The European Medicines Agency (EMA) is investigating the risk of developing thromboembolisms with Janssen’s drug and continues to analyze three other covid-19 vaccines, including Russian sputnik, for potential use in a European Union (EU), region shared by AstraZeneca use due to the potential risk of thrombi.
The Human Drugs Committee (CHMP) has opened a real-time analysis process for the US Novavax vaccine since February 3; The German CureVac since February 12 and the Russian Sputnik V since March 4, but neither has a set schedule to apply for a conditional license for use in the EU, such as those granted to Pfizer & BioNtech, Moderna, AstraZeneca and Janssen.
On March 11, the EMA approved the use of Janssen, a subsidiary of US-based Johnson & Johnson, a vaccine that is not yet used in the European Union (EU) due to delays in the administration of doses by the laboratory.
The regulator confirmed today that it is also investigating this vaccine, as has already happened with AstraZeneca, following a ‘safety signal’ related to four serious cases of blood clotting after vaccination with this preparation.
The EMA is analyzing data on four serious cases of unusual blood clotting with low platelets in patients who had previously received this vaccine, one during the clinical trial and three while using Janssen in the United States, one of which resulted in the death of the vaccinated person
“These reports point to a signal of security, but currently it is not clear whether there is a causal relationship between vaccination with the Janssen vaccine and these conditions.
The first single dose injections of this vaccine are expected to reach European countries. from April 19, as announced by the pharmaceutical company, which is expected to deliver 55 million units in the second quarter of this year. Currently it is only used in the United States with a emergency clearance
Last Wednesday, the EMA closed 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 as one of the very rare side effects of this vaccine. , approved in the EU on January 29.
However, and although several European countries now limit its use nationally only in people over 60 years of age, the EMA has not identified a risk factor, such as age, gender, or a specific clinical history, to explain the reported thromboembolisms., Y recommended to maintain its use because the benefits outweigh the risk of side effects.
Portuguese President Marcelo Rebelo de Sousa said today that Portugal, which holds the EU’s rotating presidency, is “very patient” over the differences Member States have shown about vaccination with AstraZeneca and regretted its inability to reach a common position on 27 about the vaccination campaign.
While Novavax and Curevac are not shocked so far, the Sputnik V vaccine is surrounded by controversy. The EMA will conduct “a good clinical practice inspection” in Russia to see how the trials were conducted on the volunteers to determine if the correct scientific and ethical procedures were followed.
Moscow has indicated that military and government employees have participated in trials of the vaccine, developed in a state laboratory and funded by the Russian Direct Investment Fund (RDIF), a sovereign fund of the Kremlin, which noted that there was no pressure on the people. who participated in the trials.
In addition, according to the online newspaper EUobserver, four people died in Russia today (due to problems with 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.
While it has not yet received approval from 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 Germany’s future acquisition of doses of Sputnik V, when it gets the green light of the EMA.
ROA