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Moderna receives FDA emergency authorisation for its COVID-19 vaccine

Moderna's vaccine is the second to receive FDA approval, following approval of Pfizer/BioNTech’s BNT162b2 vaccine

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Moderna’s mRNA-1273 has become the second COVID-19 vaccine to be granted a US Food and Drug Administration (FDA) emergency use authorisation (EUA), on the heels of Pfizer/BioNTech’s BNT162b2 vaccine.

The FDA issued the EUA shortly after its Vaccines and Related Biological Products Advisory Committee voted in favour of authorising the vaccine for emergency use.

Results from Moderna's primary efficacy analysis of 196 cases in the phase III trial of the COVID-19 vaccine reflected a 94.5% efficacy rate.

The committee voted 20-0 with one abstention that the benefits of the mRNA-1273 vaccine outweighed the risks in individuals aged 18 years and over.

Following this recommendation, the FDA has formally granted mRNA-1273 a EUA for the prevention of COVID-19 in individuals aged 18 years and older.

Pfizer/BioNTech’s vaccine followed a similar path, with its EUA coming only a day after it received expert panel backing.

While Moderna’s vaccine can be administered to adults aged 18 years and over, Pfizer/BioNTech’s vaccine has a slightly different authorisation, for use in individuals aged 16 years and older.

The use of Pfizer/BioNTech’s vaccine in this younger age group was a slight point of contention during the expert panel’s discussions, but ultimately the committee voted 17-4 that the benefits of the vaccine outweigh the risks for immunisation in people aged 16 years and older.

“I am proud of what the Moderna team has achieved in collaboration with our partners. We were able to create and manufacture the Moderna COVID-19 vaccine in 11 months from sequence to authorisation, while advancing clinical development with a phase 1, phase 2 and pivotal phase 3 study of 30,000 participants,” said Stéphane Bancel, chief executive officer of Moderna.

“It has been a ten-year scientific, entrepreneurial and medical journey and I am thankful to all those who have helped us get here today. We remain focused on scaling up manufacturing to help us protect as many people as we can from this terrible disease,” he added.

Following the EUA, Moderna will now begin to deliver the first mRNA-1273 doses to the US government immediately, with 20 million expected this month.

The company also expects to have between 100 million and 125 million doses available globally in the first quarter of 2021, with 85-100 million of those doses having been earmarked for the US.

Moderna’s vaccine can remain stable at 2° to 8°C – standard refrigerator temperature – for 30 days and also remains stable for up to six months at -20° C and at room temperature for up to 12 hours.

Last week the European Medicines Agency (EMA) announced that it had brought forward a meeting to discuss the marketing authorisation application for mRNA-1273 to 6 January 2021.

Previously, the EMA had been planning to meet on 12 January 2021 to discuss the vaccine.

Article by
Lucy Parsons

21st December 2020

From: Regulatory

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