William/YMB: Breaking… “Europe’s drugs regulator is meeting with four leading Covid-19 vaccine makers”
4 hours ago
Breaking News 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.”