Covid Johnson & Johnson vaccine approved in Europe


Okay to use the Johnson & Johnson anti-covid vaccine, which has received EMA approval. The European Medicines Agency has recommended conditional EU marketing authorization for the single-dose Janssen vaccine for people aged 18 and over. The green light comes on the basis of the evaluation of the experts of the EMA CHMP committee, which concluded that the data of the product “are solid and meet the criteria of efficacy, safety and quality”.

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The European Commission has also recently “authorized the use of the Johnson & Johnson vaccine in the EU. President Ursula von der Leyen reports this via social network. With the doses ordered” we could vaccinate up to 200 million people in the EU “, he recalls.

The efficacy of the product – explains the EMA – was demonstrated in a clinical study involving over 44 thousand people aged 18 and over in the United States, South Africa and Latin American countries. Half of the participants were given a single dose of the vaccine and the other half a placebo. The study found a 67% reduction in the number of symptomatic Covid cases after 2 weeks in people who received the Janssen vaccine (116 cases out of 19,630 people), compared to people who were given placebo (348 people out of 19,691). This means that the vaccine was 67% effective, EMA explains.

Side effects in the study were generally mild or moderate and resolved within a couple of days of vaccination. The most common: injection site pain, headache, fatigue, muscle aches and nausea, lists the European Medicines Agency. “The safety and efficacy of the vaccine – he specifies – will continue to be monitored through the EU pharmacovigilance system and further studies by the company and the European authorities”.

A report with the details of the EMA evaluation on the vaccine and the complete risk management plan will be published within a few days, announces the EU authority. The clinical trial data submitted by the company in the marketing authorization application will be published on the Agency’s website “in due course”, continues the regulatory body. The Janssen vaccine consists of an adenovirus modified to contain the gene for producing the Sars-CoV-2 Spike protein, which will stimulate the immune system to produce antibodies and activate T cells (white blood cells) to target it. The adenovirus contained in the vaccine cannot reproduce and does not cause disease.

The Johnson & Johnson vaccine is the fourth approved by the European Union, after those from Pfizer-BioNTech, Moderna and AstraZeneca. The European Commission has already secured 200 million doses of the Johnson & Johnson vaccine, with an option to purchase another 200 million doses. However, the pharmaceutical company will not deliver vaccines to EU countries before the second quarter of this year, possibly in the middle or end of April.

After the authorization of the EMA, tomorrow the Technical Scientific Commission (Cts) of the Italian Medicines Agency (Aifa) will also meet for the approval of the vaccine in our country.


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