Children in homes were used as guinea pigs for vaccine trials without consent

CHILDREN in mother and baby homes were repeatedly used as guinea pigs in vaccine trials during which ethical and regulatory guidelines were flouted.

The Mother and Baby Homes Commission of Investigation identified seven vaccine trials that took place at institutions between 1934 and 1973.

These included trials for a measles vaccine and a four-in-one “Quadrivax” for diphtheria, tetanus, pertussis and polio.

According to the Commission, the trials all involved either the Wellcome Foundation or Glaxo Laboratories. These companies are today both part of GlaxoSmithKline.

The Commission said it was clear from its investigations that relevant regulatory and ethical standards of the time were not complied with.

Consent was not obtained from either the mothers of the children or their guardians and the necessary licences were not in place.

However, it found no evidence of injury to the children involved as a result of the vaccines.

One of the trials, for a Wellcome “quadrivax” in 1960 and 1961, involved 58 infants. These included 25 children living in Bessborough, 14 were in Pelletstown, nine in Dunboyne and six in Castlepollard, all institutions being investigated by the Commission of Inquiry.

While there was no evidence that any child was harmed, the Commission said it was “abundantly clear” the trial did not comply with the regulatory and ethical standards.

There was no import licence in place for the vaccine, the researchers did not have a research licence to allow them work in children’s institutions and there was no evidence consent was properly sought or received.

Similar issues were found with other trials.

The Commission said GlaxoSmithKline provided it with extensive documentation about the trials, while institutional records were also provided by the Tusla, the Child and Family Agency.