Europe’s regulatory agency could endorse Moderna’s coronavirus vaccine on Wednesday, which would pave the way for a second vaccine launched between member states after an injection developed by Pfizer and BioNTech. Approval will ultimately be decided by the European Commission.
In a statement to Fox News, a spokesman for the European Medicines Agency said the EMA’s Committee for Medicinal Products for Human Use (CHMP) discussed the Modern vaccine on Monday, but negotiations have not been completed and will resume on Wednesday -market.
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“In the meantime, our experts are working hard to clear up outstanding issues with the company,” according to the statement sent by email. “In the event that the CHMP reaches an opinion at tomorrow’s meeting, the EMA will send out a press release as soon as possible after the meeting.”
The spokesman did not detail the “outstanding issues”, but noted that EMA is holding a public meeting on Friday to discuss the evaluation, approval and deployment of the COVID-19 vaccine. In a briefing on Monday, Eric Mamer, a spokesman for the European Commission, detailed the progress on the vaccination front.
A European regulator may endorse Moderna’s coronavirus vaccine on Wednesday. (iStock)
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“We signed six contracts,” said Mamer. “We have the approval of one and, hopefully, very soon, the approval of a second vaccine and more vaccines later.”
Fox News contacted Moderna with a request for comment.
If the committee resolves its “outstanding issues” and the EMA proceeds with a conditional marketing authorization recommendation, the jab – with a final nod from the European Commission – would join the recently approved Pfizer / BioNTech vaccine.
Vaccination began on December 27 among member states, although many criticized the slow process.
“It is obvious that such a complex undertaking will always bring difficulties, there will always be obstacles in the way, but we are confident that with all the efforts we put in, we will be able to guarantee the vaccination of Europeans as soon as possible”, said Mamer.
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The news also follows reports from Germany and Denmark contemplating similar measures taken in the UK to delay the second vaccination by 12 weeks, instead of three, to extend supplies. The US Food and Drug Administration has advised Americans to adhere to authorized vaccination and dosing schedules: two 21-day doses for the Pfizer / BioNTech vaccine and two 28-day doses for the Modern vaccine.
“At the moment, suggesting changes in dosage or FDA-authorized schedules for these vaccines is premature and has no solid roots in the available evidence,” says the joint FDA statement. “Without appropriate data to support such changes in vaccine administration, we are at significant risk of putting public health at risk, undermining historic vaccination efforts to protect the population of COVID-19.”
Fox News’ Alexandria Hein contributed to this report.