To ask Her Majesty's Government what information they had about the impact of the COVID-19 vaccines on people with pre-existing health conditions prior to authorising the use of those vaccines.
29 December 2020
Prior to the recent authorisation, the efficacy of COVID-19 mRNA Vaccine BNT162b2 was evaluated in two clinical studies. The first study excluded co-morbidities or pre-existing health conditions. The second study allowed enrolment of subjects with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalisation for worsening disease during the six weeks before enrolment. Also enrolled were subjects with known stable infection with HIV, hepatitis C or hepatitis B. There were no meaningful clinical differences in overall vaccine efficacy in participants who were at risk of severe COVID-19 disease including those with one or more comorbidities that increase the risk of severe COVID-19 disease.
Evaluation of data for other vaccines is ongoing but will include a robust review of all quality, safety and efficacy data, including in those with pre-existing health conditions if they were included in clinical trials.