J&J Applies to EMA for Covid Vaccine Approval

17.02.2021 - As had been awaited, US healthcare giant Johnson & Johnson has applied to the European Medicines Authority (EMA) for conditional marketing authorization of its Covid-19 coronavirus vaccine throughout the EU.

 J&J's adenovirus-based product has been under a rolling review by the EMA since the beginning of December 2020. Two other vaccines, those of Germany’s CureVac and Novavax of the US, are also currently under rolling review in Europe.

In confirming receipt of the application on Feb. 16, the EMA said approval will depend on whether the data provided by the manufacturer show the vaccine's efficacy, safety and quality are “sufficiently comprehensive and robust.”

Due to shortages across the continent, observers believe the candidate is all but certain to win the green light by mid-March. The single-dose vaccine would become the fourth vaccine to be approved for use across the 27-nation bloc. The doses will be produced by J&J subsidiary Janssen-Cilag International.

The European Commission has ordered 200 million doses of the Johnson & Johnson vaccine with an option for 200m more.

Remarking that "more safe and effective vaccines are on their way," European Commission head Ursula von der Leyen said Brussels "will be ready to grant authorization as soon as EMA delivers a positive scientific opinion.”

Author: Dede Williams, Freelance Journalist