J&J’s COVID-19 shot backed for emergency use in EU

The EU’s medicines regulator has recommended granting conditional approval to a fourth COVID-19 vaccine – a single-dose shot from Johnson & Johnson’s Janssen unit – after a review by its human medicines committee. 

The CHMP has concluded that the Ad26.COV2.S vaccine can be used in people aged over 18, saying that “the data on the vaccine were robust and met the criteria for efficacy, safety and quality".

Approval of a fourth vaccine – after jabs from Pfizer/BioNTech, Moderna and AstraZeneca – is a boost for the EU’s underperforming coronavirus immunisation campaign. The EU has ordered 55 million doses of Janssen’s COVID-19 vaccine, which are due to be delivered in the second quarter of the year.

Figures from Our World In Data suggest that less than 10% of the EU’s 445 million citizens have been vaccinated so far, compared to 35% of the UK and 29% of the US.

The disparity has led to a series of public disagreements and claims of vaccine nationalism between the EU and the UK over deliveries to and from the bloc, as well as disputes between the EU and AZ and Pfizer over missed supply objectives.

Last week, Italy said it had blocked the shipment of 250,000 doses of the AZ vaccine to Australia, saying the drugmaker had failed to meet its EU contract terms, while European Commission president Charles Michel has accused the UK of implementing a ban on vaccine exports.

Meanwhile, the decisions by Norway and Denmark to stop vaccinating with AZ’s shot after a woman who received a dose died from a blood clot will further hold back the EU’s programme.

The UK and EU regulatory authorities have said there is no evidence of a link between the vaccine and the fatality but are both keeping the issue under review.

“With this latest positive opinion, authorities across the EU will have another option to combat the pandemic and protect the lives and health of their citizens,” said Emer Cooke, the EMA’s executive director.

Ad26.COV2.S is the first shot that needs only one dose to confer its protective effects, and can be stored at standard refrigeration temperatures, unlike the mRNA-based vaccines from Pfizer/BioNTech and Moderna which require a deep freeze.

According to the CHMP, the shot is 67% effective two weeks after the single dose – fairly close to the value seen with AZ’s vaccine – with side effects that were “usually mild or moderate and cleared within a couple of days after vaccination.”

The US FDA granted emergency authorisation to the shot in late February, and Janssen has agreed to supply the federal government with 20 million doses by the end of this month.