Merck’s Recombivax Vaccine Shortage Causes Reduced Deaths In Babies

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from Collective Evolution:

In the summer of 2017, a malware virus mainly affecting the Ukraine, found its way onto the mainframe computer systems of Merck wreaking havoc for the company. The malware was called “NotPetya,” referring to the ransomeware family Petya, which disables computer systems and demands a ransom to be paid in bitcoin before it will restore access to a company’s files. It is destructive and costly, something Merck was to find out as its sales and manufacturing operations were disrupted by the June 7th attack. According to the Wall Street Journal, the incident cost the pharmaceutical giant $670 million to remediate, but more importantly, it caused disruption to the production of two of Merck’s pediatric vaccines: Gardasil 9 (Human Papillomavirus) and Recombivax (Hepatitis B virus), vaccines to help prevent sexually transmitted infections.

During the crisis, Merck borrowed from a CDC vaccine stockpile, in order to meet supply commitments for Gardasil 9. However, that was not the case with Recombivax, the Hepatitis B vaccine given to all babies beginning the first day of life. There is no clear medical reason for giving every baby a vaccine against hepatitis B if its mother tests negative for the disease. Nevertheless, American babies receive three doses each, which is 12 million doses in any given year for the US alone. Following the cyber-attack, Merck was unable to meet this high demand, citing production problems.

The CDC acted quickly in asking GlaxoSmithkline to supply its Hep B vaccine Engerix-B, to meet the needs of the US market. The CDC published a notice about a shortage of Recombivax on July 28th 2017 on its website, stating that the vaccine would be unavailable as of early August 2017. GSK was able to supply a monovalent (single) vaccine for the birth dose and subsequent newborn doses. Doctors could give the pentavalent combination vaccine Pediarix to older babies, depending on supply.

Just prior to the ransomware attack, two scientists from Europe wrote to the FDA to express concern that recent research on aluminum adjuvants in vaccines suggested that these adjuvants were contributing to Autism Spectrum Disorder and other neurological disorders

Merck initially expected to resume distributing Recombivax in February of 2018. However, this deadline came and went and the expected resumption of distribution was pushed back many times. Currently, the CDC is reporting that Recombivax will not be available until the middle of 2019, almost two years since the cyber-attack happened and without the public fully understanding why this particular vaccine was affected.

What are the wider ramifications of this incident? Just prior to the ransomware attack, two scientists from Europe wrote to the FDA to express concern that recent research on aluminum adjuvants in vaccines suggested that these adjuvants were contributing to Autism Spectrum Disorder and other neurological disorders. There is growing concern among some scientists about the aluminum adjuvant load in vaccines and its effects on the neurological health of children. Researchers are particularly concerned with Merck’s highly immunogenic adjuvant, Amorphous Aluminum Hydroxyphosphate Sulphate (AAHS). Gardasil and Recombivax are the only vaccines licensed to contain AAHS. Some scientists believe it may contribute to serious autoimmune conditions referred to as Autoimmune/Inflammatory Syndrome Induced by Adjuvants or ASIA.

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