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Americans should not expect any clearance from the U.S. Food and Drug Administration until the last half of December, experts agreed.
Indeed, Pfizer, which appears to be the first company to reach the finish line of its vaccine trial data, was unable to pull it together until the end of next week, which is already the end of November. After that, there are weeks of FDA review left.
Dr Larry Corey of the University of Washington and the Fred Hutchinson Cancer Research Center, which heads the coronavirus vaccine trials network in the United States, told CNN he believes it will take about 10 days to the FDA to review Pfizer’s clinical trial data. The agency must also review Pfizer’s manufacturing data to ensure that the facilities where the vaccine is made meet standards.
“I don’t know how long this review will take, but it could take two weeks. I think it’s reasonable,” Corey said.
Next, the FDA committed to soliciting input from the Advisory Committee on Vaccines and Related Biologics (VRBPAC), an advisory group that guides the FDA on vaccines.
Dr Paul Offit, committee member and director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, agreed on the December schedule.
“Then they will have to seek the advice of the advisory committee, which would likely be in early December, I guess,” Offit said.
The FDA must publicly schedule any VRBPAC meeting 15 days in advance, which could slow things down a bit.
It’s easy to not know what to expect, with those responsible for Operation Warp Speed promising to roll trucks within one day of an Emergency Use Clearance (EUA) from the FDA. Plus, the companies are all manufacturing doses even as they test vaccines, with tens of millions already pledged for immediate delivery.
“We want shots fired within 24 hours,” US Deputy Chief of Staff for Health and Human Services, Paul Mango, told reporters in October.
Not so fast
The FDA has said it wants companies to wait two weeks after about half of their volunteers have received a second dose of the vaccine before seeking this emergency clearance – and the doctors who conduct the clinical trials will need to count around 100 additional validated cases. of coronavirus infection to meet company goals to show that the vaccine actually works.
“They are about a week and a half away,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN on Monday.
Even Alex Azar, the secretary of the US Department of Health and Human Services, said the process of getting FDA clearance will take several weeks.
Dr Peter Marks, who as head of the FDA’s Center for Biologics Evaluation and Research leads decision-making on vaccines, said the agency will act quickly but not cut corners. It will use the EUA process, rather than full approval – but that doesn’t mean approval overnight.
Pfizer has accelerated the collection of this clinical data, said Dr. Robert Frenck, director of the Vaccine Research Center at Cincinnati Children’s Hospital, which is leading one of the Pfizer vaccine clinical trials.
“If you look at a more typical vaccine trial, you would send things out in batches,” Frenck told CNN Thursday. It’s usually a quiet process that takes weeks, he said.
But since it’s a pandemic, Frenck said his team is sending their data to Pfizer every day. “For this study, they say they need information within 24 hours,” he said. “We are reducing the downtime. Because it is an emergency, we are making people work as hard as possible,” said Frenck.
Pfizer needs to collect and review the data and determine whether more people who contracted placebos were infected than those who received the vaccine. This information is then forwarded to the FDA for review.
“The data must be reviewed and confirmed by the FDA,” said Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine. “Sometimes they discover things that the company might be missing,” he added.
This will include details on whether people who received the vaccine and were still infected had an immune response to the vaccine, whether particular groups such as the elderly were less likely to be protected and others. Important clues to how the vaccine works, Offit said. .
“You can think of that timing as a marker,” Corey said. “There is a lot of data to look at.”
The FDA will take into account all the recommendations of the VRBPAC. Concurrently, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) will meet. The FDA approves a vaccine, while ACIP decides who gets it and when.
Offit said he assumed the two processes would occur at the same time.
“I guess we’ll see that in the first half of December and the vaccine could, in theory, hit the shelves by the end of December,” Offit said.
There isn’t yet an official federal government manual for who gets vaccinated first, but the National Academies of Science, Engineering, and Medicine, as well as the CDC, have recommended that workers in the frontline health, emergency workers and the most vulnerable who are also most likely to get infected get the first vaccines.
Businesses and the federal government have said spring will be at the earliest before the general public can expect to receive vaccines against the coronavirus.
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