US: FDA panel authorizes Pfizer-BioNTech's COVID-19 vaccine for emergency use
A panel of expert advisors to the US Food and Drug Administration (FDA) has granted the emergency use authorization (EUA) to the COVID-19 vaccine developed by Pfizer and BioNTech. The authorization by the FDA's vaccine advisors reportedly came after a 9-hour-long debate on the vaccine's safety and efficacy data. To recall, Pfizer earlier said its vaccine was 95% effective in preventing COVID-19. Here's more.
- 17 experts voted in favor of granting EUA, 4 against
- The one question expert panel was tasked with answering
- 'Appears to be our way out of this awful mess'
- Earlier, UK gave emergency approval to Pfizer-BioNTech's vaccine
- FDA is expected to authorize the vaccine within days
- Time of great urgency, says FDA Commissioner
17 experts voted in favor of granting EUA, 4 against
According to reports, 17 of the advisors in the FDA expert panel voted in favor of granting EUA to Pfizer-BioNTech's COVID-19 vaccine, while four voted against and one abstained. With this approval, the US - which continues to be the world's worst-affected country by the pandemic - is just a step away from launching a mass immunization drive to fight the novel coronavirus disease.
The one question expert panel was tasked with answering
The panel of outside advisors to the FDA was reportedly tasked with answering one major question: "Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 vaccine outweigh its risk for use in individuals 16 years of age and older?"
'Appears to be our way out of this awful mess'
Dr. Paul Offit, Director of Vaccine Education Center at Children's Hospital of Philadelphia and a member of the FDA expert committee—who voted in favor of EUA—told CNN's Wolf Blitzer: "The question is never when you know everything." "It's when you know enough...I think we know enough now to say that this appears to be our way out of this awful, awful mess," he added.
Earlier, UK gave emergency approval to Pfizer-BioNTech's vaccine
The US so far recorded over 16 million COVID-19 cases and nearly 300,000 deaths. However, with the EUA to the Pfizer-BioNTech's vaccine candidate, the spread of the coronavirus and surge in deaths are expected to slow down. To recall, on December 2, the United Kingdom gave emergency approval to Pfizer-BioNTech's COVID-19 vaccine, becoming the first Western country to allow mass immunization against the disease.
FDA is expected to authorize the vaccine within days
Reports say that shots could be administered within days in the US, most importantly depending on how quickly the FDA authorizes the vaccine. The agency is expected to sign off the recommendation of the independent expert panel within days. Notably, priority will be given to healthcare workers and nursing home residents who will receive the first shots in early-2021.
Time of great urgency, says FDA Commissioner
"In this time of great urgency, FDA staff feel the responsibility to move as quickly as possible through the review process," stated FDA Commissioner Dr. Stephen Hahn. "However, they know...they must carry out their mandate to protect the public health and to ensure that any authorized vaccine meets our rigorous standards for safety and effectiveness that...American people have come to expect," he added.
