Tuesday, June 25, 2024

FDA under pressure to grant full approval to covid-19 vaccines

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Government agencies and companies are starting to mandate vaccines for at least some workers and in some circumstances. However, many employers and schools are holding off, saying that they can’t or won’t act, while the vaccines are still only authorized for emergency use.

“We’d like to see it approved as fast as humanly possible, so we can really go back to just the more normal experience,” said Jim Malatras, chancellor of the State University of New York system, which serves 400,000 students. Under guidance from the state, he cannot impose a vaccine mandate for students until the shots are granted full approval. For now the school is requiring vaccines or weekly testing, similar to the federal policy that President Biden announced on Thursday.

Three vaccines—from Pfizer Inc. and partner BioNTech SE, Moderna Inc., and Johnson & Johnson—are authorized for emergency use in the U.S. Pfizer and Moderna have filed initial paperwork for full approval. However, only Pfizer has submitted all the necessary information to the FDA, according to the companies, and analysts expect it will be the first to get the green light. Moderna says it is still completing rolling data submissions, and Johnson & Johnson says it plans to file for full approval later this year.

Advisers to the FDA and former FDA officials familiar with the process predict that full approval of at least Pfizer’s vaccine could come in September or October. President Biden said Thursday he expects the approval of the vaccines to happen in the early fall. And FDA officials have said they intend to finish the process “far in advance” of the regulatory deadline following applications, which Pfizer says is in January.

The FDA said it is reviewing Pfizer’s application for full approval “as rapidly as possible in keeping with the high-quality complete assessment that the public expects from the FDA.” The agency said it is taking an “all-hands-on-deck approach,” including shifting personnel and technological resources to the effort and reprioritizing some other activities.

Emergency use authorization is an expedited process aimed at speeding up manufacturing and administrative processes during a public health emergency to make vaccines or drugs available to the public as quickly as possible. The FDA set special requirements for the Covid-19 vaccines, including requiring two months of clinical-trial subject data. The full approval process for biologics requires at least six months of evidence as well as plant inspections and other measures to fully vet the assembly process.

Full approval won’t change how widely available the shots are but will ease restrictions on distribution and advertising for companies. Such a step will also help more states, schools and employers to introduce vaccine mandates, according to lawyers and current and former FDA officials.

Once fully approved, the vaccine would be eligible for prescriptions as booster doses by prescribers, according to the FDA. However, analysts said, the critical element for broad boosting is a recommendation from the Advisory Committee on Immunization Practices to the FDA, as physicians often follow ACIP recommendations.

Some public health experts are urging the FDA to move faster to persuade unvaccinated Americans to get Covid-19 shots to confront a national surge in coronavirus infections.

“It should have been done at the latest in June,” said Dr. Eric Topol, director of the Scripps Research Translational Institute. “By the time it gets done…the Delta wave will have passed by then.”

More than 30% of those who are unvaccinated said they would be more likely to get a vaccine if the FDA grants full approval to one of the vaccines currently authorized for emergency use, according to a June Kaiser Family Foundation survey. Kaiser, which polled 1,888 people, including 572 who haven’t been vaccinated, said the finding may be more of a proxy for general safety concerns.

“The vast difference in vaccination rates across the country tell a story about what the perceptions are about risk across the country,” said Joseph Allen, an associate professor at Harvard University’s T.H. Chan School of Public Health who, as head of Harvard’s Healthy Buildings Program, has advised companies on Covid-19. “If you’re a company operating in all 50 states and even internationally, it’s hard for them to move on the vaccine mandate and having a full FDA approval and authorization would make that easier.”

The approval process is complex and requires the FDA to review reams of data. Companies seeking permission to distribute and market vaccines for use in the U.S. typically submit Biologics License Applications, comprehensive submissions that include preclinical and clinical data and information and details of the manufacturing process and facilities.

Pfizer said it initiated a rolling submission process in May, and Moderna said it began the effort in June, allowing them to submit finished sections of their applications without having to wait until they are complete.

“It’s like if you said not all the Christmas presents are under the tree, but you can start unwrapping them,” said Dr. Jesse Goodman, a former chief scientist at the FDA now at Georgetown University.

Once a company completes its submission, the FDA has 60 days to decide whether to grant a priority review. Then, under the 1992 Prescription Drug User Fee Act, the FDA must take action on an application within six months of its submission, compared with 10 months under standard review.

The agency earlier this month granted Pfizer priority review, and Moderna has said it would request one. AstraZeneca PLC said it would apply for full approval of its vaccine, which isn’t yet authorized for emergency use in the U.S., by the end of 2021. The U.S. has an oversupply of other vaccines, but the company says its vaccine can still play a role.

Some public health experts say that full FDA approval may not boost vaccination numbers as much as expected and that any appearance of a rushed process or political pressure could also discourage people.

“This sounds like an easy fix, but I think we need to understand it isn’t,” said Arnold Monto, a professor of epidemiology at the University of Michigan and chair of a panel of outside experts that regularly advises the FDA about experimental vaccines, including for Covid-19. “If they moved more rapidly in a complicated situation, I am afraid some people would say, ‘Why did they do it so fast? Did they really scrutinize all of the data they were supposed to?’”

This story has been published from a wire agency feed without modifications to the text

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