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The EU’s drug watchdog said it could decide later today whether to authorize Moderna’s coronavirus vaccine, pushing the date forward from Wednesday.
The Amsterdam-based European Medicines Agency had already accelerated the decision from the originally scheduled date of January 12 under pressure from EU countries as infections surge.
“There is a meeting of the EMA’s committee on human medicines (CHMP) today, Monday, January 4, to discuss the Moderna vaccine,” the regulator said.
The EMA said it will issue a statement as soon as possible “in case the CHMP reaches an opinion at today’s meeting.”
If it did not make a decision on a one-year conditional marketing authorization for the Moderna vaccine, it would meet again on Wednesday, he added.
In a clinical trial of 30,400 people, the US-based Moderna jab was found to be 94.1% effective in preventing Covid-19 compared to a placebo.
The Moderna vaccine would be the second to be approved for the EU, after the EMA gave the green light to the Pfizer / BioNTech vaccine in another expedited decision on December 21.
However, the EMA said last week that the coronavirus vaccine developed by AstraZeneca and the University of Oxford, which was approved on Wednesday in the UK, is unlikely to get the green light in the EU in the next month.
As the UK and the US have pushed for the emergency authorization of two vaccines, the EMA has been under pressure to speed up its regulatory process, especially from Germany.
The EMA moved from London to Amsterdam after Brexit.
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Meanwhile, the European Commission has said its Covid-19 vaccination strategy will help the EU overcome “roadblocks” that have slowed the unfolding of the coups in the union.
“It is obvious that such a complex effort will always bring difficulties,” spokesman Eric Mamer told reporters.
EU countries started getting vaccinated on December 27 with the BioNTech / Pfizer vaccine, but progress has been much slower than in the US, Britain or Israel.
While the US, Britain and Israel have already administered vaccines to more than a million of their citizens, the EU countries have lagged far behind.
France, for example, has dealt a first blow to just over 500 people. Germany has started immunizing 200,000.
The European Commission emphasized that it had bought access to “almost two billion doses” of six possible vaccines, four times the population of the entire European Union.
But the EMA hasn’t said how many of the other vaccines were safe and effective enough to use.
“We don’t put all of our eggs in one basket,” said another commission spokesman, Stefan De Keersmaecker.
He said the commission was currently negotiating to obtain more doses of the BioNTech / Pfizer vaccine, up from the 300 million already secured. He did not give a figure.
Mr. De Keersmaecker noted, however, that “one of the main obstacles that we are all experiencing right now is production capacity.”
Mamer also said that the commission was not responsible for the deployment of every EU member state.
“It is the member states who then decide if they want to buy a specific vaccine and how many doses of that vaccine. It is not us,” he said.
“I don’t think the problem is really the quantity of vaccines, it’s the fact that we are at the beginning of a launch.”
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