(Reuters) – Europe’s drugs regulator said on Tuesday it could issue an opinion by mid-March on whether to approve drugmaker Johnson & Johnson’s COVID-19 vaccine under a speedy review.
The U.S. drugmaker said it had submitted a conditional marketing application for the vaccine, called COVID-19 Vaccine Janssen, with the European Medicines Agency (EMA). The shot is also being evaluated by U.S. authorities.
The EU watchdog said a fast-tracked review of the coronavirus vaccine by its human medicines committee was possible because it had been already assessing some data in real time, and will now look at the vaccine’s efficacy, safety and quality. (https://bit.ly/3b9M5SK)
Johnson & Johnson said it was ready to begin distributing the vaccine within the European Union in the second quarter of 2021.
The single-dose vaccine, developed by J&J’s Janssen unit, was 66% effective in preventing COVID-19 in a large global trial against multiple variants, a study showed last month.
Though rivals’ shot have reported a higher protection rate against the novel coronavirus, J&J’s vaccine could help boost supply and simplify immunization campaigns because it does not require a second shot or need to be shipped frozen.
Europe currently has approved vaccines from Pfizer/BioNTech, Moderna and AstraZeneca/Oxford.
Reuters reported last week that the EMA was planning to fast track variant-modified COVID-19 vaccines.
Endorsements by the EMA have to be formally approved by the European Union.
(Reporting by Pushkala Aripaka, Tanishaa Nadkar and Mrinalika Roy in Bengaluru; Editing by Shounak Dasgupta and Maju Samuel)
