Health Secretary Robert F. Kennedy Jr., a longtime anti-vaccine activist, has promised not to “take away anybody’s vaccines.”
Beyond restricting who is eligible for certain shots — as he’s already done for this year’s Covid vaccines — experts say Kennedy can take steps that could drive drug companies to stop making vaccines entirely.
In the 1980s, lawsuits fueled by the nascent anti-vaccine movement led more than a dozen manufacturers to stop producing vaccines, creating shortages, according to Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
Domestic vaccine production survived only because Congress stepped in to create a no-fault alternative to the traditional legal system, the National Vaccine Injury Compensation Program, or VICP, which protected vaccine makers from liability and created a special vaccine court to award financial damages to people harmed by vaccines, said Dr. Walter Orenstein, an infectious disease expert and emeritus professor of medicine at the Emory University School of Medicine.
The program’s legal protections for plaintiffs and drugmakers have helped ensure the United States has a reliable supply of vaccines ever since, Orenstein said.
As health secretary, Kennedy has that program in his sights.
Kennedy — who has long cast vaccine manufacturers as the enemy and has been involved in litigation against them — has amped up his attacks on the VICP, criticizing the program on social media and TV.
In a July post on X, Kennedy disparaged the VICP as corrupt and “broken” and vowed to “fix it.”
“The VICP routinely dismisses meritorious cases outright or drags them out for years,” Kennedy wrote. “Instead of ‘quickly and fairly’ awarding compensation, Special Masters dismiss over half of the cases.”
When asked for comment on Kennedy and VICP, Emily Hilliard, a spokesperson for the Department of Health and Human Services, referred NBC News to the secretary’s X post.
Vaccines are overwhelmingly safe and have saved 154 million lives over the past five decades, according to the World Health Organization. But about 1 in 1 million vaccinations causes a serious injury, such as a life-threatening allergic reaction or Guillain-Barre syndrome, which can cause monthslong paralysis, Offit said.
The Pharmaceutical Manufacturers of America, an industry group, said that the VICP doesn’t shield drug companies from all liability. People whose claims are denied by the VICP can still sue in a traditional court, said Andrew Powaleny, a PhRMA spokesperson.
The program, which is funded through a 75-cent surcharge on vaccines, has helped thousands of people, Powaleny said, awarding $5.4 billion to plaintiffs since its founding.
Offit said that eliminating or undermining the VICP could lead history to repeat itself.
“If you want to destroy vaccines in this country, if your goal is to eliminate vaccine manufacturing in this country, the best way to do that is through attacking the VICP,” Offit said.
‘Opening the floodgates’
The VICP is not without its limitations, said Dorit Reiss, a professor and vaccine policy expert at the University of California, San Francisco School of Law.
The program desperately needs more resources to address the backlog of cases, Reiss said. The program also allows families only three years to make a claim, even though some potentially serious injuries might not become apparent for four or five years.
Although members of Congress have tried to pass legislation several times to give the VICP more resources — including the ability to hire more special masters, who act as judges — the efforts have never succeeded.
Because Congress created the VICP, only Congress has the authority to update or eliminate it, Reiss said.
Yet the health secretary wields significant power over the program. And he has big plans.
In an interview with Tucker Carlson in June, Kennedy said, “We just brought a guy in this week who’s going to be revolutionizing the Vaccine Injury Compensation Program.”
Although Kennedy didn’t name the employee, he has brought Andrew Downing, an attorney with experience suing vaccine manufacturers, onto his staff, a development that was first reported in June by NOTUS, a digital news site. Downing is listed in HHS’ employee directory as a counselor in the Office of the Secretary. Both Downing and Kennedy, who is also a lawyer, have been involved with lawsuits against Merck over its HPV vaccine, Gardasil.
Kennedy could threaten vaccine production by making two types of changes to the VICP, experts say: by adding new conditions to the VICP’s list of injuries, or by withdrawing recommendations for certain vaccines.
The VICP compensates people who have been injured by any of the 16 routinely recommended pediatric vaccines, as long as the balance of medical evidence shows that their health problem is related to vaccines, Reiss said. So while VICP compensates people for severe allergic reactions, the program does not compensate people whose children develop autism, because research has found no link between autism and vaccines.
Offit fears that Kennedy wants to add autism and other conditions to the VICP program.
Kennedy has commissioned a report on the causes of autism and has said it would be released in September. Dr. Marty Makary, head of the Food and Drug Administration, told Bloomberg TV on Sept. 8 that the report would come out “within a month.”
An anti-vaccine activist, David Geier, was picked by Kennedy to write the report, so it’s likely that the paper will echo Kennedy’s claims linking vaccines to autism, Offit said.
Adding autism to VICP would “open the floodgates to claims previously dismissed, overwhelming the system and inflating program costs,” said Y. Tony Yang, a professor at George Washington University’s Milken Institute School of Public Health. Vaccine “manufacturers would read that as legal and reputational risk, which historically leads to exits or constrained supply.”
Changing vaccine recommendations
In order for vaccines to be included in the VICP, they must be recommended by the Centers for Disease Control and Prevention, Reiss said. If a vaccine is removed from the agency’s recommendations, people who believe they have been injured by that vaccine could no longer bring claims to the vaccine court and instead would have to go through the legal system, she said.
An onslaught of lawsuits in traditional courts could prompt drug companies to conclude that making vaccines costs them too much money, leading them to leave the market, experts say.
Orenstein said that pushing the lawsuits into the traditional legal system could also hurt plaintiffs.
The VICP protects children with legitimate vaccine injuries, he said, noting serious injuries are extremely rare. Orenstein said the nation owes a debt to families who vaccinate their children, whose immunity helps to protect medically fragile people who can’t be vaccinated or who don’t respond to vaccines.
David J. Carney, an attorney at Green & Schafle in Philadelphia and president of the Vaccine Injured Petitioners Bar Association, said that without the VICP, families of children with rare vaccine-related injuries would need to find to a lawyer to take their case and would have a much harder time winning compensation through the regular court system than through the VICP.
It “would force families into traditional civil litigation — a far more expensive and uncertain process,” Carney said.
Several long-used vaccines are slated to come up for review at an upcoming meeting of the CDC’s independent vaccine panel, which advises the agency on which vaccines to recommend. In June, Kennedy fired all 17 members of the panel and replaced them with seven new, handpicked members. Several of the members Kennedy appointed have a history of anti-vaccine statements or publications.
On the docket for discussion and possible votes are the hepatitis B vaccine, given to newborns, and the use of the combined measles, mumps, rubella and varicella (chickenpox) vaccine in kids under 5.