Reactions after pertussis vaccine: a manufacturer's experiences and difficulties since 1964

Abstract

Summary and conclusionsPertussis vaccines vary in quality, safety, and efficacy according to the production strains of Bordetella pertussis, the method of manufacture, and quality control procedures. It is therefore not justifiable to combine information on the incidence, nature, and severity of reactions after all manufacturers' pertussis vaccines as if they were a single product. Attempts were made to collect information on all suspected cases of severe reactions that occurred after administration of about 15 million doses of Wellcome pertussis vaccines in the United Kingdom and Northern Ireland from 1964 to mid-1977. Altogether six deaths, six neurological reactions with sequelae, and 17 convulsions without sequelae were reported, but some were clearly not attributable to the vaccine, while, in other cases, the available information was inadequate for assessing the role of vaccination. Neurological disorders, similar to those reported in a few children after pertussis vaccination, occur unexpectedly in apparently healthy infants at the recommended age for immunisation, so chance association between vaccination and these events can be expected in some children. The Joint Committee on Vaccination and Immunisation has made several recommendations aimed at reducing severe reactions after pertussis vaccination. These include replacing plain vaccine with aluminium-adsorbed vaccine, but there is no clear evidence that the aluminium-adsorbed vaccine produces fewer reactions than the plain.There are difficulties enough in deciding the cause of events that occur after vaccination, since these reactions often occur naturally in children of vaccination age. The task is made even harder by the assumption that various manufacturers' vaccines are the same and the lack of information available to manufacturers about cases in which their vaccine has been implicated. Information on vaccines administered is entered on immunisation records cards; it should be used and referred to if reactions occur.

Two physically and serologically distinct lipopolysaccharide profiles in strains of Bordetella pertussis and their phenotype variants

“…The LPS of Bordetella pertussis exhibits endotoxic activities similar to those of other gram-negative bacterial LPSs (11,23,27). In addition, B. pertussis LPS sensitizes mice to histamine (5), may affect lymphocytosis by lymphocytosispromoting toxin (20), and may account for some of the reactogenicity associated with vaccines containing whole cells of B. pertussis (7,13,26).…”

Opposition to Vaccination and Immunisation the UK Experience - from Smallpox to MMR

“…However, in October 1973, John Wilson, a paediatric neurologist presented a paper on the neurological complications of DPT inoculation in infancy at the British Paediatric Association, in which he related the experience of 36 children seen at the 'Hospital for Sick Children', the majority of whom had developed an encephalopathic illness within one week of receiving DPT. He concluded with a recommendation that the Department of Health's contraindications to the pertussis component of the vaccine should be more rigorously applied [45][46][47]. The case series of 36 children was subsequently published and shortly thereafter Wilson recommended setting up a State compensation scheme for vaccine-damaged children [48,49].…”

Bias in Evaluating CNS Complications Following Pertussis Immunization

“…In conclusion 1 am convinced that pertussis CNS complications are a reality and they are, in my view, under-estimated.The controversy on the legal acceptance of the existence of pertussis vaccine encephalopathy has found its end: The President of the Irish High Court "was satisfied on the balance of probability that there was a possibility that the pertussis component in the vaccine could in rare cases cause encephalopathy" (Judgement on the 1 Ith January, 1991: Best vs Wellcome et a1 (1978( No. 2641.…”