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.

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.

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.

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.

“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.

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.

"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 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".