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FDA experts back safety and efficacy of Moderna’s COVID-19 vaccine

Briefing document published ahead of advisory committee meeting

A briefing document published by the US Food and Drug Administration (FDA) has confirmed the safety and efficacy of Moderna’s mRNA-based COVID-19 vaccine, paving the way for a potential approval soon.

The document, published ahead of tomorrow's FDA’s Vaccines and Related Biological Products Advisory Committee Meeting, confirmed that the vaccine has a 94.1% efficacy rate, supporting Moderna’s own findings.

The FDA analysis found that although the mRNA-1273 vaccine caused some common adverse reactions, including injection site pain, fatigue, headache, muscle/joint pain and chills, serious adverse reactions occurred in 0.2% to 9.7% of participants.

The document concluded that the vaccine has demonstrated an ‘acceptable’ tolerability profile with no ‘significant’ safety issues.

'Based on the totality of scientific evidence available, including data from adequate and well controlled trials, if available, it is reasonable to believe that the product may be effective to prevent, diagnose, or treat such serious or life-threatening disease or condition that can be caused by SARS-CoV-2,' the document added.

Last week, the FDA approved Pfizer/BioNTech’s mRNA-based COVID-19 vaccine BNT162b2, granting it a conditional approval for emergency use in the US.

The approval was announced after an advisory committee meeting that saw experts vote 17-4 in favour of the Pfizer/BioNTech vaccine, determining that the benefits of the vaccine outweighed any risks.

If the FDA experts similarly endorse Moderna's mRNA-1273 vaccine in their advisory committee meeting tomorrow, the vaccine could gain approval in the US before the end of the week.

If so, the mRNA-based vaccine will become the second to be approved in the US, following Pfizer/BioNTech’s BNT162b2.

The US government has already secured 200 million doses of mRNA-1273, with six million of those planned to be ready to ship once FDA approval is confirmed.

In addition to being under review in the US, Moderna’s vaccine is also being reviewed on a rolling basis by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

The UK, which has already commenced the roll-out of Pfizer/BioNTech vaccinations, has secured seven million doses of the Moderna vaccine.

Moderna's mRNA-1273 vaccine is also under review by the European Medicines Agency (EMA) for potential emergency use across the European Union.

In November, the European Commission approved a contract with Moderna to provide an initial 80 million doses of mRNA-1273, set to be supplied once the vaccine has been deemed safe and effective against COVID-19 by its own regulators.

Article by
Lucy Parsons

16th December 2020

From: Regulatory



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