A Six-in-One Vaccine Associated with Sudden Infant Death…
Vaxelis combines the five components featured in Pentacel along with Merck’s genetically engineered Recombivax vaccine against hepatitis B (HepB).
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 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.
FDA Approves VAXELIS Combo Vaccine Despite Infant Mortality
Last week, the U.S. Food and Drug Administration (FDA) approved VAXELIS, a new 6-in-1 combo vaccine. The new drug, produced as a collaborative effort by pharmaceutical giants Merck and Sanofi, claims to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae (H. influenzae) type b.
The vaccine has been approved for infants as young as 6 weeks old and will be administered in a series of 3 doses between 6 weeks and 4 months of age.
The most frequently reported adverse reactions after Vaxelis administration were irritability, crying, somnolence, injection site reactions
(pain, erythema, swelling) decreased appetite, and vomiting
The safety of Vaxelis in children over 15 months of age has not been studied in clinical trials.
adsorbed on aluminium phosphate
adsorbed on amorphous aluminium hydroxyphosphate sulfate
The vaccine may contain traces of glutaraldehyde, formaldehyde, neomycin, streptomycin and polymyxin B which are used during the manufacturing process