FDA to Limit Covid Shot Approval to Elderly, Those With Medical Conditions
By Rachel Roubein and Lena H. Sun
It was not immediately clear if healthy people under 65 would be able to get the shots or whether insurers would pay for them if so.
“If they do not make it permissive — meaning that individuals who are not in a risk group or who are under 65 years of age want to be vaccinated — it’s likely now that payers will not pay for that vaccine,” said Michael Osterholm, a University of Minnesota infectious-disease expert who advised President Joe Biden’s transition team. “Therefore, in a sense, it’s the equivalent of taking away a vaccine from someone.”
It is up to the CDC’s vaccine advisory panel to recommend who should get an FDA-approved or authorized coronavirus vaccine. That panel could add a sentence to a targeted recommendation that allows others who are not in high-risk groups to get a shot to protect themselves from the virus, said William Schaffner, an infectious-disease physician who is a member of the panel’s covid-19 working group.
“They could add that line … and it would allow those people very focused on prevention who would like to get the vaccine and have it paid for by their insurance,” Schaffner said.
It is up to the CDC’s vaccine advisory panel to recommend who should get an FDA-approved or authorized coronavirus vaccine. That panel could add a sentence to a targeted recommendation that allows others who are not in high-risk groups to get a shot to protect themselves from the virus, said William Schaffner, an infectious-disease physician who is a member of the panel’s covid-19 working group.
“They could add that line … and it would allow those people very focused on prevention who would like to get the vaccine and have it paid for by their insurance,” Schaffner said.
About 74 percent of adults have at least one condition that puts them at higher risk of severe illness from covid-19, according to the CDC.
Prasad recently replaced Peter Marks, an architect of the U.S. program to rapidly develop coronavirus vaccines whom the Trump administration forced out in late March.
Federal health officials had already been weighing limiting recommendations for a coronavirus shot to older adults and high-risk individuals. But that change was set to come from the CDC, which is charged with developing recommendations for which populations should get the shots. The FDA is tasked with reviewing the safety and efficacy of vaccines, approving the shots and creating regulatory frameworks for drugs and vaccines.
During a presentation Tuesday afternoon, FDA leaders did not directly say whether healthy people younger than 65 would be eligible to get the shots. Prasad said the agency is interested in companies conducting studies to show whether there is a benefit to vaccination for healthy people.
“The Centers for Disease Control may issue recommendations on who should receive the FDA-approved vaccines, and we look forward to that,” Prasad said. “But the FDA can only approve products if it concludes, based on the available scientific evidence, the benefit-to-harm balance is favorable.”
The CDC’s vaccine advisory panel is scheduled to meet June 25 to vote on a coronavirus vaccine recommendation for the fall. Members are expected to be asked to vote to replace the current universal coronavirus vaccination recommendation with the more targeted one outlined by the FDA. Once the recommendations are approved by the CDC director — or another authority if there is no acting or permanent director — they become official U.S. policy, and insurance companies are required to cover the cost of the shots with no out-of-pocket charges to consumers.
Moderna, one of the makers of a commonly administered coronavirus shot, said the company was “committed to working with the Agency to provide the data they need to ensure access for Americans.”
The other manufacturer, Pfizer, said that it is evaluating the details the FDA shared Tuesday, adding that its vaccine has been administered to over a billion people and generated “robust” safety data.
“We stand by the science behind the Pfizer-BioNTech covid-19 vaccine and continue to believe that broad vaccination programs are an essential tool for helping to prevent covid-19-associated hospitalizations and severe disease, including death,” Pfizer said in a statement.
Five years after the coronavirus first launched mass shutdowns and a global health emergency, health experts say many more Americans have protection against the virus either through natural infection or multiple vaccinations. While the virus still causes significant health impacts for certain individuals, covid-19 is now less deadly.
Amesh Adalja, an infectious-disease physician and senior scholar at the Johns Hopkins Center for Health Security, said he always believed updated shots should have been targeted toward high-risk groups, such as the way some other countries approach the vaccines.
But some vaccine experts expressed concern that the messaging could undermine public confidence in previously established science.
“They keep talking about gold standard science,” Osterholm said, “and that’s really the mantra right now across [the Department of] Health and Human Services, is somehow science before the arrival of this administration was not gold standard.”
In recent weeks, the Trump administration has questioned the testing of vaccine safety for coronavirus shots, introducing uncertainty over whether an updated shot would be available in the fall. Robert F. Kennedy Jr., the nation’s health secretary and founder of a prominent anti-vaccine group, has said he intends to shift the way vaccines are tested, a notion that has sparked concern among medical experts who say that the U.S. has one of the most rigorous vaccine safety systems and that doing so could limit access to lifesaving shots.
Kennedy has a long history of disparaging vaccines, including falsely calling the coronavirus shot “the deadliest ever made.” Kennedy has countered that he is simply seeking good data about vaccines, and his health department has since taken aim at reexamining coronavirus vaccines.
During a podcast-style interview, Makary asked Prasad whether Kennedy wrote the paper in the New England Journal of Medicine. Prasad responded that he has never spoken with the secretary and that it was developed by him and Makary.
Some vaccine experts raised concerns about conducting a clinical trial where some of the participants ages 50 through 64 would get an inert substance, such as a saline shot. It would be unethical, many public health experts have said. Many ethical review groups in institutions around the country would say, “You cannot withhold the vaccine, even for a period of time to that population,” Schaffner said.
The vaccine is already recommended for individuals in the age groups in which it would be tested in a clinical trial.
Just over half of adults say they are at least “somewhat confident” that coronavirus vaccines are safe. This includes nearly 9 in 10 Democrats, compared with just 3 in 10 Republicans. The perceived safety of the shots is lower than for other common immunizations, such as the flu and MMR vaccines, according to an April poll from KFF, a health policy research organization.
On Friday, the FDA granted a narrow approval to Novavax’s coronavirus vaccine that tracks with the agency’s framework outlined Tuesday. The FDA was on track to grant full approval to the vaccine April 1 for Americans 12 and older, according to two people familiar with the matter who spoke on the condition of anonymity to share internal deliberations. But top Trump FDA officials told agency regulators to pause the approval for the only vaccine that uses a more traditional protein base instead of messenger RNA.
