OT (covid-19 related) Pfizer Covid Vaccine Faces Hurdles After FDA Filing Friday
Pfizer, BioNTech to Seek Emergency FDA Authorization for Covid Vaccine
Pfizer Inc. and BioNTech SE requested emergency authorization of their Covid vaccine on Friday, and it could take at least three weeks for a U.S. Food and Drug Administration decision as trial data is probed by agency staff and outside advisers.
Shown to be 95% effective and without any major safety issues, their vaccine could be the first to be cleared for use, but first it must undergo a thorough vetting. The filing could enable its use by the middle to the end of December, the companies said in a statement.
A key step along the way is a meeting of outside FDA advisers, all experts in infectious diseases and vaccines. The FDA will convene the advisory group Dec. 10 to discuss Pfizer and BioNTech’s vaccine, according to a statement from the agency Friday. The FDA will spend the few short weeks between the emergency authorization request and the meeting sorting through the trial data.
“I don’t find that time frame to be unreasonable in light of the amount of data the agency needs to analyze and in order to ensure full participation by all stakeholders in the advisory committee,” said John Taylor, who served as counselor to the head of the FDA during the Obama administration and now works as a consultant at Greenleaf Health. “It ensures that the agency can conduct a well run, well attended advisory committee in order to ensure maximum transparency, which I think will be an important factor in patients’ willingness to take the vaccine.”
Read More: Vaccine Safety to Remain Unclear Until Millions Get Their Shots
FDA Commissioner Stephen Hahn also said earlier this week the agency will post documents related to its review of any vaccine granted an emergency authorization. The aim is to “contribute to the public’s confidence in the agency’s rigorous review of scientific data and the appropriate use of authorized products.”
Pfizer gained 1.4% in New York, while BioNTech’s American depositary receipts rose 9.6%.
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Pfizer, BioNTech to Seek Emergency FDA Authorization for Covid Vaccine
Pfizer Inc. and BioNTech SE requested emergency authorization of their Covid vaccine on Friday, and it could take at least three weeks for a U.S. Food and Drug Administration decision as trial data is probed by agency staff and outside advisers.
Shown to be 95% effective and without any major safety issues, their vaccine could be the first to be cleared for use, but first it must undergo a thorough vetting. The filing could enable its use by the middle to the end of December, the companies said in a statement.
A key step along the way is a meeting of outside FDA advisers, all experts in infectious diseases and vaccines. The FDA will convene the advisory group Dec. 10 to discuss Pfizer and BioNTech’s vaccine, according to a statement from the agency Friday. The FDA will spend the few short weeks between the emergency authorization request and the meeting sorting through the trial data.
“I don’t find that time frame to be unreasonable in light of the amount of data the agency needs to analyze and in order to ensure full participation by all stakeholders in the advisory committee,” said John Taylor, who served as counselor to the head of the FDA during the Obama administration and now works as a consultant at Greenleaf Health. “It ensures that the agency can conduct a well run, well attended advisory committee in order to ensure maximum transparency, which I think will be an important factor in patients’ willingness to take the vaccine.”
Read More: Vaccine Safety to Remain Unclear Until Millions Get Their Shots
FDA Commissioner Stephen Hahn also said earlier this week the agency will post documents related to its review of any vaccine granted an emergency authorization. The aim is to “contribute to the public’s confidence in the agency’s rigorous review of scientific data and the appropriate use of authorized products.”
Pfizer gained 1.4% in New York, while BioNTech’s American depositary receipts rose 9.6%.
Key Moments
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