The Food and Drug Administration will permit use of Covid vaccines by adults over 65 and those with certain medical conditions in the fall, but may require additional studies before approving the shots for healthy Americans younger than 65, agency officials said on Tuesday.
At this point, the additional doses offer “uncertain” benefits to many young and middle-aged people who have already been vaccinated or have had Covid, Dr. Vinay Prasad, the F.D.A.’s vaccine division chief, and Dr. Martin Makary, the agency’s commissioner, wrote in The New England Journal of Medicine.
“The F.D.A. will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk,” the officials wrote.
Until now, annual Covid shots were recommended for everyone aged 6 months and older. Scientific advisers to the F.D.A. are set to meet Thursday to decide on the composition of the Covid vaccine to be made available in the fall.
During the pandemic, both Dr. Prasad and Dr. Makary sharply criticized vaccine mandates and other public health measures intended to turn back the coronavirus.
Robert F. Kennedy Jr., the health secretary, is a longtime vaccine skeptic who spent years campaigning against the Covid shots, falsely claiming at one point that the Covid vaccines had killed more people than the virus.
As a measles outbreak spreads through Texas and other states this year, Mr. Kennedy has offered only muted support for vaccinations and has repeatedly raised questions about the safety of the measles shot while suggesting, falsely, that miracle treatments, like cod liver, oil were available.
During a livestreamed “town hall” on Tuesday afternoon, Dr. Prasad said he thought the new approach to Covid vaccination was “a reasonable compromise,” leaving the shots available to many Americans “but also generating evidence.”
Some Americans are worried that the F.D.A. has “not fully documented and interrogated the safety harms” of the vaccines, while others “are desperate for additional protection,” he added, describing himself as an “extreme pro-vaccine person.”
Before approving Covid vaccines for wider use, the F.D.A. “anticipates the need” for new clinical trials in which participants under 65 are randomly assigned to receive the new shots or a placebo, Dr. Prasad and Dr. Makary wrote in the journal.
Vaccine manufacturers should follow participants for at least six months and evaluate whether the effect of the vaccine persists over that time, Dr. Prasad said during the livestream.
Some experts said the new criteria go too far, erecting barriers for people who will want the shots.
“This is overly restrictive and will deny many people who want to be vaccinated a vaccine,” Dr. Anna Durbin, director of the Center for Immunization Research at Johns Hopkins University, said in an email.
Dr. Daniel Griffin, a physician in New York who has treated thousands of Covid patients, said, “I think that changes like this will lead to more unnecessary deaths.”
“such What they’re really doing is they’re very slowly reducing vaccination in the country.”
Some experts said that while they agreed with aspects of the agency’s rationale, the new restrictions would unnecessarily limit access for healthy Americans who may be at high risk from Covid because of their jobs or for other reasons.
This “doesn’t preserve people’s choice to get vaccinated,” said Dr. Denise Jamieson, vice president for medical affairs at the University of Iowa and an adviser to the Centers for Disease Control and Prevention.
In a statement, Pfizer said it is evaluating the details shared Tuesday and is in ongoing discussion with the F.D.A. The company said its Covid vaccines have been given to over a billion people, “generating robust data demonstrating a favorable safety profile. “
Moderna, maker of another widely used Covid vaccine, did not immediately comment.
The new recommendations mark a departure from the previous policy of offering annual Covid shots to everyone 6 months and older, the “most aggressive” strategy when compared with the standards used in other nations, the F.D.A. officials noted.
Dr. Makary and Dr. Prasad have often been described as Covid contrarians. But recommending the vaccine for every American 6 months and older, regardless of health status, is in fact the “contrarian” approach, they said at the town hall.
“Now we are back in line with the rest of the world,” Dr. Prasad said. Other high-income nations have long adopted “risk-based” recommendations targeting the shots to those most in need.
The original vaccine trials were conducted years ago, at the onset of the pandemic. The virus was much different, and most people had not yet been exposed. It’s unclear whether the shots would still prove as beneficial now, the F.D.A. officials said.
Yet federal agencies do have robust data showing that even now Covid vaccines offer modest protection against hospitalization and death even at younger ages, some scientists noted.
“We need to also include the role of observational data and the role of the C.D.C. in continuously monitoring vaccine safety and efficacy,” Dr. Jamieson said. “We have a lot of accumulated data at this point.”
But Dr. Prasad cast doubt on the quality of such data, saying those studies are “at high risk of bias and broadly uninformative.”
He and Dr. Makary also said there was insufficient evidence that getting the vaccine would prevent transmission of the virus to others at risk from the virus.
Deaths from Covid have fallen each year since the start of the pandemic, but there were still roughly 1,000 deaths per week last winter, most of them in adults 75 and older.
In the year ending in August, the C.D.C. reported 150 pediatric deaths, a number comparable to deaths among children in a typical flu season.
Children under 4 remain at high risk from Covid, but the absolute numbers of seriously affected children are low, the officials said, and children with medical conditions would still qualify for the vaccine.
It is the C.D.C. that usually defines who should get a vaccine and when, based on guidelines set by a panel of external advisers. “C.D.C. is the agency that really has the expertise in that area,” Dr. Jamieson said.
It is unclear how the new criteria will affect availability of Covid vaccines in the fall. The revised approvals process could upend insurance and public coverage of Covid vaccines, experts said.
The proposed regulations align with the agency’s recent decision to narrow the eligibility for the Novavax Covid vaccine.
The F.D.A. on Friday approved that shot for use only in adults over 65 and for others over age 12 who have at least one medical condition that puts them at high risk should they contract Covid.
The decision was met with some criticism, given the absence of new evidence to suggest concerns about the effectiveness or side effects.
It “does seems to be based more on this administration’s hostility to vaccines and resentment of Covid prevention methods,” Dr. Durbin, of Johns Hopkins, said.
The officials said the F.D.A. would rely on results from lab tests showing that Covid vaccines still provide valuable protection to Americans older than 65 and to those older than 6 months who have other conditions, as defined by the C.D.C.
The list of such risk factors is long, including asthma, diabetes, physical inactivity, and mental health conditions like depression. Dr. Prasad and Dr. Makary estimated that one-third of Americans would be eligible for a Covid vaccine, even under the new approach.
“At-risk Americans can be reassured that they will be covered by such approvals,” Dr. Prasad said.
Christina Jewett covers the Food and Drug Administration, which means keeping a close eye on drugs, medical devices, food safety and tobacco policy.
Apoorva Mandavilli reports on science and global health, with a focus on infectious diseases, pandemics and the public health agencies that try to manage them.
The post F.D.A. Poised to Restrict Access to Covid Vaccines appeared first on New York Times.
