Drugmakers Meet With EMA on Vaccines Targeting Omicron
(Bloomberg) -- Europe’s drugs regulator is meeting with four leading Covid-19 vaccine makers to discuss potential trials for shots targeting the fast-spreading omicron variant, the agency’s executive director said.
Representatives of Pfizer Inc., Moderna Inc., Johnson & Johnson and Novavax Inc. will sit down with the European Medicines Agency in coming days for talks on the matter, Emer Cooke told Bloomberg in an interview Friday.
The discussions will precede a virtual meeting scheduled for Wednesday between a global group of regulators, co-chaired by the EMA and U.S. Food and Drug Administration. That gathering will seek to improve coordination between agencies on approaches to the trials, she said.
“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.”
Cooke told the European Parliament in November that regulatory approval for a variant-specific vaccine could be completed in three to four months after the companies begin development, raising the possibility that shots could be authorized as soon as the spring. She said Friday that the timeline was unchanged, but questions around how the trials would be run and measured against the efficacy of existing booster doses still need to be resolved.
Data so far suggest that while omicron is highly contagious, it isn’t sparking a surge in severe disease or hospitalizations. Because booster shots are already providing a high level of protection against the strain, any vaccine targeting omicron would need to outperform those existing shots in trials to be worth pursuing, Cooke said.
Nor is omicron the only variant to consider. Delta still accounts for about half of infections across the region, she said, although omicron is now responsible for close to 95% of cases in some countries.
Beyond vaccines, the EMA is also evaluating Covid treatments. A green light for Pfizer’s antiviral pill, paxlovid, could come this month, according to Cooke. The regulator is examining more data on Merck & Co.’s Covid pill after concerns were raised over its impact on unborn children, with a decision likely in February, she said.
While the pandemic is consuming much of Cooke’s time and energy, she highlighted three specific areas where change is needed beyond the crisis: more pregnant and lactating women need to be included in clinical trials; very small trials should be stopped and combined into larger studies to produce more meaningful data; and regulators, policymakers and scientists need better coordination.
“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 round the corner for Covid.”
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