The European Medicines Agency (EMA) Investigates the risk of developing thromboembolisms with the drug Janssen, also continues to analyze three vaccines of covid-19, including the Russian Sputnik, for possible use in a European Union (EU), A region that is divided by the use of AstraZeneca in the face of the possible risk of thunderstorms.
The Human Drugs Committee (CHMP) It has opened a process of real-time analysis of the US Novavax vaccine since February 3; Germany’s CureVac since February 12, and Russia’s Sputnik V since March 4, but none has a timetable for taking the step of applying for a conditional license to use in the EU, such as the one granted to Pfizer & BioNtech, Moderna, AstraZeneca and Janssen.
The EMA on March 11 supported the use of Janssen, a subsidiary of Johnson & Johnson, a vaccine that is not yet in use in the European Union (EU) due to delays in the delivery of dose by laboratory.
The regulator has confirmed today that it is also investigating this vaccine, as happened with AstraZeneca, following a “safety signal” related to four severe cases of blood clotting subsequent to vaccination with this preparation.
The EMA analyzes data on four serious cases of unusual blood clotting with low platelets in patients who had previously received this vaccine, one of them during the clinical trial — three during the use of Janssen in the United States, one of which resulted in the death of the vaccinated person.
“These reports point to a security signal, but currently it is not clear whether 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 arrive in European countries from 19 April, As announced by the pharmaceutical company itself, which should deliver 55 million units in the second quarter of this year. At the moment, it is only being used in the United States with one emergency authorization.
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, authorized in the EU on 29 January.
However, and although several European countries are now limiting their use nationally only to people over 60, the EMA did not identify a risk factor such as age, sex or a specific medical history. , to explain the reported thromboembolisms, and recommend maintaining 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 EU presidency, is having “a lot of patience” over the differences that member countries have shown over vaccination with AstraZeneca and lamented its impossibility of reaching a common position at 27 on the vaccination campaign.
While Novavax and Curevac have not been shocked so far, the Sputnik V vaccine is shrouded in controversy. The EMA will conduct an “inspection of good clinical practice” in Russia on how the trials were conducted on volunteers to determine whether appropriate procedures were followed at the scientific and ethical level.
Moscow has indicated that military and state employees have participated in trials of the vaccine, developed in a state laboratory and funded by the Russian Direct Investment Fund (RDIF), a sovereign wealth 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 digital newspaper EUobserver today, four people died in Russia (from problems related to the heart, lungs or blood sugar) and six developed medical complications in the days following receiving Sputnik V, although it is not clear that these cases were directly related to vaccination.
Although it has not yet received the support of European scientists, nor has a centralized purchase agreement been signed with Brussels, Berlin and the Russian Direct Investment Fund (IDF) have opened bilateral negotiations for the future acquisition of Germany of dose of Sputnik V, when this one obtains the approval of the EMA.
ROA