Robert F. Kennedy Jr. has spent the last few weeks upending longstanding US practices around vaccines. His moves could dramatically alter which vaccines are recommended, how available they are and has raised a major question: Will shots still be free? In short, nobody knows. Vaccines today follow a well-established pathway from development to your arm. They’re created and later approved (or rejected) by the Food and Drug Administration. The shots are then considered by a panel of vaccine and public health experts on the Advisory Committee on Immunization Practices, or ACIP. The group, part of the Centers for Disease Control and Prevention, meets three times a year. Its specialists churn out recommendations about who should get shots and when. One of ACIP’s most well-known — and these days, controversial — roles is helping determine what goes on the childhood vaccine schedule. The CDC director typically approves whatever suggestions ACIP makes, and that sets in motion the process of insurance companies paying for shots given at doctors’ offices. But Kennedy, a longtime vaccine critic, is bringing about big changes. Last month, he took the unusual step of overriding an ACIP recommendation around Covid shots for healthy kids and pregnant people. Then this week, he removed all 17 members of ACIP and named eight replacements, including several vocal vaccine critics and one who has said Covid shots cause AIDS. All this has left providers unsure of which shots will get full coverage because they don’t know what will be recommended. They also don’t know what the stance of insurance companies will be toward shots the CDC no longer explicitly calls for. For example, the CDC now says that healthy children may receive Covid shots after their parents consult with doctors, a recommendation formally known as “shared clinical decision-making.” Some insurers have refused to cover other vaccines under that type of recommendation in the past. Others say they’ll still pay. Insurers’ legal requirements are a gray area if ACIP moves away from recommending vaccines for routine use for kids, health-care attorneys told Bloomberg. People should expect variability in coverage, prior authorization and out-of-pocket costs, “all of which will discourage uptake,” says Richard Hughes, a lawyer at Epstein Becker Green and former Moderna executive. Even those people willing to cough up the full cost of a vaccine — as much as $141.80 for a Covid shot, for example — may run into another problem: The shifting financial conditions could affect availability. The fact that insurers pay for all recommended shots is a powerful incentive for pharma companies to manufacture vaccines. Spottier coverage will affect their cost-benefit analysis. There are also federal programs that protect the makers of recommended vaccines from lawsuits if the shots cause injuries. Overall, the outlook for free and plentiful lifesaving shots just got a lot hazier. — Kelly Gilblom |