Author: Christina Jewett and Apoorva Mandavilli
Agency leaders said there was evidence to justify approval only for older people and those with medical conditions. Many others may not be able to get the shots.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, claiming falsely at one point that the Covid vaccines have killed more people than the virus.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.
The agency narrowed who can get the shot and added new study requirements that could cost the company tens of millions.The Food and Drug Administration on Friday approved the Novavax Covid-19 vaccine, but only for older adults and for others over age 12 who have at least one medical condition that puts them at high risk from Covid.Scientific advisers to the Centers for Disease Control and Prevention, who typically make decisions on who should get approved shots and when, have been debating whether to recommend Covid shots only to the most vulnerable Americans. The F.D.A.’s decision appeared to render at least part of their discussion moot.The new restriction will sharply limit access to the Novavax vaccine for people under 65 who are in good health. It may leave Americans who do not have underlying conditions at risk if a more virulent version of the coronavirus were to emerge. It could also limit options for people who want the vaccine for a wide array of reasons, including to protect a vulnerable loved one.The vaccine had previously been authorized under emergency use. Covid vaccines developed by Pfizer-BioNTech and Moderna, which are more widely used by Americans, were granted full approval in 2022. However, the companies are working on updated shots for the fall, and the new restrictions on the Novavax shot portend a more restrictive approach from the F.D.A.The F.D.A.’s new restrictions also appeared to reflect the high degree of skepticism about vaccines from Robert F. Kennedy Jr., the health secretary, and the other leaders he has appointed at health agencies.“This is incredibly disappointing,” said Dr. Camille Kotton, an infectious disease physician at Massachusetts General Hospital who cares for immunocompromised patients, and a former adviser to the C.D.C.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.