EMA Links AstraZeneca Vaccine To Rare Cases Of Thrombi

The European Medicines Agency (EMA) has recognized that there is “a possible link” between people vaccinated with the AstraZeneca antidote and the very rare cases of unusual blood clots reported. However, he considers that the general benefits of this vaccine in the prevention of covid19 continue to outweigh the risks of possible side effects.

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“The EMA safety committee has concluded that unusual blood clots with low blood platelets should be included as very rare side effects of Vaxzevria (as the AstraZeneca vaccine has been renamed),” the evaluation committee of risks and pharmacovigilance (PRAC) following a latest investigation in which it points out that a plausible explanation for the combination of blood clots and low blood platelets “is an immune response that leads to a condition similar to that sometimes observed in treated patients with heparin ”.

For this reason, the EMA has again recommended that healthcare professionals and all people receiving the AstraZeneca vaccine be aware of the possibility of blood clots within two weeks after injection, be aware of possible symptoms and seek urgent medical attention if suffer from any of them (shortness of breath, chest pain, persistent abdominal pain, headache or blurred vision among others).

Women under 60
Until now, as explained by the executive director, Emer Cooke , the majority of cases of blood clots have occurred in women under 60 years of age, although with the evidence currently available “no specific risk factors have been confirmed” or due to gender, age, or prior medical conditions.

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“Although most cases have occurred in people under 60 years of age and in women, due to the different ways in which the vaccine is used in different countries, the PRAC has not concluded that age and sex are clear risk factors for these rare side effects, “said its manager, Sabine Strauss .

Unrestricted use
For this reason, the EMA still does not recommend limiting or restricting the use of the vaccine and insists that it should continue to be used. “Covid19 is a very serious disease with very high levels of hospitalization and deaths. The vaccine has proven to be highly effective in saving lives, “said Cooke, who considers it” very important “to use available vaccines because” the risk of mortality from covid19 is much higher than the risk of very rare side effects. “

The PRAC has analyzed in recent weeks a total of 62 cases of cerebral venous thrombosis (CVST) and 24 of venous splenic thrombosis, reported until March 22, of which 18 were fatal. Until April 4, however, the cases reported to the EudraVigilancia system totaled 169 and 53 respectively in a population of 34 million vaccinated people in the European Economic Area and the United Kingdom.

Since it was approved by the EMA for its commercialization on January 29, the vaccine from the pharmaceutical company AstraZeneca, the third authorized in the EU, has lived on a roller coaster.

In the first place, due to the controversy surrounding the contract signed by the EU with the company on behalf of the Twenty-seven or the continuous production problems of the laboratory and, secondly, due to the trickle of Member States that decided to stop vaccination with this antidote or limit it. to some age groups as a result of the rare cases of thrombi identified.

Meeting of the Twenty-seven
Summoned by the rotating Portuguese presidency of the EU, the 27 health ministers have addressed this Wednesday the conclusions of the latest EMA opinion in a new attempt to combine positions and try to harmonize the different approaches applied when administering the AstraZeneca antidote. “AstraZeneca’s experience shows that our pharmacovigilance system works.

But it is essential that we follow a coordinated approach across the European Union: we must speak with one voice to increase public confidence in vaccines”, claimed the health commissioner , Stella Kyriakides, which together with the Portuguese presidency of the EU has appealed to all member states to work towards “a position as coordinated as possible”.

“It is a technical decision, not a political one. We must continue to follow the best scientific information provided by the EMA. We must not forget that individual decisions affect everyone,” recalled the Portuguese Minister of Health, Marta Temido , in a statement in which underline that the Twenty-seven agree on the need for “more pharmacovigilance studies” on the impact of vaccines on specific groups.

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Countries such as Denmark or Norway have taken a very cautious approach and have temporarily suspended the administration of the vaccine.

Others like Sweden decided on March 25 to resume vaccinations but only to those over 65, the same as Finland , while Germany only injects people over 60 years old and France in those over 55 years old. Following the EMA’s decision, Belgium on Wednesday decided to reserve this antidote for at least the next four weeks only for those over 55 years of age.