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This time the EMA was not taken by surprise. The decision of the US authorities to suspend Johnson & Johnson’s administration comes after last week the European Medicines Agency decided to launch a further investigation to evaluate some cases of thromboembolic events found in people subjected to the Janssen anti-covid vaccine, produced by J&J. “We are investigating and we will decide if regulatory action may be necessary”, replies Ema, questioned by Huffpost on the news from overseas on the day when the first doses of the new vaccine authorized in the old continent landed in Europe on 11 March. A cold shower.
“Last week, EMA initiated the review of a ‘safety signal’ to ascertain reports of thromboembolic events (formation of blood clots, resulting in obstruction of a vein) in people who have received the Covid-19 vaccine. Janssen ”, the European Agency explains to Huffpost. “As mentioned in our communication last Friday, cases of unusual blood clots with low platelets have been reported following vaccination with the Covid-19 Janssen vaccine. These reports have sparked a ‘safe signal’, but it is currently unclear whether there is a causal link between vaccination with the Janssen Covid-19 vaccine and these adverse reactions. The Prac (the Pharmacovigilance Committee for Risk Assessment) is investigating these cases and will decide whether regulatory action may be necessary “.
The Agency reserves the right to communicate “once the evaluation has been completed. The Agency’s scientific opinions provide Member States with the information they need to make decisions on the use of vaccines in their national vaccination campaigns, ”adds Ema. But this time, the European Commission specifies, the Amsterdam institute will rely on the US health authorities, given that J&J has not yet been administered in Europe and the cases of adverse reactions are in the US. “The EMA will therefore have to rely on other regulators, from the countries where the vaccine was administered, such as the Food and Drug Administration, before deciding on the next steps”, specify from Palazzo Berlaymont.
So far, the Janssen Covid-19 vaccine has been used on over 6 million people in the United States, with an emergency use authorization. The Food and Drug Administration and the US government have ordered the suspension of the vaccine due to 6 cases of thromboembolism found, the same ones on which Ema is also investigating. These would be adverse reactions similar to those reported for Astrazeneca: headache, abdominal and leg pain, particularly affect young women. Few cases but considered worthy of further investigation.
However, this does not harm the vaccination campaign in the United States, assures Jeffrey Zients, head of the White House’s anti-covid strategy: “Johnson & Johnson was used for only 5 percent of the population.” The US has other American vaccines, Pfizer and Moderna. Instead, the stop on J&J throws clouds over the European vaccination campaign, short of doses.
According to some US sources, the suspension should not last more than a few days, but there are no certainties on this. In the meantime, the company announced a slowdown in deliveries to the EU “with a view to transparency and awaiting the assessments of the European health authorities”.
Meantime, the vials arriving in Europe are blocked, they will be kept. “Today’s developments with the Johnson & Johnson vaccine in the United States are being closely monitored by the European Medicines Agency (EMA) and its pharmacovigilance bodies, with an open line with the United States Food and Drug Administration. America and other international regulators ”, says EU Health Commissioner Stella Kyriakides. “The launch in the EU has been suspended by the company. Vaccine safety is always paramount, ”he adds.
The doses landed in Italy will be stored in Pratica di Mare where the extraordinary commissioner Francesco Paolo Figliuolo went this morning to underline the event with his presence, which also ended up in the shadow of bad news from the USA. “In our containers, the doses can be stored for up to two years, there is plenty of time for the necessary investigations and then proceed”, Stefano Sbaccanti, from the commissioner for the Covid emergency, explains to Rainews 24.
Of course, the suspension of Johnson & Johnson, which was supposed to be the new European hope to put in place a vaccination campaign crippled by the cuts in supplies of Astrazeneca and the limitations placed as a precaution on the use of this product, is another blow to the Union. Also because the aftermath of the decision to limit the use of Astrazeneca to the over 60s, adopted in several countries including Italy, are heavy in terms of trust on the part of citizens. In our country the percentages of those who refuse to be injected AZ are high. A widespread phenomenon in the EU. Consequently, Bulgaria, for example, is considering whether to completely withdraw the Anglo-Swedish serum. “Interest in the AstraZeneca vaccine has dropped to symbolic percentages in the country, with people who would like to be immunized with this vaccine on their fingers,” says Bulgarian Health Minister Kostadin Anghelov.
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