Fda Panel Votes To Authorize Emergency Use Of Pfizer Vaccine: Minute By Minute
FDA says committee vote is “important step”
The US Food and Drug Administration (FDA) said that the vote of its vaccine advisers in favor of recommending the emergency use authorization of Pfizer’s covid-19 vaccine is an “ important step ”in the review process.
The FDA said its Vaccine and Related Biologics Advisory Committee, made up of independent scientists and public health experts, provides “valuable advice and input” to help the FDA make its vaccine decision.
“Importantly, the final decision on whether to authorize the vaccine for emergency use will be made by career FDA officials,” the agency said in a statement.
“At this time of great urgency, FDA staff feel a responsibility to move forward through the review process as quickly as possible. However, they know that they must fulfill their mandate to protect public health and ensure that any licensed vaccine meets our rigorous standards of safety and efficacy that the American people expect, ”said FDA Commissioner Dr. Stephen Hahn, in the statement.
“The entire FDA, including myself, remains committed to keeping the public informed about the evaluation of the data for a potential COVID-19 vaccine so that once it is available, Americans can have confidence and security in receiving the vaccine. vaccine for their families and themselves.
FDA Commissioner Promises Staff Will Consider Committee Input to Evaluate Pfizer Vaccine Authorization
Advisers to the U.S. Food and Drug Administration (FDA) voted to recommend emergency use authorization for the coronavirus vaccine from Pfizer and BioNTech, but FDA Commissioner Dr. Stephen Hahn said the agency should continue the review before deciding.
“Thank you to the scientific and public health experts who participated in the FDA Advisory Committee on Vaccines and Related Biologics meeting held today to discuss a request for an Emergency Use Authorization of a vaccine to prevent # COVID19,” Hahn said on Twitter.
“It is important that this process is open and transparent. Thousands of people watched this meeting live online to hear their knowledge and experience about this vaccine candidate. FDA career staff will consider the committee’s input as they continue their review, ”he tweeted.
“FDA staff feel a responsibility to act as quickly as possible. However, they know that they must fulfill their mandate to protect public health and ensure that any licensed vaccine meets our rigorous standards of safety and efficacy that the American people expect, “he adds.
It is not clear when the FDA will actually decide to grant an emergency use authorization, although Hahn and other top officials have indicated that the agency will grant it.
Biden on the vaccine recommendation: “A bright light in unnecessarily dark weather”
President-elect Joe Biden stated the FDA panel’s recommendation that the agency authorizes the emergency use of Pfizer and BioNTech’s COVID-19 vaccine.
“We are grateful to the scientists and researchers who developed this vaccine. And we are grateful to the scientists and public health experts who evaluated the safety and efficacy of this vaccine free from political influence. The integrity of science brought us to this point, ”wrote Biden.
FDA Advisors Vote to Recommend Agency Authorize Pfizer Covid-19 Vaccine
The U.S. Food and Drug Administration (FDA) Advisory Committee on Vaccines and Related Biologicals voted Thursday to recommend that the agency grant an emergency use authorization to Pfizer’s vaccine. against the coronavirus.
A total of 17 members voted in favor, 4 against and one abstained.
FDA Vaccine Committee Moves To Discuss Whether To Recommend Pfizer Vaccine Licensing
The Advisory Committee on Vaccines and Related Biologics is debating whether to recommend that the FDA grant an Emergency Use Authorization (US) for Pfizer’s coronavirus vaccine.
The question to be voted on is: based on the totality of the available scientific evidence, do the benefits of the Pfizer and BioNTech covid-19 vaccine outweigh the risks of its use in 16-year-olds? And older?
The committee’s definition does not mean full approval, as the FDA makes that decision separately from the committee’s vote. The FDA typically follows the committee’s recommendations and has indicated that it will grant an emergency clearance quickly. However, it is not known when the FDA would make that decision.
The advisory committee is comprised of independent vaccine experts, infectious disease specialists, industry representatives, and a consumer representative. It has 17 regular members and 13 temporary voting members.
FDA Vaccine Advisors Raise Concern Over Allergic Reactions To Pfizer Vaccine In UK
Vaccine advisers to the U.S. Food and Drug Administration (FDA) say they are concerned about how the U.S. public will react to reports of severe allergic reactions to Pfizer’s coronavirus vaccine in the U.S. UK.
“I am concerned about these severe anaphylactic reactions,” said Dr. Paul Offit, director of the Center for Vaccine Education at the Children’s Hospital of Philadelphia, during the debate leading up to the committee vote.
On Wednesday, reports emerged from the UK of two healthcare workers with a significant history of allergies who had reactions after getting vaccinated against COVID-19. Since then they have recovered.
We don’t know the details of those two things. We don’t know specifically what they were allergic to or what their history of severe allergies was, ”Offit said during the Vaccines and Related Biologics Advisory Committee meeting.
Offit, a voting member of the committee, said he was concerned that Americans with allergies feared getting vaccinated. Britain’s Public Health officials are now telling people with a history of severe allergies not to get vaccinated, Offit said.
“There are tens of millions of people in this country who carry EpiPens with them, because they have a peanut allergy, because they have an egg allergy, that they are now going to believe that they cannot get this vaccine,” Offit said. “That’s a lot of people.”
Pfizer said earlier that it had not recorded serious allergic reactions to the vaccine in the phase 3 trial that involved 44,000 volunteers. However, people with a history of allergic reactions to vaccines were excluded from the trial.
Dr. William Gruber, senior vice president of vaccine research and clinical development at Pfizer said that ‘the nature of what was actually excluded from the trial was really restricted to those individuals who had had a severe allergic reaction to a vaccine, any vaccine, previously, or obviously during the course of the trial if they had received the first dose, and had a significant type one hypersensitivity response, then that would preclude the administration of a second dose. ‘
Gruber said that the Pfizer researchers did not find anyone who had to be excluded from receiving the second dose of the vaccine during the trial.
There are no serious allergic reactions among coronavirus vaccine volunteers, Pfizer told the FDA committee.
Pfizer officials told U.S. Food and Drug Administration (FDA) vaccine advisers on Thursday that they did not observe serious allergic reactions among volunteers who tested the coronavirus vaccine made by the company.
“Among the 44,000 subjects, we saw no serious allergic reactions to the vaccine,” Dr. William Gruber, senior vice president of clinical vaccine research and development at Pfizer, told the FDA’s Advisory Committee on Vaccines and Related Biologics.
“Within the clinical trial, we have not actually seen evidence to suggest a signal related to an allergic reaction to the vaccine,” he added.
“Obviously, we are aware of the report that has occurred with the use in the UK,” Gruber said but declined to comment.
Two health workers who received the vaccine on the first day of deployment Tuesday in Britain suffered allergic reactions, England’s National Health Service said.
Pfizer excluded from its clinical trial anyone with a history of allergies, such as a serious adverse reaction associated with a vaccine and/or a severe allergic reaction “to any component of the study intervention (s).”
Pfizer Says It Searched For The Safest Possible Vaccine While Researching Candidates
Pfizer was seeking the safest possible vaccine by selecting multiple candidates for a coronavirus vaccine, Pfizer’s senior vice president and head of vaccine research and development said Thursday.
“Given the enormity of our mission, clinical data was important to us in deciding the right candidate for a COVID-19 vaccine,” Pfizer’s Kathrin Jansen told the FDA’s Advisory Committee on Vaccines and Related Biologics.
“We screened not just one, but four different candidates in Phase 1 so that we could make real-time scientific decisions to select the best candidate,” added Jansen.
“With regard to safety, we were looking for the most favorable safety and tolerability profile in both young and old adults. With regard to immunogenicity, we were looking for the broadest antiviral immune responses, probably associated with efficacy. And with regard to a rapid response to a pandemic, we were looking for the candidate that could be developed and produced in the most efficient way, ”he said.
Jansen said that when it comes to mRNA vaccines, “we have a deep scientific understanding of how these vaccines work.”
He said mRNA vaccines “can be developed and expanded rapidly,” offering “a distinct advantage” over other types of vaccines.
A key meeting
Americans could have the first real ray of hope that the pandemic that has changed their lives will be ended on Thursday when a key advisory panel takes a vote that could pave the way for the US Food and Drug Administration. The U.S. (FDA) green-lit a covid-19 vaccine in a few days.
The FDA advisory panel will meet Thursday to discuss whether the agency should authorize emergency use of the Pfizer and BioNTech vaccine at a dark time in the pandemic when the U.S. recorded the highest count in a single day of more than 3,000 deaths, and some communities continue to resist precautionary measures such as mask-wearing mandates, while a few falsely claim that the pandemic does not exist.