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RFK Jr.'s panel tackles it Thursday.
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Hi, it’s Jessica in New York. A highly anticipated vaccine panel meeting is taking place in Georgia today, and one vaccine discussion is drawing particular interest ...

Today’s must-reads

  • Lilly’s GLP-1 pill outperformed an older Novo drug in a head-to-head trial. 
  • Aledade is seeking a $500 million loan as it awaits Medicare savings payments.
  • India’s bulk drugmakers are preparing for Novo to lose some weight-loss patent protections.

The next vaccine battleground

Health Secretary Robert F. Kennedy Jr. has gotten little pushback over his moves to restrict access to Covid vaccines. The hepatitis B shot could be the next test of his ability to limit a broader set of vaccines. 

In June, Kennedy removed all 17 members of the Advisory Committee on Immunization Practices, one of the main panels advising the US government on vaccine safety and policy. On Thursday, his hand-picked ACIP members will review presentations including ones on the hepatitis B vaccine and whether the first dose should be given at birth.

Hepatitis B is a highly transmissible viral infection that can attack the liver. The CDC currently recommends that the first dose of the hepatitis B vaccine be given within 24 hours of birth to protect newborns who may have been exposed to the virus during labor and delivery. The American Academy of Pediatrics says this is critical to reduce chronic hepatitis B later in life. 

But some in the anti-vaccine movement believe the dose is given too early, since hepatitis B is often transmitted through sex or shared needle use. 

The problem is that many infected adults may be asymptomatic and don’t know they have the virus. Hepatitis B is transmitted through blood or body fluids, so mothers can unknowingly infect their children. In fact, mother-to-baby exposure and close contact to other family members is the most common way for the disease to spread, said Chari Cohen, president of the Hepatitis B Foundation.

The World Health Organization recommends the birth dose for all countries for this reason, and more than 100 countries have “birth doses” in their vaccination schedules.

After completing the full three to four dose vaccine series, 98% of healthy newborns achieve immunity to hepatitis B, the American Academy of Pediatrics says. According to the AAP, the US had been on track to eliminate perinatal cases of hepatitis B, with only 13 cases reported in 2022. Without the birth dose, that progress is threatened. 

"It’s a simple, safe, cheap, effective vaccine which can prevent these cases,” said Sean O’Leary, professor of pediatrics and infectious diseases at the University of Colorado Anschutz.

Martin Kulldorff, the head of Kennedy’s revamped ACIP panel, added subcommittees to review the current childhood immunization schedule, including whether hepatitis B vaccines are given too early. The advisers will also evaluate the total number of vaccines on the schedule and their cumulative effect, he said. Anti-vaccine organizations argue the US requires too many immunizations in comparison with other countries.

Kulldorff, an epidemiologist, had previously served as an expert witness for plaintiffs’ attorneys alleging Merck hid the risks of its Gardasil vaccine designed to prevent cancers tied to human papillomavirus. Kennedy, an attorney, previously earned fees for cases referred to a law firm that’s made claims against a Health and Human Services-managed program to compensate people injured by vaccines.

In a Senate Health, Education, Labor and Pensions committee hearing Wednesday, Susan Monarez, the ousted head of the Centers for Disease Control and Prevention, testified that Kennedy is seeking more changes to national vaccination policy

Senator Bill Cassidy, the Republican chair of the committee, ended the hearing by making a plea for retaining the birth dose of the hepatitis B vaccine.

I’m going to speak as a liver doctor,” said Cassidy, who practiced medicine for two decades before entering politics. “Before 1991, as many as 20,000 babies were infected with hepatitis B in the United States of America. And that changed when the hepatitis B vaccine was approved for newborns.” 

Kennedy has long said that children are given too many shots. If his revamped vaccine panel recommends cutting the hepatitis B birth dose, that could end its inclusion in the Vaccines For Children program that treats millions of low-income kids.

“This would be the first major change to the childhood vaccine recommendation schedule,” Cohen said. “I don't think it will be the last. I think it’s the stepping stone." – Jessica Nix

What we’re reading

Can drug users be forced into rehab? The New York Times reviews US laws. 

Trendy prenatal supplements are often missing folic acid, which doctors recommend to prevent neural-tube defects, New York Magazine reports

Florida’s end of vaccine mandates could heighten risks for meningococcal outbreaks on college campuses, the Atlantic reports

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