EMA recommends Janssen Covid-19 vaccine for authorisation in EU
The European Medicines Agency (EMA) said on March 11 that it had recommended granting a conditional marketing authorisation for Covid-19 Vaccine Janssen to prevent Covid-19 in people from 18 years of age.
After a thorough evaluation, EMA’s human medicines committee (CHMP) concluded by consensus that the data on the vaccine were robust and met the criteria for efficacy, safety and quality, the statement said.
The Janssen vaccine is the fourth recommended in the EU for preventing Covid-19. Conditional marketing authorities earlier were granted to the BioNTech-Pfizer, Moderna and AstraZeneca vaccines.
“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,” EMA executive director Emer Cooke said.
“This is the first vaccine which can be used as a single dose,” he said.
Results from a clinical trial involving people in the United States, South Africa and Latin American countries found that Covid-19 Vaccine Janssen was effective at preventing Covid-19 in people from 18 years of age, the EMA said.
This study involved over 44 000 people. Half received a single dose of the vaccine and half were given placebo (a dummy injection). People did not know if they had been given the Janssen vaccine or a placebo.
The trial found a 67 per cent reduction in the number of symptomatic Covid-19 cases after two weeks in people who received the Janssen vaccine (116 cases out of 19 630 people) compared with people given placebo (348 of 19 691 people). This means that the vaccine had a 67 per cent efficacy.
The side effects with the Janssen vaccine in the study were usually mild or moderate and cleared within a couple of days after vaccination. The most common ones were pain at the injection site, headache, tiredness, muscle pain and nausea.
The safety and effectiveness of the vaccine will continue to be monitored as it is used across the EU, through the EU pharmacovigilance system and additional studies by the company and European authorities, the EMA said.
(Archive photo: Sofia municipality)
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