Eyes also focused on Italy Johnson&Johnson after requesting a precautionary suspension at federal sites the use of the vaccine by the CDC (the most important public health control body in the United States) and FDA (the American government body that regulates the use of drugs and foods). And the US health authorities are talking about problems similar to AstraZeneca.
After the suspension in the US: how the Johnson & Johnson vaccine works
by Daniele Banfi
April 13, 2021-
Meanwhile, in Italy, a meeting was held at the Ministry of Health on the J&J case, the Italian Medicines Agency (Aifa) also present. “We had a meeting today with our scientists and AIFA and we are in connection with the EMA: we will evaluate in the next few days, as soon as Ema and the USA give us more definitive news, which will be the best way but I think that this too vaccine will have to be used because it is an important vaccine, “the Minister of Health told ‘Porta a portà Roberto Speranzaat the end of the meeting.
“The US choice is precautionary, J&J’s choice not to put the vaccine on the market immediately in the EU is also a precautionary choice. Our hope is to be able to solve these problems as soon as possible, and use this vaccine too” Hope continued. “In the meantime, there was a choice in the hours following the ruling of the US regulatory authorities to suspend the J&J vaccine by the same company, which has chosen to postpone the marketing of this vaccine in all European countries for a limited time. vaccine. It is an important vaccine, which has a particularly significant characteristic because it manages to immunize with a single dose instead of two. It is clear that compared to the choice made by the USA, the company has chosen not to immediately market the vaccine in Europe and to do first – he concluded – checks on American data “.
The J&J vaccine is highly safe with a clearly favorable risk-benefit ratio as has been shown by the studies “but” there are many similarities with the Astrazeneca vaccine, the limitations are therefore possible and reasonable and it will probably be the direction in which we all move together. “, confirmed the general manager of Aifa on Tg1, Nicola Magrini. “The data speak of very rare events, 6 cases out of 7 million vaccines, does not change the benefit-risk ratio of this drug is a pause of great caution, perhaps excessive in the pandemic phase”.
J&J’s choice
The request from the FDA and the CDC to suspend the vaccine comes after a few cases of coagulation and on the day when the first 184 thousand doses are expected in Italy. But in the meantime Johnson & Johnson, which today delivered its doses of the anti-Covid vaccine also in the Old Continent, specifies that it has decided to “delay the launch” of its serum in Europe “with a view to transparency and awaiting the evaluations of the European health authorities “explaining that they are” examining “with the European authorities the six cases of thrombosis reported following the administration of his vaccine. “We are collaborating closely with experts and health authorities and strongly support transparent communication to health professionals and citizens,” reads a statement. “The safety and well-being of the people who use our products are our number one priority,” adds the pharmaceutical group, saying that the company is “aware that extremely rare diseases have been reported in a small group of people who have low platelet levels following the use of our Covid-19 vaccine “.
After the AstraZeneca and J&J cases: what thrombosis is and how to prevent it
by Tina Simoniello
09 April 2021-
Avoiding a new ‘AstraZeneca case’
While Alessio D’amato, Lazio Health Councilor, asks that on the J&J vaccine “there is a quick, clear, definitive decision, without hesitation and uncertainty. We must avoid doing what has been done with the AstraZeneca vaccine”. And he adds: “The authorities should speak with one voice also because in the US they are in a totally different situation, having already administered millions of doses to the population. I hope that a level of rationality and pragmatism will be maintained, the risk of a storm perfect is very tall “.
Johnson & Johnson, former EMA director Guido Rasi: “I don’t think the numbers justify suspension”
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Reshape the vaccination plan
Per Andrea Crisanti, director of the Department of Microbiology of the University of Padua, neither the cases of thrombosis that occurred after the administration of the Johnson & Johnson vaccine, nor the suspension requested by the FDA and Cdc, “do not surprise”. The serum from J&J works like that from AstraZeneca, so it’s obvious that it can cause the same problems.
“The important thing now”, says Crisanti, “is that the government immediately reshape the vaccination plan”. For the rest, “what is happening is completely normal: vaccines have a life of their own which is better defined as the number of people vaccinated increases. It is a natural process”.
Coronavirus in the world, the US acquits Johnson & Johnson: “No link between vaccine and thrombosis”
09 April 2021-
Meanwhile, following the signaling procedure conducted at European level, the Italian Medicines Agency (Aifa) has issued a new note on the AstraZeneca vaccine to update health professionals on the points that emerged from the vaccine evaluation. The key elements are that “a causal relationship between vaccination with Vaxzevria and the occurrence of thrombosis in combination with thrombocytopenia is considered plausible. Although such adverse reactions are very rare, they have exceeded what was expected in the general population.” But at this stage “no specific risk factors have been identified”. In any case, writes the AIFA, “health professionals must monitor the signs and symptoms of thromboembolism and / or thrombocytopenia and inform the vaccinated accordingly. The use of this vaccine must comply with official national recommendations”.
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