Experts at the European Medicines Agency (EMA) are "working hard" to clear up outstanding issues with drugmaker Moderna to give the Covid-19 vaccine a "green light" on Wednesday, January 6, the regulator said today. European.
In a press release, the European agency informs that "the discussion of the EMA Committee for Medicines for Human Use on the [Modern] vaccine was not concluded [on Monday] and will continue on Wednesday", noting that its "experts are working hard to clear up outstanding issues with the company."
"If the Committee for Medicinal Products for Human Use reaches an opinion at tomorrow's meeting [Wednesday], the EMA will send a press release as soon as possible after the meeting," the European regulator said in a short message, alluding to the expected approval .
The information was released after the EMA said on Monday that it would only comment on the vaccine from the pharmaceutical company Moderna for Covid-19 after further consultations with the company.
This after, also on Monday, the Committee of Medicines for Human Use of the EMA held an extraordinary meeting in which there were no conditions for the conclusion of discussions on the vaccine of the North American pharmaceutical company.
This means that contacts with Moderna continue for a few more hours, with the hope that on Wednesday there will be a “green light” for the authorization of the vaccine in European territory.
The continuation of the discussions will continue on Wednesday so that experts have more time to analyze the clinical and laboratory data made available to them by the North American pharmaceutical company.
If a positive conclusion is reached, Moderna's vaccine will be the second to receive the "green light" from researchers in the European Union (EU), after the approval, last 21 December, of the drug developed by pharmaceutical companies Pfizer and BioNTech, which is being used in the European space since last week.
Since December 1 of last year, the committee has also opened two real-time review processes for vaccines developed by the pharmaceutical company Janssen, a subsidiary of US-based Johnson & Johnson and Oxford University, and Astrazeneca, although none of them has requested one. conditional authorization to use the drug in the EU.
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