Saturday, December 4

The process to fully approve covid-19 vaccines


(CNN) — The U.S. Food and Drug Administration (FDA) insists it works as quickly as possible to review applications for full approval of covid-19 vaccines as the number of cases continues to rise. and vaccination rates are declining across the country.

Although the FDA has yet to reveal a timeline for when its work will finish, medical experts and sources familiar with the process told CNN that full approval could come in the coming months. While that would amount to a record pace, the urgency for a fully approved vaccine is increasing, given the worrying growth in COVID-19 cases across the country.

An FDA official told CNN on Wednesday that the agency continues to work as quickly as possible to review applications. The official noted that as part of the emergency use authorization granted last year, the vaccines have already undergone a “thorough scientific evaluation” to “meet the FDA’s rigorous standards for safety, efficacy and manufacturing quality.” .

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Still, federal medical officials and business leaders agree that full FDA approval would be helpful in fighting vaccine reluctance and support companies eager to issue vaccine mandates to returning employees. the office.

But the Joe Biden administration has been cautious on the issue and does not want the huge pass of full approval to have a political tinge. A federal official told CNN this week that the White House is not pressuring the FDA to expedite full approval of coronavirus vaccines.

That doesn’t mean that Biden officials aren’t interested. The White House has been attentive to the FDA approval process – “obsessively,” in the words of a senior Biden adviser – but has intentionally steered clear of any appearance of trying to tip the balance or rush the outcome, officials say. of the administration.

Within the West Wing, and throughout the scientific community, there is a high degree of confidence that the FDA will fully approve Pfizer and Moderna vaccines against covid-19, although the exact timing is far from certain. Johnson & Johnson has yet to apply for full FDA approval of its coronavirus vaccine.

There is no sense within the White House that the FDA is slowing down, officials said, particularly compared to the years-long process it normally takes to approve a major vaccine.

“The FDA is the gold standard for vaccine review and approval,” Jeff Zients, the White House’s senior adviser on coronavirus, said in a briefing last week. “They will run an independent and rigorous scientific process and when that process is complete, the American people can rest assured that the FDA maintained those world-class standards during this period.”

Fight vaccine reluctance with FDA approval

The bigger question is whether such approval would actually ease doubts about vaccines across the country, officials say.

“Yes, it will be another tool in the toolkit. We are not naive in thinking that it will suddenly change all minds,” a Biden senior adviser told CNN, speaking on condition of anonymity to express himself freely about internal deliberations.

One of the federal government’s top medical officials says full approval could also lead to employers getting additional legal coverage to require their employees to be vaccinated.

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“If it was approved with full FDA approval, which we all anticipate will come very soon … maybe in the next few months, then the legal capacity to enforce an order becomes much stronger,” said Dr. Francis Collins, director of the National Institutes of Health.

The White House has increased its outreach to business and civic leaders. Some have told government officials that they will have more influence to require vaccines from employees after the FDA grants full approval.

Less litigation if full FDA approval of vaccines is achieved

Ken Langone, co-founder of Home Depot who also serves as chairman of the board of trustees for NYU Langone Medical Center, believes there will be far less litigation if vaccines are fully approved.

“You get the FDA to say, ‘It’s final, it’s approved,’ and I can guarantee you that everywhere I’m involved, if you don’t get vaccinated, they will fire you,” Langone told CNBC on Wednesday. “You have an obligation to your neighbor to protect him as well as yourself,” he added.

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A senior administration official said the sentiment expressed by Langone was one of among other business executives who had also expressed it to the White House. But it’s far from certain how widespread the opinion is or whether some kind of broad movement could be triggered by a green light from the FDA.

A Kaiser Family Foundation Survey of American Adults published this month found that among a third of adults surveyed who are not yet vaccinated, 16% said the vaccine was too new, too unknown, or not tested enough.

Some said in this survey that they would not receive a vaccine until it was required. While companies may require the vaccine, experts believe that more will make it a requirement if it gets full approval.

Many benefits if full FDA approval is achieved

Dr. William Schaffner, a professor in the Division of Infectious Diseases at Vanderbilt University Medical Center, said “a lot of things” would change once the vaccine is fully licensed for use, emphasizing that full authorization was critical to increase vaccination rates.

“We need a full license to reach more unvaccinated people,” Schaffner said. “And obviously getting more people vaccinated as quickly as possible is critical to our attempt to control this ongoing pandemic, which is now on the rise once again in the United States,” he said.

New York Governor Andrew Cuomo noted Wednesday that final approval of COVID-19 vaccines would give states more legal authority to require vaccination.

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“Under the emergency use authorization, states are limited in what they can require,” Cuomo said, addressing the Association for a Better New York in a virtual meeting. “Once the vaccine is finally approved, the state has more legal authority to require the vaccine,” he added.

Within the approval process

The FDA should have all the documentation and data from Pfizer’s vaccine trials and be in the review process, medical experts said.

In July, Pfizer announced that the FDA had given its vaccine a priority review, speeding up the process from 10 months to six, which means that technically approval should be granted in January.

But FDA Acting Commissioner Dr. Janet Woodcock has said the FDA intends to complete the review well before its January deadline. Several officials told CNN that the FDA is working tirelessly to get through the grant review and approval process.

They think approval would be next month

Former FDA Commissioner Dr. Scott Gottlieb said Wednesday that he believed approval could come next month.

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“For a long time I felt that the FDA would approve the vaccine probably within three to four months of the application being submitted. Those applications were submitted about two and a half, three months ago … So I think that puts it in (a) deadline of the end of August or September in terms of when they will be approved, “Gottlieb explained.

Medical experts emphasized that the vaccine approval process takes time, even for something as vital as COVID-19 vaccines.

“People are saying, ‘Why is it taking so long?’ Well, the FDA wants to make sure it has a protective duration, a long-term effect, “said Melissa Tice, director of the regulatory affairs program and assistant professor of clinical research and leadership in the College of Medicine and Health Sciences at the United States. George Washington University.

“It is not that the agency, I think, has any concerns about the vaccine itself, simply, according to the licensing requirements, it is necessary to have this additional data,” he said.

Emergency approval and everything to check

The covid-19 vaccines received an emergency use authorization based on interim data that showed they were safe and effective for only about three months. For full approval, the FDA has to review at least six months of efficacy data, and that means reviewing and analyzing a tremendous amount of information.

“When we were reviewing applications when they were on paper, there were so many that they would not fit on the forklift. That’s how big the application is. You have a lot of data to review,” said Norman Baylor, who used to run the Office of Vaccine Review and Research at the FDA and has been through this process multiple times. He is the current CEO of Biologics Consulting.

An interdisciplinary team of FDA experts reviews millions of these documents, running their own analysis, obtaining any clarification you need from vaccine companies, and conducting a thorough inspection of the manufacturing process.

And it’s not just someone from the FDA doing the review, Baylor said. There is a secondary and tertiary review. So a doctor would review the material and then a supervisor would need to review it and then it would go to the division director.

Because the FDA has already reviewed the manufacturing materials and has been reviewing the clinical data the entire time, Tice said, “We do not expect the full six-month priority review clock to pass.”

Tice says he believes full approval of the Pfizer vaccine could come in September.

CNN’s Maggie Fox contributed to this report.


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