FDA works to approve vaccines in the US 0:55
(CNN) -
Pfizer's covid-19 vaccine is only approved for emergency use in the United States, but could get full approval from the Food and Drug Administration (FDA) in few weeks.
The ramifications could alter the course of the pandemic in a number of ways.
First, the 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 yet to be vaccinated.
To obtain authorization for emergency use, the manufacturers of the covid-19 vaccines submitted about three months of clinical trial data.
This included at least 2 months of safety data in fully vaccinated participants, as most vaccine side effects occur 2-3 months after vaccination.
For some Americans, that data has not been enough to convince them to get vaccinated.
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Full approval of a COVID-19 vaccine requires much more data, including safety and efficacy generated in the real world, outside of a clinical trial.
The CDC has been tracking real-world data on vaccines, and more than 165 million people in the US are now vaccinated against the virus.
More than 99.9% of those fully vaccinated have not had a serious post-vaccination infection, according to the CDC
The additional data can help convince more people that vaccines are not dangerous.
"For some, getting full FDA approval will help allay that fear. Even if it's a relatively small number of people. Everything helps against this virus," said Dr. David Dowdy, associate professor in the division of epidemiology. of Infectious Diseases from the Johns Hopkins Bloomberg School of Public Health.
Three in 10 unvaccinated adults said they would be more likely to get vaccinated if one of the vaccines was fully approved, according to a survey by the Kaiser Family Foundation.
However, Kaiser cautioned that some of the people surveyed were confused about vaccines.
Two-thirds thought the vaccines were already fully approved or were unsure about it.
This finding may simply mean that full approval "is a proxy for general concern for safety."
Dr. Michael Wolf, Associate Vice President for Research in the Department of Medicine at Northwestern Feinberg School of Medicine, hopes the approval will get 5 to 10% more safety-conscious people vaccinated.
According to Dr. Paul Offit, a prominent member of the FDA's vaccine advisory committee and director of the Center for Vaccine Education at Philadelphia Children's Hospital, the FDA is "working tirelessly" on the approval of the COVID-19 vaccine. .
"I think from the public's point of view, it really shouldn't matter," Offit said.
"It has been administered to half the American population. We have more than 300 million doses delivered. This is far from experimental. We have a tremendous portfolio of safety and efficacy in these vaccines, that is, it is more than most of the authorized products out there now. "
And yet he acknowledged that, for some at least, it does matter.
The FDA knows this too, he said.
"I think they realize that at least there is a psychological question as to what these vaccines look like, in terms of whether they are a licensed product or are just approved through emergency use authorization," he said. Offit.
"Carrots" and "sticks" will encourage vaccination
Full approval of a COVID-19 vaccine could also ease workplace mandates.
Many unvaccinated people would have an economic reason for getting vaccinated: they would need it to keep their jobs.
"FDA approval alone is not going to make many individuals rush to get vaccinated now, but you are going to start to see that healthcare systems and employers will be more determined to enforce it," Wolf said.
"There are precedents for mandatory vaccinations and immunizations."
Work centers already have legal authority to require the COVID-19 vaccine, according to the United States Equal Employment Opportunity Commission.
But full approval could lessen any legal challenge.
"FDA approval is the gold standard. Regulators around the world look to our FDA as the beacon when it comes to issues like this," said George Karavetsos, a former legal expert who had worked at the FDA and now provides advice. strategic to FDA regulated companies as an attorney at Buchanan Ingersoll Rooney.
"I can guarantee that they will make sure everything goes smoothly."
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Erik Nisbet, the Owen L. Coon Professor of Policy Analysis and Communication and director of the Center for Communication and Public Policy at Northwestern University's School of Communication, agreed.
"If you want to exceed the threshold of 70% of people who have been vaccinated so far, you have to have carrots and sticks," said Nisbet.
"The only way to do it is the mandate. The authorization removes one of the impediments to the more generalized mandates."
A bit of political coverage
Full approval can also provide political coverage for more people to get vaccinated.
On Wednesday, Louisiana Governor John Bel Edwards said he would not consider requiring the vaccine from state employees "unless the FDA fully licenses one or more of the covid vaccines."
The state has the highest number of cases per capita in the country and one of the lowest vaccination rates.
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San Francisco announced that it would require all city employees to be vaccinated no later than 10 weeks after full FDA approval.
According to Nisbet, the full approval could even nullify laws such as Ohio's, which prohibits the imposition of vaccines under authorization for emergency use.
"The approval eliminates that," he said.
Will there be a possible booster bonus?
Full approval can also mean that fully vaccinated could receive an additional vaccine, even before boosters are approved.
"The approval will make it easier for doctors to administer the vaccine outside of the norm," explained Dowdy.
"If people can convince their doctor that they need it."
FDA May Design National Covid-19 Booster Vaccine Strategy By Early September
Many scientists hope that people don't do that.
Although there are several ongoing clinical trials, the FDA and CDC are not yet recommending boosters.
Trials have shown that immunosuppressed people may not respond as well to vaccines and may need a booster.
Dr. Anthony Fauci, director of the National Institutes of Allergy and Infectious Diseases, said Tuesday that attempts are being made to make boosters for this population available "very soon."
"Right now, what we really want to do is have the patient population here in the US get at least one dose and not get ahead of the data," said Melissa Tice, program director for regulatory affairs and adjunct professor at clinical research and leadership at the George Washington University School of Medicine and Health Sciences.
"Hopefully the approval will see at least more people getting their first dose."
What does approval mean for children?
It remains unclear how having a fully licensed coronavirus vaccine may impact the authorization or approval timeframe for coronavirus vaccines for children under 12 years of age, if at all, Offit said.
The Pfizer / BioNTech covid-29 vaccine is licensed for ages 12 and older, while the Moderna and Johnson & Johnson vaccines are licensed only for adults 18 years of age and older.
"Does getting full approval of an adult vaccine matter in terms of speeding up the approval process for pediatric vaccines? I think the answer to that question is probably no," Offit told CNN on Friday.
Overall, "this is all kind of new territory: the notion of emergency use authorization is obviously new, certainly for vaccines that have been used in this measure. We had emergency use authorizations for anthrax vaccines, but this is not so, "he said.
"I'm not sure how the FDA sees it."
- CNN's Jacqueline Howard contributed to this report.
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