The European Medicines Agency (EMA) investigates the risk of developing thromboembolisms with Janssen’s drug, and continues to analyze three other covid-19 vaccines, including the Russian Sputnik, for possible use in a European Union (EU), region that is divided by the use of AstraZeneca due to the possible risk of thrombi.
The Human Drugs Committee (CHMP) has opened a real-time analysis process for the US Novavax vaccine since last February 3; Germany’s CureVac since February 12, and Russia’s Sputnik V since March 4, but neither has a set schedule to take the step of requesting a conditional license for use in the EU, such as the one granted to Pfizer & BioNtech, Moderna , AstraZeneca and Janssen.
The EMA endorsed on March 11 the use of Janssen, a subsidiary of the US Johnson & Johnson, a vaccine that is not yet being used in the European Union (EU) due to delays in the delivery of doses by the laboratory.
The regulator confirmed today that it is also investigating this vaccine, as it already happened with AstraZeneca, after a “safety signal” related to four severe cases of blood clotting after vaccination with this preparation.
The EMA analyzes data on four severe cases of unusual blood clotting with low platelets in patients who had previously received this vaccine, one of them during the clinical trial and three during the use of Janssen in the United States, of which one resulted in the death of the vaccinated person.
“These reports point to a signal of safety, but currently it is not clear if there is a causal association between vaccination with the Janssen vaccine and these conditions.
The first injections of this single-dose vaccine are expected to reach European countries. from April 19, as announced by the pharmaceutical company, which must deliver 55 million units in the second quarter of this year. At the moment, it is only being used in the United States with a emergency clearance.
Last Wednesday, the EMA concluded an investigation stating that there is a possible link between AstraZeneca and dozens of cases of blood clotting detected in the two weeks after the injection, so it decided to include this clinical picture among the very rare side effects of this vaccine, licensed in the EU on January 29.
However, and although several European countries are now nationally limiting its use only in people over 60 years of age, the EMA did not identify a risk factor such as age, sex or a specific clinical history, to explain the reported thromboembolisms. , Y recommended to keep its use because its benefits outweigh the risk of side effect.
Portuguese President Marcelo Rebelo de Sousa said today that Portugal, which holds the rotating presidency of the EU, is having “a lot of patience” about the divergences that member countries have shown on vaccination with AstraZeneca and regretted its impossibility of reaching a common position at 27 about the vaccination campaign.
While Novavax and Curevac have not been shocked so far, the Sputnik V vaccine is surrounded by controversy. The EMA will carry out a “good clinical practice inspection” in Russia on how the trials were conducted on the volunteers to determine whether the proper scientific and ethical procedures were followed.
Moscow has indicated that military and state employees have participated in trials of the vaccine, developed in a state laboratory and financed by the Russian Direct Investment Fund (RDIF), a sovereign fund of the Kremlin, which noted that there was no pressure on the people who took part in the trials.
In addition, according to the online newspaper EUobserver today, four people died in Russia (from problems related to the heart, lungs or blood sugar) and another six developed medical complications in the days after receiving Sputnik V, although it is not clear that these cases were directly related to vaccination.
Although it has not yet received the endorsement of European scientists, nor has a centralized purchase contract been signed with Brussels, Berlin and the Russian Direct Investment Fund (FIDR) have opened bilateral negotiations for the future acquisition by Germany of doses of Sputnik V, when it gets the go-ahead from the EMA.