F.D.A. Panel Offers Inexperienced Gentle to Pfizer’s Covid Vaccine

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F.D.A. Panel Gives Green Light to Pfizer's Covid Vaccine

Pfizer's Covid-19 vaccine passed a critical milestone on Thursday when a panel of experts from the Food and Drug Administration officially recommended approval of the vaccine. The agency will likely do this in a matter of days, with healthcare workers and nursing home residents being given first priority to begin the first admissions early next week.

The F.D.A.'s Vaccination Advisory Board, made up of independent scientific experts, infectious disease doctors and statisticians, voted 17 to 4, with one member abstaining, in favor of an emergency permit for people aged 16 and over. With rare exceptions, the F.D.A. follows the advice of its advisory bodies.

With this formal blessing, the nation could finally begin to slow the spread of the virus as infections and deaths rise, and hit a record of more than 3,000 daily deaths on Wednesday. The F.D.A. According to people familiar with the agency's planning, an emergency permit will be issued on Saturday. However, they warned that last minute legal or bureaucratic requirements could postpone the announcement to Sunday or later.

According to federal officials, the first delivery of 6.4 million cans will be delivered within 24 hours of approval by the F.D.A. leave the camp. About half of these doses are mailed across the country and the other half is reserved for first-time recipients who will receive their second dose about three weeks later.

The arrival of the first vaccines marks the beginning of a complex, month-long distribution plan coordinated by federal and local health authorities, as well as major hospitals and pharmacy chains, which, if successful, will help restore a grieving and economically depressed country to appear normal, perhaps until summer.

"Given the high efficacy and safety profile of our vaccine and the largely runaway pandemic, vaccine adoption is an urgent need," said Kathrin Jansen, senior vice president and head of vaccine research and development at Pfizer at the meeting.

The vote closes a whirlwind year for Pfizer and its German partner BioNTech, who started work on the vaccine eleven months ago. This will break all the speed records for vaccine development that normally take years. It's also a triumph for the F.D.A., which, despite months of political pressure from President Trump to link his political destiny to the success of a vaccine, has affirmed its reputation as the global gold standard for drug control. The Pfizer vaccine has already been given to people in Bahrain and the UK, where it was approved on December 2nd. Canada approved him on Wednesday.

US approval of the Pfizer vaccine is expected to be soon followed by one for the Moderna version, which uses similar technology and has shown promising results in clinical trials. Operation Warp Speed, the Trump administration's billion dollar program to accelerate vaccine development, pre-ordered 100 million doses of Pfizer's vaccine in July and strongly supported the development and manufacture of the Moderna vaccine.

More than 100 F.D.A. Staff worked almost around the clock reviewing Pfizer's Nov. 20 application, compressing the month-long analysis into weeks as they went through thousands of pages of clinical trial and manufacturing data.

Earlier this week, career scientists at the F.D.A. published an analysis showing the vaccine is effective in a variety of demographic groups and has some effectiveness even after the first of two doses.

During Thursday's one-day meeting, panel members provided experts from companies and agencies with detailed questions about the safety and effectiveness of the vaccine, which was 95 percent effective in a late clinical study. Some members expressed concern that there wasn't enough data from 16- and 17-year-olds to know if the vaccine would help them, but the committee decided that the benefits for this group outweighed the risks.

Some members asked about the likelihood of serious allergic reactions in the face of news that UK regulators this week recommended that people with a history of anaphylactic allergic reactions to medicines and foods not receive the vaccine while they witnessed two cases of allergic reactions in workers in the UK Investigate healthcare. According to Pfizer representatives, there were no cases of serious allergic reactions in the 44,000-participant study. People with a history of allergic reactions to vaccines were excluded from the study.

One of the panel members, Dr. Paul Offit of Philadelphia Children's Hospital said he feared statements from UK regulators, as well as remarks from Moncef Slaoui, a senior US vaccine official, could lead "tens of millions" of people with serious allergies to rejecting the vaccine, despite evidence of a link were unclear with the shots. He asked Pfizer to do a separate study in people with a history of severe allergies, because "this problem won't die away until we have better data."

The F.D.A. said it had asked Pfizer to include allergic reactions in its safety surveillance plan and would include a warning in its instructions on how to use the vaccine.

One of the hottest controversial questions was how the vaccine's full approval could affect the ongoing clinical trial. Some experts have argued that volunteers who received a placebo should ethically be offered the vaccine once approved, but others fear that moving it could affect the long-term results of the study.

During the public portion of the meeting, consumer and public health advocates largely urged the agency to approve the vaccine, highlighting the urgency of the pandemic. One speaker who identified himself as Kermit Kubitz stated that apart from "many older relatives" he had no conflicts of interest to report.

"You need that vaccine yesterday," he said.

However, proponents also urged regulators to be transparent about potential safety issues and to closely monitor the vaccine as soon as it becomes available. Several said such measures were necessary to reassure a public who are reluctant to take a new vaccine, especially blacks and Native Americans who have been ill-treated by the medical community in the past. "Before approval is granted, affected communities must have confidence that the vaccine is safe and effective," said Sarah Christopherson of the National Women's Health Network.

By insisting that the Advisory Committee vote on a vaccine, regulators created a shield against pressure from the White House to approve a product before the presidential election. When panelists met in October to review the guidelines of the F.D.A. for the approval of Covid-19 vaccines, they urged the agency to take its time and warned that speeding up the process could lead to a lack of critical safety data and further undermine public confidence.

The scene that played out on Thursday, in which outside experts embroiled government officials for hours in an intense but often highly technical discussion about vaccine research, wasn't always exciting. But the circumstances were certainly dramatic as the experts were asked to carefully weigh the risks and benefits of the vaccine, even as the United States hit the grim milestone on Wednesday of more than 3,000 Covid deaths, and like thousands of people in the UK have already received it.

The F.D.A. has struggled internally and externally to move its vaccination and treatment considerations forward quickly to contain the spread of the deadly virus – but not so quickly that it undermines public confidence. It was a thin line to go and not helped by the stream of troubling allegations from Mr. Trump and his advisors that the agency was moving too slowly.

Just days before Pfizer filed its application, the company sent an enormous tranche of manufacturing data to the F.D.A. – including materials to increase production – regulators must endeavor to assess them in time for possible approval.

As part of its supervision, the F.D.A. The teams also had the company's manufacturing facilities and clinical trial sites checked and verified that the records matched the accounts Pfizer had submitted to federal agencies.

At the same time, regulators were evaluating an equally complex emergency permit application submitted by Moderna, the data of which was submitted during another F.D.A. external consultation meeting next week.

The road to a coronavirus vaccine ›

Answers to your vaccine questions

As the coronavirus vaccine nears U.S. approval, here are some questions you may be wondering about:

    • If I live in the US, when can I get the vaccine? While the exact order of vaccine recipients may vary from state to state, most doctors and residents of long-term care facilities will come first. If you want to understand how this decision is made, this article will help.
    • When can I get back to normal life after the vaccination? Life will only get back to normal when society as a whole receives enough protection against the coronavirus. Once countries approve a vaccine, they can only vaccinate a few percent of their citizens in the first few months. The unvaccinated majority remain susceptible to infection. A growing number of coronavirus vaccines show robust protection against disease. However, it is also possible for people to spread the virus without knowing they are infected because they have mild or no symptoms. Scientists don't yet know whether the vaccines will also block the transmission of the coronavirus. Even vaccinated people have to wear masks for the time being, avoid the crowds indoors and so on. Once enough people are vaccinated, it becomes very difficult for the coronavirus to find people at risk to become infected. Depending on how quickly we as a society achieve this goal, life could approach a normal state in autumn 2021.
    • Do I still have to wear a mask after the vaccination? Yeah, but not forever. The two vaccines that may be approved this month clearly protect people from contracting Covid-19. However, the clinical trials that produced these results were not designed to determine whether vaccinated people could still spread the coronavirus without developing symptoms. That remains a possibility. We know that people who are naturally infected with the coronavirus can spread it while they don't have a cough or other symptoms. Researchers will study this question intensively when the vaccines are introduced. In the meantime, self-vaccinated people need to think of themselves as potential spreaders.
    • Will it hurt What are the side effects? The vaccine against Pfizer and BioNTech, like other typical vaccines, is delivered as a shot in the arm. The injection is no different from the ones you received before. Tens of thousands of people have already received the vaccines, and none of them have reported serious health problems. However, some of them have experienced short-lived symptoms, including pain and flu-like symptoms that usually last a day. It's possible that after the second shot, people will have to plan to take a day off or go to school. While these experiences are not pleasant, they are a good sign: they are the result of your own immune system's encounter with the vaccine and a strong reaction that ensures lasting immunity.
    • Will mRNA vaccines change my genes? No. Moderna and Pfizer vaccines use a genetic molecule to boost the immune system. This molecule, known as mRNA, is eventually destroyed by the body. The mRNA is packaged in an oily bubble that can fuse with a cell, allowing the molecule to slide inside. The cell uses the mRNA to make proteins from the coronavirus that can stimulate the immune system. At any given moment, each of our cells can contain hundreds of thousands of mRNA molecules that they produce to make their own proteins. As soon as these proteins are made, our cells use special enzymes to break down the mRNA. The mRNA molecules that our cells make can only survive a few minutes. The mRNA in vaccines is engineered to withstand the cell's enzymes a little longer, so the cells can make extra viral proteins and trigger a stronger immune response. However, the mRNA can hold for a few days at most before it is destroyed.

Regulators sometimes didn't get documents from companies until midnight and worked through the Thanksgiving holiday. Dr. Peter Marks, the F.D.A.'s chief vaccine regulator, joked at an American Medical Association event last week that his team ate turkey buns while reviewing documents.

“Of all global regulators, we're the ones who don't just look at the company's tables. We actually get dirty and look at the actual adverse event reports, the bad spelling mistakes that doctors sometimes make, and so on, ”he said on the event.

Dr. Stephen M. Hahn, the F.D.A. Commissioner, kept a certain distance from the review, according to those familiar with her.

Dr. Hahn had given in to pressure earlier this summer to approve an old anti-malarial drug, hydroxychloroquine, for use in Covid patients, although there was little evidence that it was working. That decision was reversed after the agency found the drug is unlikely to be effective in Covid patients and carries the risk of potentially dangerous side effects. And Dr. Hahn was criticized by the scientific community for exaggerating the benefits of another treatment, convalescent plasma, a mistake he later corrected.

Mr Trump accused agency officials of being part of the "deep state" and hinted that a vaccine could come before a "very special day" – election day. The reputation of the F.D.A. seemed to be going in the same direction as the Centers for Disease Control and Prevention, which were widely criticized for not opposing the president.

But high-ranking supervisory authorities – and finally Dr. Hahn himself – pushed back. The agency's senior career figures posted a statement in USA Today recognizing the integrity of the F.D.A. had been questioned and insisted that they would "follow science" during the pandemic. The agency prevailed in the battle with the White House to impose stricter guidelines on companies developing Covid vaccines.

"In such an environment, where there has been so much pressure and concern, the process offers important control and balance," said Dr. Jesse L. Goodman, previously the chief scientist of the F.D.A. acted. By holding an open meeting, the public can also "be assured that a wider scientific and clinical community will be happy with the decision".

On Tuesday, the president held a summit to demonstrate the government's role in developing a vaccine. "We are only a few days from the approval by the F.D.A. and we're pushing them hard, "Trump said at the event.

Many healthcare workers across the country are already barely keen to get the vaccine. Dr. Andrew Barros, an intensive care physician in Charlottesville, Virginia, about to have his Pfizer shot at 2:30 p.m. On December 15, he said he was looking forward to having an aching arm and hopefully getting a step closer to Covid.

Pfizer's clinical trial continues even after the vaccine was approved by the F.D.A. and the company and the F.D.A. will continue to be vigilant for security concerns.

Pfizer announced Thursday that full approval will be sought in April 2021 after the company collected six months of safety data. At that point, Pfizer could sell its vaccine directly to hospitals and other health care providers.

Carl Zimmer and Katherine J. Wu contributed to the coverage.

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