Tista' taqra bil- Malti.
The coronavirus vaccine developed by AstraZeneca and Oxford University, which was recently approved in Britain, is unlikely to get a green light in the European Union in January, according to the European Medicines Agency.
The EU regulator approved the Pfizer-BioNTech vaccine on 21 December and is expected to approve Moderna’s vaccine on 6 January.
In a statement the agency said that it requested 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 (CMA) from the company.
“Further information from the ongoing clinical trials is also expected from January,” the EMA said.
The agency earlier told AFP that it had not yet received any formal marketing authorisation and that it had set no timetable for approving the vaccine.
The deputy executive director Noel Walthion was quoted saying that a possible approval in January is “unlikely”.
The AstraZeneca-Oxford vaccine is currently undergoing a “rolling review” which allows the EMA to examine safety and efficacy data as they are released, even before a formal application for authorisation is filed by the manufacturer.
This procedure speeds up the evaluation of a marketing authorisation application once it is made, the EMA said.
The agency said yesterday it is “aware that the UK MHRA has granted a temporary authorisation of supply of the vaccine in the emergency use setting, which is distinct from a marketing authorisation”.
A spokesperson from AstraZeneca was quoted by AFP saying that it “has submitted a full data package to support an application for conditional marketing authorisation for the AstraZeneca Covid-19 vaccine to the European Medicines Agency”.
The spokesperson added: “AstraZeneca has been submitting data on a rolling basis and will continue to work closely with the EMA to support the start of a formal CMA application process.