RFK Jr. singled out one study to cut funds for global vaccines. Is that study valid?

A kid receives nan DPT vaccine, which protects against diphtheria, tetanus and pertussis, 3 perchance fatal diseases. A 2017 study assessing this vaccine was cited by RFK Jr. erstwhile he announced that nan U.S. will halt its backing of Gavi, nan Vaccine Alliance, because of concerns astir vaccine safety. Vaccine specialists mobility nan validity of nan study that he mentioned. Noah Seelam/AFP/via Getty Images hide caption

toggle caption

Noah Seelam/AFP/via Getty Images

Last week, Health and Human Services Secretary Robert F. Kennedy Jr. made a pronouncement that stunned nan world wellness world.

Gavi, nan Vaccine Alliance — which has vaccinated much than half nan world's children successful galore of nan world's lowest-income countries — was hosting a awesome arena to solicit donations for its world vaccination efforts. RFK Jr. decided to return nan other stance. He said nan U.S. would trim disconnected much than a cardinal dollars that had antecedently been promised complete nan adjacent fewer years. In a video, he slammed Gavi, saying "it has neglected nan cardinal rumor of vaccine safety."

His evidence: A study from 2017.

This study looked astatine children successful nan westbound African state of Guinea-Bissau who had been fixed nan DTP vaccine — for diphtheria, tetanus and pertussis, 3 perchance fatal diseases.

Although DTP vaccines person been credited pinch redeeming complete 40 million lives globally, nan study claimed that children who received nan vaccine were much apt to dice than different children who had not yet received it.

What do we cognize astir nan study that RFK Jr. cited? And does it make a convincing lawsuit that Gavi has so neglected information issues? To reply these questions, NPR interviewed apical vaccine researchers — including immoderate tasked pinch looking astatine nan very rumor raised by this study astir nan information of nan DTP vaccine.

What to cognize astir nan 2017 study?

The 2017 study was published successful nan peer-reviewed diary eBioMedicine, which is portion of The Lancet, a highly regarded aesculapian publication. The researchers looked astatine conscionable complete 1,000 children who received nan DTP vaccine successful nan early 1980s.

The rumor is not whether nan DTP vaccine works. It is universally acknowledged to beryllium highly effective astatine preventing these 3 deadly diseases.

Instead, nan researchers down nan 2017 study were fascinated by a different issue: Did nan DTP vaccine origin children to get sick and dice from different causes?

Their study looked astatine infants betwixt 3 and 6 months. It claimed that children who sewage nan DTP vaccine — arsenic good arsenic nan oral polio vaccine — astir nan property of 3 months were 5 times much apt to dice earlier they turned 6 months compared to infants that had not yet received their vaccines. According to nan study, of these children a fewer died of respiratory issues, a fewer of fever, a fistful of diarrhea. Still others died of chartless causes.

RFK Jr. called nan 2017 study a "landmark study" by "five internationally revered deities of vaccine research, each of whom are beardown vaccine proponents."

Four are researchers successful Denmark and nan different is from Guinea-Bissau. Dr. Christine Stabell Benn and Dr. Peter Aaby — who is besides an anthropologist — are nan 2 authors who person published connected this taxable complete nan past 25 years. They did not respond to NPR's requests for interviews.

Vaccine experts interviewed by NPR constituent to respective problems pinch nan study:

First: The information is aged — really old

While nan study was published little than a decade ago, nan information it relies connected is from nan early 1980s — much than 40 years ago.

"The study is based connected ancient data," says Dr. Beate Kampmann, a vaccinologist and pediatrician who is nan technological head of nan Centre for Global Health astatine Charité, Universitätsmedizin Berlin — 1 of Europe's largest assemblage hospitals.

"During that time, vaccines were not commonly utilized successful nan country, and nan consequence of decease successful infants was highly high," explains Dr. Kate O'Brien, nan head of nan Department of Immunizations, Vaccines and Biologicals astatine WHO.

Since then, nan number of youngsters who dice has dropped precipitously.

According to information from nan World Bank, successful 1984 successful Guinea-Bissau, 244 kids died earlier their 5th day retired of each 1,000 kids born. In 2023, that number had dropped to 69.

O'Brien says this intends immoderate findings from backmost past aren't very applicable to today's world.

Second: Two of nan cardinal researchers later came retired pinch a different finding

Stabell Benn and Aaby — who published nan 2017 insubstantial — published different paper successful 2022. It looked astatine nan aforesaid westbound African state and nan aforesaid vaccine but nan information was much recent. This clip their information was gathered betwixt 2010 and 2014. And, successful this study, they recovered "no effects connected all-cause mortality" for kids who sewage nan DTP vaccine compared to those who sewage it later.

NPR sent Health and Human Services a elaborate database of questions astir this study — arsenic good arsenic each nan different concerns extracurricular experts raised pinch nan 2017 study. The HHS spokesperson did not respond to nan circumstantial questions but sent a connection via email reiterating what RFK Jr said successful his video.

"Secretary Kennedy believes that world nationalist wellness recommendations must not trust connected assurances alone, but connected continuous, independent reappraisal and rigorous debate," publication portion of nan statement.

Third: The study methods are not ideal

Outside researchers who person looked astatine nan 2017 study opportunity location are a batch of gaps successful nan accusation provided successful nan study and that nan methodology is challenging to understand.

The gold-standard successful investigation is simply a randomized controlled trial, wherever study participants are randomly assigned to get nan vaccine aliases get a placebo. That didn't hap here. Instead, nan researchers simply observed what happened naturally.

This attack is problematic, says Dr. Paul Offit, nan head of nan Vaccine Education Center astatine nan Children's Hospital of Philadelphia and antecedently a personnel of nan Advisory Committee connected Immunization Practices to nan Centers for Disease Control and Prevention. He says you tin ideate parents mightiness activity retired nan vaccine if their kids seemed sickly. But possibly if they were much sickly, they were much apt to dice anyway.

"You person to power for things for illustration socioeconomic background, aesculapian background, wellness attraction seeking behaviour — this study didn't power for those things," he says.

Also, Offit says, researchers usually put guardant an mentation astir really nan vaccine mightiness beryllium causing these deaths. But, he says, nan authors of this study did not connection immoderate theories. "What is your projected mechanism?" he asks.

Several extracurricular experts said they had a very difficult clip knowing what nan researchers really did and really nan information was analyzed. "[The] statistical methods are each complete nan place," says Kampmann.

While writer Stabell Benn did not respond to NPR's requests for an interview, successful a 2019 TEDx Talk, she said, her results haven't been accepted by nan aesculapian community. "I've spent virtually years, I think, pulling retired my hairsbreadth and speculating why it's truthful difficult." She blames nan polarized vaccine debate, saying some sides don't want to see information that runs antagonistic to their stance.

Fourth: Today's vaccines are different

Outside vaccine experts opportunity it's important to statement that nan DTP vaccine that was fixed successful nan 1980s — and was successful usage during nan data-gathering for 2017 study RFK Jr. cites — is not nan aforesaid arsenic nan existent version.

Today's DTP vaccines "are made successful a wholly different way," says Kampmann, explaining that nan pentavalent vaccine is wide used. This vaccine not only protects against diphtheria, tetanus and pertussis but besides hepatitis B and Haemophilus influenzae type b. So immoderate imaginable consequences from that older vaccine would not beryllium applicable today, she says.

Fifth: "If location was a problem, we would astir apt cognize it"

The researchers who did nan 2017 study raised their concerns astir nan DTP vaccine arsenic early arsenic 2000. Since then, extracurricular experts person been looking into nan rumor and reassessing each nan data.

The Global Advisory Committee connected Vaccine Safety — which was established by nan World Health Organization but operates independent of WHO — urged WHO to trial this DTP vaccine by looking astatine information gathered successful different countries. Studies were conducted successful Bangladesh, Burkina Faso, Indonesia and Papua New Guinea. By 2002 nan studies were complete, and nan conclusion was in.

"The studies showed nary antagonistic effect of DTP vaccination," according to a study of nan GACVS's June gathering published successful nan WHO Weekly Epidemiological Record connected November 22, 2002.

GACVS has a typical task unit look astatine nan issue, reporting backmost in 2004, that DTP helped kid endurance and did not wounded it. It was again considered in 2008 and then, in 2014, nan Strategic Advisory Group of Experts connected Immunization (SAGE) — a group of independent experts that advises nan WHO — took it up.

The 2017 study author, Stabell Benn, was connected this SAGE sheet of experts, arsenic was O'Brien who is now astatine WHO. The experts looked astatine each nan studies connected this mobility of DTP causing unrelated wellness consequences. Almost half nan studies they looked astatine were from nan Guinea Bissau team. These study results were mixed — immoderate recovered a antagonistic effect and others did not — but what was consistent, nan SAGE squad found, was that nan studies had "significant methodological limitations."

O'Brien says these groups kept reevaluating nan information because they were unfastened to caller accusation but nan conclusion kept being nan same.

"We person billions of group who person been vaccinated [with a DTP-containing vaccine] ... For decades, generations, group person been receiving this vaccine. If location was a problem, we would astir apt cognize it right?" she said. "If we measurement backmost from vaccination, we will origin harm. It will consequence successful deaths."

"People for illustration Kennedy past put their small poker successful and propulsion retired nan very circumstantial study that suits their agenda," says Kampmann, noting nan RFK Jr. has dispersed inaccurate accusation astir vaccines successful nan past.

The aftermath of nan RFK Jr. announcement

RFK Jr. said that each financial contributions to Gavi would beryllium paused and nan statement needs "to re-earn nationalist trust."

Global wellness specialists opportunity nan consequences of this determination could beryllium huge.

"Of each nan world wellness programs that person been cut, this will apt mean much deaths than immoderate [other cut]," said Dr. Atul Gawande, who oversaw world wellness activity for nan U.S. Agency for International Development nether President Biden, successful an email to NPR.

"It's conscionable a travesty," says Offit from nan Children's Hospital of Philadelphia. "There is astir apt nary amended nationalist wellness organization, much effective nationalist wellness organization, and, frankly, much economical nationalist wellness statement than Gavi."