European regulator to deliver verdict on Oxford-AstraZeneca COVID-19 vaccine by 29 January

The COVID-19 vaccine developed by AstraZeneca and Oxford University may be given the go-ahead for distribution in the EU by 29 January after the company applied for conditional marketing authorisation

The Oxford-AstraZeneca COVID-19 vaccine is being evaluated by the European Medicines Agency
The Oxford-AstraZeneca COVID-19 vaccine is being evaluated by the European Medicines Agency

The European Medicines Agency has received an application for conditional marketing authorisation for a COVID-19 vaccine developed by AstraZeneca and Oxford University.

The assessment of the vaccine, known as COVID-19 Vaccine AstraZeneca, will proceed under an accelerated timeline, EMA said on Tuesday.

The European agency is expected give an opinion on the marketing authorisation by 29 January during a meeting of its scientific committee for human medicines.

Once EMA gives its go-ahead, it will be up to the European Commission to grant authorisation for the vaccine to be distributed.

Approval will depend on whether the data on quality, safety and efficacy of the vaccine are sufficiently robust and complete and that any additional information required for the assessment is promptly submitted.

“Such a short timeframe for evaluation is only possible because EMA has already reviewed some data on the vaccine during a rolling review,” the agency said.

EMA has already approved the vaccines produced by Pfizer-BioNTech and Moderna for distribution in the EU.

The AstraZeneca vaccines was approved by the UK regulatory agency last December.

The AstraZeneca vaccine does not need super low temperatures to store, which makes it easier and faster to roll out.

Malta has a million doses ordered from AstraZeneca as part of the EU joint procurement process.

How is the vaccine expected to work?

COVID-19 Vaccine AstraZeneca is expected to work by preparing the body to defend itself against infection with the coronavirus SARS-CoV-2.

This virus uses proteins on its outer surface, called spike proteins, to enter the body’s cells and cause disease.

COVID-19 Vaccine AstraZeneca is made up of another virus (of the adenovirus family) that has been modified to contain the gene for making the SARS-CoV-2 spike protein. The adenovirus itself cannot reproduce and does not cause disease.

Once it has been given, the vaccine delivers the SARS-CoV-2 gene into cells in the body. The cells will use the gene to produce the spike protein. The person’s immune system will treat this spike protein as foreign and produce natural defences − antibodies and T cells − against this protein.

If, later on, the vaccinated person comes into contact with SARS-CoV-2, the immune system will recognise the virus and be prepared to attack it: antibodies and T cells can work together to kill the virus, prevent its entry into the body’s cells and destroy infected cells, thus helping to protect against COVID-19.

Source: European Medicines Agency