EMA ‘hopeful’ Oxford/AstraZeneca jab will be given EU green light this month

PA

The head of the EU medicines regulator has said that she is “hopeful” that the Oxford/AstraZeneca coronavirus vaccine will be given European approval at the end of the month.

But Emer Cooke, executive director of the European Medicines Agency (EMA), warned it was “challenging” and “things can go wrong”.

The makers of the Oxford/AstraZeneca jab applied to the EU on Tuesday for approval of its Covid-19 vaccine.

Ms Cooke also said she hopes Johnson & Johnson will seek EU approval for its jab next month.

She made the remarks during an address to the Dublin-based Institute of International and European Affairs (IIEA) via video link on Friday.

The Irishwoman said the health body had a “tentative” plan in place to make a decision on the Oxford/AstraZeneca jab on January 29 but that the health body was receiving new information all the time.

“There are two big trials ongoing,” she said. “We know with one of them we won’t have all the information by the end of January. But we do hope we’ll have sufficient (data) to be able to come to a scientific conclusion by then.

“At the same time things can go wrong. These dates depend on everything going right.

“It’s challenging but I’m hopeful.”

Britain approved the Oxford/AstraZeneca vaccine last month and has begun administering it.

Its low cost, availability and ease of use is expected to make it an important vaccine in many countries.

When asked about the Johnson & Johnson jab, Ms Cooke said: “We hope it is to come in February but whether I could confirm that that’s the case – I’m afraid I’m not in a position to do so.”

The EMA has been criticised over delays in getting coronavirus vaccines approved compared to the US and the UK.

To date the health body has granted approval for two Covid-19 vaccines from makers Pfizer/BioNTech and Moderna.

“We constantly hear criticism about perceived delays in the EU, particularly in view of the emergency use authorisations which were granted in the UK and the US,” she said.

“There is no European provision for such emergency approvals but I don’t think that’s what’s important.

“What’s important is that European member states told us that the conditional marketing authorisation was the most appropriate regulatory mechanism for use in the current pandemic emergency.”

She admitted that the EMA’s process does take “a bit longer” before approvals are granted but she described it as a “very robust” system which was very important in the long run.

She added that the EMA had taken “every step to expedite” its evaluation process and that “the same robust standards” had been applied to the coronavirus jabs as they would have for any vaccine.

The Dublin native, who took over the helm of the agency two months ago, said it could not have happened at a “more challenging or exciting time”.

She added the agency had never been more visible and even become “mainstream” and was under “intense pressure” .

Although the first two vaccines have been approved, Ms Cooke said Europe was “not yet” at a turning point in this pandemic.

“We will need more vaccines to cover the needs, not only for Europeans, but for all global citizens who are suffering as a result of this pandemic,” she said.

“While the authorisation of vaccines is a very positive step in the right direction – vaccines alone will not be the silver bullet that will allow us to return to ‘normal’ life immediately,” she added.

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