New Six-in-One Vaccine Associated with Sudden Infant Death

The childhood vaccine schedule in the U.S. features numerous combination vaccines—formulations that bundle multiple antigens for multiple diseases into one injection. Examples of combination vaccines currently given to American children include Merck’s four-component ProQuad vaccine against measles, mumps, rubella and varicella and Sanofi’s five-in-one Pentacel vaccine against diphtheria, tetanus, pertussis, polio and Haemophilus influenzae type b. Now, the U.S. is preparing to up the combination vaccine ante still further. At the close of 2018, the FDA approved the nation’s first six-in-one (hexavalent) vaccine—a Merck and Sanofi joint effort called Vaxelis intended for infants at ages two, four and six months. Like hexavalent vaccines given to infants in other countries, Vaxelis combines the five components featured in Pentacel along with Merck’s genetically engineered Recombivax vaccine against hepatitis B (HepB). What about hexavalent vaccine risks, publicized in other countries for decades? On that topic, the CDC and FDA have been largely silent, perhaps because of the next-to-useless design of the U.S. Vaxelis clinical trials, which compared one heavily vaccinated group against another—rather than comparing Vaxelis against an inert placebo. Unsurprisingly, this bogus procedure allowed researchers to conclude that adverse reactions to the vaccines were similar across groups. In other words, “nothing to see here.” Before U.S. agencies open the floodgates for hexavalent vaccination, they would do well to remember that “public trust can be lost only once and not acting or acting too late on a [safety] signal . . . could damage credibility of those supporting and maintaining vaccination for many years.”

Are Vaccine Manufacturers Concealing Deaths Caused by Vaccines by Manipulating Post-marketing Data?

National and international health agencies such as the Centers for Disease Control and Prevention (CDC), the European Medicines Agency (EMA) and the World Health Organization (WHO) routinely and emphatically claim that serious adverse events following vaccination are rare. Nowhere is officialdom’s minimization of vaccine risks more apparent than in these agencies’ position on vaccine-related deaths. The WHO, for example, states that “so few deaths can plausibly be attributed to vaccines that it is hard to assess the risk statistically.” Nevertheless, once regulators have deemed that a given vaccine is safe enough to be licensed and widely marketed, vaccine manufacturers are supposed to do just that—that is, continue to statistically assess a vaccine’s risks, including the risk of death—and regulators are supposed to carefully review the postlicensure data that pharmaceutical companies submit. A 2017 commentary by India-based physicians Jacob Puliyel and C. Sathyamala in the Indian Journal of Medical Ethics describes a shocking dereliction of duty on the part of regulators who were presented with vaccine data carefully tailored to obscure serious risks. Tackling concerns about infant deaths that have occurred following hexavalent vaccination in several European countries, the authors of the commentary show that GlaxoSmithKline (GSK) neglected to report to regulatory authorities that there was a statistically significant increased risk of sudden infant death in the four days after administration of its hexavalent vaccine—and the regulatory agency in question (the EMA) ignored the omission and accepted GSK’s apparently whitewashed data at face value.