EU drugs regulator approves new single dose vaccine

EU drugs regulator approves new single dose vaccine
Photo: Justin Tallis/AFP
The European Medicines Agency has recommended approving Johnson & Johnson's single dose Covid vaccine after a successful trial.

“The European Medicines Agency has recommended granting a conditional marketing authorisation for COVID-19 Vaccine Janssen (made by Johnson & Johnson) to prevent COVID-19 in people from 18 years of age,” read a statement from the EMA on Thursday.

Results from a trial of about 44,000 participants show the jab was 67 percent effective in preventing moderate-to-severe Covid globally.

The jab is the fourth to be endorsed for use in the EU after vaccines from Pfizer-BioNTech , AstraZeneca-Oxford University and Moderna, and is recommended for those over 18 years of age, the European Medicines Agency (EMA) 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. This is the first vaccine that can be used as a single dose,” said Emer Cooke, EMA’s Executive Director.

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 EMA said.

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,” said the EMA.

The European Commission will now fast-track the decision-making process to grant a decision on the conditional marketing authorisation for COVID-19 Vaccine Janssen, allowing vaccination programmes to be rolled out across the EU.


Member comments

The Local is not responsible for content posted by users.

Become a Member to leave a comment.Or login here.