EU recommends granting a conditional marketing authorization for Moderna’s Covid-19 vaccine

Categories: Vaccine

3 replies

  1. The European Union’s main drug regulator on Wednesday cleared Moderna Inc.’s Covid-19 vaccine for use, offering the region a second shot to fight the coronavirus at a time when it is already struggling to distribute the doses it has.

    The decision, which is expected to be formalized by the European Commission within 24 hours, comes more than two weeks after Moderna’s shot received emergency-use authorization in the U.S. and U.K., a timeline that shows how the EU’s regulators have struggled to assess vaccines as quickly as their Western counterparts.

    The agency said the vaccine should be administered in two doses, the second 28 days after the first, as intended by the manufacturer. The recommendation comes after public-health institutions elsewhere have explored the possibility of delaying second doses so that more people can receive their first.

    “This vaccine provides us with another tool to overcome the current emergency,” said Emer Cooke, executive director of the European Medicines Agency. “It is a testament to the efforts and commitment of all involved that we have this second positive vaccine recommendation just short of a year since the pandemic was declared.”

  2. MILAN, Jan 7 (Reuters) – Italy’s medicines regulator AIFA said on Thursday it approved the use of a coronavirus vaccine developed by Moderna Inc. , paving the way for its roll-out across Italy.

    On Wednesday Moderna’s vaccine was the second to win the regulatory green light of the European Medicines Authority (EMA) as authorities accelerate the roll-out of shots aimed at curbing the pandemic amid worries about more infectious variants.

    “We welcome with enthusiasm the possibility of having a second instrument for this vaccination campaign which is achieving great results in Italy,” said AIFA Director General Nicola Magrini in a statement.

  3. Shares of Moderna Inc. were up 1.3% in premarket trading on Monday after the company said it plans to launch new development programs using its mRNA technology that will focus on developing vaccines for seasonal flu, HIV, and the Nipah virus. This follows the success of its mRNA COVID-19 vaccine, which is one of two vaccines to be authorized so far in the U.S. CEO Moderna also said it plans to expand its respiratory syncytial virus to include older adults, and it plans to test different vaccine combinations that fight the flu, COVID-19, RSV, and human metapneumovirus. “The uniquely challenging year of 2020 for all of society proved to be an extraordinary proof-of-concept period for Moderna,” CEO Stéphane Bancel said in a news release. As part of its corporate update, Moderna said it had about $5.2 billion in cash as of Dec. 31, compared to the $1.2 billion in cash it had at the same time a year ago, and it expects to generate at least $11.7 billion in revenue in 2021 for its COVID-19 vaccine based on advance purchase agreements.

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