The EMA assures that the AstraZeneca vaccine is "effective and safe"

The European Medicines Agency (EMA for its acronym in English) has ruled this Thursday on the questioned AstraZeneca vaccine.

"This is an effective and safe vaccine," explained Emer Cooke, director of the agency.

"Its benefits," he added, "outweigh the possible risks."

The EMA concludes that the use of this drug is not associated with a general increase in the risk of suffering thromboembolic episodes.

However, the regulator has not been able to rule out a possible link to rare thromboembolic events detected, which "require further investigation," said Cooke, adding that they will launch additional investigations to dig deeper.

The decision of the so-called Pharmacovigilance Risk Assessment Committee of the EMA, the body in charge of supervising the safety of already approved drugs, comes after a few weeks of doubts about the safety of the vaccine.

The alarm was triggered after at least thirty thromboembolic episodes detected in several countries after administering the vaccines, some of which caused the death of patients.

More information

• Denmark, Norway and Iceland temporarily suspend vaccination with AstraZeneca after several cases of thrombi in the EU

• Spain suspends vaccination with AstraZeneca for two weeks

• Health investigates three thrombi after vaccination with doses of AstraZeneca

Preventively, 16 EU countries, including Spain, decided over the last seven days to partially or totally suspend the campaign with the doses from this laboratory.

The governments from France to Italy assured that they would resume vaccination if the EMA issued a positive opinion after the study.

Since the beginning of the episodes, the European regulator has repeated in up to three statements, and in a public appearance by its director, Emer Cooke, who still recommended its use: "The benefits continue to outweigh the risks," said Cooke.

However, it considered that the new data provided required a detailed evaluation and decided to put the monitoring mechanisms in place to clear up doubts and study whether there was a “causal relationship” between the vaccines and the incidents.

The EMA had defended until now that the episodes were detected in a small number of people, when it is known that thousands of people develop thrombi and embolisms annually for many and diverse reasons, and that these did not seem "superior to those of the general population" .

The investigation has not ruled out any hypothesis: specific items have been tracked, the manufacturing process in European plants has also been analyzed, as well as the general and individual clinical information of the cases reported by the different countries, just in case. the drug could affect certain subpopulations.

Spain, for example, is investigating three thrombi that occurred after vaccination.

AstraZeneca's injected vaccine ratio, the third approved by the EU after the EMA medical green light in late January, is the lowest in the European portfolio.

Member States have received 15.8 million doses from this laboratory, of which 8.6 million have been injected so far, according to data from the European Center for Disease Prevention and Control (ECDC).

The proportion is 54%, well below the Pfizer-BioNtech preparation, whose proportion exceeds 90% (39.4 million of the 43.5 million supplied have been punctured).

In Spain, which stopped the immunization campaign with AstraZeneca for two weeks on Monday, 940,722 doses of the more than one and a half million received (59%) from this laboratory have been injected to date.