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Moderna seeks “emergency use authorisation” for its vaccine in USA & Europe

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US biotech-firm Moderna has announced that it is to file for ‘Emergency Use Authorization’ of its Covid-19 vaccine in the USA and Europe on Monday, after full results confirmed a high efficacy estimated at 94.1%.

‘We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalisations and death,’ said Stéphane Bancel, CEO of Moderna. ‘I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, as well as the staff at clinical trial sites who have been on the front lines of the fight against the virus.’

Moderna said it was seeking ‘Emergency Use Authorization (EUA)’ from the US Food and Drug Administration (FDA) as well as ‘conditional approval’ from the European Medicines Agency (EMA).

If the FDA agrees that it is safe and effective and gives approval for emergency use, then the first of the drug’s two doses could be administered in the United States by mid-December.

American pharmaceutical Pfizer and Germany’s BioNTech applied for similar approvals last week, and their vaccine could also be given permission for use in the USA shortly after 10 December.

The Moderna vaccine, which was co-developed with the US National Institutes of Health (NIH), is being studied in a clinical trial with more than 30,000 participants across the United States.

An interim analysis announced earlier this month was based on 95 patients who had fallen ill with Covid-19.

The final analysis was based on 196 cases, 185 of which were observed in a group assigned a placebo versus 11 who received the shots. Thirty people had severe cases — all of whom were in the placebo group — which also included one person who died.

Significantly, efficacy was ‘consistent across age, race and ethnicity, and gender demographics’, the company said. The 196 Covid-19 cases included 33 adults over the age of 65, and 42 participants identifying as being from diverse communities ‘including 29 Hispanic or LatinX, 6 Black or African Americans, 4 Asian Americans and 3 multiracial participants’, the statement read.

The vaccine was generally well tolerated, with the most common side effects including injection site pain, fatigue, muscle pain, joint pain, headache, and redness at the site. These increased in frequency and severity after the second dose in the vaccinated group.

The press statement included the line: ‘no new serious safety concerns have been identified by the Company’ — but it did not explicitly say whether serious concerns have been flagged previously.

Moderna said it expects to have approximately 20 million doses of the vaccine, called mRNA-1273, available in the US by the end of the year. It also expects to manufacture 500 million to 1 billion doses globally in 2021.

Click here for all previous reports on: Coronavirus in Spain

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