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, 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.
Once vaccines were on the market there would be ongoing additional studies of safety which will be rolled out at the same time, added Ms Cooke. 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 1st.”
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 11th 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.”