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Moderna Inc shows high efficacy, asks for approval for its COVID-19 vaccine in Europe and the US

BioTech company Moderna said that it will seek for approval of its COVID-19 vaccine in both Europe and the US.

Moderna Inc shows high efficacy, asks for approval for its COVID-19 vaccine in Europe and the US

Sentinel Digital DeskBy : Sentinel Digital Desk

  |  30 Nov 2020 3:38 PM GMT

Cambridge (Massachusetts): The Us based firm Moderna Inc. has said that it would ask American and European regulators to allow emergency use of its COVID-19 vaccine as new results on Monday confirm that the shots offer strong protection against the coronavirus infection.

The firm made the announcement as it said that the most recent trial results showed its vaccine was 94.1% effective. Moderna said the vaccine was 100% effective against severe COVID-19. This was largely in line with preliminary results earlier this month.

Moderna Inc said that the shots' effectiveness and a good safety record meet with the requirements set by the US Food and Drug Administration for emergency use before the final-stage testing is complete.

The company will file for conditional approval from the European Medicines Agency and for an emergency use authorisation from the US Food and Drug Administration.

Stephane Bancel, chief executive officer of Moderna said, "This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and importantly, the ability to prevent severe COVID-19 disease."

It came after results showed that 196 of the 30,000 participants in Moderna's phase three trials contracted COVID-19. Just 11 of those cases were among people who received the Moderna candidate vaccine.

The company has worked with the US National Institutes of Health (NIH) and said it expects an advisory committee meeting with the US FDA on December 17.

Moderna has an agreement with the European Commission for 80 million doses of the vaccine, with EU having the option to secure a total of up to 160 million doses.

The side effects of the vaccine were "mild or moderate" and it included pain and headache, the company said.

The company also said that there were no serious safety concerns identified related to the vaccine.

The vaccine is based on the new technology that contains mRNA or genetic instructions that help the body to recognise coronavirus spike protein.

Two other companies – Pfizer and AstraZeneca recently released efficacy information about their vaccines, as well as, fuelling hopes that a vaccine could be approved by the end of the year or early next year.

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