EU regulator approves Johnson & Johnson's one-shot vaccine

Thursday, March 11

By David Brophy

The European Medicines Agency (EMA) has recommended granting a conditional authorisation Johnson & Johnson single dose Covid-19 vaccine.

However, the company has already told the EU that the vaccine will not be available for delivery until mid-April.

"After a thorough evaluation, EMA's human medicines committee concluded by consensus that the data on the vaccine were robust and met the criteria for efficacy, safety and quality," EMA’s Executive Director Emer Cooke 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," she added.

The Johnson & Johnson vaccine is the fourth one to be approved by the EU regulator, after Pfizer/BioNTech, AstraZeneca/Oxford University and Moderna.

A clinical trial involving over 44,000 people in the US, South Africa and Latin American countries found it had a 67 per cent efficacy rate.

The vaccine is made up of a virus modified to contain the gene for making the SARS-CoV-2 spike protein, which once injected, triggers the immune system into producing antibodies to counter it.

Side effects "were usually mild or moderate and cleared within a couple of days after vaccination," the EMA said in its statement. The most common ones were pain at the injection site, headache, tiredness, muscle pain and nausea.

The EU signed a contract with the vaccine developer last October 2020 to purchase 200 million doses, with the option to acquire a further 200 million doses.

The vaccine was authorised for use in the US in February and the company said that it would deliver 20 million doses to the US in March and a total of 100 million by the end of June.