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Moderna wins EU authorisation for COVID-19 vaccine

EU Commission approval comes on the same day as positive CHMP opinion

Moderna’s COVID-19 vaccine has been granted a conditional marketing authorisation from the European Commission (EC) for use in people aged 18 years and older.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the Moderna vaccine following two meetings which took place this week.

The EMA issued a statement on Tuesday that the initial discussion did not concluded in the first meeting, warranting a further meeting yesterday, after which the CHMP recommended the vaccine for the prevention of COVID-19.

In a phase 3 study, 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.

Following the EC authorisation, Moderna is expecting to send the first deliveries of its vaccine to European countries from its dedicated non-US supply chain next week.

Moderna’s European manufacturing partner Lonza received authorisation from Swiss regulators last week to begin producing mRNA-1273 at its plant in Switzerland.

In addition to its Moderna vaccine doses, the EC also has supply deals in place for vaccines from AstraZeneca, Pfizer/BioNTech, Sanofi/GlaxoSmithKline, Johnson & Johnson and CureVac.

“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 WHO,” said Emer Cooke, executive director of 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.

As part of the conditional marketing authorisation, Moderna will continue to provide results from the main trial of the vaccine for two years.

This trial, plus additional studies, will continue to provide details on how long the vaccine’s protection lasts, how well it protects from severe COVID-19 and the level of the protection it offers immunocompromised people.

Article by
Lucy Parsons

7th January 2021

From: Regulatory



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