ENTERTAINMENT

The FDA panel approves Pfizer's shot


The US Food and Drug Administration (FDA) vaccine advisory board has decided to grant emergency approval for Pfizer's coronavirus vaccine.

It is the final crucial decision before the FDA approves the shot to Americans. This is a historic step in the fight against the COVID-19 pandemic in the US, which set another grim record with more than 3,000 deaths on Wednesday.

Now the FDA itself must accept the committee's recommendation and Commissioner Stephen Hahn must sign the emergency clearance.

Officials typically accept the recommendations of these panels of experts, and the FDA is expected to approve the shot tomorrow – but there is no guarantee that the final verdict will be made before the weekend.

Peter Marks, director of the FDA vaccines division, said there could be "days to a week" between the committee vote and the FDA's decision to actually approve the vaccine.

Once that happens, Pfizer's vaccine could be delivered to all U.S. Marshal-led states and territories within 24 hours, Operation Warp Speed ​​officials have promised.

Vaccine Initiative Co-Leader General Gustave Perna said there would be "gun shots" within 96 hours of approval.

After nearly nine hours of deliberations on Thursday, 17 members of the Advisory Committee on Vaccines and Related Biological Products voted in favor of granting emergency clearance for the first coronavirus vaccine to be marketed in the United States.

Four committee members voted against the urgency permit and one abstained.

They concluded that the benefits of the vaccine outweigh the risks for Americans 16 and older.

If the FDA officially approves the shot as expected, the US will be the third western nation to begin distributing a coronavirus vaccine.

UK regulators approved Pfizer's push last Wednesday and released the first doses on Tuesday. Canada approved the same vaccine on Wednesday.

Seventeen out of 23 scientists on the FDA Advisory Committee on Thursday voted to recommend emergency approval of Pfizer's coronavirus vaccine based on this question

Assuming FDA officials sign the panel's recommendation, Pfizer's shot could be approved in "days to a week".

Assuming FDA officials sign the panel's recommendation, Pfizer's shot could be approved in "days to a week".

Scientists on the FDA's COVID Vaccine Advisory Board have spent all morning hearing arguments for and against.

The main sticking points: Some experts wanted to change the recommendation at the last minute and vote on approving it only for people aged 18 and over.

Others were deeply concerned about two reports of severe allergic reactions in two Britons who received the vaccine on the first day in the UK.

Experts have also looked into whether the shot has been adequately tested on blacks, Latinx and Indians. They were just as concerned about whether these groups would trust the vaccine as that it could actually be dangerous for them.

And concerns were raised about counseling pregnant women who were not being recruited for Pfizer's vaccine study.

Hoping to resolve these issues, the experts made it clear that Pfizer should continue to conduct trials even after the shot is approved.

That could be tricky because these studies require people to sign up for a placebo – a sham vaccine.

Now that the vaccine will be available outside of trials, experts fear that people will no longer have the incentive to join them or stay in them with a 50/50 chance of getting the placebo.

The committee's vote on the vaccine came after the deadliest day ever in the US, with more than 3,000 deaths reported on Wednesday

The committee's vote on the vaccine came after the deadliest day ever in the US, with more than 3,000 deaths reported on Wednesday

Daily cases are reaching near record highs in the US as well, and more than 15.5 million Americans have been infected

Daily cases are reaching near record highs in the US as well, and more than 15.5 million Americans have been infected

But ultimately, none of these issues outweighed the bigger problem: Americans need protection from COVID-19 and the need as soon as possible.

& # 39; The UK and Canada are already rolling out the vaccine. It's time for the FDA to act quickly, "a former FDA official and current president of the Center for Medicine in the Public Interest told DailyMail.com in comments emailed to DailyMail.com.

A separate advisory board met last week and recommended that vaccines go to healthcare workers and residents and nursing home workers first.

Much like the FDA, the Centers for Disease Control and Prevention must sign off the vaccine and recommendation of who will get it first.

The US states have been told to prepare to receive the first 2.9 million doses of Pfizer's vaccine next week.

Some American experts, including Dr. Anthony Fauci, have criticized the UK for approving Pfizer's vaccine with little criticism (although Dr. Fauci apologized for his comments).

Others, however, have resisted the lengthy U.S. process that is speeding up and killing thousands of Americans each day from COVID-19.

The independent advisory body met today to discuss the outcomes of the Pfizer process, nearly three weeks after it was submitted for emergency approval and days after its UK and Canadian approval.

The FDA advisory panel spent the day discussing the benefits and potential problems of the Pfizer vaccine

The FDA advisory panel spent the day discussing the benefits and potential problems of the Pfizer vaccine

Scientists spent all morning hearing arguments from people on the matter, including a woman whose husband had committed suicide after taking antidepressants. She said the entire study was "a great human experiment" and the great drug was the only winner.

Twelve people were invited to speak in front of the panel this morning.

23 separate scientists, doctors and industry experts on the advisory board will then vote on whether the vaccine should be approved. Then the FDA will review your recommendation and ultimately make a decision.

It prolonged an already slow US response to getting the vaccine off the ground, angering millions of Americans as COVID cases continue to rise.

Wednesday was the deadliest day of the pandemic with 3,045 deaths.

Tens of thousands more are expected in the winter before a vaccine becomes widely available.

Johns Hopkins Professor Mark Makary MD said there was no reason for the delay.

“It's war, but you'd never find out from the agency's week-long review.

& # 39; We are in a health emergency. The US will soon suffer more than 3,000 deaths a day from COVID-19. By the time the FDA is reviewing the vaccine trial data, around 35,000 people in the US will have died from the virus, ”he wrote on Thursday.

During the virtual meeting on Thursday, Peter Doshi, one of the experts, asked how long it would take.

SCHEDULE ON PFIZER Vaccine

November 18: Pfizer announces its vaccine is 94% effective

November 23: Pfizer is submitting trial data to the FDA for emergency approval

3rd of December: UK approves Pfizer vaccine

December 7th: The first doses are given in England

December 8th: The FDA publishes a preliminary analysis stating the vaccine is safe and effective but has not yet been approved

9th of December: Canada approves the vaccine

9th of December: Deadliest day for the US with 3,045 deaths

10th of December: The FDA advisory panel meets to discuss the vaccine

“Preventing COVID for two or three months is one thing, but protection has to take a lot longer.

& # 39; Will it still hit the FDA's 50 percent threshold after six months or a year?

"It's hard to say," said Peter Doshi of the University of Maryland.

The scientists also heard from "panelists," including Kim Witczak, who founded Woody Matters in memory of her late husband, who committed suicide while on antidepressant medication.

Another expert called it "a great human experiment" and said the only guaranteed winners are large pharmaceutical companies.

& # 39; The public is the real clinical trial – it's a great human experiment.

"The only ones who have 100% immunity are the drug companies. They get all the benefits of selling with no legal liability in case something goes wrong," said Kim Witczak of Woody Matters.

Another moral dilemma will be what to do with the 22,000 study participants who did not receive the vaccine and were given a placebo.

The only way to prove whether a vaccine works is to compare it to a placebo. The study should continue after an emergency clearance so the scientists can better understand the long-term effects.

However, Pfizer cannot prevent placebo participants from receiving the vaccine once it is available to the public.

Panellists asked how the company will prevent these individuals from leaving the study to receive the vaccine. That would protect them from the virus, but it would end the study and therefore not provide any future data on the long-term effects of the vaccine.

Pfizer's current plan is to offer the vaccine to subjects who received the placebo and notify them that they received the mock shot as soon as they are eligible to receive it under the emergency clearance.

Pfizer was filed with the FDA for emergency approval on November 23rd. So many people have died of COVID since then

Pfizer was filed with the FDA for emergency approval on November 23rd. So many people have died of COVID since then

In other words, once the FDA issues emergency vaccine approval, a health care professional who signed up for the Pfizer study could ask the test runners if they received a placebo shot.

Pfizer would disclose what the participant got and offer the real vaccine.

The problem with this, however, is that Pfizer may soon run out of placebo participants, and those who found out they got the shot could become dangerous, go maskless and ignore social distancing because they assume the vaccine will protect them explained Dr. Steven Goodman, a bioethicist from Johns Hopkins University.

The FDA wants Pfizer to keep researching how well the shot works, and losing the placebo group would get in the way.

Dr. Goodman suggested a strange solution: once they qualify for the off-trial shot, give volunteers who received a placebo the correct shot, and those who accidentally received the vaccine a placebo shot.

Sarah Christopherson's National Women's Health Network said there is still not enough data.

& # 39; We have serious concerns that we need to proceed with (Emergency Authorization) based on so little data on so many of the communities hardest hit by this virus.

THE SCIENTISTS WHO CHOOSE PFIZER VACCINE

Hana El Sahly, M.D.

Expertise: vaccines, infectious diseases

Associate Professor, Department of Molecular Virology and Microbiology, Baylor College of Medicine

Tammy Beckham, D.V.M., Ph.D.

Expertise: Infectious Diseases

Deputy Secretary Secretary for Vaccines and Infectious Diseases Office of the Deputy Secretary of the Department of Health for Health and Human Services

Paula Annunziato, M.D.

Expertise: industry representatives

Vice President and Head of Therapeutic Services, Vaccines Clinical Research at Merck

Archana Chatterjee, M.D., Ph.D.

Expertise: pediatrics, infectious diseases

Dean of Chicago Medical School and Vice President for Medical Affairs Rosalind Franklin University of Medicine and Science

Hayley Goose, M.D.

Expertise: pediatrics, infectious diseases

Professor of Pediatrics, Department of Pediatrics, Stanford University Medical Center

CAPT Amanda Cohn, M.D.

Expertise: pediatrics, vaccines

Chief Medical Officer, National Center for Vaccination and Respiratory Diseases, Centers for Disease Control and Prevention

Holly Janes, Ph.D.

Expertise: biostatistics

Associate member. Fred Hutchinson Cancer Research Center, Department of Vaccines and Infectious Diseases Department of Public Health Sciences

Michael Kurilla, M.D., Ph.D.

Expertise: Infectious Diseases, Pathology Director, Clinical Innovation Department, National Center for the Advancement of Translation Studies, National Health Institutes

Myron Levine, M.D., D. T. P. H., F. A. A. P.

Expertise: Infectious Diseases

Simon & Bessie, Grollman Distinguished Professor Associate Dean of Global Health, Vaccine and Infectious Diseases, Center for Vaccine Development, University of Maryland School of Medicine

H. Cody Meissner, M.D.

Expertise: Infectious Diseases

Professor of Pediatrics, Tufts University School of Medicine, Director, Pediatric Infectious Disease, Tufts Medical Center

Paul Offit, M.D.

Expertise: Infectious Diseases

Professor of Pediatrics, Department of Infectious Diseases, Abramson Research Building, Philadelphia Children's Hospital

Steven Pergam

Expertise: Infectious Diseases

Medical Director for Infection Prevention, Seattle Cancer Care Alliance

Andrea Shane, M.D., M.P.H., M.Sc.

Expertise: Childhood and Infectious Diseases

Professor of Pediatrics, Director of the Department of Pediatric Infectious Diseases, Emory University School of Medicine

Paul Spearman, M.D.

Expertise: Childhood and Infectious Diseases

Director of Infectious Diseases Division Albert B. Sabin Chair of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center,

Professor, Department of Pediatrics University of Cincinnati School of Medicine

Geeta K. Swamy, M.D.

Expertise: Infectious Diseases

Senior Associate Dean Assistant Chair of Research and Faculty Development, Associate Professor, ObGyn, Department of Obstetrics and Gynecology, Department of Maternal-Fetal Medicine, Duke University

Gregg Sylvester, M.D., M.P.H. +

Expertise: Alternative industry representative

Vice President, Medical Affairs, Seqirus Inc.

Sheldon Toubman, J.D. **

Expertise: law

New Haven Legal Assistance Association attorney

Oveta Fuller

International Institute of the African Studies Center, Associate Professor of Microbiology and Immunology, President of the Medical Faculty and Chief Executive Officer

University of Michigan

James Gildreth, Sr., PhD, M.D.

Professor, Department of Internal Medicine, School of Medicine, President and Chief Executive Officer, Meharry Medical College

Juan Gea-Banacloche, MD

Professor of Medicine, Senior Associate Consultant, Department of Infectious Diseases

Mayo Clinic

David Kim, MD, MA

CAPT US Public Health Services, Director, Vaccines Division, Office of Infectious Diseases and HIV / AIDS Policy, Office of the Assistant Secretary of Health, US Department of Health

Jeannette Lee, PhD

Professor, Department of Biostatistics, University of Arkansas for Medical Sciences

Ofer Levy, MD, PhD

Medical Officer and Principal Investigator, Director, Precision Vaccines Program, Infectious Diseases Department, Boston Children's Hospital, Professor, Harvard Medical School

Pamela McInnes, DDS, MSC

Retired Assistant Director, National Center for the Advancement of Translational Science, National Institutes of Health Patrick Moore, MD, MPH, Professor of the Distinguished and American Cancer Society, Pittsburgh Founding Chair in Innovative Cancer Research, University of Pittsburgh Cancer Institute

Stanley Perlman

Professor, Departments of Microbiology and Immunoloy, Professor of Pediatrics

Mark Stinski

Chair of Virology at the University of Iowa

Eric Rubin, MD, PhD

Assistant Professor, Microbiology and Molecular Genetics, Harvard Medical School, Chair, Department of Immunology and Infectious Diseases

Mark Sawyer, MD, FAAP

Professor of Clinical Pediatrics, Department of Infectious Diseases

University of California Medical School at San Diego

Ralph Tripp, PhD

Professor, Department of Infectious Diseases, University of Georgia

Melinda Wharton M.D. M.P.J.

Director of the National Center for Immunization Services for Immunization and Respiratory Diseases

The UK approved the vaccine last week and people started receiving the vaccine on Tuesday. Above, a woman in Cornwall, England who received the vaccine on Wednesday

The UK approved the vaccine last week and people started receiving the vaccine on Tuesday. Above, a woman in Cornwall, England who received the vaccine on Wednesday

Johns Hopkins Professor criticizes the FDA for the 35,000 Americans who have died since the vaccine was announced

A Johns Hopkins professor has condemned the FDA for taking so long to review the Pfizer vaccine while thousands of Americans continue to die from COVID.

Pfizer announced in early November that its vaccine was effective according to a widespread global study of 44,000 volunteers.

She submitted her results to the FDA for approval on November 23, but has not yet been approved.

Martin Makary MD

Martin Makary MD

Since then, 34,000 Americans have died from the virus.

Martin Makary, MD, wrote for Med Page today Thursday that there was no reason to delay.

“It's war, but you'd never find out from the agency's week-long review.

& # 39; We are in a health emergency. The US will soon suffer more than 3,000 deaths a day from COVID-19. By the time the FDA is reviewing the vaccine trial data, around 35,000 people in the United States will have died from the virus.

“That is more Americans than died during the Iraq and Afghanistan wars and September 11th combined. We are in a war now. Given the overwhelming results of the Phase III trials and dire prognoses for the next few months, the FDA should move from peacetime to war pace.

"There's simply no scientific reason why the FDA-mandated review couldn't be done in a few days without compromising safety," he said.

"It will do little to allay legitimate concerns in these communities about the use of these vaccines," she said.

One study found that less than 25 percent of African Americans said they would take the vaccine, even though the death rate from COVID is three times higher among blacks than whites.

Eighty percent of the study participants were white.

Fewer than 2,000 African Americans actually received the infection, and only 131 Native Americans received it.

The distribution almost corresponds to the general population; 76 percent are white, 13 percent are black, and 18 percent are Hispanic.

During Thursday's talks, they also commented that there was no information on whether the vaccine is safe for pregnant women and how they "knew" and would continue to monitor reports of two UK health workers with anaphylactic shock.

We are aware of reports of anaphylactic reactions and continue to collect information to closely monitor the situation

The scientists also heard from "panelists," including Kim Witczak, who founded Woody Matters in memory of her late husband

The scientists also heard from "panelists," including Kim Witczak, who founded Woody Matters in memory of her late husband

The U.S. recorded its deadliest day since the pandemic began on Wednesday, with more than 3,045 deaths and hospitals across the country.

The UK and Canada both approved the vaccine, and the first people in the world received it in England on Tuesday, but a deadline has not yet been set for when Americans can expect access.

On all three of the big morning shows – Good Morning America, Today, and CBS This Morning – FDA Commissioner Steve Hahn refused to give Thursday an approval date or inquire about how long the process would take.

“I will not anticipate what the advisory board is saying.

& # 39; This is an advisory board that doesn't bind the FDA, but we think their contributions are really important. That's why we want to hear the scientific and medical discussion and then incorporate it into our decision-making.

“We can act quickly and we intend to – we understand the urgency of the situation.

“There can be problems, medical and scientific problems that we need to address after the discussion, and we will.

"We want to make sure we are making the absolute best decision for the American people," he said on Good Morning America.

He then said today that the vaccine meets FDA standards, but they still want to hear from the advisory board.

"Our initial assessment is that this is a vaccine that meets our criteria … but we want to hear from the Vaccine Advisory Committee," he said.

One source of discussion at the committee meeting on Thursday will be that two UK health workers suffered an allergic reaction after receiving the shot.

Hahn said that's the kind of thing they want to take a closer look at before approving the vaccine.

There is still no date when people actually start vaccinating.

The federal government had announced that the first doses would run out this month.

Nursing home staff and residents will receive it first, then it will go to healthcare workers.

After them, the general public will have access to it.

Another possible obstacle will be whether there are enough doses of the vaccine to get around.

The government is actively engaged in talks with Pfizer, Moderna, and other vaccine companies to try to get as many doses as possible.

There is still great skepticism about the vaccine in the US.

Many fear that it was politically motivated and tried to improve President Trump's election chances.

The experts all say it doesn't and that they will be among the first to receive it when it becomes available.

But 41 percent of the public aren't yet convinced it's safe.

"That concerns me … We have to achieve herd immunity, and that requires a significant percentage of Americans to be vaccinated," Hahn said Thursday.

In a preliminary analysis posted online Tuesday, a group of FDA scientists said it was safe.

Of the 20,000 people given the vaccine in Pfizer's global study, 137 had allergic reactions, as did 111 people given the placebo, leading scientists to dismiss it as a potential hazard.

Four people developed some type of facial paralysis after receiving it, but the study's scientists said it wasn't necessarily the sting that caused it and at the general rate of Bell's palsy was equivalent in the wider population.

The UK Medicines and Health Products Regulator (MHRA) warned people with a severe allergy to food or medication not to get it on Wednesday.

In America, this applies to at least 200,000 people with food allergies and many more with drug allergies.

The two health care workers affected are wearing EpiPens but no additional information was provided. You should now have a good rest.

British scientists have told the public not to panic and say the vaccine is safe, but there is still great skepticism.

It also begs the question of whether the US is rightly taking longer to clear the shot despite the pressure from Americans to give it the go-ahead because the UK did so.

On December 3, Dr. Fauci that the British had gone too fast.

"To do justice to so many of my British friends, they came around the corner of the marathon and joined it on the last mile," he said.

“I think that would be a good metaphor for that … because they really went through that consent. I love the British, they are great, they are good scientists, but they just took the data from the Pfizer company and instead of really, really carefully checking it, they said, "OK, let's go ahead and approve it, that's it. " And they went with me.

"In fact, they have been criticized quite severely even by their counterparts in the European Union who said, 'It was kind of a hot dog game," he said.

He then apologized for his comments, saying they were competitiveness driven.

On Wednesday, after the UK cases became public, Fauci said he was "concerned".

The document will be reviewed on Thursday when the expert group is convened

The document will be reviewed on Thursday when the expert group is convened

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