By Michelle Amponsah, Damian Garde and Denise Lu, Bloomberg
Health and Human Services Secretary Robert F. Kennedy Jr.’s changes to US vaccine policy are putting the $24 billion US market for shots at risk, potentially making it harder for Americans to access them.
RELATED: Kennedy’s new vaccine panel alarms pediatricians with inquiries into long-settled questions
The leader of the Kennedy-appointed panel said it will reconsider the government’s recommendations for childhood vaccines and take another look at any shots that haven’t been examined in the last seven years. It was an unexpected move from a panel that normally discusses topics like flu shot effectiveness, and came Wednesday during its first gathering since the group was revamped.
The two-day meeting drew thousands of watchers and could have sweeping implications for vaccines in the US. The panel, known as the Advisory Committee on Immunization Practices, has historically influenced which shots are given when and, vitally, whether they get broad insurance coverage. Changing federal recommendations could alter the routine medical care of for millions of people around the country.
Earlier this month, Kennedy fired every member of the panel and named eight replacements, including some who have espoused discredited theories about vaccine safety. 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 revamped panel has already stoked a backlash. Senator Bill Cassidy, a Louisiana Republican who voted to confirm Kennedy after securing a promise he wouldn’t change the lineup of ACIP experts, had unsuccessfully called for the panel to delay the meeting out of concern the new members weren’t qualified. On Wednesday, he questioned why the committee wasn’t getting any data showing the vaccine preservative thimerosal was safe, something that is widely accepted by the medical establishment.
Committee chairman Martin Kulldorff, a biostatistician who said he was fired by Harvard University after refusing to take a Covid vaccine, used his opening remarks Wednesday to defend his fellow panelists and insist the group had “a clear mandate to use evidence-based medicine” in its recommendations.
“Some media outlets have been very harsh on the new members of this committee, issuing false accusations and making concerted efforts to put scientists in either a pro- or anti-vaccine box,” Kulldorff said. “Such labels undermine critical scientific inquiry and it further feeds the flames of vaccine hesitancy.”
If the panel 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.
Its actions are being closely watched. More than 4,000 people tuned into a webcast of the meeting, which traditionally draws little attention.
The group is also debating whether to back Merck & Co.’s shot to prevent RSV in newborns and digging into a little-used vaccine preservative falsely linked to childhood autism.
One of ACIP’s newly announced working groups will consider whether hepatitis B vaccines are given too early, Kulldorff said. Infants currently get it within 24 hours of birth to prevent transmission from an infected mother, who may not know if she has it, according to the Centers for Disease Control and Prevention.
The decisions of the revamped panel could influence whether companies manufacture vaccines 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 US 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 US vaccine policy dates back to the 1980s. Then, a now-debunked documentary about the potential side effects of the combined diphtheria, whooping cough and tetanus shot that aired on TV led to a wave of lawsuits against manufacturers. Companies curtailed production and the US 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 CDC for children or pregnant people. The CDC typically bases those recommendations on the advice of ACIP, which reviews the science of each shot.
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, sat before the Senate Health, Education, Labor and Pensions Committee in a confirmation hearing during the morning as ACIP met.
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 reestablish public confidence in vaccine science.”
The new members will be reviewing shots the CDC already supports. They are expected to vote on recommendations for vaccines containing thimerosal, a mercury-containing preservative that is used in about 4% of flu vaccines. That would possibly affect products already on the market from 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 they would. However, Richard Hughes IV, a lawyer at Epstein Becker & Green PC and former Moderna Inc. executive, said it would take time for the change to happen.
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.
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 the federal government providing them to families who can’t afford them through the Vaccines for Children Program.
About half of kids in the US 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.”
–With assistance from Jessica Nix, Rachel Cohrs Zhang and Gerry Smith.
More stories like this are available on bloomberg.com
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