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

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

The European Medicines Company mentioned it was recommending the COVID-19 jab for these over 18 “after a radical analysis” discovered it met the standards for efficacy, security and high quality

The European Medicines Company has authorised Johnson & Johnson’s one-dose coronavirus vaccine, giving the European Union’s 27 nations a fourth licensed vaccine to attempt to curb the pandemic amid a stalled vaccination drive within the bloc.

In a choice issued Thursday, the EU medicines regulator mentioned it was recommending the vaccine be authorised for all adults over 18 “after a radical analysis” of J&J’s knowledge discovered the vaccine met the standards for efficacy, security and high quality.

“With this newest constructive opinion, authorities throughout the European Union can have one other choice to fight the pandemic and shield the lives and well being of their residents,” mentioned Emer Cooke, EMA’s govt director.

The EMA has already permitted COVID-19 vaccines made by Pfizer-BioNTech, Moderna and AstraZeneca — however all of these vaccines require two doses, a number of weeks aside.

In its assertion, the EMA mentioned the J&J vaccine was about 67 p.c efficient.

The US Meals and Drug Administration permitted the J&J shot in late February. Well being specialists hope that having a one-dose vaccine will velocity efforts to immunise the world in opposition to COVID-19 , particularly given the arrival of worrying new variants in current months.

The EU has struggled to rapidly roll out photographs and immunise its most susceptible residents. It ranks far behind nations together with Israel, Britain, Chile and the US.

Europe recorded 1 million new COVID-19 circumstances final week, a rise of 9 p.c from the earlier week and a reversal that ended a six-week decline in new infections. The World Well being Organisation’s European workplace blamed that surge partly on virus variants, together with one first recognized in Britain that’s considered 50 p.c extra transmissible.

A large research that spanned three continents discovered the J&J vaccine was 85 p.c efficient in defending in opposition to extreme sickness, hospitalisations and loss of life. That safety remained sturdy even in nations like South Africa, the place variants have been recognized that look like much less vulnerable to different licensed vaccines, together with the one made by AstraZeneca.

J&J can be looking for emergency authorisation of its vaccine in Britain and by the World Well being Organisation. The corporate is hoping to make about 1 billion doses this yr. The vaccine has additionally been permitted to be used in Bahrain and Canada.

Specialists say that having a fourth vaccine possibility throughout Europe, particularly one which requires just one dose, may assist immunise individuals faster, despite the fact that vital quantities of the shot are unlikely to be obtainable till the second half of 2021.

J&J has confronted manufacturing delays within the US and Europe however has not too long ago signed agreements with rival prescribed drugs who will assist make their vaccine. In February, Sanofi Pasteur mentioned it could be capable of make about 12 million doses of the J&J vaccine at one among its French manufacturing websites as soon as the shot is permitted.

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