US pharmaceutical giant Johnson & Johnson has applied for authorization of its COVID-19 vaccine in the European Union, the European Medicines Agency (EMA) announced on Tuesday, adding that a decision was expected in March .
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This single-injection vaccine that does not require very low temperatures for storage would be the fourth to be approved in the EU if it received the green light from the Amsterdam-based EMA.
The agency, which is under pressure from European capitals facing delays in vaccine deliveries, said it had “received an application for marketing authorization for a vaccine against Covid-19 designed by Janssen-Cilag International NV ”, the European subsidiary of Johnson & Johnson.
European experts “could issue an opinion in mid-March 2021, provided that the company’s data on the efficacy, safety and quality of the vaccine are sufficiently complete and convincing,” she added.
Johnson & Johnson’s vaccine has been under continuous evaluation by the EMA since December 1.
The President of the European Commission Ursula von der Leyen welcomed the submission of this request, stressing that the EU “will be ready to give its authorization as soon as the EMA has provided a positive scientific opinion”. “More safe and effective vaccines are coming,” she said.
The three vaccines authorized to date on the European market are those of AstraZeneca, Pfizer / BioNTech and Moderna.
The European Commission has ordered 200 million doses of the vaccine from Johnson & Johnson, with an option for 200 million more. One hundred million doses must be delivered by June if the vaccine is approved.
Two other vaccines, those from the German company CureVac and the American company Novavax are currently being evaluated by the EMA, while Hungary has unilaterally decided to use the Chinese Sinopharm and Russian Sputnik V vaccines.
In the United States, Johnson & Johnson has asked relevant authorities for emergency clearance of its COVID-19 vaccine.
In January, the company assured that clinical trials showed the product to be 66% effective overall and even 85% effective in preventing severe forms of the disease.
However, its protection is not as good against the so-called South African variant of Covid-19 which is currently spreading rapidly on the planet.