The European Medicines Agency (EMA) has received an application for a conditional marketing authorisation (MA) for the candidate vaccine developed by Janssen-Cilag International N.V. The assessment of the vaccine candidate will take place under an accelerated timetable. An opinion on the MA will be issued by the EMA by mid-March 2021, provided that the company’s data are sufficiently comprehensive and robust to prove the vaccine’s quality, safety and efficacy.
Such a short time for evaluation is only possible because EMA has already reviewed some data during a rolling review.
During the evaluation and throughout the duration of the pandemic, the EMA and the scientific committees are assisted by the COVID-19 EMA Pandemic Task Force (COVID-ETF), a group that brings together experts from across the European medicines regulatory network (of which the FAMHP is a member) to facilitate rapid and coordinated regulatory action on medicines and vaccines for COVID-19.
What may happen next?
If the EMA concludes that the benefits of the vaccine outweigh the risks of protection against COVID-19, it will recommend granting a conditional MA. The European Commission will then accelerate the decision-making process to grant a conditional marketing authorisation valid in all EU and EEA member states.
This is the fourth application for a conditional market authorisation for a COVID-19 vaccine since the start of the current pandemic. The vaccines of BioNTech/Pfizer, Moderna and AstraZeneca are already authorised in the EU and are used in Belgium, among other countries, in the fight against COVID-19.
How does the vaccine work?
The Janssen (Johnson & Johnson) vaccine is a viral vector vaccine. This type of vaccine uses a known virus that does not cause disease in humans.
This may be an innocuous virus or a live attenuated virus used in another vaccine. In Janssen's case, it is an adenovirus.
An antigen (spike protein) or the genetic code of an antigen is added to this viral vector. Some viral vector vaccines can replicate in the host cell (replicating viral vector vaccines), others cannot (non-replicating viral vector vaccines), depending on the changes made to the vector genome. Janssen's vaccine is a non-replicating viral vector vaccine.