Now that the Delta coronavirus variant is posing a serious risk to unvaccinated Americans, some experts are calling for the Food and Drug Administration to fully approve the Pfizer and Moderna COVID-19 vaccines, which are currently being used under emergency use authorization.
Granting full approval, these experts argue, is a key step to address vaccine hesitancy, and to help persuade Americans to get the shots. Vaccine holdouts are potentially at great risk of contracting the Delta variant, which is quickly becoming dominant in the United States. But Americans who have received the Pfizer or Moderna vaccines are extremely unlikely to get sick from Delta or any other coronavirus variant.
Both Pfizer/BioNTech and Moderna have already submitted a Biologics License Application, or BLA, to receive the FDA’s full approval. Pfizer began the process on May 7. Moderna applied later, on June 1.
Yahoo News Medical Contributor Dr. Kavita Patel, a primary care physician in Washington, D.C., who also serves as a health policy fellow at the Brookings Institution, told Yahoo News that drug and vaccine manufacturers can expect a process like this to take usually “anywhere from three to six months,” and that it is not unusual that the agency has not yet made a decision.
However, Patel describes the pandemic as a “very high priority” and says “important stakes” are in play. “There are probably a lot of people who are waiting,” she says. Giving full approval to the vaccines “will be the sign of confidence that the vaccine is safe to take,” Patel added.
Data backs up that assertion. According to a Kaiser Family Foundation poll from May, about a third of unvaccinated people — 32 percent — said they would be more likely to get the shots if a vaccine received full approval.
All the COVID-19 vaccines have undergone rigorous safety protocols in order to be granted emergency use authorization by the FDA. And billions of people worldwide have now been vaccinated without any complications, a sure sign, in Patel’s words, that they are “incredibly safe.”
If that process is going to take longer than four or six months, Patel says, the FDA should announce why that is. Otherwise, “We need to make a case to Americans that they need to get vaccinated today, because we're seeing newer cases of the [Delta] variant in unvaccinated people almost exclusively,” she said.
So far, the FDA hasn’t offered any information related to the process or a timeline, but Patel believes agency officials are probably “being as cautious as they can,” taking time to carefully review the available data, and probably waiting for more real-world evidence to come in.
Dr. Joseph Ross, professor of medicine and public health at Yale University, told Yahoo News that since the FDA’s Center for Biologics Evaluation and Research – the division that handles the approval of the vaccines – had high standards for the emergency use authorization, this may explain why there’s no rush with the full approval process.
“They said, ‘Even though this is going to be an emergency use authorization, our standard will be high. It’s going to be nearly the same as a full approval.’ So that’s why I think the pressure is off them to have to do it more immediately, because they really required rigorous data to support the authorization on effectiveness and on safety. They’re working with the companies to collect longer-term data, and so I think it’s a matter of time,” Ross said.
Other experts have been more critical of the FDA and have said the decision is taking too long.
Dr. Eric Topol, founder-director of the Scripps Research Translational Institute in La Jolla, Calif., told U.S. News last week that these COVID-19 vaccines “should be getting full licensure now, because the FDA has already done plant inspections. They already have a humongous amount of data on safety, efficacy and effectiveness.” He added that in his view, the full approval was “overdue.”
Patel says holding back full approval of these COVID-19 vaccines is also “hard to swallow” in the context of the FDA’s recent approval of the controversial Alzheimer’s drug aducanumab. The medication, which is manufactured by Biogen, was approved under the accelerated approval pathway, despite the objections of an FDA advisory committee. Two House committees have launched an investigation into the approval and pricing of the drug.
“The drug hasn’t really had unremarkable trial data and is very expensive and not that effective, per experts in the area,” Patel said. “Compare that to the fact that we’ve got vaccines that are incredibly effective, desperately needed, and should be a no-brainer for approval.”
It’s important to underscore that the group within the FDA that handles approval of treatments such as the Alzheimer’s drug is different from the one in charge of approving the vaccines. As Ross puts it, “They're like different types of trains on different types of tracks,” so it’s not unusual that one division may have moved at a different pace from the other.
However, Patel says that the public should demand answers from the FDA and its acting commissioner, Janet Woodcock.
“We should demand some explanation — or at least some accountability — as to what they’re doing,” Patel said. “We want clarity. Where are they in the process? Why is it taking longer? Or how long will it take? Because it’s not knowing that’s really troubling the American public.”
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