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Moderna scores FDA panel backing for mRNA-based COVID-19 vaccine

EMA also brings forward review meeting of vaccine

Moderna – snapping at the heels of Pfizer/BioNTech – has won backing from a US Food and Drug Administration (FDA) expert panel for its mRNA-based COVID-19 vaccine.

The Vaccines and Related Biological Products Advisory Committee met yesterday to discuss the jab, which scored a 94.1% efficacy rate in a phase 3 trial.

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

If it follows in the path of Pfizer/BioNTech’s COVID-19 vaccine BNT162b2, an FDA emergency use authorisation (EUA) for mRNA-1273 could be expected very soon – BNT162b2 was granted an EUA only a day after scoring expert panel backing.

In a statement, the FDA said that following the positive adcomm vote “it will rapidly work toward finalisation and issuance of an emergency use authorisation”.

“We were grateful for the opportunity to present the clinical data package for our mRNA vaccine against COVID-19 to the FDA’s advisory committee today. We thank the committee for their review and for their positive recommendation in support of emergency use authorisation,” said Stéphane Bancel, chief executive officer of Moderna.

“We have been working with the US Centers for Disease Control and Prevention and Operation Warp Speed to prepare for the distribution of mRNA-1273, if the FDA chooses to grant an emergency use authorisation. We look forward to getting our vaccine to people in the US to help address this ongoing public health emergency,” he added.

Although the FDA does not have to follow the guidance issued by the adcomm, it more often than not aligns with the advice provided by expert panels.

If mRNA-1273 does win an EUA, Moderna will begin to deliver the first doses immediately, with 20 million expected this month and a further 80 million planned for the first quarter of 2021.

Last Friday, the US government exercised an option to purchase an additional 100 million doses of mRNA-1273, bringing its total order commitment to 200 million doses. The new order will be delivered in the second quarter of 2021, Moderna said in a statement.

Moderna previously signed a deal with Lonza to bolster manufacturing capabilities to support the scale-up of production for the shot.

On the distribution side, Moderna’s vaccine remains stable at 2° to 8°C – standard refrigerator temperature – for 30 days. It also remains stable for up to six months at -20° C and at room temperature for up to 12 hours.

Pfizer/BioNTech’s vaccine, on the other hand, must be stored at -70°C – the companies are shipping BNT162b2 in special containers which maintain this temperature and allow for the transportation of the shot.

These containers can keep up to 5,00 doses of the vaccine at the specified -70°C temperature for ten days if unopened. The vaccine can then be stored for up to five days in a standard fridge temperatures.

In addition to the FDA panel backing, the European Medicines Agency (EMA) announced that it has brought forward a meeting to discuss the marketing authorisation application for mRNA-1273 to the 6 January 2021.

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

Article by
Lucy Parsons

18th December 2020

From: Regulatory



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