Whether you are considering a COVID-19 vaccine or just want to look beyond the media headlines to get a better understanding of the COVID-19 vaccine rollout and products involved, we’ve put together a reading list of relevant government, NHS and manufacturer documents.
Many of these are quite complex in nature and we hope to bring you articles exploring these documents in layman’s terms in the coming weeks.
Corporate Press Releases
These are press releases issued by the manufacturers when their COVID-19 vaccine product was given emergency use authorisation.
Regulation 174 Information for UK Healthcare Professionals
Regulation 174 refers to Regulation 174 of the Human Medicine Regulations and additions made to it during 2020. The original regulation states:
“Supply in response to spread of pathogenic agents etc
174. The prohibitions in regulation 46 (requirement for authorisation) do not apply where the sale or supply of a medicinal product is authorised by the licensing authority on a temporary basis in response to the suspected or confirmed spread of—
(c)chemical agents; or
which may cause harm to human beings.”
These documents set out the basis on which the vaccines have been authorised for emergency use.
Patient Information Leaflet
A document to be given to patients to provide them with important information on which to base their decision whether to consent to treatment