France and Italy said the European Medicines Agency’s preliminary considerations on the AstraZeneca vaccine were “encouraging”

European Medicines Agency (EMA) comments on AstraZeneca vaccine “encouraging”French President Emmanuel Macron and Italian Prime Minister Mario Draghi said on Tuesday.

“Today’s opening statements from the EMA are encouraging”, said in a statement released by Draghi’s office, which added that they are willing to resume vaccinations with the AstraZeneca formula if the vaccine receives the green light from the community regulator.

About fifteen countries, including Germany, Spain, France and Italy, as a precaution, have suspended use of the AstraZeneca vaccine after blood problems have been reported in people who have been vaccinated, such as difficulty in clotting.

In Italy’s case, the suspension means around 200,000 fewer vaccinations this week, according to government sources, who have expressed confidence that they can make up for the setback.

The EMA however assured this Tuesday that “No evidence” of suspected negative effects of the vaccine developed by the British laboratory and remains “convinced” of its benefits.

“We remain firmly convinced that the benefits of the AstraZeneca vaccine in preventing covid-19, with its associated risk of hospitalization and death, outweigh the risks of these side effects.”Said the executive director of the European regulator, Emer Cooke.

However, Cooke stressed that there will be no hesitation in taking action if experts detect a problem in their research that “cannot be resolved”, but clarified: “We must first study all the facts in depth scientifically, we owe it to Europeans. citizens ”.

For its part, the expert group of the World Health Organization (WHO) on the vaccine also planned to meet on Tuesday to analyze whether the drug from the British laboratory is safe. For now, the organization advises to continue administering this vaccine against the coronavirus.

The first suspicions that led to the suspension of the AstraZeneca vaccine were based on a possible relationship between it and the formation of clots or thrombi, which can cause phlebitis and even pulmonary embolism.

“At this time, there is no evidence that the vaccination caused these conditions. They did not appear in clinical trials and are not listed as known or expected side effects “Cooke said.

Every year, thousands of cases of developing blood clots are detected in European citizens for different medical reasons, and since the start of vaccination in the European Union at the end of December, the number of thromboembolic events in those vaccinated does not appear. not greater than that observed. in the general population, according to Cooke.

In addition, during clinical trials conducted by AstraZeneca before obtaining a conditional use license in the EU at the end of January, no cases of thromboembolism were detected after vaccinationTherefore, this condition is not included as a possible side effect of the vaccine, which usually causes headache or muscle pain, discomfort with the puncture, fatigue or fever, among other mild symptoms. or moderate.

“If millions of people are vaccinated, it is inevitable that accidental cases will occur and stand out. It’s up to us to find out if this is really related to the vaccine or if there are other causes, ”added Cooke, who stressed that the reported complications have only occurred in“ a very small number of people ”. , although he declined to detail the exact number of vaccinees who reported bleeding problems in the EU.

The Medical Institute Paul-honest, which advises the German government, reported a “surprising accumulation of a very unusual specific form of cerebral venous thrombosis, associated with blood platelet deficiency”.

Therefore, Germany has suspended the use of the vaccine, as a preventive measure. France, Spain and Italy have adopted the same measure.

Cerebral venous thrombosis (formation of clots in the veins of the brain) are “on the one hand much more unusual than classic thromboses and on the other hand they are potentially more serious”, explained the infectologist to the AFP agency. Odile Launay, member of the COVID-19 Vaccines Committee created by the French government.

These conditions can cause stroke.

In addition, other countries have found cases of bleeding that could correspond to “disseminated intravascular coagulation” (DIC), Launay added. These are “exceptional syndromes, which occur in severe sepsis” and which can lead to “thromboses and hemorrhages”.

There is currently no evidence of cause and effect between the vaccine and these conditions.

The Amsterdam-based EMA security committee met on Tuesday to assess the new information and would come to a conclusion at a special meeting on ThursdayCooke said.

With information from AFP and EFE

KEEP READING: