COVID-19 Approved Vaccine Information
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.
Vaccines with conditional authorisation
Vaccines with conditional authorisation
AstraZeneca COVID-19 Vaccine
- Information for UK COVID-19 AstraZeneca Vaccine recipients
- Information for Healthcare Professionals on UK COVID-19 AstraZeneca Vaccine
BioNTech – Pfizer Comirnaty Original/Omicron BA.1 (15/15mcg)/ dose dispersion COVID-19 Vaccine 12+ Years
- Information for BioNTech – Pfizer GB Comirnaty Covid-19 Vaccine recipients
- Information for Healthcare Professionals on BioNTech – Pfizer GB Comirnaty Covid-19 Vaccine
BioNTech – Pfizer Comirnaty 30mcg/dose concentrate COVID-19 Vaccine 12+ Years
- Information for BioNTech – Pfizer GB Comirnaty Covid-19 Vaccine recipients
- Information for Healthcare Professionals on BioNTech – Pfizer GB Comirnaty Covid-19 Vaccine
BioNTech – Pfizer Comirnaty 10mcg/dose concentrate COVID-19 Vaccine Children 5 to 11 Years
- Information for BioNTech – Pfizer GB Comirnaty Covid-19 Vaccine recipients
- Information for Healthcare Professionals on BioNTech – Pfizer GB Comirnaty Covid-19 Vaccine
Novavax COVID-19 Vaccine
- Information for Novavax Vaccine recipients
- Information for Healthcare Professionals on Novavax Covid-19 Vaccine
Moderna Biotech UK Ltd Spikevax Bivalent COVID-19 mRNA Vaccine 18+ Years
- Information for Spikevax Bivalent COVID-19 mRNA Vaccine recipients
- Information for Healthcare Professionals on Spikevax Bivalent COVID-19 mRNA Vaccine
Moderna Biotech UK Ltd Spikevax COVID-19 mRNA Vaccine Children 6+ Years
Conditional Marketing Authorisation
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
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.