'All going well' European Medicines Agency could approve vaccine before Christmas

The agency's  Irish-born executive director said the EMA was very optimistic about the details that had been presented to them to date
'All going well' European Medicines Agency could approve vaccine before Christmas

Avial of coronavirus vaccine developed by AstraZeneca and Oxford University. File picture

The Irish-born executive director of the European Medicines Agency (EMA), Emer Cooke has said that “all going well” the agency could be in a position to approve new Covid-19 vaccines before Christmas.

Speaking on RTÉ radio’s News at One, Ms Cooke said that the EMA needed to ensure that all Covid-19 vaccines were safe, of a high quality and effective.

“The safety requirements for these vaccines are the same for any vaccine,” she explained, which meant the EMA needed to analyse “a huge amount of data” to ensure that the vaccine “does what it says on the box.” 

Ms Cooke said that the EMA was very optimistic about the details that had been presented to them to date. 

“We want to be able to assure the public that what has been done meets the highest standards.” 

New technology used to make the Covid-19 vaccines meant that the EMA had to have staff with the right expertise to analyse the date. Even if the vaccines had been developed rapidly the requirements for safety monitoring were very tough, she said.

Ms Cooke added that once vaccines were on the market there would be ongoing additional studies of safety which will be rolled out at the same time. 

There would be the same safety requirements as for any vaccine. The EMA will commission independent ‘real life’ studies on the vaccine.

The agency has had to divert internal resources from their core business to focus on the Covid response, she said. 

“We have got additional funding from the European Commission and we've just been promised additional resources from January 1.” 

The EMA was “working very hard” on the information they have received to date, but that they had not yet received full information from the companies, what they were doing was a “rolling review”. 

“The onus is on us to be as transparent as possible so the public can have trust in these vaccines.” 

The EMA will hold a public meeting on December 11 to give the public the opportunity to voice any concerns and ask questions. 

This will also help the EMA in how it communicates information in the vaccines as there was “so much misinformation”. 

“It behoves us to be a source of reliable information in a way that meets the needs of the public.”

The latest news around vaccines comes as the Tánaiste said it is impossible to rule out another level 5 lockdown in January.

It is feared that there will be a rise in cases over Christmas but Leo Varadkar says he hopes a post-Christmas move to level 5 would not be as long as the current six-week lockdown.

The National Public Health Emergency Team is meeting today and will advise Cabinet of the best move to make with restrictions due to end on December 1.

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