Those drugs that have not been given a marketing authorisation. What is a ‘genetically modified human embryonic kidney (HEK) 293 cell’? What is ‘*Recombinant, replication-deficient chimpanzee adenovirus vector’?
Decision
Information for UK recipients on COVID 19 Vaccine AstraZeneca
Updated 28 January 2021
This medicinal product has been given authorisation for temporary supply by the UK Department of Health and Social Care and the Medicines and Healthcare products Regulatory Agency. It does not have a marketing authorisation, but this temporary authorisation grants permission for the medicine to be used for active immunisation of individuals aged 18 years and older for the prevention of coronavirus disease 2019 (COVID-19).
4. Possible side effects
Very Common (may affect more than 1 in 10 people)
- tenderness, pain, warmth, redness, itching, swelling or bruising where the injection is given
- generally feeling unwell
- feeling tired (fatigue)
- chills or feeling feverish
- headache
- feeling sick (nausea)
- joint pain or muscle ache
6. Contents of the pack and other information
What COVID-19 Vaccine AstraZeneca contains
One dose (0.5 ml) contains: COVID 19 Vaccine (ChAdOx1-S* recombinant) 5 × 10^10 viral particles
*Recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS CoV 2 Spike glycoprotein. Produced in genetically modified human embryonic kidney (HEK) 293 cells.
This product contains genetically modified organisms (GMOs).
The other excipients are:
- L-histidine
- L-histidine hydrochloride monohydrate
- magnesium chloride hexahydrate
- polysorbate 80
- ethanol
- sucrose
- sodium chloride
- disodium edetate dihydrate
- water for injections
AstraZeneca UK Ltd
Tel: 08000541028
ness365 