Johnson & Johnson vaccine, no second dose: leaflet, side effects

The Johnson & Johnson vaccine, recommended in Italy for over 60s after EMA evaluations on rare cases of thrombosis, “is a single dose vaccine and remains so. The booster, as for other vaccines, we will evaluate after 9- 12 months, annually. In the coming winter we will evaluate for all vaccines, based on the circulation of the virus or if there will be variants “, the need for a new administration. This was clarified by the director general of the Italian drug agency (Aifa), Nicola Magrini, answering the questions at the hearing in the Senate Health Commission. “The J&J vaccine is based on a single dose because the studies presented by the company were done on a population that received only one dose. It is possible that studies aimed at testing a possible incremental advantage provided by the second dose could prove this, but at the moment they are not available today “, said Franco Locatelli, president of the Superior Health Council (Css) and coordinator of the Technical Scientific Committee (CTS) in his speech at the hearing. From the end of April, after reports of rare cases of thrombosis , the Johnson & Johnson vaccine in Italy is recommended “preferentially” for “people over the age of 60, or those who, having a high risk of serious and fatal disease, need to be protected as a priority”, read in a note signed by Magrini, by Franco Locatelli, president of the Superior Health Council and Gianni Rezza, general director of Prevention of the Ministry of Health. The decision came after the “pronouncement of Ema”, the European drug agency, and after the “opinion of the CTS of Aifa, which reiterates the extreme rarity of thrombosis events associated with thrombocytopenia described following vaccination against Covid -19 carried out with the Janssen – Johnson & Johnson vaccine “. “Considering that this vaccine has proven to be certainly effective in reducing the risk of serious illness, hospitalization and death related to COVID-19, the same conditions of use as the Vaxzevria vaccine are recommended,” namely the AstraZeneca vaccine.
JOHNSON & JOHNSON VACCINE, THE LIE The Johnson & Johnson vaccine was the fourth to be recommended in the EU to prevent Covid-19 after 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 percent effective, explains EMA. 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.” 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.