Larry Saltzman has blood cancer. He\u2019s also a retired doctor, so he knows getting covid-19 could be dangerous for him \u2014 his underlying illness puts him at high risk of serious complications and death. To avoid getting sick, he stays away from large gatherings, and he\u2019s comforted knowing healthy people who get boosters protect him by reducing his exposure to the virus.<\/p>\n
Until now, that is.<\/p>\n
Vaccine opponents and skeptics in charge of federal health agencies \u2014 starting at the top with Health and Human Services Secretary Robert F. Kennedy Jr. \u2014 are restricting access to covid shots that were a signature accomplishment of President Donald Trump\u2019s first term and cost taxpayers about $13 billion to develop<\/a>, produce, and distribute. The agencies are narrowing vaccination recommendations, pushing drugmakers to perform costly clinical studies, and taking other steps that will result in fewer people getting protection from a virus that still kills hundreds<\/a> each week in the U.S.<\/p>\n \u201cThere are hundreds of thousands of people who rely on these vaccines,\u201d said Saltzman, 71, of Sacramento, California. \u201cFor people who are immunocompromised, if there aren\u2019t enough people vaccinated, we lose the ring that\u2019s protecting us. We\u2019re totally vulnerable.\u201d<\/p>\n The Trump administration on May 20 rolled out tougher approval requirements for covid shots, described as a covid-19 \u201cvaccination regulatory framework,\u201d that could leave millions of Americans who want boosters unable to get them.<\/p>\n The FDA will encourage new clinical trials on the widely used vaccines before approving them for children and healthy adults. The requirements could cost drugmakers tens of millions of dollars and are likely to leave boosters largely out of reach for hundreds of millions of Americans this fall.<\/p>\n Under the new guidance<\/a>, vaccines will be available for high-risk individuals and seniors. But the FDA will encourage drugmakers to commit to conducting post-marketing clinical trials in healthy adults when the agency approves covid vaccines for those populations.<\/p>\n For the past five years, the shots have been recommended<\/a> by the Centers for Disease Control and Prevention for everyone 6 months and older. They have been available each fall after being updated to reflect circulating strains of the virus, and the vaccines have been shown to be safe and effective in clinical trials.<\/p>\n Vinay Prasad, who leads the FDA\u2019s division overseeing vaccines, cited \u201cdistrust of the American public\u201d as he announced the new guidelines at a May 20 briefing.<\/p>\n \u201cWe have launched down this multiyear campaign of booster after booster after booster,\u201d he said, adding that \u201cwe do not have gold-standard science to support this for average-risk, low-risk Americans.\u201d<\/p>\n The details were outlined in a May 20 article in The New England Journal of Medicine<\/a>, written by FDA Commissioner Marty Makary. He and Prasad later followed up with the briefing, which appeared the same day on YouTube<\/a>.<\/p>\n The added limits on access aren\u2019t the result of any recent data showing there are new health risks from the covid vaccines. Instead, they reflect a different regulatory stance from Kennedy, who has a history of anti-vaccine activism, and Makary, who has questioned the safety data on covid mRNA shots.<\/p>\n Announcing a major regulatory change in a medical journal and YouTube video is a highly unusual approach that still leaves many questions about implementation unanswered. It remains unclear when the changes will go into effect or whether there will be any public comment period. The changes were announced by the administration before an FDA advisory committee meeting on May 22<\/a> to consider the 2026 covid vaccine formula.<\/p>\n It\u2019s a sharp reversal from the first Trump administration, which launched Operation Warp Speed<\/a> \u2014 the effort that led to the development of the covid shots. Trump called the vaccines the \u201cgold standard\u201d and a \u201cmonumental national achievement.\u201d<\/p>\n Concerns About Higher Transmission<\/strong><\/p>\n The announcement is rattling some patient advocacy groups, doctors, nursing home leaders, and researchers who worry about the ramifications. They say higher-risk individuals will be more likely to get covid if people who aren\u2019t at risk don\u2019t get boosters that can help reduce transmission. And they say the FDA\u2019s restrictions go too far, because they don\u2019t provide exceptions for healthy individuals who work in high-risk settings, such as hospitals, who may want a covid booster for protection.<\/p>\n The limits will also make it harder to get insurance coverage for the vaccines. And the FDA\u2019s new stance could also increase vaccine hesitancy by undermining confidence in covid vaccines that have already been subject to rigorous safety review,<\/a> said Kate Broderick, chief innovation officer at Maravai Life Sciences, which makes mRNA products for use in vaccine development.<\/p>\n \u201cFor the public, it raises questions,\u201d she said. \u201cIf someone has concerns, I\u2019d like them to know that of all the vaccines, the ones with the most understood safety profile are probably covid-19 vaccines. There is an incredible body of data and over 10 billion doses given.\u201d<\/p>\n Some doctors and epidemiologists say it could leave healthy people especially vulnerable if more virulent strains of covid emerge and they can\u2019t access covid shots.<\/p>\n \u201cIt\u2019s not based on science,\u201d said Rob Davidson, an emergency room doctor in Michigan and executive director of the Committee to Protect Health Care<\/a>, which works to expand health care access. \u201cIt\u2019s what we were all worried would happen. It risks peoples\u2019 lives.\u201d<\/p>\n Current federal regulators say there is no high-quality evidence showing that vaccinating healthy people, including health workers who are near or around immunocompromised people, provides an additional benefit.<\/p>\n \u201cIt is possible, actually, that such approvals and strategies provide false reassurance and lead to increased harms,\u201d Prasad said.<\/p>\n The covid vaccines underwent clinical trials to assess safety, and they have been subject to ongoing surveillance and monitoring<\/a> since they obtained emergency use authorization from the FDA amid the pandemic. Heart issues and allergic reactions can occur but are rare, according to the CDC<\/a>.<\/p>\n On a separate track, the FDA on May 21 posted letters sent in April to makers of the mRNA covid vaccines<\/a> to add information<\/a> about possible heart injury on warning labels, a move that one former agency official described as overkill. The action came after the Permanent Subcommittee on Investigations, a panel of the Senate Homeland Security and Governmental Affairs Committee, held a hearing<\/a> on alleged adverse events associated with covid vaccines.<\/p>\n Limiting boosters to healthy people goes against guidance from some medical groups.<\/p>\n \u201cThe COVID-19 vaccine is safe, effective, and the best way to protect children,\u201d Sean O\u2019Leary, chair of the Committee on Infectious Diseases at the American Academy of Pediatrics, said in an email. \u201cYoung children under 5 continue to be at the highest risk, with that risk decreasing as they get older.\u201d<\/p>\n Unsupported Claims About mRNA Vaccines<\/strong><\/p>\n The covid booster clampdown is supported by many adherents of the \u201cMake America Healthy Again<\/a>\u201d movement, which casts suspicion on traditional medicine. Some opponents of covid mRNA vaccines say without evidence that the shots cause \u201cturbo\u201d cancer, are genetic bioweapons, and cause more heart damage than the covid virus.<\/p>\n There is no evidence the shots lead to rapid and aggressive cancers. Cancer rates decreased an average of 1.7% per year for men and 1.3% for women from 2018 to 2022, according to the National Institutes of Health<\/a>. The covid vaccines debuted in 2021.<\/p>\n Federal regulators say narrowing who can get the boosters will align the U.S. with policies of European nations. But other countries have vastly different economic structures for health care and approaches to preventive care. Many European countries, for example, don\u2019t recommend flu shots for the entire population. The U.S. does in part because of the financial drain attributed to lost productivity when people are sick.<\/p>\n They also want more information. \u201cI think there\u2019s a void of data,\u201d Makary told CBS News<\/a> on April 29. \u201cAnd I think rather than allow that void to be filled with opinions, I\u2019d like to see some good data.\u201d<\/p>\n A massive five-year study on covid vaccine safety by the Global Vaccine Data Network, involving millions of people, was underway, with about a year left before completion. The Trump administration terminated funding for the project<\/a> as part of cuts directed by the president\u2019s Department of Government Efficiency, and work on the study has stopped for now.<\/p>\n There are a multitude of studies, however, on the vaccines\u2019 effectiveness in preventing severe illness, hospitalization, and death.<\/p>\n Limiting boosters for healthy people can be risky, some doctors say, because people don\u2019t always know when they fall into higher-risk categories, such as individuals who are prediabetic or have high blood pressure. The covid vaccine restrictions could deter them from getting boosted, and they might experience worse complications from the virus as a result. For example, about 40% of people with hepatitis C<\/a> are unaware of their condition, according to a study published in 2023.<\/p>\n The number of people getting covid vaccines has already dropped significantly since the height of the crisis. More than half of the more than 258 million adults in the U.S. had gotten a covid vaccination as of May 2021, according to the CDC<\/a>. In each of the past two seasons, less than 25% of Americans received boosters, CDC data shows.<\/p>\n While deaths from the virus have dropped, covid remains a risk, especially when cases peak in December and January. Weekly covid deaths topped 2,580 as recently as January 2024, according to CDC data<\/a>.<\/p>\n Some high-risk individuals are worried that the new restrictions are just the first salvo in halting all access to mRNA shots. \u201cThe HHS motivation really is hidden, and it\u2019s to dismiss all mRNA technology,\u201d said Michael Osterholm, an epidemiologist at the University of Minnesota.<\/p>\n Officials at the NIH have told scientists to remove references to mRNA<\/a> in grant applications. HHS also announced plans in May to develop new vaccines<\/a> without mRNA technology, which uses messenger RNA to instruct cells to make proteins that trigger an immune response.<\/p>\n Rose Keller, 23, is concerned about future access to covid shots. She would be eligible under the current announcement \u2014 she has cystic fibrosis, a progressive genetic condition that makes the mucus in her lungs thick and sticky, so covid could land her in the hospital. But she is concerned the Trump administration may go further and restrict access to the vaccines as part of a broader opposition to mRNA technology.<\/p>\n \u201cI\u2019ve had every booster that\u2019s available to me,\u201d said Keller, a government employee in Augusta, Maine. \u201cIt\u2019s a real worry if I don\u2019t have the protection of a covid booster.\u201d<\/p>\n KFF Health News<\/a> is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF\u2014an independent source of health policy research, polling, and journalism. Learn more about KFF<\/a>.<\/p>\nUSE OUR CONTENT<\/h3>\n