TALLINN - The European Medicines Agency (EMA) has recommended granting a conditional marketing authorization 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. COVID-19 Vaccine Janssen is the fourth vaccine recommended in the EU for preventing COVID-19, EMA said in a press release.
"It is a vaccine that contains a viral vector into the DNA of which the spike protein coding sequence has been inserted. What makes the Janssen coronavirus vaccine different is that it is given as a single dose," Triin Suvi, head of the department of biologicals at the Estonian State Agency of Medicines, 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. 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 COVID-19 Vaccine Janssen or placebo.
The trial found a 67 percent reduction in the number of symptomatic COVID-19 cases after two weeks in people who received COVID-19 Vaccine Janssen -- 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 percent efficacy.
The side effects with COVID-19 Vaccine Janssen 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.
There are currently nearly 80 vaccine candidates in clinical trials worldwide.
To date, more than 100,000 people have been vaccinated in Estonia with the first dose of Pfizer and BioNTech, Moderna and AstraZeneca COVID-19 vaccines.
A conditional marketing authorization is one of EU's regulatory mechanisms for facilitating early access to medicines that fulfil an unmet medical need, including in emergency situations such as the current pandemic. A conditional marketing authorization is a formal authorization of the vaccine, covering all batches produced for the EU and providing a robust assessment to underpin vaccination campaigns.