Vaccine Downsides

Vaccines

Sadly, it's not all rainbows and unicorns...

Vaccine Disasters

The Lubeck Disaster (1930)

THE LÜBECK DISASTER

In the German city of Lubeck 252 infants were given BCG that came originally from the Pasteur Institute in Paris, but it was prepared for administration in the TB laboratory in Lubeck.

Seventy two of the children developed TB and died within a year as a result of the disease. A subsequent investigation carried out by German TB experts, revealed that the vaccine had become contaminated with the distinct virulent human strain during its preparation at a local laboratory. Two people who had worked in the local laboratory were sent to prison in 1932 for "bodily injury due to negligence."

The Cutter Incident (1955)

Cutter Laboratories

The Incident

In 1955, Cutter Laboratories was one of several companies licensed on April 12 by the United States government to produce Salk polio vaccine. In what came to be known as the Cutter Incident, some lots of the Cutter vaccine – despite having passed the required safety tests – contained live polio virus in what was supposed to be an inactivated-virus vaccine. Cutter withdrew its vaccine from the market on April 27 after vaccine-associated cases were reported. Drs. William Tripp and Karl Habel, both from NIH, were sent by Surgeon General Scheele to Berkeley to inspect Cutter's facilities, question their workers, and examine their records. After a thorough investigation nothing was found wrong with Cutter's method of production.[2] A congressional hearing was held in June 1955 and it concluded that the problem was primarily the lack of scrutiny from the NIH Laboratory of Biologics Control (and its excessive trust in the National Foundation for Infantile Paralysis reports).[3]

A number of civil lawsuits were filed against Cutter Laboratories in subsequent years, the first of which was Gottsdanker v. Cutter Laboratories. The jury found Cutter not negligent, but liable for breach of implied warranty and monetary awards were made to the injured parties. This set the precedent for later lawsuits. All five companies that produced the Salk vaccine in 1955 – Eli Lilly, Parke-Davis, Wyeth, Pitman-Moore, and Cutter – had difficulties in completely inactivating the polio virus, and three companies other than Cutter were sued but the cases were settled out of court.[4]

The Cutter incident was one of the worst pharmaceutical disasters in U.S. history and caused several thousand children to be exposed to live polio virus upon vaccination.[5] The NIH Laboratory of Biologics Control, which had certified the Cutter polio vaccine, had received advance warnings of problems: in 1954, staff member Dr. Bernice Eddy had reported to her superiors that some of the inoculated monkeys had become paralyzed (pictures were sent as well). William Sebrell, the director of NIH wouldn't hear of such a thing.[3]

Numbers affected

The mistake resulted in the production of 120,000 doses of polio vaccine that contained live polio virus. Of the children who received the vaccine, 40,000 developed abortive poliomyelitis (a form of the disease that does not involve the central nervous system), 56 developed paralytic poliomyelitis and of these 5 children died as a result of polio infection.[6] The exposures led to an epidemic of polio in the families and communities of the affected children, resulting in a further 113 people paralyzed and 5 deaths.[5]

Administrative consequences

The director of the microbiology institute lost his job, as did the equivalent of the assistant secretary for health. Oveta Culp Hobby stepped down. Dr Sebrell, the director of the NIH, resigned.[3]

Vaccines Can Increase Virulence

"Bordetella pertussis Strains with Increased Toxin Production Associated with Pertussis Resurgence"

Emerging Infectious Diseases • www.cdc.gov/eid • Vol. 15, No. 8, August 2009

[[1]]

"Before childhood vaccination was introduced in the 1940s, pertussis was a major cause of infant death worldwide. Widespread vaccination of children succeeded in reducing illness and death. In the 1990s, a resurgence of pertussis was observed in a number of countries with highly vaccinated populations, and pertussis has become the most prevalent vaccine-preventable disease in industrialized countries. We present evidence that in the Netherlands the dramatic increase in pertussis is temporally associated with the emergence of Bordetella pertussis strains carrying a novel allele for the pertussis toxin promoter, which confers increased pertussis toxin (Ptx) production. Epidemiologic data suggest that these strains are more virulent in humans. We discuss changes in the ecology of B. pertussis that may have driven this adaptation. Our results underline the importance of Ptx in transmission, suggest that vaccination may select for increased virulence, and indicate ways to control pertussis more effectively."

Vaccines Can Suppress Immunity To Other Illnesses

"Acellular pertussis vaccination enhances B. parapertussis colonization"

[[2]]

"An acellular whooping cough vaccine actually enhances the colonization of Bordetella parapertussis in mice; pointing towards a rise in B. parapertussis incidence resulting from acellular vaccination, which may have contributed to the observed increase in whooping cough over the last decade."

Side Effects

There are some cases where vaccines have genuinely had side-effects leading to their withdrawl.

Disease	Problem Vaccine	Timespan	Condition	Seriousness	Incidence	Replacement	Replacement Incidence
Mumps	Urabe Strain	1986-1992	asceptic meningitis	10 in 100,000	1 week illness, no long-term effects	Jeryl-Lynn strain	< 0.2 (maybe zero)
Rotavirus	RotaShield	1998-1999	intussusception	20 in 100,000	~ 100 affected, 50 operations, 1 death	Rotarix	2
Flu	Pandemrix	2009-2011	narcolepsy	2-7 in 100,000	permanent disability	Others	0

Reporting

VAERS

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