EMA recommends COVID-19 Vaccine by Johnson & Johnson for authorisation in the EU

The European Medicines Agency (EMA) has recommended granting a conditional marketing authorisation for Johnson & Johnson’s Janssen COVID-19 Vaccine to prevent infection in people from 18 years of age.

The vaccine is produced by Janssen, a subsidiary of a subsidiary of US pharma giant Johnson & Johnson.

“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,” the EMA said in a statement.

“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,” said Emer Cooke, EMA’s Executive Director, adding, “this is the first vaccine which can be used as a single dose”.

Results from a clinical trial involving people in the United States, South Africa and Latin American countries found the vaccine 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 the Johnson & Johnson vaccine.

The trial found a 67 per cent reduction in the number of symptomatic COVID-19 cases after two weeks in people who received the 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% efficacy.

The side effects with the Johnson & Johnson 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 stressed.

The Johnson & Johnson vaccine is expected to arrive in the EU by 1st April, at the very earliest.

As reported by Politico, unlike Pfizer, Johnson & Johnson has not committed any shipments until the second quarter of the year, meaning there will likely be at least a three week lag between its approval and its distribution.

So far, the EMA has approved three other vaccines for use in the EU: Pfizer, Moderna and AstraZeneca