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EMA recommends authorisation of Moderna’s COVID-19 vaccine

European Commission likely to formally approve the vaccine soon

Moderna’s COVID-19 vaccine is moving closer towards EU approval after scoring a recommendation for conditional marketing authorisation from the European Medicines Agency (EMA).

The EMA’s Committee for Medicinal Products for Human Use (CHMP) met to discuss the Moderna vaccine, mRNA-1273, on Monday.

In a statement issued yesterday afternoon, the EMA said that the initial discussion did not conclude in the first meeting, warranting a further meeting today to ‘clarify outstanding issues with the company’.

After today's meeting, the EMA announced that it has given the mRNA-based vaccine a positive opinion for the prevention of COVID-19 in people aged 18 years and older.

Following this recommendation, the European Commission (EC) is likely to grant mRNA-1273 a formal conditional marketing authorisation sooner rather than later.

“This vaccine provides us with another tool to overcome the current emergency. It is a testament to the efforts and commitment of all involved that we have this second positive vaccine recommendation just short of a year since the pandemic was declared by the World Health Organization (WHO),” said Emer Cooke, executive director of the EMA.

“As for all medicines, we will closely monitor data on the safety and effectiveness of the vaccine to ensure ongoing protection of the EU public. Our work will always be guided by the scientific evidence and our commitment to safeguard the health of EU citizens,” he added.

In a phase 3 study of mRNA-1273, the jab demonstrated a 94.1% efficacy rate in reducing the number of symptomatic cases of COVID-19 in people who received the vaccine compared to participants who received a placebo.

The trial also showed a 90.9% efficacy rate in participants who were at risk of developing severe COVID-19 infection, including people with chronic lung disease, heart disease, obesity, liver disease, diabetes or HIV infection.

In November 2020, the EC secured up to 160 million doses of Moderna’s COVID-19 vaccine candidate, which includes an initial purchase of 80 million doses and an option to secure the further 80 million doses.

The EC also has supply deals in place for potential vaccines from AstraZeneca, Pfizer/BioNTech, Sanofi/GlaxoSmithKline, Johnson & Johnson and CureVac.

Moderna’s European manufacturing partner Lonza received authorisation from Swiss regulators last week to begin producing mRNA-1273 at its plant in Switzerland. Moderna also announced this week that it could potentially deliver one billion doses of its COVID-19 vaccine in 2021, following continued investment in its manufacturing capabilities.

Article by
Lucy Parsons

7th January 2021

From: Regulatory



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