The European Union drug regulator said Tuesday it will be prepared to approve a new COVID-19 vaccines targeting the Omicron variant within three to four months.
European Medicines Agency (EMA) executive director Emer Cooke told the European Parliament that the EMA is prepared if pharmaceutical companies need to modify the existing COVID-19 vaccines for them to protect against Omicron.
“Were there a need to change the existing vaccines, we could be in a position to have those approved within three to four months,” Cooke said.
“Companies adapting their formulations to include the new sequencing ... will then have to show that the production system works, they will then have to do some clinical trials to determine that this actually works in practice.”
In a separate statement, the EMA clarified that the review will begin when drugmakers decide that modification to the vaccine is necessary and begin to work on that.
“We expect to receive smaller (data) packages which would reduce the evaluation time,” EMA said, based on guidance that has been in place since February for any variant-specific vaccine upgrade.
The EMA’s guidance, issued in February, intended to accelerate the approval process for drugmakers that modify their COVID-19 vaccines against new variants.
“I think it’s going to be a material drop. I just don’t know how much because we need to wait for the data. But all the scientists I’ve talked to … are like ‘this is not going to be good,’” Bancel told the Financial Times.
Cooke repeated the calls for people to get vaccinated with the approved vaccines that are currently available, saying that they will continue to provide protection even as the new Omicron variant becomes more widespread.
Omicron has several mutations similar to two previous variants—Beta and Gamma—making them less vulnerable to vaccines. In addition, Omicron has 26 unique mutations, many of them in areas that would have been vulnerable to vaccine antibodies.
