EU drug regulator approves J&J's one-shot COVID-19 vaccine for adults

The European Medicines Agency has authorised Johnson & Johnson’s one-dose coronavirus vaccine, giving the European Union’s 27 nations a fourth licensed vaccine to try to curb the pandemic amid a stalled vaccination drive in the bloc. In a decision issued Thursday, the EU medicines regulator said it was recommending the vaccine be authorised for 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 approved COVID-19 vaccines made by Pfizer-BioNTech, Moderna and AstraZeneca — but all of those vaccines require two doses, several weeks apart. In its statement, the EMA said the J&J vaccine was about 67 percent effective. The US Food and Drug Administration approved the J&J shot in late February. Health experts hope that having a one-dose vaccine will speed efforts to immunise the world against COVID-19, especially given the arrival of worrying new variants in recent months. The EU has struggled to quickly roll out shots and immunise its most vulnerable citizens. It ranks far behind countries including Israel, Britain, Chile and the US. 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 Organisation’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. A massive study that spanned three continents found the J&J vaccine was 85 percent effective in protecting against severe illness, hospitalisations and death. That protection remained strong even in countries like South Africa, where variants have been identified that appear to be less susceptible to other licensed vaccines, including the one made by AstraZeneca. J&J is also seeking emergency authorisation of its vaccine in Britain and by the World Health Organisation. The company is hoping to make about 1 billion doses this year. The vaccine has also been approved for use in Bahrain and Canada. Experts say that having a fourth vaccine option across Europe, especially one that requires only one dose, could help immunise people quicker, even though significant amounts of the shot are unlikely to be available until the second half of 2021. J&J has faced production delays in the US and Europe but has recently signed agreements with rival pharmaceuticals who will help make their vaccine. In February, Sanofi Pasteur said it would be able to make about 12 million doses of the J&J vaccine at one of its French production sites once the shot is approved.