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Johnson & Johnson applies for EU approval of its vaccine16 February 2021

European Medicines Agency plans to issue opinion in mid-March

Johnson & Johnson on Tuesday applied for conditional marketing authorization of its COVID-19 vaccine, the European Medicines Agency (EMA) said in a statement.

“EMA’s human medicines committee (CHMP) will assess the vaccine, known as COVID-19 Vaccine Janssen, under an accelerated timetable,” the statement said.

The EMA noted that the decision could be announced in mid-March at the meeting of its Committee for Medicinal Products for Human Use if the vaccine is proven to be safe and effective.

“This is the fourth CMA [conditional market authorization] application for a COVID-19 vaccine since the start of the current pandemic. It comes after EMA’s evaluation of vaccines from BioNTech/Pfizer, Moderna and AstraZeneca. These vaccines are now authorised in the EU and are among the tools Member States are using to combat COVID-19,” said the EMA.

The European Commission should give the final authorization for marketing after the EMA gives its opinion on the vaccine.

The EU, which has a population of 450 million, signed advanced purchase agreements with six firms – Pfizer-BioNTech, Moderna, AstraZeneca, CureVac, Johnson & Johnson, and Sanofi/GlaxoSmithKline – for about 2.3 billion vaccine doses.

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