EU Drugs Agency Can Clear Omicron Shot in 4 Months If Needed

(Bloomberg) -- The European Medicines Agency would use expedited procedures to approve new versions of the Covid-19 vaccines to address the omicron variant should the current ones prove insufficient to fight it off.

Emer Cooke, the agency’s director, told the European Parliament on Tuesday that regulatory approval could be completed in three to four months from when the companies are ready to move forward, but that testing is ongoing to evaluate how the variant responds to the current vaccines.

“A lot of this work will have to go on at the company level at this stage, but I want to assure you that we’re working with the companies and with other regulators to make sure that we’re as prepared and ready as possible,” she said. “Were there a need to change the vaccines, we could be in a position to have those approved within three to four months.”

The EMA said later Tuesday that it expects regulatory approval could come three to four months after the companies begin the development process for the updated vaccines, raising the possibility that something could be approved as soon as the spring. The agency said its guidance aims to ensure companies provide more targeted, smaller data packages for review to speed evaluation time.

The EMA introduced new guidance for drugmakers in February on how vaccine updates would be handled to tackle new variants. The agency asked companies to investigate how well their shots held up against existing mutations and set out what data and studies would be needed to expedite adapted versions. Throughout the pandemic the regulator has used tools such as real-time reviews of trial data to accelerate the authorization process.

Vaccine makers would need to show consistency in their already-approved manufacturing processes for any new shot, and any change to the potency or other key aspects of the vaccine would need clinical data to support it, according to the guidance.

With other mutations such as the delta variant, the vaccines have been shown to provide protection, though the efficacy is reduced. The concern with the omicron variant is the number of mutations that it has from the original strain, particularly to the spike protein, which the virus uses to enter cells and has been the target of most vaccines.

Pfizer Inc. Chief Executive Albert Bourla told Bloomberg Television that the company will know within two to three weeks how well its Covid-19 vaccine holds up against the new variant, and even in a worst-case scenario he expects the existing formula will retain some efficacy against the heavily mutated strain. Moderna Inc.’s top executives also said this week that the omicron variant’s many mutations suggest new vaccines will be needed.

“It’s very important to stress that we are prepared,” said Cooke, who took up the post a year ago. “We know that viruses mutate, we know that at some stage there will be a mutation that means we have to change the current approach.”

Separately, Cooke said the vaccine from Novavax Inc. could be authorized “within a matter of weeks,” adding to the EU’s current stable of four vaccines available for use. While the shot demonstrated high efficacy in trials, it has faced a number of delays in gaining approval due to manufacturing issues.

The EU has an advance purchase agreement for as many as 200 million doses of the vaccine.

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