The European Medicines Agency (EMA) has recommended conditional marketing authorisation for Johnson & Johnson (J&J) subsidiary Janssen’s Covid-19 vaccine.
Janssen’s Covid-19 vaccine is the fourth to be recommended for use in adults in the EU; it follows vaccines produced by Pfizer/BioNTech, Moderna and AstraZeneca/Oxford. Like the AstraZeneca/Oxford vaccine, it is an adenovirus product and relies on Janssen’s proprietary AdVac platform.
The J&J vaccine is the first approved jab that is designed to be effective after a single dose. The other approved vaccines require two doses spaced over a number of weeks for optimal immunisation.
The next step towards authorisation is for the European Commission (EC), the EU’s executive body, to confirm the approval. European Commissioner for health and Food Safety Stella Kyriakides tweeted:
Welcome @EMA_News announcement of a positive opinion on the @JNJNews vaccine for use in ????????.
This marks another key step towards ensuring that all citizens can access safe and effective vaccinations as soon as possible. @EU_Commission authorisation will follow shortly.
— Stella Kyriakides (@SKyriakidesEU) March 11, 2021
The recommendation came after a thorough evaluation by the EMA’s Committee for Medicinal Products for Human Use of clinical trial data submitted by J&J in December. The committee determined that the data for the vaccine was robust and met the criteria for efficacy, safety and quality.
In the Phase III ENSEMBLE study, which was carried out in the US, South Africa, as well as countries across Latin America, Janssen’s Covid-19 vaccine was found to be 67% effective at preventing symptomatic Covid-19 and 85% effective at preventing severe disease.
EMA executive director Emer Cooke said: “With this latest positive opinion, authorities across the European Union will have another option to combat the pandemic and protect the lives and health of their citizens.”
J&J chief scientific officer and vice-chairman of the executive committee Paul Stoffels commented: “The EMA’s recommendation is a landmark moment for J&J and for the world.
“Now, as we await a decision on the use of our single-dose COVID-19 vaccine in the European Union, we remain confident that the J&J vaccine will prove a critical tool for fighting this pandemic.”
Janssen’s Covid-19 has already received emergency use authorisations in the US and Canada. J&J has also submitted rolling review submissions in other parts of the world and is seeking emergency use listing with the World Health Organization.