(Adnkronos)
Covid Johnson & Johnson vaccine gains EMA approval. How is the drug made? What are the side effects? Janssen’s vaccine is the fourth to be recommended in the EU to prevent Covid-19 after drugs Pfizer, Moderna and AstraZeneca. 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.
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