PARLIAMENTARY WRITTEN QUESTION
Coronavirus: Vaccination (16 December 2020)
Question Asked
To ask the Secretary of State for Health and Social Care, what the standard procedure is for assessing the effect on people with allergies of a vaccine during the trial stages.
Asked by:
Esther McVey (Conservative)
Asked by:
Esther McVey (Conservative)
Answer
Entry of patients into a clinical trial is managed by the implementation of inclusion and exclusion criteria that are defined in the trial protocol and approved by the regulator. The inclusion and exclusion criteria will have been carefully selected by the trial sponsor to enable the objectives of the trial to be achieved and also to maximise safety for all patients enrolled into the trial. Allergic reactions can occur to any constituent of a medicinal product, including vaccines and clinical trials may exclude subjects who are known to have had a severe allergic reaction in the past to the same or similar constituents.
Answered by:
Ms Nadine Dorries (Conservative)
11 January 2021
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