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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.
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!