Stop, as a precaution, the vaccine Johnson & Johnson in the United States. The American pharmaceutical company consequently decided to postpone deliveries of its vaccines to Europe. Health Minister Roberto Speranza declared, a Door to door, “We had a meeting with our scientists, with the Italian Medicines Agency, we are clearly in connection with the European agency and we will evaluate in the coming days as soon as Ema and the Americans give us more formal and definitive news which will be the best way . But I think that this vaccine must also be used because it is an important vaccine ».
On Tuesday – as anticipated by New York Times— la Food and Drug Administration he asked to stop administering Johnson & Johnson with immediate effect. The suspension is already operational in federal centers, while individual states could, in theory, decide otherwise.
The decision is due to the reactions of six women aged between 18 and 48 in the two weeks following the vaccine: they developed a rare disease related to blood clots. One of the six women died, another is in critical condition. In the US, 6.8 million people have received the single dose of the Johnson & Johnson vaccine, and another 9 million doses have already been sent to various states.
The note from the Centers for disease control and Fda explains that the two authorities are studying the six cases, “extremely rare”: a causal link between the administration of the vaccine and the development of the rare disease is not yet certain.
In order to evaluate them, the Centers for disease control have convened a meeting of the Advisory Committee on Immunization Practices for Wednesday. The suspension – explains Fda – will remain in force until the analysis of Fda and Cdc is completed. It should be a matter of days. The analysis – as anticipated by New York Times – could lead to a restriction of the use of the vaccine, for example for some age groups.
In the meantime, the FDA and the CDC suggest contacting their doctor to those who have received the vaccine and develop, within three weeks of the injection, some symptoms (such as “severe headache, abdominal or leg pain, difficulty breathing). “Normally, the treatment of coagulation cases takes place through anticoagulants such as heparin,” the note reads. “In this case, heparin can be dangerous. The treatment of this specific type of thrombosis is different from that of normal thrombosis ».
Johnson & Johnson commented saying that “Causal links are not currently established between” our vaccine and these rare thromboembolic events.
The return to Europe
In Europe, 200 million doses of this vaccine were expected by 2021. After the stop in the US, Johnson & Johnson has decided to postpone distribution in the Old Continent: «We have examined these cases (the American ones, ed) with the European health authorities and we have decided to proactively delay the launch of our vaccine in Europe. We have worked closely with medical experts and health authorities and we strongly support the open communication of this information to health professionals and the public ”reads the note released by the company.
The European Medicines Agency (Mom) stated, following the announcement by the United States, that “it is currently unclear whether there is a causal link between vaccination with Johnson & Johnson’s Covid-19 drug and cases of blood clots ». The safety committee of the European agency “is investigating and will decide whether regulatory action may be needed.”
The similarity with the AstraZeneca case
The suspension in the United States of Johnson & Johnson comes at a critical moment in the vaccination campaign in the European Union and in Italy.
On April 7, the safety committee of the European Medicines Agency EMA (PRAC) concluded that “unusual blood clots with low platelets” – the same rare disease found by the FDA and CDC and which could be linked to J&J vaccine – to be listed as very rare side effects of Vaxzevria (AstraZeneca’s vaccine) and spoke of a ‘link’ to the vaccine, even if the benefits of vaccination outweigh the associated risks.
In the United States, the AstraZeneca vaccine is not used. Until now, Pfizer-BioNTech, Moderna, and Johnson & Johnson vaccines have been used in the United States.
Australia’s choices
On Tuesday, before the announcement by the States, the Australian government decided not to buy the Johnson & Johnson vaccine. Health Minister Greg Hunt ruled out a J&J contract because his vaccine was similar – in that it was based on one viral vector technology, and not to mRna like Pfizer and Moderna – to the product AstraZeneca, for which Australia already has a contract for 53.8 million doses.
In recent days, Australia – which was banking on the AstraZeneca vaccine to accelerate the pace of its vaccination campaign – said the best option for those under 50 is Pfizer’s vaccine, based on the discovery of a rare thrombosis case. A second case was registered on Tuesday. In Australia, therefore, a total of two cases of rare thrombosis have been recorded out of 700 thousand doses of AstraZeneca injected.
The Australian government has not clarified whether the decision not to purchase the Johnson & Johnson vaccine is linked to potential problems related to the technology used by the two vaccines.
The Johnson & Johnson vaccine in Italy
In Italy the vaccine Johnson & Johnson it arrived on Tuesday, after being approved by the European drug agency (Ema) and the Italian one (Aifa). After the news from the United States, the Ministry of Health and Aifa organized a summit to take stock.
The 184 thousand doses of the Janssen vaccine (this is the name of the Johnson & Johnson preparation) arrived at the national defense hub of Pratica di Mare. They will remain “stored” pending verification of the rare adverse events reported. “In our containers the doses can be stored up to two years, there is plenty of time for the necessary investigations and then proceed”, he explained to Rainews 24 Stefano Sbaccanti, of the Covid emergency commissioner structure.
In Italy, at the moment, there are no restrictions on the use of approved vaccines except for AstraZeneca (used only for the over 60s, according to this circular from the Ministry of Health). The Johnson & Johnson vaccine – unless the Aifa or Ema pronouncements – can therefore be administered to everyone, according to the directives of precedence established by the plan launched by the government.
On April 9, EMA announced an investigation into 4 cases of rare thrombosis in people who have received the Johnson & Johnson vaccine in the United States.