The health ministry on Thursday published an update from the European Medicines Agency (EMA), the body in charge of the evaluation of medicinal products, on the AstraZeneca Covid-19 vaccine, one of the vaccines Cyprus has ordered to combat the spread of the virus.
The island is expected to receive 600,000 vaccines from AstraZeneca, 200,000 from Johnson&Johnson and 200,000 from Pfizer/BioNTech.
Britain on Wednesday became the first country to approve AstraZeneca and Oxford University’s home-grown UK COVID-19 vaccine.
However, the EMA explained the UK has been granted a temporary authorisation of supply of the vaccine in the emergency use setting, which is distinct from a marketing authorisation.
“So far, some evidence has been assessed on safety and efficacy coming from a pooled analysis of interim clinical data from four ongoing clinical trials in the UK, Brazil and South Africa,” the EMA announced.
“The latest clinical package was received on December 21 and is currently being assessed. CHMP [Committee of Medicinal Products for Human Use] has already assessed data from laboratory studies (non-clinical data) and is currently assessing data on the vaccine’s quality (on its ingredients and the way it is manufactured).”
According to the report, additional scientific information on issues related to quality, safety and efficacy of the vaccine is deemed necessary to support the rigour required for a conditional marketing authorisation and this has been requested from the company.
Further information from the ongoing clinical trials is also expected from January. Interim data from a large trial ongoing in the USA are expected in the first quarter of 2021.
“EMA will complete its assessment according to its usual standards for quality, safety and effectiveness. A marketing authorisation ensures that Covid-19 vaccines meet the same high EU standards as for all vaccines and medicines.”