In a recorded message to Gavi, the international vaccine alliance, health secretary Robert F. Kennedy Jr. accused members of “not taking vaccine safety seriously” and announced that under his leadership, the United States would stop funding Gavi. This is a deadly mistake. Since 2000, Gavi has supported vaccination of more than 1 billion children and prevented an estimated 18.8 million deaths.
Vaccination programs exist to protect children and others — from illness and from the risk of vaccines. Gavi, the Centers for Disease Control and Prevention, the World Health Organization, and other organizations that recommend or support vaccination programs take safety very seriously. If a medication is given to someone who is sick, some risk may be acceptable because the alternative is worse.
Vaccines are different. They’re given to healthy people who might never get the disease the vaccine protects against, so they have to be extremely safe to be approved and recommended. Any possible adverse effect — which, if rare, may only become apparent after millions of people have received the vaccine — is assessed carefully.
To justify defunding Gavi, Kennedy said the organization was wrong to use one type of pertussis vaccine when the “developed world” has switched to a “much safer” version of the vaccine. Although the details are nuanced, the facts about this situation are clear. The U.S. phased out the whole-cell pertussis vaccine in the 1990s, switching to an acellular version that causes fewer short-term reactions but loses effectiveness sooner and doesn’t prevent spread as effectively.
This is one reason we have a resurgence of pertussis in the U.S. Many countries choose to continue using the whole-cell vaccine. Their populations may have a greater risk of serious illness, or their health care system may be less able to deal with serious pertussis infection, or they may simply have made the opposite decision — more short-term adverse reactions, better protection against pertussis.
Calling this choice not “taking vaccine safety seriously” is wrong and dangerous.
Kennedy also went into detail about a study that suggested that the diphtheria-tetanus-pertussis (DTP) vaccine is harmful — that “girls vaccinated with DTP were 10 times more likely to die from all causes in the first six months of life than children who were unvaccinated.” The 2017 study Kennedy cited has long been used to claim that DTP vaccines harm children.
The problem is that the study is fundamentally flawed.
Scientific reviews provide general critiques of articles such as the one Kennedy cited. The problem with articles such as these critiques is that they’re too hard for nonspecialists to understand, and, perhaps, too polite. For example, one concludes: “The increased mortality after DTwP might be confined to West-African countries and/or certain postulated risks of bias might have inflated these relative risks.”
Translation: The finding of an increased risk of death is bullshit.
The study only analyzed reported deaths, but many deaths were unreported, and unvaccinated children, especially girls, were far less likely to have their deaths reported. Sadly, not only are many deaths of infants unrecorded, but girls are also less likely to receive care and have their deaths recorded.
How can we know this? Easy. The authors claim that the death rate among infants 3-11 months old doubled between 1980 and 1984. What almost certainly happened is that the reported death rate increased because reporting of deaths became more complete. Here are the data from their study converted to an annualized mortality rate per 1,000 children ages 3-11 months and compared with the estimated actual death rate for this time period based on standard global estimates for that age group:
If vaccinated and unvaccinated children were equally likely to have their deaths unregistered, this wouldn’t matter. But that’s almost certainly not the case. Children who are not vaccinated are less likely to have their deaths registered, as they have less access to the medical system. And if vaccination rates rose later in the study, this would make not being vaccinated seem safer, since there would be more unvaccinated children in those early years with less complete data on deaths.
Below are the death rates reported in the study among infants aged 3-11 months per 1,000. Vaccinated boys likely have the highest access to care and the most complete death registration.
The observed rate of death among unvaccinated girls of 14 per 1,000 compares with a baseline of 90 per 1,000. This is almost certainly a sad reflection of the unrecorded deaths of girls, who had less access to both vaccination and death recording.
Let’s apply common sense. The authors claim that skipping one vaccination would reduce a girl’s risk of death six-fold from the average rate in the country — including the rate before vaccination was introduced. This finding is clearly absurd, which is why no rigorous study has ever found anything like this.
Unrecorded deaths are a likely cause of the spurious finding of apparently higher mortality among vaccinated children. (The lack of accurate death registration remains a crucial gap in global health, 45 years after data collection for the flawed article Kennedy cited and more than 400 years after London began complete death registration.)
There are other methodological problems. The number of children studied was small — fewer than 700 — so just a few unrecorded deaths would change the findings substantially, and small differences can occur by chance. Other much larger and much more rigorously conducted studies have consistently found no increase, and a possible decrease, in mortality among infants who received the DTP vaccine.
Despite these many flaws, Kennedy cherry-picked this single small study to justify a deadly policy decision. That’s concerning enough for someone in charge of health policy for the United States. It’s also an example of the broader pattern in which flawed studies are weaponized. Kennedy is using misrepresentations of facts and an inaccurate study to justify withholding lifesaving funds.
The DTP vaccine protects against three serious diseases: diphtheria (which can close airways), tetanus (which causes severe muscle spasms and is often fatal, particularly in low-resource settings), and pertussis (whooping cough, which kills infants). Since 1990, this vaccine is estimated to have saved more than 40 million lives.
Kennedy’s tactics are the anti-vaccine playbook: Focus on flawed research and ignore overwhelming evidence in the opposite direction. I was literally nauseated by Kennedy’s remarks. Disinformation can kill. Unless Gavi is funded, parents all over the world will grieve for children who died unnecessarily, and the world will be poorer without these children.
Tom Frieden, M.D., M.P.H., is president and CEO of Resolve to Save Lives, a global health organization that partners with countries to scale up solutions to the world’s deadliest health threats. He is former director of the Centers for Disease Control and Prevention, former commissioner of the New York City Health Department, and author of the forthcoming book “The Formula for Better Health: How to Save Millions of Lives — Including Your Own” (MIT Press, Sept. 30).
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