Belgian-based company Janssen Pharmaceutica, owned by US pharmaceutical giant Johnson & Johnson on Tuesday submitted its COVID-19 vaccine to Europe’s medicines watchdog for conditional marketing authorisation.
“EMA has received an application for conditional marketing authorisation for COVID-19 vaccine Janssen,” the European Medicines Agency (EMA) wrote in a Twitter post on Tuesday, laying out the procedure that will follow.
A decision could be made by mid-March, “provided the company’s data on the vaccine’s efficacy, safety and quality are sufficiently comprehensive and robust,” said the Amsterdam-based watchdog.
EMA has received an application for conditional marketing authorisation for #COVID19 Vaccine Janssen:
👉https://t.co/vBZXDaINdN pic.twitter.com/PBFxayMMkL— EU Medicines Agency (@EMA_News) February 16, 2021
The European Commission has agreed for 200 doses with an option to order an extra 200 million. The first jabs could be available in Europe by April 1.
Contrary to the shots developed by Pfizer/BioNTech, Moderna and AstraZeneca/Oxford, the J&J vaccine is administered as a single shot, – a logistical advantage -, that could salvage countries in need to speed up inoculations.
In late January, J&J said their new single shot COVID-19 vaccine has an overall efficacy of 66% and an 85% efficacy in preventing severe forms of the disease.