AMSTERDAM (AP) – The European Medicines Agency on Thursday gave the green light to the single-dose coronavirus vaccine, giving the 27 nations of the European Union a fourth vaccine to try to speed up the much-criticized launch of the block vaccination.
The EU Medicines Authority has recommended that the vaccine be discontinued for use in all adults over the age of 18 “after a thorough evaluation” of J&J data, which found that the vaccine meets the criteria for efficacy, 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 their citizens,” said Emer Cooke, EMA’s executive director.
The EMA has already recommended COVID-19 vaccines produced by Pfizer-BioNTech, Modern and AstraZeneca – but all these vaccines require two doses, a few weeks apart. Production delays also affected all three vaccine manufacturers.
In its statement on Thursday, the EMA said the J&J vaccine is about 67% effective. It was said that most side effects were usually mild or moderate and were eliminated within days of vaccination. The most common side effects were pain at the injection site, headache, fatigue, muscle aches and nausea.
The US Food and Drug Administration has granted an emergency permit n to the J&J shot at the end of February. Health experts hope that the administration of a single dose vaccine will accelerate efforts to immunize the world against COVID-19, especially given the recent peaks in infection in Europe caused by the worrying new variants.
The EU has fought to quickly fire shots and immunize its most vulnerable citizens. It is far behind some countries, including Israel, the United Kingdom, Chile and the United States
J&J said it was committed to supplying the EU with 200 pre-ordered doses starting in the second quarter. The EU also has options to buy more vaccines at a later date.
Europe saw 1 million new cases of COVID-19 last week, a 9% increase from the previous week and a reversal that ended a six-week decline in new infections. The European Office of the World Health Organization has blamed this increase partly on virus variants, including one first identified in the UK, which is thought to be 50% more transmissible.
A massive study spanning three continents found that the J&J vaccine was 85% effective in protecting against severe illness, hospitalization and death. This protection has remained strong even in countries such as South Africa, where variants have been identified that appear to be less susceptible to other vaccines, including the one developed by 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 the Pfizer and Moderna vaccines, which require colder storage.
J & J’s shot uses a virus as cold as a Trojan horse to carry the coronavirus tip gene into the body, where cells make harmless copies of the protein to drive the immune system where the real virus appears. It’s the same technology the company used to make its Ebola vaccine and similar to COVID-19 photos taken by AstraZeneca and China CanSino Biologics.
J&J is also seeking the emergency authorization of its vaccine in the UK 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 has recently signed agreements with rival pharmaceuticals that will help make the vaccine. In February, Sanofi Pasteur said it would be able to produce about 12 million doses of J&J vaccine at one of its production sites in France once the blow is removed by the EMA.
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