Since the mid-1980s, the number of childhood shots on the Centers for Disease Control and Prevention (CDC) vaccine schedule has more than quadrupled. When parents express reluctance about turning their little ones into perpetual pin cushions, drug makers and doctors have a ready answer — combination vaccines that “simplify” the schedule by decreasing the number of injections administered.
This month marks the U.S. launch of the Merck/Sanofi joint-venture vaccine, Vaxelis, a six-in-one (hexavalent) combination vaccine that contains diphtheria, tetanus and acellular pertussis (DTaP) components as well as components said to protect against polio, Haemophilus influenzae type b (Hib) and hepatitis B.
Public health officials optimistically believe that bundling all of these components into one shot will help close noncompliance loopholes and increase the likelihood that children will complete “all recommended vaccinations.”
Though Vaxelis is the nation’s first hexavalent injection, it joins other four- or five-in-one vaccines already on the CDC schedule. The U.S. Food and Drug Administration (FDA) approved Vaxelis in late 2018 — as a three-dose series for 2-, 4- and 6-month-old infants — but it is only now, two-and-a-half years later, that the shot is being readied for widespread distribution.
Warning signs were ignored
There are numerous warning signs that potent all-in-one vaccines are too much for immature immune systems to handle. Concerning safety signals have emerged not just for hexavalent but also pentavalent (five-in-one) vaccines.
In Europe, where infants have been given hexavalent vaccines for some years (including Vaxelis since 2016), the formulations have produced many troubling reports of sudden infant death.
Absurdly, none of the clinical studies assessing Vaxelis safety and efficacy conducted fair comparisons against an inert placebo. Instead, in the two U.S. clinical trials for Vaxelis, not only did investigators compare infants receiving Vaxelis to babies who received Sanofi’s five-in-one Pentacel — but babies in both groups also received rotavirus and pneumococcal vaccines at the same time!
In this context, the CDC’s sales pitch to the public — and its claims that side effects are “usually mild” — cannot be considered credible.
Here are some of the other facts missing from the CDC’s communications:
- In the two U.S. trials six infants died (slide #27) in the Vaxelis group (some after receiving just one dose); one infant also died in the “control” group that received five-in-one vaccines.
- All six Vaxelis recipients died within six weeks of vaccination. This timing matches other published accounts of infant deaths “clustering” following hexavalent vaccination.
- The reported causes of death for the infants who received Vaxelis included asphyxia, sepsis, fluid in the brain and sudden infant death syndrome (SIDS). These outcomes correspond to the types of adverse events reported following hexavalent vaccination in Europe.
- Package inserts for other vaccines on the CDC schedule list similar causes of death, suggesting these fatal Vaxelis outcomes are plausibly associated with vaccination.
- In the clinical trials, the rate of fever was notably higher in Vaxelis recipients even when compared to children receiving five-in-one vaccines (47% vs. 34%).
Juicing vaccine sales
In the no-liability context enjoyed by vaccine makers in the U.S., combination vaccines are already quite popular. In fact, market watchers and health economists praise the jumbo shots as being a catalyst for positive industry trends and a “key to commercial success.”
Thus, financial analysts expect Vaxelis to “garner significant patient share following its [U.S.] launch” — predicting that it will account for almost a third of U.S. DTaP vaccinations by 2028 — or $841 million in annual sales.
These predictions represent good news for Merck and Sanofi, two of the “big four” pharma giants that dominate the childhood vaccine market in the United States.
Merck is already doing a booming vaccine business, recently reporting annual sales growth of 14.8% for its pneumococcal vaccine (Pneumovax 23) and 5.4% for its human papillomavirus (HPV) vaccine Gardasil-9.
However, Merck also faces proliferating Gardasil-related lawsuits — including legal actions alleging that the company knew about and ignored life-changing adverse events from the get-go, many of which (when not fatal) have involved autoimmunity and chronic pain. In fact, before the advent of emergency use COVID vaccines (responsible for an alarming escalation of vaccine-related adverse events),
Gardasil had had “more side effects reported than all other vaccines combined.”
Sanofi, too, is embroiled in thousands of lawsuits worldwide — notably for its disastrous and sometimes fatal dengue vaccine. As with Merck, this has not dampened overall vaccine sales growth, which continues its strong upward trajectory, likely to be further strengthened by the U.S. Vaxelis rollout.
Although Sanofi has not been a front-runner in the COVID vaccine race, the company is currently running clinical trials for messenger RNA (mRNA) vaccines for both COVID and seasonal influenza.