The European Medicines Agency on Thursday gave the green light to Johnson & Johnson’s one-dose coronavirus disease 2019 (Covid-19) vaccine, handing the European Union’s (EU) 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 Covidf-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-percent effective. It said most side effects were usually mild or moderate and cleared within a couple of days after vaccination. The most common side effects were pain at the injection site, headache, tiredness, muscle pain and nausea.
The US Food and Drug Administration gave an emergency authorization 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.
The EU has struggled to quickly roll out shots and immunize its most vulnerable citizens. It ranks far behind countries including Israel, Britain, Chile and the US.
J&J said it has committed to providing the EU with its pre-ordered 200 million doses starting in the second quarter. The EU also has options to buy more vaccines at a later date.
Europe recorded 1 million new Covid-19 cases last week, an increase of 9 percent from the previous week and a reversal that ended a six-week decline in new infections. The World Health Organization’s European office blamed that surge partly on virus variants, including one first identified in Britain that is thought to be 50-percent more transmissible. SOVEREIGNPH