Leiden developed Covid-19 vaccine submitted to EMA for approval

A vaccine against Covid-19 which was developed in Leiden was submitted for approval to the European Medicines Agency, the EMA said on Tuesday. The vaccine was developed by Janssen Vaccines, part of a subsidiary company owned by pharmaceutical giant Johnson & Johnson.

If approved, it could be the first single-dose vaccine allowed for use in the European Union, with the Netherlands having the right to acquire nearly 11.3 million doses throughout 2021. The manufacturers said it was about 66 percent effective against Covid-19, and it prevented serious illness from Covid-19 in 85 percent of trial candidates.

The EMA's human medicines committee will assess the application, and could issue its ruling midway through March. "Such a short time for evaluation is only possible because EMA has already reviewed some data during a rolling review," the EMA stated.

The vaccine is comprised of a modified adenovirus meant to target the spike protein on the surface of the SARS-CoV-2 coronavirus. "If, later on, the person comes into contact with SARS-CoV-2 virus, their immune system will recognise the spike proteins on the virus and be ready to defend the body against it." the EMA stated.

"The adenovirus in the vaccine cannot reproduce and does not cause disease."

The rolling review process included the examination of how well a vaccinated person produces antibodies against SARS-CoV-2 and clinical safety data. A full review of additional data could lead to the EMA recommending to the European Commission that the vaccine be allowed to enter the European market.

Comirnaty, a vaccine produced by Pfizer and BioNTech, was the first Covid-19 vaccine approved for use in Europe. That was first rolled out in the Netherlands on January 6. The EMA later gave positive recommendations to a vaccine produced by Moderna, which was first distributed in the Netherlands on January 11.

A vaccine made by AstraZeneca went first went into use in the country last week.