AMSTERDAM (AP) – The European Medicines Agency on Thursday gave the green light to the Johnson & Johnson coronavirus vaccine and handed over a fourth vaccine to the 27 countries of the European Union to try to speed up the bloc’s much-criticized vaccination rollout.
The EU medicines regulator recommended that the vaccine should be approved for use in all adults over 18 years of age “after a thorough review” of J & J’s data, which showed that the vaccine met the criteria for efficacy, safety and quality.
“With this latest positive advice, authorities across the European Union will have another option to fight the pandemic and protect the lives and health of their citizens,” said Emer Cooke, EMA Executive Director.
The EMA has already recommended COVID-19 vaccines made by Pfizer-BioNTech, Modern and AstraZeneca – but all those vaccines require two doses, a few 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. It said most side effects were usually mild or moderate and resolved within a few days of vaccination. The most common adverse reactions were injection site pain, headache, fatigue, muscle pain and nausea.
The United States Food and Drug Administration has issued an emergency permit n to the J&J recording in late February. Health experts hope that having a single-dose vaccine will speed up efforts to immunize the world against COVID-19, especially given the recent peaks of infection in Europe due to worrying new variants.
The EU has been struggling to quickly deploy shots and immunize the most vulnerable civilians. It is far behind countries such as Israel, Great Britain, Chile and the US.
J&J said it is committed to providing the EU with the pre-ordered 200 million doses from the second quarter. The EU also has options to buy more vaccines at a later date.
Europe registered 1 million new COVID-19 cases last week, an increase of 9% from the previous week and a reversal that ended a six-week drop in the number of new infections. The World Health Organization’s European office blamed that wave partly on virus variants, including one first identified in Britain and believed to be 50% more transmissible.
A large-scale study spanning three continents found the J&J vaccine to be 85% effective in protecting against serious illness, hospitalization and death. That protection has remained strong even in countries like South Africa, where variants have been identified that appear to be less susceptible to other vaccines, including those from AstraZeneca.
The J&J vaccine can be stored at normal refrigerator temperatures, similar to the AstraZeneca vaccine, which should make it easier to use than Pfizer and Moderna vaccines, which should be stored colder.
J & J’s shot uses a cold virus like a Trojan horse to deliver the coronavirus spike gene into the body, where cells make harmless copies of the protein to boost the immune system in case the real virus comes along. It’s the same technology the company used to make its Ebola vaccine and is comparable to COVID-19 shots taken by AstraZeneca and China’s CanSino Biologics.
J&J is also requesting an emergency permit for its vaccine in Britain and by the World Health Organization. The company hopes to make about 1 billion doses this year. The vaccine has also been approved for use in Bahrain and Canada.
J&J has faced production delays in the US and Europe, but recently signed agreements with rival drugs that 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 manufacturing sites once the shot is approved by the EMA.
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