There are a lot of things about the latest anti-vaccine bombshell that won’t surprise you…
For one thing, the “bombshell” isn’t recent. Anti-vaccine folks are just re-posting it now because a new hexavalent vaccine just got FDA approval.
The Latest Anti-Vaccine Bombshell on Infanrix Hexa is Just Another Dud
What about the 1,271 page confidential GSK document that was leaked to the press?
It was actually a document that was submitted as part of an Italian court case.
What about the idea of “missing deaths” and under-reporting of vaccine deaths?
“Before specifically addressing your analysis, it’s important to note that the issue of whether there is an increased risk of Sudden Infant Death following vaccination generally and following vaccination with DTP-containing vaccines more specifically is one that has been considered and thoroughly evaluated not only by GSK but also by a number of world-renowned regulatory agencies and public health authorities, including the European Medicines Agency, the US Centers for Disease Control and Prevention and the World Health Organization. The clear consensus amongst such agencies and authorities is that one cannot reasonably conclude, based on available data and information, that there is a causal relationship between vaccination generally or vaccination with Infanrix hexa and Sudden Infant Death.”
Dr. Norman Begg, Chief Medical Officer, GSK Vaccines on Infanrix hexa and sudden death: a review of the periodic safety update reports submitted to the European Medicines Agency
It’s no bombshell that this is all propaganda and these issues have been thoroughly investigated. Or that someone got a “study” that manipulated and misinterpreted data published in a predatory journal.
The idea that the hexavalent vaccines could be causing unexplained cases of sudden infant death shortly after vaccination began after a few case reports from Germany in 2003. Further studies, including a large study in Italy, found no risk.
What about the idea of “missing deaths” in safety reports from the manufacturer?
Of course, there are no missing deaths.
The GSK report explains that twelve deaths were excluded from analysis, apparently eight from the first year (101 cumulative) and three from the second year (five cumulative), which is why the cumulative deaths dropped from eight to five.
Why?
“A cumulative review of Sudden Death (SD) since launch has been performed. Follow-up information received for older cases was taken into account. Design of the below observed to expected analysis was revisited in view of comments EMA expressed in the assessment report of PSUR 15-16 (dated 26 April 2012).”
GlaxoSmithKline Biological clinical safety and pharmacovigilance’s confidential report to the EMA: PSUR 19, page 440
Keep in mind that these are cumulative deaths since they began using the vaccine in 2000, and which are below the expected background rates of SIDS.
Vaccines are safe.
Hexavalent vaccines are safe.
Do your research before buying into the next anti-vaccine bombshell that try to throw at you to scare you away from vaccinating and protecting your kids.
More on the Latest Anti-Vaccine Bombshell
- GlaxoSmithKline Biological clinical safety and pharmacovigilance’s confidential report to the EMA: PSUR 15 and PSUR 16
- GlaxoSmithKline Biological clinical safety and pharmacovigilance’s confidential report to the EMA: PSUR 19
- Sir Andrew Witty CEO GlaxoSmithKline responds through Norman Begg to Infanrix controversy related to PSUR 16
- Study – Sudden unexpected deaths and vaccinations during the first two years of life in Italy: a case series study.
- Vaccine Adverse Event Reporting System Reporting Source: A Possible Source of Bias in Longitudinal Studies
- EMEA update on hexavalent vaccines: Hexavac and Infanrix Hexa
- EMEA reviews hexavalent vaccines: Hexavac and Infanrix Hexa
- EMA – Infanrix Hexa
- Italian court vaccine autism ruling – caused by unreliable expert
- Italian MMR Autism Decision Overturned
- Infanrix-hexa
- 6-in-1 Vaccine
- Combined hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus-Haemophilus influenzae type B vaccine; Infanrix™ hexa: twelve years of experience in Italy.
- Immunization of preterm infants with GSK’s hexavalent combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus-Haemophilus influenzae type b conjugate vaccine: A review of safety and immunogenicity.
- Impact of Haemophilus influenzae type b conjugate vaccination on hospitalization for invasive disease in children fifteen years after its introduction in Italy.
- A Randomized Controlled Study of a Fully Liquid DTaP-IPV-HB-PRP-T Hexavalent Vaccine for Primary and Booster Vaccinations of Healthy Infants and Toddlers in Latin America.
- New perspectives for hexavalent vaccines.
- Safety and immune response to a challenge dose of hepatitis B vaccine in healthy children primed 10years earlier with hexavalent vaccines in a 3, 5, 11-month schedule: An open-label, controlled, multicentre trial in Italy.
Last Updated on January 2, 2019