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).
The inclusion of Recombivax raises an instant red flag, given that it contains a problematic proprietary aluminum adjuvant possibly linked to serious autoimmune conditions. In fact, when a Merck cyberattack in the summer of 2017 temporarily forced Recombivax out of the U.S. pediatric market and American children received GlaxoSmithKline’s HepB vaccine instead, annual reports of HepB vaccine-related deaths to the Vaccine Adverse Event Reporting System (VAERS) dropped by roughly 75% and injury reports halved.
GlobalData cited the FDA’s approval of Vaxelis as “a major regulatory breakthrough,” noting that a CDC endorsement would “help to bolster vaccination rates across the US,” given that “shot burden” is a “key reason for parents’ failing to adhere to national recommendations.” Right on cue, the CDC’s Advisory Committee on Immunization Practices (ACIP) took the initial step, in June 2019, of recommending Vaxelis for the low-income families who receive vaccines free of charge through the federally funded Vaccines for Children Program. Manufacturers estimate that Vaxelis will become available in the U.S. sometime in 2020.
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.”
The Vaxelis package insert does note that in the two trials, six infants died in the Vaxelis group (versus one death in the vaccinated comparison group). Trial investigators’ assessment of the deaths denied any relationship to Vaxelis, even though all six infants died within a month and a half of vaccination and even though the murky causes listed—sudden infant death syndrome (SIDS), “unknown cause,” asphyxia, sepsis and fluid in the brain—match up to the types of adverse events reported following hexavalent vaccination in Europe. Considering the Vaxelis package insert information alongside other troubling reports of infant deaths and serious reactions raises questions about whether the FDA and CDC have done proper due diligence.