Rome, 11 March 2021 – Green light fromMom al vaccine anti Covid on Johnson & Johnson. Janssen serum is the fourth, in chronological order, to be approved for use in Europe after those from Pfizer / BioNtech, Moderna and Astrazeneca, but it is the primor so far to be monodose (the others all need a reminder). On March 1 it was approved in the US, where the FDA had confirmed “the safety and efficacy of the single dose of Johnson & Johnson’s coronavirus vaccine, particularly in severe cases”.
Covid Bulletin: the data of Italy of 11 March
The reasons for the EMA
The effectiveness of the product – explains the European Medicines Agency – has been demonstrated in one clinical study which involved over 44,000 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.
The side effects in the study they 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”.
How the J&J vaccine works
The Janssen vaccine consists of a adenovirus (a monkey “cold” virus) modified to contain the gene for Sars-CoV-2’s Spike protein, which will stimulate the immune system to make antibodies and activate T cells (white blood cells) to target it. The adenovirus contained in the vaccine cannot reproduce and does not cause disease.
Where it is produced
To increase production, the American company has signed one since 2020 partnership con la Catalent, which is headquartered in New Jersey. The agreement provides that part of the vaccine production will be made in the USA and in Italy, in the Anagni plant of Catalent, in the province of Frosinone. Another agreement, for the five-year production of vaccines, has been signed with Emergent BioSolutions, whose plants are located in Maryland. The French pharmaceutical company Sanofi also offered J&J its Marcy l’Etoile plant for the production of the Janseen vaccine (J&J subsidiary) at a rate of 12 million doses per month.
Italy vaccination plan: the new draft
J&J vaccine in Italy
According to what the AGI learns, tomorrow the meeting should be held Aifa scientific technical commission for the approval and indications for the distribution of the Johnson & Johnson vaccine in Italy. “We now have an extra tool to fight Covid-19. A particularly useful tool because it is the first single-dose vaccine,” says the Minister of Health. Roberto Speranza. “We keep high the attention of all health institutions, Italian and international, on safety and surveillance. Vaccines are the most important key to winning the challenge against the pandemic”.
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