Johnson & Johnson vaccine, first doses in Italy: leaflet, efficacy

Johnson & Johnson vaccine arrives in Italy on the day of the US precaution for 6 strokes. 184,000 doses of Janssen will take place at the National Defense Center in Pratica di Mare in the afternoon. Between the leaflet, efficacy, side effects, Ema and information on the single dose vaccine, here’s everything you need to know.

184,000 doses in Italy, day off in the US: Ministry meeting

This is the first batch of the United States vaccine to reach our country. This was announced by the structure of the Extraordinary Commissioner for Coronavirus Emergency Francesco Paolo Vigliolo. About 175,000 doses of the Vaxzevria vaccine were delivered late yesterday evening. The arrivals are part of the 4.2 million doses that will arrive in Italy from 15 to 22 April, which, together with those available to the regions, will contribute significantly to the achievement of the campaign goal at the national level. Vaccine access and storage is managed at the National Pratica di Mare by the Joint Chief Operating Officer as part of Operation Eos. Janssen is the fourth vaccine approved by national health authorities, after Pfizer, Moderna and Faxsephria.

Meanwhile, there will be a “technical” meeting at the Health Department at 4 pm after the United States stops the Johnson & Johnson vaccine by the Food and Drug Administration and the Centers for Disease Control and Prevention. The Italian Medicines Agency should also participate in the meeting.

“Johnson & Johnson is a vaccine that is used and it is safe,” meanwhile Minister of Regional Affairs and Self-Government Mariastella Gelmini confirmed to TgCom24. “On the issue of Johnson & Johnson, it’s a movie that has already been watched, Astrazeneca also had the same path but vaccines are safe, we shouldn’t be concerned about these measures – he added -.” In essence, Johnson & Johnson cases are numerically smaller than those of The fact that this comment exists means that there is great data transparency and monitoring. Today the only risk is not to vaccinate. “

Leaflet, efficacy, side effects

The expectation of the drug, which is a single dose vaccine, is very high especially after the case of AstraZeneca, recommended for more than 60 years after rare cases of thrombosis found after vaccination. The product’s effectiveness – EMA explains – was demonstrated in a clinical study of more than 44,000 people aged 18 and over in the United States, South Africa, and Latin America. Half of the participants were given a single dose of the vaccine and the other half were placebo. The study found a 67% decrease in the number of symptomatic Covid cases after two weeks in people who received the Janssen vaccine (116 cases out of 19,630 people), compared to people who received a placebo (348 people out of 19,691). This means that the vaccine was 67% effective, the EMA explains.

Side effects in the study were generally mild or moderate and resolved within two days of vaccination. Most common: injection site pain, headache, fatigue, muscle aches and nausea, according to the European Medicines Agency. “The safety and effectiveness of the vaccine will continue to be monitored – he said – through the pharmacovigilance system in the European Union and other studies by the company and European authorities,” he said.

The Janssen vaccine consists of an adenovirus that has been modified to contain the gene to produce the Sars-CoV-2 Spike protein, which will stimulate the immune system to produce antibodies and activate T cells (white blood cells) to target them. The adenovirus contained in the vaccine cannot reproduce and does not cause disease.

What does Emma say

Rare cases of blood clots have also been reported after vaccination with the Johnson & Johnson vaccine. The European Union’s regulatory body said in a statement that it was examined by the EMA’s BRAC Pharmacovigilance Committee. So experts have begun reviewing the safety flag for the Johnson & Johnson vaccine. After this shield injection, “4 severe cases of abnormal blood clots associated with low levels of platelets” were reported, the rare forms of thrombosis observed even after vaccination with AstraZeneca, according to updated data reported today in the note.

For Janssen vaccine, “1 case occurred during a clinical trial and 3 cases during the launch of the vaccine in the United States, one of which was fatal. The J&J vaccine is currently used only in the United States, with permission for emergency use. The product has been approved in the European Union in March 11, the product launch has not yet started in any of the European Union countries, but it is expected in the coming weeks.

These reports indicate a “safety indication,” but at present “it is not clear if there is a causal link between vaccination with the Janssen vaccine and these conditions. PRAC is investigating these cases and will decide whether a procedure may be necessary. The legislation, which usually consists of Update to product information. The EMA undertakes to communicate the results of the ongoing assessment.

What does Johnson & Johnson say?

“We are aware that cases of thromboembolism, including those with thrombocytopenia, have been reported for all Covid-19 vaccines. Our close monitoring of side effects revealed a limited number of very rare events following vaccination. Currently, there is a clear causal relationship to why Fixes between these rare events and the Janssen (Johnson & Johnson Group, ed.) Vaccine against Covid-19, “J&J specifies. “The safety and well-being of people who use our products are our top priority – the company stresses in a note – we share all reports of adverse events on people who have received the Covid-19 vaccine, along with our assessment of these reports, with health authorities for compliance with regulatory standards.”

“We continue to work closely with experts and regulatory authorities to evaluate the data and encourage open communication of this information with health professionals and the public – J&J adds – to help ensure that where a very rare disease is present, appropriate measures can be taken for rapid diagnosis and treatment.” “ It is important – Johnson & Johnson – recalls – that people who receive any vaccine against Covid-19 seek medical help immediately if they experience the following symptoms: shortness of breath, chest pain, swollen legs, persistent abdominal pain, neurological symptoms, Including severe and persistent headache or blurred vision, small spots of blood under the skin outside the injection site, easy or excessive bruising.