Johnson & Johnson vaccine suspended in the United States for thrombosis cases. Italy has accepted the first 184 thousand doses of the single-dose drug, which should ensure the acceleration of the vaccination campaign. Now, the red light triggered in America after 6 cases of thrombosis out of about 6.8 million doses is likely to have consequences also on this side of the Atlantic Ocean.
HOPE
With the AstraZeneca vaccine recommended for over 60s, Italy is counting on the Johnson & Johnson vaccine to move closer and reach the goal of half a million doses per day. Now, fatally, the plans are in danger of changing. “We had a meeting with our scientists and clearly with the Italian drug agency, we are in connection with the European agency Ema and we will evaluate in the coming days, as soon as Ema and the Americans give us more definitive news, which will be the best way . But I think that this vaccine will also have to be used because it is an important vaccine, “said Health Minister Roberto Speranza in his speech at Porta Porta. The Minister of Health then reiterated how “the US choice is a precautionary choice” and Johnson & Johnson’s “choice not to immediately market the vaccine in Europe is also a precautionary choice. Our hope – ha supported Speranza – is to be able as soon as possible to untie these knots and also use this vaccine which would be the fourth, and which we particularly need “.
AIFA
“We will evaluate whether to give the” Johnson & Johnson “vaccine against Covid-19 to the over 60s, and we will do so as soon as we can resume the vaccination campaign” with this vaccine, “within 2-3 days, maybe even less. then it will be possible to open to the administration by the family doctor, in the pharmacy or in the points of free access that will increase, we will see “, the general director of the Italian drug agency, Nicola Magrini, told ‘Porta a Porta’, hypothesizing a solution ‘AstraZeneca style’.
“Let’s look at what the American organizations will decide – he explains – after the reporting of six cases out of 7 million vaccinated, a risk of 1 per million, very rare. Also in this case it is young women, between 18 and 48 years old, it could be a mechanism similar to that of the AstraZeneca vaccine “. Is one case per million enough to block a drug? “No – replies Magrini – I am confident that by identifying the categories at the greatest risk of becoming ill with serious Covid, the benefits” of vaccination “are absolutely not comparable with these very rare risks”.
UNITED STATES
US federal health authorities have recommended a “precautionary pause” in the use of the vaccine after 6 cases of blood clots were recorded two weeks after the vaccine. In all cases, these are women between 18 and 48 years old. One woman has died and another is hospitalized in serious condition in Nebraska. “The Centers for Disease Control and the Food and Drug Administration are examining the data relating to 6 cases of rare thrombosis that involved women aged between 18 and 48 years. Symptoms emerged between 6 and 13 days after the administration of the vaccine” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “This is a recommendation, not an imposition. If a body administering the vaccine has an interview with a patient and determines that the benefit-risk balance is appropriate, we will not stop the body from administering the vaccine. We are recommending a break. for an excess of precaution, but on an individual basis providers and patients can decide “.
EUROPEAN UNION
We have made the decision to delay the distribution of our Covid 19 vaccine in Europe “, the” proactive “choice announced by the US pharmaceutical group. 170 million doses of the vaccine are expected in the European Union by the end of September, as announced in the in recent days by the EU Commissioners for Industry, Thierry Breton. With the suspension of deliveries decided by the US company, it is not clear at the moment how this will impact the vaccination campaign in Europe. According to forecasts, the company should have delivered at least 50 million of doses to Europe by the end of June, and another 120 million doses between July and September. These deliveries are part of the 200 million dose contract signed between the US company and the European Commission in October last year. under the agreement, member states will be able to purchase an additional 200 million doses of the J&J vaccine.
EMA
The European drug agency Ema is “investigating the cases” of rare thrombosis reported after the anti-Covid vaccination “to decide whether action is necessary” from a “regulatory” point of view. This is what the EU agency said in a statement bounced in the international press after the US decision to pause the administration of the Johnson & Johnson anti-Covid vaccine. The EMA has started the review of the safety signals regarding this shield product, as announced in recent days by taking stock of what emerged from the meeting of the Agency’s Prac Pharmacovigilance Committee, and specified that at the moment “it is not clear whether ‘is a causal link between the vaccine and the observed clots.