for the vaccine is currently underway, having enrolled 43,661 participants to date. The companies are presenting data intended to persuade the FDA to issue the EUA, including information from 170 verified cases among the trial participants, safety data gathered directly from 8,000 participants, and additional data obtained passively from a further 38,000 individuals.

Although global manufacturing is increasing for this vaccine and others in advanced stages of development, and an EUA could allow access for vulnerable populations, such as healthcare professionals, large-scale vaccination initiatives are not expected to commence until the following year, and most likely later into 2021.