AMSTERDAM (AP) – The European Medicines Agency on Thursday gave the green light to Johnson & Johnson’s single-dose coronavirus vaccine, which gave the 27 nations of the European Union a fourth vaccine to try to speed up the vaccination launch so criticized by the blog.
The EU drug regulator advised that the vaccine be removed for use in all adults over the age of 18 “after a thorough evaluation” of J&J data that found the vaccine met the criteria for efficiency, safety and quality.
“With this latest positive opinion, authorities across the European Union will have another option to fight the pandemic and protect the lives and health of its citizens,” said Emer Cooke, EMA’s executive director.
The EMA has already recommended COVID-19 vaccines manufactured by Pfizer-BioNTech, Modern and AstraZeneca – But all these vaccines require two doses, separated by several weeks. Delays in production have also affected all three vaccine manufacturers.
In its statement Thursday, the EMA said the J&J vaccine was about 67% effective. It was said that most side effects used to be mild or moderate and were eliminated within a couple of days after vaccination. The most common side effects were pain at the injection site, headache, fatigue, muscle aches, and nausea.
The U.S. Food and Drug Administration issued an emergency permit n to the J&J shot in late February. Health experts hope that having a vaccine with a dose will accelerate efforts to immunize the world against COVID-19, especially given the recent peaks in infection in Europe driven by concern about new variants.
The EU has fought to quickly fire shots and immunize its most vulnerable citizens. It ranks far behind countries such as Israel, Britain, Chile and the US
J&J said it was committed to providing the EU with its 200 million pre-ordered doses from the second quarter. The EU also has options to buy more vaccines later.
Last week, Europe recorded 1 million new cases of COVID-19, a 9% increase over the previous week and a reversal that ended with a six-week decline in new infections. The European Office of the World Health Organization blamed this increase partly on virus variants, including one first identified in Britain that is believed to be 50% more transmissible.
A massive study spanning three continents found the J&J vaccine to be 85% effective in protecting against serious illness, hospitalizations and deaths. This protection remained strong even in countries such as South Africa, where variants that appear to be less susceptible to other vaccines have been identified, including the one made by AstraZeneca.
The J&J vaccine can be stored at normal temperatures in the refrigerator, similar to the AstraZeneca vaccine, which should be easier to use than vaccines made by Pfizer and Moderna, which require colder storage.
The J&J trait uses a cold virus like a Trojan horse to carry the coronavirus ear gene to the body, where cells make harmless copies of the protein to prepare the immune system in case the real virus appears. It is the same technology the company used to make the Ebola vaccine and similar to the COVID-19 shots made by AstraZeneca and China’s CanSino Biologics.
J&J is also seeking emergency authorization for its vaccine in Britain and from the World Health Organization. The company expects 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 United States and Europe, but has recently signed agreements with rival pharmaceuticals that will help make its 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 EMMA clears the shot.
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