Pfizer Seeks Emergency FDA Approval for Highly Effective COVID-19 Vaccine
Pfizer and BioNTech officially apply for FDA emergency use authorization for their coronavirus vaccine, which shows 95% efficacy in final trials. If approved, the first doses could reach high-risk Americans by mid-December.
Pfizer and BioNTech apply for emergency use authorization from the Food and Drug Administration for their coronavirus vaccine. This submission makes Pfizer the first company to seek this regulatory approval in the United States. The application relies on final trial data showing the vaccine is 95% effective at preventing COVID-19 infections.
The FDA review process takes a few weeks, with an advisory committee meeting scheduled for early December. If the agency approves the request, the initial vaccine supply rolls out in phases. Healthcare workers, elderly individuals, and people with underlying health conditions receive the first inoculations, followed by essential workers and other vulnerable populations.
The vaccine uses messenger RNA technology to provoke an immune response against the virus. However, it requires ultra-cold storage at minus 94 degrees Fahrenheit, which presents logistical challenges for widespread distribution. The United States already agrees to purchase 100 million doses for nearly $2 billion as part of Operation Warp Speed.