CDC, FDA prepare mass distribution of a Merck/Sanofi six-in-one vaccine for kids, turning blind eye to safety signals

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.

(Article republished from ChildrensHealthDefense.org)

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.

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%).

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