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COVID-19 vaccine astrazeneca (CHADOX1 NCOV-19) is a viral vector vaccine for preventing COVID-19 infection. It is also known by the names Vaxzevria, AZD1222, and ChAdOx1 nCoV-19.[5] The substance is classified as a non-replicating viral vector COVID-19 vaccine with ATC code J07BN02.[1] It is a structurally diverse substance of vaccine origin, given by intramuscular use.[1]
The vaccine received conditional marketing authorisation from the European Medicines Agency, with an application submitted in January 2021 under an accelerated assessment timeline.[2] Conditional marketing authorisation is a fast-track procedure used during public health emergencies to speed up approval of treatments and vaccines that fulfil an unmet medical need.[2]
COVID-19 vaccine astrazeneca (CHADOX1 NCOV-19) is a non-replicating viral vector vaccine. This means it uses a modified virus that cannot replicate in the body to deliver genetic instructions for making the SARS-CoV-2 spike protein. The immune system then recognises this protein and produces antibodies against it, preparing the body to defend against future COVID-19 infection.[1]
The vaccine works by generating an antibody response. The phase 3 trial evaluates the proportion of seropositive subjects — people who have developed antibodies — with antibody levels above a target threshold at 6 months after two doses.[1]
The vaccine is administered by intramuscular injection.[1] In the phase 3 trial, it is given as an emulsion for injection at a dose of 250,000,000 international units per intramuscular injection.[1]
The EU Clinical Trials Information System lists one completed phase 3 trial for COVID-19 vaccine astrazeneca (CHADOX1 NCOV-19). This interventional study enrolled 4,000 participants to evaluate immune responses after COVID-19 vaccination with different vaccine formulations.[1]
The primary outcome measures the proportion of seropositive subjects with an antibody level above the target level in groups of vaccine recipients receiving different vaccine products at 6 months after two doses against the prevailing virus variant.[1]
The trial compares COVID-19 vaccine astrazeneca (CHADOX1 NCOV-19) with several other COVID-19 vaccines, including BIMERVAX, Spikevax, Comirnaty, and Nuvaxovid, all given by intramuscular injection.[1]
Post-authorisation active surveillance in the UK monitored the safety and utilisation of COVID-19 vaccine astrazeneca (AZD1222) in approximately 18,000 adults and children vaccinated during the mass vaccination programme. The study included adolescents from 12 years of age and adults of all ages, including immunocompromised individuals and pregnant women.[3]
The European Medicines Agency's Pharmacovigilance Risk Assessment Committee assessed a signal for embolic and thrombotic events — blood clots in blood vessels — associated with COVID-19 Vaccine AstraZeneca. The signal was confirmed in March 2021, and the product is no longer authorised.[4]
Post-authorisation active surveillance in the UK monitored all vaccinee-reported adverse events following vaccination with COVID-19 vaccine AstraZeneca (AZD1222).[3]
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