Drug producers to meet EMA on the vaccine trials targeting Omicron

Bloomberg – EMA, the Drug regulator of the UK is meeting four popular vaccine manufacturers of Covid-19 to discuss trials on shots of the contagious variant Omicron, according to the agency’s director.

In an interview given on Friday, Emer Cooke told that, in the coming days, the representatives of Novavax Inc., Pfizer Inc, and Johnson and Johnson will have a meeting with the European Medicines Agency.

According to the director, the discussion will lead to the virtual meeting planned for Wednesday between the regulator’s group co-chaired by the US Food and Drug Administration and EMA. The meeting will likely talk about improving coordination among the authorities on trial approaches.

“What we still don’t know is whether omicron is going to be replaced by something else, which could mean that you could put all your focus on omicron, only to realize — by the time the vaccines were ready — that something else was more prevalent,” said Cooke, 60, who took the helm at the EMA just over a year ago. We’re “trying to see what we can do right now to be prepared for where we think we might be once the trials come through.”

In November, Cooke notified the European Parliament that regulatory approval for the Omicron variant vaccine would be completed in three to four months once the companies start development which levitates the possibility of authorization of the shots toll spring.

She added on Friday, that the duration of three to four months remained unchanged but how the trials would run and how the vaccines efficiently work against the boosters is still under consideration.

The data shows that the Omicron is highly infectious, but the surge regarding the diseases hasn’t been seen in the hospitals. This may be because the boosters are already providing protection against the virus and the new variant. Cooke said that the vaccine specially designed for targeting the variant should strongly outperform the existing shots in its trial period to make it worth pushing.

Data also suggests that not only Omicron but Delta is still the reason for more than half of the contagious diseases across Europe. She added that although Delta is more infectious Omicron is liable for up to 95% of the cases in most countries.

Other than vaccines, the EMA is considering evaluating Covid-19 treatments in the hospitals as well. In addition to that, a Pfizer antiviral pill, paxlovid, is expecting to hit the market this month, she added.

European regulators are examining data on the Covid pills from Merck & Co. after the concerns have been raised against its impact on pregnant women. Where the decision is expected to be announced this February she said.

“We’ve had a lot thrown at us and we’ve risen to the challenge,” said Cooke, who hopes to have a delayed 60th birthday party when Covid subsides. But “we still don’t know what’s around the corner for Covid.”