In response to the FDA chief, the company will shortly approve Pfizer’s Covid vaccine for an emergency
The Food and Drug Administration is “working fast” to clear Pfizer’s Covid-19 vaccine for emergency use after a key panel overwhelmingly approved the shots on Thursday evening, Commissioner Stephen Hahn said in a statement Friday.
“Following yesterday’s positive outcome from the Pfizer-BioNTech COVID-19 vaccine meeting of the Advisory Committee, the US Food and Drug Administration has informed the sponsor that it will work swiftly towards completion and emergency approval “said Hahn in a joint statement with Dr. Peter Marks, director of the FDA Center for Biologics Evaluation and Research.
“The agency has also notified the US Centers for Disease Control and Prevention and Operation Warp Speed so that they can implement their plans for a timely distribution of the vaccine,” said Hahn and Marks.
Hahn added in a tweet that the FDA is “finalizing the necessary documents to ensure that patients and providers have the information they need to make informed decisions and safely administer the vaccine.”
The FDA’s comments come after the FDA’s Advisory Committee on Vaccines and Related Biological Products on Thursday voted 17 to 4 with one abstention on recommending the vaccine, which the company developed with BioNTech, for emergency approval. The FDA usually follows the advice of the advisory committee, but it is uncommon for the agency commissioner to announce intention to evacuate the product prior to the announcement.
Data on the Pfizer vaccine shows it was about 95% effective against Covid-19 in study participants. The FDA is expected to approve emergency use as early as Friday.
The vaccine should be approved “in the next few days,” said Alex Azar, secretary for the Department of Health and Human Services, on ABC’s Good Morning America on Friday.
“We’re not seeing 20 million Americans vaccinated for the next few weeks, up to 50 million by the end of January, and we believe we can get 100 million actual vaccinations by the end of February,” Azar said.
After the FDA released Hahn and Marks’ statement on Friday, President Donald Trump, who has repeatedly stated that he had urged the agency to speed up the approval of various treatments for Covid-19, said the FDA “is still one.” big, old firm is, slow turtle. “
“Get the dam vaccines out NOW, Dr. Hahn @SteveFDA,” he said on Twitter, tagging the FDA commissioner. “Stop playing and save lives !!!”
At the advisory board meeting on Thursday, Pfizer’s head of vaccine research and development, Kathrin Jansen, argued at her company why the committee should recommend that the FDA issue an emergency approval for the vaccine. She said the vaccine was one of society’s greatest hopes of ending the pandemic that killed nearly 300,000 people in the U.S. in less than a year and returning to a sense of normalcy.
However, Thursday’s meeting was not without debate. FDA advisors interviewed Pfizer and FDA staff on a number of questions, including a lack of data on the vaccine’s safety profile in pregnant women and young children. After the vote, some committee members who voted against the recommendation for a permit said they did so because they did not want anyone under the age of 18 to be included on the emergency permit because the data on that age group was too “thin”. The advisory board recommended its use in people aged 16 and over.
Dr. Paul Offit, who had voted in support of the emergency clearance, grilled Pfizer at the meeting over two cases of allergic reactions reported by UK health workers vaccinated against Covid-19. He urged Pfizer and FDA staff on their plans to ensure the vaccine is safe for Americans with a history of allergies.