European regulator may endorse Moderna's COVID-19 vaccine Wednesday
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Europe’s regulatory agency may endorse Moderna’s coronavirus vaccine Wednesday, which would pave the way for a second vaccine rolled out among member states, following a shot developed by Pfizer and BioNTech. The approval will ultimately be decided by the European Commission.
In a statement to Fox News, a spokesperson for the European Medicines Agency said EMA’s Committee for Medicinal Products for Human Use (CHMP) discussed the Moderna vaccine on Monday, but the talks did not conclude and will resume on Wednesday.
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"In the meantime our experts are working hard to clarify outstanding issues with the company," per the emailed statement. "In the event that the CHMP reaches an opinion at tomorrow’s meeting, EMA will send out a press release as soon as possible after the meeting."
The spokesperson did not detail the "outstanding issues," but did note that the EMA is holding a public meeting on Friday to discuss COVID-19 vaccine assessment, approval and rollout. In a briefing Monday, Eric Mamer, chief spokesperson of the European Commission, detailed progress on the vaccination front.
A European regulator may endorse Moderna’s coronavirus vaccine Wednesday. (iStock)
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"We signed six contracts," Mamer said. "We have approval of one and hopefully very soon approval of a second vaccine and further vaccines later on."
Fox News has reached out to Moderna with request for comment.
If the committee resolves its "outstanding issues" and the EMA follows with a recommendation for conditional marketing authorization, the jab – with a final nod from the European Commission – would join the recently approved Pfizer/BioNTech vaccine.
Vaccinations began on Dec. 27 among member states, though many have criticized the slow process.
"It's obvious that such a complex endeavor is always going to bring with it difficulties, there will be always bumps on the road, but we are confident that with all the efforts that we have put in, we will be able to ensure vaccination of Europeans as quickly as possible," Mamer said.
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The news also follows reports of Germany and Denmark contemplating similar steps taken in the U.K. to delay second vaccinations by 12 weeks, as opposed to three, to extend supply. The U.S. Food and Drug Administration on Monday advised Americans to adhere to authorized dosing and vaccination schedules: two doses 21 days apart for Pfizer/BioNTech vaccine and two-doses 28 days apart for the Moderna vaccine.
"At this time, suggesting changes to the FDA-authorized dosing or schedules of these vaccines is premature and not rooted solidly in the available evidence," reads the FDA's joint statement. "Without appropriate data supporting such changes in vaccine administration, we run a significant risk of placing public health at risk, undermining the historic vaccination efforts to protect the population from COVID-19."
Fox News' Alexandria Hein contributed to this report.
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