Full FDA approval may facilitate COVID-19 vaccination, but experts recommend waiting

(New York) — One-third of unvaccinated U.S. adults say they will line up with COVID-19 jabs only if fully approved, but health professionals say there is a risk of waiting. Stated.

Moderna announced last week that it has begun the approval process for people over the age of 18 as the latest COVID-19 vaccine manufacturer to apply for full approval by the Food and Drug Administration. This follows Pfizer’s announcement in early May that it is seeking approval for people over the age of 16.

So far, about half of the countries have obtained at least one dose of the COVID-19 vaccine, and the public emergency caused by the pandemic has made it available through an emergency use authorization in the United States. Full FDA approval may help them as vaccination rates decline.by Kaiser Family Foundation’s latest vaccine surveillance reportNearly one-third (32%) of unvaccinated adults await full FDA approval before obtaining the vaccine.

Dr. William Moss, Executive Director of the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health, said most of the people awaiting approval were surprised.

“In my sense, it probably means more to the general public than it really needs,” Moss told ABC News. “The approval process is everything and the final thing. It is irrelevant to me to think that

Both approval and approval are rigorous processes for examining the safety and efficacy of vaccines, Moss said. The main difference between the two is that at least 2 months of follow-up data from Phase 3 clinical trials are considered for approval, whereas at least 6 months are considered for approval.

The FDA will take several months to review the complete dataset before granting approval. Several experts said ABC News was likely to do so. Moss has been administered nearly 300 million times in the United States, so “a review process that reveals what we don’t know is There is nothing. “

“Yes, this is like a sign of formal approval, but I don’t think it actually offers more than we already know,” he said. “Before full approval review Even so, there is more data on vaccine safety than any other vaccine. “

Both Pfizer and Modana continue to provide strong protection for their vaccines, including those against new variants, six months after the second vaccination, raising serious safety concerns. It states that it has not been reported. The Vaccine Adverse Event Reporting System also provided transparency and helped identify the very rare potential for blood clotting diagnosed after Johnson & Johnson vaccination.

Full approval will allow the vaccine to be used after it is open to the public. health This will allow businesses to promote vaccines to people and may help encourage vaccination, said Dr. James McDavid, senior vice president and dean of clinical affairs at Baylor College of Medicine, ABC News. Told to.

“I think it would be a great benefit to start a personally produced, professionally produced ad that encourages people to vaccinate,” he said. “It can be an important driver.”

At the same time, McDeavitt advises people not to wait for approval if they plan to get the vaccine.

“Waiting for a month or two puts you at unnecessary and preventable risk.”[The COVID-19 vaccine is] It’s free, very safe, and ready to use. In my personal opinion, it doesn’t make sense to wait. “

Dr. John Brownstein, an epidemiologist and ABC News contributor at Boston Children’s Hospital, said that if more people were to be vaccinated awaiting approval, that would be good, but the COVID-19 infection He also said there is a risk in waiting because he remains active.

“All signs show full approval,” he said. “Therefore, it can influence the expected approval and determination of the potential risk of unvaccinated.”

Beyond approval, paid leave was another problem for people who have not yet been vaccinated. According to a Kaiser Family Foundation study, 21% of unvaccinated adults employed are more likely to get the vaccine if their employer takes paid leave to recover from side effects. Become.

In addition, a study found that 10% to 15% of unvaccinated adults said they were more likely to be vaccinated if they had financial incentives such as money or free tickets.

7% say they will be vaccinated “only when needed”. Full approval by the FDA could increase the number of businesses and schools that require it, and could increase vaccine intake, Brownstein said.

“I think employers and other agencies, and perhaps government agencies, will make vaccines even more mandatory,” Moss said. “After getting full approval, they will find it more comfortable to require employees to be vaccinated. Obviously, there are certain rules regarding exemptions.”

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