The European Medicines Agency (EMA) said on March 18 that a special investigation had established that the AstraZeneca vaccine against Covid-19 was safe and effective and that the benefits of using it were far greater than the risks.
The investigation was prompted by reports of some recipients of the vaccine subsequently experiencing blood clots or thromboembolic events, which prompted a number of European Union countries to suspend administering the AstraZeneca vaccine.
EMA executive director Emer Cooke said that the agency’s Pharmacovigilance Risk Assessment Committee (PRAC) had concluded that the vaccine was safe and effective and was not associated with an increase in the overall risk of thromboembolic events or blood clots.
Cooke said that awareness should be raised and information about any risks should be included in the product information.
She said that a small number of cases had been found of a rare and unusual, but serious, blood clotting disorder. Currently, a link between it and the vaccine could not be ruled out. The EMA would be launching an additional investigation, with targeted observation studies.
Seven million people in the EU and 11 million in the United Kingdom had received the AstraZeneca vaccine. It remained very important that all side effects be closely monitored and reported, Cooke said.
The EMA was aware that some EU countries had paused use of the vaccine. Given that thousands of people were dying every day, it had been really crucial for the agency to review as rapidly as possible all the available evidence.
PRAC head Sabine Straus said that cases examined in Europe showed that there was no higher overall risk, and in fact, the risk of such events might even be lowered.
Straus said that there were rare cases of a condition associated with low blood platelets, but at this stage there was not sufficient information to link these cases to the vaccine.
She said that incidences of blood clots were lower than might be expected in the general population.
Bulgaria is among the 13 countries that suspended first vaccinations with AstraZeneca, in particular after a reports that a woman in her 50s, who had a previous history of heart trouble and other serious illnesses, had died several days after receiving the jab.
Health Minister Kostadin Angelov told local media on March 18 that an autopsy had established that there was no connection between the vaccine and the woman’s death.
Bulgaria’s government has said repeatedly that once the EMA gave the AstraZeneca vaccine the all-clear, the country would resume administering the vaccine, of which it currently has about 100 000 doses in stock.
Bulgaria, which has struggled with shortfalls in doses of vaccines, will from March 22 go into a 10-day period of heightened anti-epidemic measures, including closing restaurants and schools, suspending public events and allowing only stores supplying essential services to be open in shopping malls.
The Sofia Globe’s coverage of the Covid-19 situation in Bulgaria is supported by the Embassies of Switzerland and Finland.
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