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As pressure mounts on the Food and Drug Administration to grant formal approval to Pfizer’s Covid-19 vaccine, doctors and public health experts across the country say it is still unclear which impact, if any, such approval would have on patients and providers.
One hope is that full approval could convince those hesitant to vaccinate that the injections are safe. A June survey by the Kaiser Family Foundation, for example, found that 3 in 10 unvaccinated adults would be more likely to be vaccinated if any of the vaccines received FDA approval.
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“People are going to get full approval and they will feel a lot more confident about taking the vaccine,” said Dr. Robert Murphy, executive director of the Institute of Global Health at the Feinberg School of Medicine at Northwestern University.
Murphy said part of the lack of confidence in a vaccine that has only received emergency use authorization is a misunderstanding of what that type of authorization means.
“That doesn’t mean it’s experimental. All the experimental work has been done,” he said.
Others agreed that FDA approval might boost some people’s confidence, but cautioned that the overall effect would likely be small.
“I don’t think it’s going to have much change at all,” said the president of the American Academy of Family Physicians. Dr. Ada Stewart, a community clinic physician in Columbia, South Carolina. “Maybe it will increase confidence.”
Dr Jesse Goodman, an infectious disease specialist at Georgetown University Medical Center, said there was too much misinformation behind the vaccine hesitation to change most opinions.
“I think maybe on the perceptual side, some people who thought this was an extremely or rapidly developed product, developed only for emergency use – there might be people who have more confidence, ”Goodman said. “Although I wouldn’t overestimate that. “
Indeed, the same Kaiser Family Foundation survey also found that two-thirds of adults, including many of those who weren’t vaccinated, believed the three vaccines available in the United States were either already approved or that they were not. didn’t know if they had been or not.
Yet public health experts say full approval could also help companies and cities with vaccine mandates, which are becoming more mainstream but still surrounded by controversy.
“I think a lot of large companies, public and private, are waiting for approval to impose vaccines on students and employees,” said former FDA associate commissioner Peter Pitts, president of the Center for Medicine in the Public Interest. , a non-profit organization. group.
And there are other more concrete changes that come with full FDA approval.
One is the ability to prescribe an “off label” drug – a common practice in which physicians prescribe approved drugs for unapproved uses. For example, metformin, a diabetes medicine, is sometimes prescribed for weight loss because one of its side effects is to reduce a person’s appetite.
The practice is legal under FDA guidelines, as long as a patient’s doctor determines it “is medically appropriate for their patient.”
However, off-label use is not authorized for medicinal products with an emergency use authorization. In the context of an emergency authorization, a medicinal product may only be used in the specific circumstances described in the authorization.
So could the full approval of the Pfizer-BioNTech vaccine open the door for doctors to give booster doses to some fully vaccinated adults or even vaccinate children under 12?
Experts say, technically, yes. But should they? It’s more complicated.
“As an approved product, like all medical products, it can be used off-label at the discretion of a health care provider and the patient,” said Goodman, who is also a former chief scientist at the FDA. and a former director of the agency. Biologics Assessment and Research Center. “But it could have complicated effects.”
Goodman said little safety data is still available around Covid booster shots, so doctors would be taking a risk.
“I think most would follow the approvals recommended by the FDA and what was recommended” by the Advisory Committee on Immunization Practices, he said, referring to the Centers for Disease Control and Independent Advisory Group. Prevention which helps to define vaccination guidelines. “But clearly not all. There are people who have strong beliefs or if a patient or family member presses a doctor, they can say OK. This opens the door to some problematic uses.”
The FDA declined to comment on the use of off-label approved vaccines for recalls. Spokeswoman Abigail Capobianco said in a statement: “Americans who have been fully vaccinated do not need a booster at this time. The FDA, CDC, and NIH are in a rigorous, scientific process to determine if or when a recall might be necessary. “
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More worryingly, doctors may give an off-label vaccine to children under 12, a group that is still under investigation, Pitts said.
“When you use an off-label vaccine you are playing with fire because you don’t have the data, and that’s not a good idea,” Pitts said, adding that when drugs are used for non-prescription purposes. approved, some supporting data is usually already available.
“Vaccinating someone without data to support this decision is a risky proposition, and it shouldn’t happen,” he said.
But anecdotal reports suggest it’s already happening, especially in fully vaccinated adults looking for extra doses. On Twitter, Dr. Eric Topol, physician-researcher at Scripps Research in California, noted he sees the start of “booster mania”, with people going to pharmacies and lying about their vaccination status.
Besides the health risk, Murphy warns there could be a legal risk.
Murphy said that because the US government bought all the doses of Pfizer, it technically owns them. Patients trying to get third doses or doctors giving reminders by fooling the system could be committing fraud.
“If the vaccine is technically owned by the US government, then it is fraud,” he said. “You are swindling the government. But if Pfizer is selling to private bureaus, then there is nothing they can do.”
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