AMSTERDAM – The European Medicines Agency on Thursday gave the green light to Johnson & Johnson’s one-dose coronavirus vaccine, handing the European Union's 27 nations a fourth vaccine to try to speed up the bloc's much-criticized vaccination rollout.
The EU medicines regulator advised that the vaccine be cleared for use in all adults over 18 “after a thorough evaluation” of J&J’s data found the vaccine met the criteria for efficacy, safety and quality.
“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.
The EMA has already recommended COVID-19 vaccines made by Pfizer-BioNTech, Moderna and AstraZeneca — but all of those vaccines require two doses, several weeks apart. Production delays have also plagued all three vaccine manufacturers.
In its statement Thursday, the EMA said the J&J vaccine was about 67% effective. The most common side effects were pain at the injection site, headache, tiredness, muscle pain and nausea.
The European Commission quickly granted a conditional marketing authorization to the vaccine.
“The entry on the market of the (J&J) vaccine ensures that we have access to a total of up to 1.8 billion doses of approved vaccines from different technology platforms,” Health Commissioner Stella Kyriakides said.
The U.S. Food and Drug Administration gave an emergency authorizatio n to the J&J shot in late February. Health experts hope that having a one-dose vaccine will speed efforts to immunize the world against COVID-19, especially given the recent infection spikes in Europe driven by worrying new variants.