Bulgaria Resumes Vaccinations with AstraZeneca, EMA Commission Proved Vaccine Safe

Vaccination with the AstraZeneca vaccine may continue in all EU countries from tomorrow, Bogdan Kirilov, executive director of the Bulgarian Drug Agency said on March 18.

He added that there is an official statement which confirms the effectiveness of the vaccine and there is no problem to continue using it.

"There is no problem in the quality of the vaccines, we have a conclusion about the death of the woman from Plovdiv - no thrombosis was observed," said Kirilov.

According to the director of the BDA, at this stage there is no direct link between vaccination and deaths of vaccinated people.

The work of the online Covid-19 jabs registration system will start tomorrow, March 19, as well as the vaccination of the persons who were registered through it earlier, announced Zheni Nacheva, Deputy Minister of Health.

"Tonight we will inform the people who have been registered for vaccination so that they can come to the vaccination centres tomorrow and receive their first dose of the vaccine," she said.

Maria Popova from the Bulgaria Drug Agency said that the EMA’s expert committee came to the conclusion that the benefits of the AstraZeneca vaccine in protecting people from Covid-19 with the associated risks of death and hospitalisation hugely outweigh the risks.

She added that EMA's safety committe made 4 important conclusions:

• the benefits of the vaccine in combating the still widespread threat of COVID-19 (which itself results in clotting problems and may be fatal) continue to outweigh the risk of side effects;
• the vaccine is not associated with an increase in the overall risk of blood clots (thromboembolic events) in those who receive it;
• there is no evidence of a problem related to specific batches of the vaccine or to particular manufacturing sites;
• however, the vaccine may be associated with very rare cases of blood clots associated with thrombocytopenia, i.e. low levels of blood platelets (elements in the blood that help it to clot) with or without bleeding, including rare cases of clots in the vessels draining blood from the brain (CVST).

Maria Popova clarified that this concerns very rare cases of extremely specific syndromes, which include a small number of platelets and the formation of blood clots, with or without bleeding. They are rare and will continue to be studied.

As they are important for human health, the committee formulates recommendations that will be included in the summary or package leaflet so that patients can react on time if something happens.

There are no reactions reported in Bulgaria that resemble these rare reactions, Popova reassured.

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