Americans’ access to lifesaving vaccines threatened by RFK Jr. overhaul

Health and Human Services Secretary Robert F. Kennedy Jr.’s changes to U.S. vaccine policy are putting the $24 billion U.S. market for shots at risk, potentially making it harder for Americans to access them.

A key test of how deep and widespread the impact will be comes Wednesday, when an influential panel of vaccine advisers gathers in Atlanta for one of its three annual meetings. They will discuss a decades-old childhood vaccine that isn’t on the federal government’s schedule of shots, and the use of a rarely used preservative in flu shots that has been deemed safe by the medical community for years.

Earlier this month, Kennedy fired every member of the panel and named eight replacements, including several vaccine critics. One new member, Michael Ross, stepped down during the “financial holdings review required of members before they can start,” according to an HHS spokesperson. The meeting still appears poised to proceed.

While the topics on the agenda affect only a small portion of shots on the market, the discussions will provide clues on how members think about immunizations.

If the panel, known as the Advisory Committee on Immunization Practices, ultimately reverses past decisions, it would change the calculus for companies that manufacture vaccines. Shots that lose the stamp of approval from ACIP may become too financially risky to manufacture, according to public health experts and investors.

Panelists are also scheduled to vote on a shot for a dangerous respiratory virus in pregnant people. ACIP recommendations affect whether health insurance covers shots and could influence whether the companies that create them are insulated from lawsuits over side effects. Revoking recommendations for the shots would almost certainly make them harder to come by, ending a decades-long era in the U.S. of affordable and plentiful lifesaving vaccines.

“It’s important for everyone to realize there will be no vaccines if there are no vaccine manufacturers,” said James Campbell, who has represented the American Academy of Pediatrics at ACIP meetings. “People can critique the manufacturers, and there are reasonable critiques, but there is nobody else to make vaccines if we don’t have vaccine manufacturers.”

Lawsuit protection

Current U.S. vaccine policy dates back to the 1980s. Then, a now-debunked documentary about the potential side effects of the combined diptheria, whooping cough and tetanus shot that aired on TV led to a wave of lawsuits against manufacturers. Companies curtailed production and the U.S. struggled with shortages.

Congress then created the National Vaccine Injury Compensation Program to shield companies from the financial liability of lawsuits. It includes a taxpayer-backed fund to help patients who experience damaging vaccine side effects.

For a vaccine to be covered by the fund, it has to be recommended by the Centers for Disease Control and Prevention for children or pregnant people. The CDC typically bases those recommendations on the advice of ACIP, which reviews the science of each shot. It also has to be subject to an excise tax passed by Congress.

Recommendations made by ACIP are generally adopted by the CDC director to become the agency’s official policy. President Donald Trump’s nominee for the job, Susan Monarez, will sit before the Senate Health, Education, Labor and Pensions Committee in a confirmation hearing during ACIP’s meeting.

Normally, ACIP members undergo an extensive vetting process and have a background in immunizations. The current members have relatively little scientific background in vaccines and include one self-proclaimed “anti-vaxxer.” Kennedy said he made the unusual decision to remove all 17 former members and appoint new ones “to re-establish public confidence in vaccine science.”

Based on an agenda, this week the members appear to be considering shots the CDC already supports. For example, they’ll vote on recommendations for vaccines containing thimerosal, a mercury-containing preservative that is used in about 4% of flu vaccines. That would possibly affect flu shots already on the market manufactured by Sanofi SA and CSL Ltd.

Public health and legal experts have conflicting views about whether those shots would immediately lose their liability protection if the new ACIP panel votes against them. Dorit Reiss, a law professor at the University of California at San Francisco, said that it would almost immediately. Richard Hughes IV, lawyer for Epstein Becker & Green PC and former Moderna Inc. executive, said the change wouldn’t happen right away.

The removal of financial protections for manufacturers would make it difficult for companies to invest, said Jeff Jonas, a portfolio manager at Gabelli Funds.

“I think companies are going to be hesitant or even unlikely to start new vaccine programs,” he said. “You have to be really confident in the technology and the market size and the ability to afford a larger and longer randomized clinical trial to get it to market.”

Kennedy has been a strong critic of the vaccine injury fund, saying it removes the financial incentive for drugmakers to make vaccines safer. He also has the ability to reject the advice of ACIP and the CDC if he doesn’t like it, which he already did with Covid shots for healthy children and pregnant people.

There has already been significant pushback to his decisions by the fired ACIP members and medical associations. And on Monday, Senator Bill Cassidy, who voted to confirm Kennedy after securing a promise he wouldn’t change the lineup of ACIP experts, called for this week’s meeting to be delayed.

Damage Done

Adding to the difficult environment, ACIP recommendations affect how insurance will pay out. Typically, when the panel calls for a shot, the CDC director and HHS secretary agree with that assessment. That leads to insurers fully covering the vaccines and for the federal government to provide them to families who can’t afford them through the Vaccines for Children Program.

About half of kids in the U.S. are eligible for taxpayer-funded shots. Widespread coverage provides another financial incentive for manufacturers to make vaccines.

Earlier this month, some insurers said they were monitoring changes in ACIP recommendations.

“So much of our vaccine policy nationally and at the state level, really is automatically tied to these recommendations,” said Hughes, the former Moderna executive and lawyer. “The vast majority of Americans have health insurance coverage that is dependent on these recommendations.”

The effects of the overhaul Kennedy has undertaken may be long term. While a new administration could reverse decisions he and a revamped ACIP make, it would be harder to address the cultural impact.

The vaccine system depends on “public understanding, public clarity, health care providers and patients having confidence in the safety, the effectiveness of vaccines as well as the institutions and organizations that oversee them,” according to Jason Schwartz, a professor at the Yale School of Public Health.

Now, he said “wholesale distrust” has been creeping into all those systems, and the approach to shots has become a partisan matter.

“To some degree, the damage will have been done,” Schwartz said.