Information for recipients and healthcare professionals on COVID-19 vaccines approved for use in the UK is available on emc. The medicinal products listed have been authorised by the UK Department of Health and Social Care and the Medicines and Healthcare products Regulatory Agency (MHRA). They will have either been given conditional authorisation, for medicinal products that fulfil an unmet medical need, or authorisation for temporary supply under Regulation 174 of the Human Medicines Regulations.

Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.

Conditional Marketing Authorisation

This scheme is intended for medicinal products that fulfil an unmet medical need. Examples would be for serious and life-threatening diseases where no satisfactory treatment methods are available or where the product offers a major therapeutic advantage.

A Conditional Marketing Authorisation may be granted by MHRA where comprehensive clinical data is not yet complete, but it is judged that such data will become available soon.

Regulation 174 of the Human Medicines Regulations

This regulation permits the supply of medicinal products that are given temporary authorisation by the UK Department of Health and Social Care and the Medicines and Healthcare products Regulatory Agency. These medicinal products do not have marketing authorisations but this temporary authorisation grants permission for the medicine to be used for active immunisation for the prevention of coronavirus disease 2019 (COVID-19), review the ‘Product Information’ tab for age applicable information. As with any new medicine in the UK, this product will be closely monitored to allow quick identification of new safety information.

Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.

The Regulation 174 Information for UK COVID-19 Vaccine Recipients can be found under the PIL tab and the Regulation 174 Information for Healthcare Professionals can be found under the SmPC tab.