European regulator ‘very hopeful’ of delivering positive verdict on Covid vaccines before Christmas

European Medicines Agency set to review trial data from three leading candidates as soon as possible

The European Medicines Agency (EMA) has said it is “very hopeful” of delivering a positive verdict on the three coronavirus vaccines seeking regulatory approval before Christmas.

British drugmaker AstraZeneca and Oxford University this week followed Pfizer and Moderna in publishing trial results for their Covid-19 candidate, which appears to be up to 90 per cent effective in preventing disease.

Data from the three vaccines will be immediately put to regulatory bodies across the world in the hope of securing approval before the new year – and the EMA is confident it will be able to move swiftly in assessing the different jabs.

“All going well we would be very hopeful that we could have a positive opinion before Christmas,” EMA executive director Emer Cooke told RTE, Ireland’s national television and radio broadcaster, in an interview on Wednesday.

Ms Cooke said the results from the three clinical large-scale trials were encouraging but “until the EMA has looked at all the raw data to ensure it is what is says on the box it cannot recommend it for the European public”.

She insisted that the vaccines had high safety standards to meet “and what is expected from the companies is tough”.

“Let me say that 90 per cent effective is very, very good for a vaccine, so the possibility that this will be supported in practice by what we see in the dossier makes us look very optimistically at this,” Ms Cooke said, when asked about data from all three companies.

She said the EMA is diverting internal resources to focus on its Covid-19 response, with additional support from the European Commission to fund post-authorisation safety studies.

Ms Cooke was also quoted on Tuesday by the Irish Independent as saying the EMA's aim was to reach a positive recommendation on a similar timeline to the US Food and Drug Administration (FDA), which is expected to have a verdict in mid-December on Pfizer’s proposed vaccine.

Gustave Perna, who is leading the US Operation Warp Speed programme, said this week he was confident that vaccines will be “on the street” and distributed among communities just 24 hours after being authorised by the FDA.

Separately, the European Commission announced on Wednesday that it had reached an agreement with Moderna for 80 million doses of its two-dose vaccine – enough to inoculate 40 million Europeans across the continent.

Under the terms of the agreement, the European Commission has the option to increase its purchase to up to 160 million doses.

Delivery of the vaccine could begin in the first quarter of next year if it is approved for use by the EMA, which started a rolling review of the candidate on 17 November.