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The EMA was originally scheduled to decide on the US-based Moderna vaccine on January 12, but said the company had submitted additional data on Thursday “ahead of schedule.”
THE HAGUE – The EU drug watchdog said on Thursday it had pushed the date for a decision on the authorization of Moderna’s coronavirus vaccine by nearly a week to Jan.6.
The Amsterdam-based European Medicines Agency (EMA) has been under increasing pressure to accelerate, and earlier this week it accelerated the deadline for the Pfizer / BioNTech coup.
The EMA was originally scheduled to decide on the US-based Moderna vaccine on January 12, but said the company had submitted additional data on Thursday “ahead of schedule.”
“Taking due account of the progress made, the Committee has scheduled an extraordinary meeting for January 6, 2021 to conclude its evaluation, if possible,” said the EMA, referring to the drug committee that decides on these issues.
“The meeting scheduled for January 12, 2021 will be held if necessary.”
A clinical trial of 30,400 people found that the Moderna vaccine was 94.1% effective in preventing COVID-19 compared to a placebo, with slightly better performance in younger adults compared to the elderly.
EMA chief Emer Cooke said the agency under fire had shown it could respond.
“We have been able to revise the timelines for the evaluation of COVID-19 vaccines due to the incredible efforts of everyone involved in these evaluations,” Cooke said in a statement.
“The number of infections is increasing across Europe and we are aware of the enormous responsibility we have to bring a vaccine to market as quickly as possible, while maintaining the robustness of our scientific review.”
As Britain and the United States have pushed for the emergency authorization of the Pfizer / BioNTech vaccine, the EMA has been under pressure to accelerate, especially from Germany.
The watchdog, which moved from London last year after Brexit, will decide on a one-year “conditional marketing authorization” for Pfizer / BioNTech on Monday, after pushing forward the date to December 29.
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