Today is the day Pfizer moves closer to being a COVID-19 vaccine supplier for the pandemic. The pharmaceutical giant and German partner BioNTech will seek emergency authorization from the Food and Drug Administration for a significant advancement in battling the deadly spread.
The FDA approval process is expected to take a few weeks, but some people could receive the first dose in about a month. The phased rollout of vaccinations would begin with healthcare workers, senior citizens and people with underlying health conditions. An FDA advisory committee will review the vaccine’s clinical in early December.
“Hope and help are on the way,” Health and Human Services Secretary Alex Azar said at a press conference. “No American will face an out-of-pocket cost for getting a COVID-19 vaccine. The ultimate goal here is to make getting a COVID-19 vaccine as convenient as getting a flu shot.”
The second phase of vaccine recipients would be essential workers, teachers, the homeless population and prisoners, followed by children and young adults.
On Wednesday, Pfizer revealed that its final-stage vaccine testing showed 95% efficacy in its two-dose vaccine.
“Filing (for emergency authorization) in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” Pfizer CEO Dr. Albert Bourla said in a statement.
Pfizer is the first company to file for emergency approval in the U.S. and already submitted to worldwide organizations, such as European Medicines Agency and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency.
The FDA’s emergency use authorization allows for use before full approval if the “known and potential benefits outweigh its known and potential risks.”
It does not take an FDA official to know that. The COVID death toll of more than 252,000 is telling enough.