FDA approval of Covid-19 vaccine could mean more people get vaccinated for some unexpected reason

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The ramifications could alter the course of the pandemic in several ways.

First, full approval of a Covid-19 vaccine could persuade more people to get vaccinated.

More than 30% of the eligible population in the United States has still not received a vaccine.

To qualify for emergency use authorization, manufacturers of Covid-19 vaccines submitted approximately three months of clinical trial data. This included at least 2 months of safety data on fully vaccinated participants, since most vaccine side effects occur 2-3 months after vaccination.

For some Americans, this was not enough to convince them to get the vaccine.

Full approval of a Covid-19 vaccine requires much more data, including safety and efficacy data generated in the real world, outside of a clinical trial. The CDC has been tracking real-world vaccine data and more than 165 million people in the United States are now vaccinated against the virus.

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The additional data can help convince more people that vaccines are not dangerous.

“For some, getting full FDA approval will help allay this fear. Even if it is only a relatively small number of people. Every little bit helps against this virus,” Dr. David Dowdy, associate professor in the epidemiology of infectious diseases division. at the Johns Hopkins Bloomberg School of Public Health, said.
Three in ten unvaccinated adults said they would be more likely to be vaccinated if any of the vaccines passed for full approval, according to a Kaiser Family Foundation survey.

However, Kaiser warned that some interviewees were confused about the gunfire. Two-thirds thought the vaccines were already fully approved or were not sure. This finding may simply mean that the full approval “is an approximation of general security concerns.”

Full FDA approval of Covid-19 vaccines could help fight vaccine hesitation, officials say
Dr Michael Wolf, associate vice president of research, Northwestern Feinberg School of Medicine Department of Medicine, expects approval would get about 5-10% more people concerned about the safety of themselves. get vaccinated.

The FDA is “currently working tirelessly” on the approval of the Covid-19 vaccine, according to Dr. Paul Offit, a senior member of the FDA’s vaccine advisory committee and director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.

“I think from a public perspective it really shouldn’t matter,” Offit said. “It’s been given to half the American population. We have over 300 million doses. It’s far from experimental. We have a huge portfolio of safety and efficacy on these vaccines – I mean, that’s more than most of the licensed products that are out there now. “

And yet, he acknowledged that, at least for some, it matters. He said the FDA knows it too.

“I think they realize that at least there is a psychological problem with the way these vaccines are perceived, whether it is a licensed product or just approved by the EUA,” he said. declared Offit.

“Carrots” and “sticks” will encourage vaccination

Full approval of a Covid-19 vaccine could also facilitate workplace mandates. Many unvaccinated people would face a financial reason to get one; they will need it to keep their jobs.

“The FDA approval alone won’t make a lot of people run for it now, but you’re going to start to see healthcare systems and employers feel more emboldened to demand it,” Wolf said. “There is a precedent for mandatory vaccinations and immunizations.”

According to the US Equal Employment Opportunity Commission, workplaces already have the legal authority to impose the Covid-19 vaccine. But full approval could reduce the power of any legal challenge.
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“FDA approval is the gold standard. Regulators around the world see our FDA as the beacon when it comes to issues like this,” said George Karavetsos, a legal expert who had worked at the FDA and now provides strategic advice to companies regulated by the FDA as an attorney for Buchanan Ingersoll Rooney, said. “I can assure you that they will make sure they get it right.
Erik Nisbet, Owen L. Coon Full Professor in Policy Analysis and Communication and Director of the Center for Communication & Public Policy at Northwestern University’s School of Communication, agreed.

“If you ever want to exceed the 70% threshold of people who have been vaccinated so far, you have to have carrots and you have to have sticks,” Nisbet said. “The only way to do that is with the warrant. The authorization removes one of the barriers to broader mandates.”

A little political cover

Full approval can also provide political coverage to get more people immunized. Louisiana Gov. John Bel Edwards on Wednesday said he would not consider requiring the vaccine for state employees “unless and until the FDA grants a full license to one or several of the Covid vaccines “. The state has the highest number of cases per capita of any state and one of the lowest vaccination rates.
San Francisco has announced that it will require all city employees to be vaccinated no later than 10 weeks after full FDA approval.

According to Nisbet, full approval might even be able to override laws like Ohio’s that prohibit vaccination warrants under emergency use authorization.

“The approval eliminates that,” he said.

A potential recall bonus?

Full approval can also mean that people who are fully vaccinated could receive an additional vaccine, even before boosters are approved.

“The approval will make it easier for doctors to give the vaccine off-label,” said Dowdy. “If people can convince their doctors that they need it.”

Many scientists hope people won’t. Although a number of clinical trials are ongoing, boosters are not yet recommended by the FDA and CDC.

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Tests have shown that people who are immunocompromised may not respond as well to vaccines and may need a booster. There is an effort to make boosters available to this population “very soon,” said Dr. Anthony Fauci, director of the National Institutes for Allergies and Infectious Diseases on Tuesday.

“Right now what we really want to do is have the patient population here in the US at least get a chance and not get ahead of the data,” said Melissa Tice, program director of regulatory affairs and Assistant Professor of Clinical Research and Leadership in the School of Medicine and Health Sciences at George Washington University. “I hope that the approval will at least encourage more people to receive their first dose.”

What does approval mean for children?

It is still unclear how having a fully licensed coronavirus vaccine can impact the timing of the authorization or approval of coronavirus vaccines for children under 12 – if at all. , Offit said.

The Pfizer / BioNTech Covid-29 vaccine is currently licensed for ages 12 and over, while the Moderna and Johnson & Johnson vaccines are only licensed for adults 18 and over.

“Is full approval of an adult vaccine important to speeding up the approval process for childhood vaccines? I think the answer to that question is probably no,” Offit told CNN on Friday.

Overall, “this is kind of new territory – the notion of emergency use authorization is obviously new, certainly for the vaccines that have been used to that extent. We had EUAs for the vaccines against. anthrax, but that’s not it, ”he said. “I don’t know how the FDA views this.”

Jacqueline Howard of CNN contributed to this report.

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