This isn’t just a small tweak. The old approach—straightforward and backed by mountains of research—helped drive hepatitis B infections in infants and children down by 99%. That’s not just a win; it’s one of the biggest public health victories in recent memory.
Dr. Scott Gottlieb, who ran the FDA during Trump’s first term, went on “Face the Nation” to break down why medical experts are so rattled by this change. The science is pretty clear: the younger a child is when they catch hepatitis B, the worse the outcome. Kids over five who get infected usually beat it and walk away with lifelong immunity. But the chances of clearing the infection plummet for younger kids. Between ages one and five, only about half manage to fight it off. The rest become chronically infected, and a quarter of those children will eventually die from complications.
Newborns are at the highest risk. If a baby catches hepatitis B during delivery—a common way for infants to get exposed—about 90% of them will get stuck with chronic infection for life. Of those, roughly a quarter die from liver disease or cancer down the road. That’s brutal.
The birth dose of the vaccine, especially when paired with
immune globulin for at-risk babies, is almost 99% effective at stopping this
from happening. Give the shot within 12 hours of birth, and you basically wipe
out the risk of a baby ending up with chronic hepatitis B. It’s one of the rare
medical interventions that comes close to a guaranteed win.
Let’s start with the basics: prenatal screening just isn’t reaching everyone. The CDC says about 16% of pregnant women miss out on hepatitis B testing. Sometimes doctors don’t offer the test. Sometimes patients don’t follow through. Either way, these gaps mean some mothers living with hepatitis B go undetected—and their babies are left at risk.
But even when women do get tested, the results don’t always make it where they need to go. Hospitals are busy, and sometimes crucial test results never reach the delivery team. This isn’t just a rare fluke. It happens more often than anyone would like to admit, and each time, it puts patients in danger.
And here’s another problem that doesn’t get enough attention: the tests themselves aren’t perfect. Gottlieb pointed out that standard hepatitis B tests miss about 2% of cases. So, for every 100 infected women, two will get a clean bill of health even though they’re carrying the virus. That might sound small, but stretched across the country, it adds up fast.
The numbers are sobering. That 2% error rate means about 1,000 babies are born every year to mothers who test negative but actually have hepatitis B. These newborns won’t get the birth dose vaccine because nobody knows they’re at risk. Later, families find out the test was wrong. The FDA ran the numbers and estimated that, in the first year after new screening guidelines rolled out, about 1,400 babies would catch hepatitis B this way. Around a quarter of those cases would be fatal.
This is exactly why the birth dose vaccine matters. It’s a safety net. It recognizes that mistakes happen—sometimes tests miss an infection, sometimes paperwork gets lost. By vaccinating all newborns, no matter what the screening says, the program shields the most vulnerable babies from slip-ups in the system.
Broader Vaccine Policy Concerns: FDA Changes and What’s Next
The hepatitis B decision grabbed headlines, but Gottlieb says this is just the start. He pointed out that the FDA plans to scrap something called “immunobridging studies.” These studies have been around for ages, and they’re the reason the FDA can approve updated vaccines quickly when viruses or bacteria change.
Here’s why immunobridging matters. It lets the FDA approve new versions of vaccines—like flu or COVID shots—without starting from scratch every time with huge clinical trials. Scientists already know these vaccines are safe, so as long as they produce enough antibodies, that’s good enough. For flu and COVID, which shift constantly, this shortcut keeps vaccines up to date.
But if the FDA gets rid of immunobridging, companies would have to run massive outcome studies every year just to prove the new flu shot works, or that the latest COVID booster protects against whatever’s out there. That’s not really doable. It would slow everything down, maybe even freeze vaccine formulas in place while viruses keep evolving. And if that happens, forget about improved or variant-specific vaccines that actually target what’s circulating now.
Gottlieb stressed that this isn’t only about COVID. These changes could shape how we handle every seasonal virus. Annual updates might disappear, and developing new vaccines for the next big threat could take years—if it’s possible at all.
Questions About the Decision-Making Process: Politics Over Science?
There’s something unsettling about how ACIP reached its
decision. In June 2025, Health and Human Services Secretary Robert F. Kennedy
Jr. replaced 17 ACIP members with his own picks. Kennedy’s been the country’s
loudest vaccine skeptic for years, and some of his appointees have publicly
pushed anti-vaccine views or don’t have standard public health backgrounds.
That’s raised real questions about whether science or politics is steering the
ship.
At the ACIP meeting where they made the hepatitis B call, some panelists who voted “no” didn’t hold back their frustration. One just said flat-out, “CDC is doing harm.” Another went even further: “No rational science has been presented, and the committee must accept responsibility when harm is caused.” You don’t usually hear this kind of blunt criticism from inside a panel like this. It’s a sign that some members really doubt whether science is still guiding these decisions.
Gottlieb didn’t mince words either. He described ACIP as mostly “anti-vax activists who were put there to carry out a specific agenda,” except for a handful of members. He’s not just upset—he’s worried the committee cares more about ideology than solid medical evidence. Gottlieb also pointed out that Kennedy hasn’t exactly hidden his goals. Kennedy’s said before he wants to “eliminate childhood immunization, or many of these childhood immunizations.”
This isn’t just about one decision. ACIP’s reputation has a huge ripple effect—around 600 state laws connect vaccine requirements to what this committee recommends. Now, as trust unravels, the fallout spreads. Seventeen states have already passed laws saying they won’t automatically follow ACIP anymore. Insurance companies are starting to look elsewhere, too, like the American Academy of Pediatrics, for guidance on vaccine coverage. ACIP used to be the gold standard. Now, its authority looks badly shaken, maybe for good.
There’s a bigger crisis here—a breakdown in trust around vaccine policy. Gottlieb warned that this kind of damage isn’t easy to fix. “I don’t think you can just flip the switch and restore this where people are going to suddenly respect its decisions again,” he said. When people lose faith in these institutions, that alone threatens public health. It can drag down vaccine rates for years.
The American Academy of Pediatrics, which represents the
country’s pediatricians, made their alarm clear. Their leaders said they’re
“deeply alarmed” by the ACIP vote. That’s not just bureaucratic noise—it’s the
people who actually care for kids and families saying this new policy goes
against medical consensus.
What’s Next
Now, the hepatitis B recommendation just needs a sign-off from either the CDC director or HHS Secretary Kennedy to become official. Until then, it's a big signal about where vaccine policy could be heading with this administration. You’ve got former FDA commissioners publishing warnings in the New England Journal of Medicine. Gottlieb’s raising alarms too—he’s not happy about plans to sweep aside long-standing vaccine development rules. Honestly, it feels like everything’s about to shift, and not in a small way. Public health could really feel the impact.
These policy changes aren’t just about one vaccine—they’re
about flipping the whole system for how vaccines get made, approved, and
recommended. Instead of sticking with the scientific methods that have kept
people safe for years, leaders seem ready to try a completely different
approach. It’s a pretty dramatic shake-up.
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