When will COVID-19 vaccines be fully approved – and does it matter that they are? | Science

By Rachel FrittsChristmas. 21, 2021, 11:00

In many parts of the United States, the Delta variant of SARS-CoV-2 has caused a further upsurge in the COVID-19 pandemic. The 7-day average of daily new cases over the past week has increased by almost 70%, to over 26,000; hospitalizations have jumped by more than a third, according to the Centers for Disease Control and Prevention.

Part of the reason is that less than half of the American population is fully vaccinated. Some scientists and doctors fear that the reluctance to vaccinate may be fueled by the fact that the injections available in the United States – manufactured by Pfizer and BioNTech, Moderna and Johnson & Johnson (J&J) – have been urgently authorized but have not not yet fully approved. . Vaccine activists, talk show hosts and far-right politicians have made the “experimental” nature of vaccines a topic of discussion.

Full approval from the Food and Drug Administration (FDA) could help win over skeptics, says Monica Gandhi, an infectious disease physician at the University of California, San Diego. “It means something to people that this is approved,” she said. “It seems like the simplest, easiest thing we can do right now.”

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Pfizer and Moderna have both sought full FDA approval for their jabs, but it could take months. Here is where it stands.

Why have the vaccines available in the United States not yet been approved?

All three vaccines have received Emergency Use Clearance (EUA), which the FDA offers during crises as a quick way to give people access to potentially life-saving drugs. In the past, USA has generally been used for drugs in “very catastrophic immediate circumstances, such as an anthrax attack,” says Jesse Goodman, former chief scientist of the FDA who is now at Georgetown University. . The COVID-19 pandemic marks the first time that EUAs have been granted for new vaccines.

To receive an EUA, vaccine manufacturers had to follow a special set of guidelines that called for safety and efficacy data from clinical trials involving tens of thousands of participants, as well as information on quality and consistency. vaccines. Pfizer and Moderna both received an EUA in December 2020; J & J’s arrived in February. Based on the actual data they’ve collected since then, Pfizer applied for full approval from the FDA in early May and Moderna on June 1. J&J should follow soon.

What is the difference between a full approval and an EUA?

It’s a ladder. The FDA will be looking at a lot more data, spanning a longer time frame, before granting full approval. “It’s not a huge difference, but it’s a real difference,” says Goodman. The agency will analyze data from additional clinical trials and look at real-world data on efficacy and safety. He will inspect the manufacturing facilities and make sure the quality control is very strict. “It’s a comprehensive review,” Goodman says.

However, the FDA already knows a lot of the data, for example on the very rare side effects caused by the J&J and Pfizer vaccines that have not shown up in clinical trials.

When could vaccines be approved?

On July 16, the FDA granted Pfizer’s “priority review” request, which means it will run faster than standard reviews, which typically take at least 10 months; the agency now has until January 2022 to review the documents. It sounds like a long time, but last week an FDA official told CNN the decision should be made within 2 months. “The review… is underway, is one of the agency’s highest priorities, and the agency intends to complete the review well in advance of [January] Date, ”an FDA press secretary confirmed to Science in a report.

The FDA has not formally accepted Moderna’s request, possibly because the company has yet to submit all of the required documents.

Why have there been calls for faster approval?

Full approval could help overcome vaccine hesitation, wrote Eric Topol, director of the Scripps Research Translational Institute, in a recent editorial in The New York Times. “Some people who understand that the ‘E’ in ‘EUA’ means ’emergency’ wait for full FDA approval before they get an injection,” he wrote.

“I think it’s fair to say that many of us who are clinical infectious disease and public health physicians are frankly a little surprised at how long the process takes,” says William Schaffner, professor of infectious diseases at Vanderbilt University. Medical Center.

“I want [FDA] pay attention. I also want them to get things done, ”Schaffner says. “Frankly, I would like them to work on weekends. People who vaccinate work on weekends. The virus works on weekends.

Will the approval really convince more people to get the vaccine?

About 30% of unvaccinated people say they were waiting for full vaccine approval, according to a survey of 1,888 adults conducted in June by the Kaiser Family Foundation. But the report warns that for many people, FDA approval is likely “an indicator of general safety concerns.” Anyone now focused on approval can actually get a vaccine, especially if they perceive the approval process as rushed or politically motivated.

“For people who are really opposed to getting the vaccine at this point, I don’t know if the FDA fully approving it is going to make a huge difference,” says Krutika Kuppalli, an infectious disease physician at the University of medicine. from South Carolina who says many of his patients are wary of COVID-19 injections.

But total approval can influence some people. For example, for members of groups who have been poorly treated by the health system, signing a consent form to be vaccinated – a requirement for vaccines with an EUA – can be a psychological barrier, says Gandhi: consent that says ‘experimental’ and the expression ‘experimental’ raises questions of experimentation on black and brown communities.

Will the approval pave the way for mandatory vaccinations?

More than 500 US universities and some top hospitals have already issued vaccination warrants, which means staff and students need to be vaccinated.

But many schools and hospitals are reluctant to ask their employees to take what is still technically an experimental product and wait for full approval; the US military too. Some states, including those with some of the lowest immunization rates in the country, such as Alabama, Arkansas, and Tennessee, have gone so far as to ban school and college mandates until vaccines are fully approved. (Conversely, a judge this week upheld Indiana University’s vaccine mandate after it was challenged by a group of eight students.) Once a vaccine is approved, “I think it’s will be on a more solid footing for organizations and businesses to mandate it, ”Goodman says.

In France, where vaccine reluctance is also high, more than a million people signed up for a vaccine after President Emmanuel Macron announced on July 12 that vaccination would become mandatory for healthcare workers and that “health cards” would be needed to enter shopping malls, bars, restaurants and other public places. But these measures also proved controversial: tens of thousands of people took to French streets on Saturday in protest.

Could the FDA speed up its approval process?

Maybe, but the agency doesn’t want to rush. “Any vaccine approval without the completion of the high-quality review and evaluation that Americans expect the agency to perform would undermine the statutory responsibilities of the FDA, would affect public confidence in it.” agency and would do little to help combat vaccine reluctance, ”wrote FDA’s Peter Marks in The New York Times in response to Topol’s call for speed.

“Everything claims that it takes a long time [are] almost like saying you don’t want the FDA to do the normal, comprehensive job it does, ”Goodman says. Regulatory rigor is especially important for messenger RNA vaccines, which use a whole new technology, he adds.

Is it safe to get a vaccine that only has emergency approval, not full approval?

Each expert Science we spoke to had the same message: Data collected so far shows that vaccines administered by EUA in the United States are very safe and very effective. “It was really amazing to see how well these vaccines worked in clinical trials,” Gandhi said.

“Vaccines are such a gift,” says Cody Meissner, a pediatrician at Tufts Children’s Hospital specializing in infectious diseases and a member of the FDA’s vaccine advisory committee. “Every adult should get this vaccine. “