By Lauren Dunn - NBC News
As pressure mounts on the Food and Drug Administration (FDA) to formally approve the COVID-19 vaccine (so far only authorized for emergency use due to the urgency of the pandemic), Doctors and public health experts across the country say it is not yet clear what impact, if any, such approval would have on patients and providers.
One hope is that
full approval may convince vaccine doubters that they are safe.
A June survey by the Kaiser Foundation, for example, revealed that 3 in 10 unvaccinated adults would be more willing to get vaccinated if one of the vaccines received FDA approval.
"People are going to see full approval and they
are going to feel a lot more confident about getting the vaccine,"
said Dr. Robert Murphy, executive director of the Institute for Global Health at Northwestern University Feinberg School of Medicine.
[Find out here where, when and how to get vaccinated where you live]
Murphy said part of the lack of confidence in a vaccine that has only been cleared for emergency use lies in a
misunderstanding
of what that kind of clearance means.
"It does not mean that it is experimental. All the experimental work has been done," he said.
Some People Who Got COVID-19 Have Symptoms After Two Months, Study Finds
Aug. 10, 202101: 32
Others agreed that full FDA approval might boost some people's confidence but cautioned that the overall effect will likely be small.
"I don't think it's going to make a big difference
,
"
said the president of the American Academy of Family Physicians, Dr. Ada Stewart, who works at a community clinic in Columbia, South Carolina.
"Maybe confidence will increase," he said.
Dr. Jesse Goodman, an infectious disease specialist at Georgetown University Medical Center, believes
there is too much misinformation
driving questions about vaccines to change most opinions.
"Some people who felt this was a very rapidly developed product, for emergency use only, might be more confident," Goodman said.
"I wouldn't overestimate it though," he warned.
[Political and judicial battle in Florida and Texas so that children can wear a mask despite the prohibitions of the governors]
In fact, the same Kaiser Foundation survey also found that two-thirds of adults, including many of those who were not vaccinated, believed that the three vaccines available in the United States were already approved or that they were not sure whether or not they were approved. do not.
Still, public health experts say
full approval could also help companies and cities with vaccination mandates,
which are increasingly common but still surrounded by controversy.
AMLO thanks the US for offering vaccines against COVID-19
Aug. 10, 202102: 07
"I think a lot of big companies, public and private, are waiting for approval to force vaccinations for students and employees," said former FDA associate commissioner Peter Pitts, president of the Center for Medicine in the Public Interest, an advocacy group without profit.
And there are other more concrete changes that come with full FDA approval.
[Biden to force federal workers to get vaccinated or rigorously tested against COVID-19]
One of these is the ability to
prescribe an "off-label" drug,
a common practice in which doctors prescribe approved drugs for unapproved uses.
For example, metformin, a diabetes drug, is sometimes prescribed for weight loss because one of its side effects is reduced appetite.
This practice is legal under FDA guidelines, as long as the patient's physician deems it "medically appropriate for their patient."
However, off-label use is not allowed for medicines authorized for emergency use.
Under an emergency authorization, a drug can only be used in the specific circumstances described in the authorization.
The Pentagon will require that members of the Army get vaccinated starting September 15
Aug. 10, 202100: 26
So will Pfizer-BioNTech's full approval of the vaccine open the door for doctors
to give booster doses
to certain fully vaccinated adults or even vaccinate children under 12 years of age?
Experts say that,
technically, yes.
But should they?
That is more complicated.
"As an approved product, like all medical products, it can be used off-label at the discretion of a healthcare provider and patient," said Goodman, who is also a former FDA chief scientist and director of the Center for Evaluation and Evaluation. Agency Biological Research.
"But that could have complicated effects."
Goodman said
there is still little data available on the safety of booster vaccines,
so doctors may be taking a risk.
"I think most would follow the approvals recommended by the FDA and what has been recommended" by the Advisory Committee on Immunization Practices, he said, referring to the independent advisory panel of the Centers for Disease Control and Prevention (CDC, in English) that helps establish immunization guidelines.
"But it is clear that not all. There are people who have strong beliefs or if a patient or relative puts pressure on a doctor, he can say yes. That opens the door to some problematic uses," he added.
[The Government plans to authorize shortly the booster dose of vaccine against COVID-19 for the most vulnerable people]
The FDA declined to comment on the use of approved off-label vaccines for boosters.
Spokeswoman Abigail Capobianco said in a statement: "Americans who have been fully vaccinated do not need a booster shot at this time. The FDA, CDC, and NIH (the National Institutes of Health) are engaged in a rigorous and based process. scientific to consider whether or when a booster is needed. "
Even more concerning is that doctors may administer an off-label vaccine
to children under the age of 12,
a group that is still being studied, Pitts said.
They urgently call for approval of the COVID-19 vaccine for children in the US.
Aug. 9, 202103: 04
"When you use an off-label vaccine,
you are playing with fire,
because you do not have the data, and that is not a good idea," said Pitts, adding that when drugs are used for unapproved uses, they usually already has some supporting data.
"Vaccinating someone without data to support that decision is a risky proposition, and it shouldn't happen," he
said.
But anecdotal reports suggest that it is already happening, especially among fully vaccinated adults seeking additional doses.
On Twitter, Dr. Eric Topol, a physician-scientist at the Scripps Research Center in California, said he's seeing the start of
"booster-mania,"
with people going to pharmacies and lying about their vaccination status.
In addition to the health risk, Murphy cautions that there could be a legal risk.
["It's frightening". Children's hospitals are filling up due to the increase in COVID-19 cases among children]
Murphy said that since the US government bought all the doses of Pfizer, it technically owns them.
Patients trying to get third doses or doctors who give boosters by tricking the system
could be committing fraud.
"If the vaccine is technically owned by the US government, then that is a fraud," Murphy said.
"The government is being defrauded. But if Pfizer sells to private offices, then there is nothing they can do," he concluded.