The European Medicines Agency (EMA) has diagnosed a possible association of the AstraZeneca vaccine with very rare cases of abnormally low platelet blood clots, but confirms that the overall benefit-risk balance remains positive.
In particular, the head of the organization Emer Cook at a press conference of EMA on Wednesday afternoon, announced that the EMA Security Committee (PRAC) concluded that "unusual blood clots with low platelets should be recorded as very rare side effects. (former COVID-19 Vaccine AstraZeneca). ”
"The benefits outweigh the side effects," said Emer Cook, adding that the vaccine saves lives and should be continued.
The director noted that COVID-19 associated with a definite risk of hospitalization and death. The reported combination of blood clots and low platelets is very rare and the overall benefits of the vaccine in preventing COVID-19 outweigh the risks of side effects.
As she explained, "a reasonable explanation for the combination of blood clots and low platelets is an immune response, leading to a condition similar to that sometimes seen in patients receiving heparin (heparin-induced thrombocytopenia, HIT)."
He further clarified that "Vaxzevria is one of the four vaccines approved in the EU for protection against COVID-19. Studies show that it is effective in preventing disease. It also reduces the risk of hospitalization and death from COVID-19. "
The PRAC Committee has requested new studies and modifications to ongoing studies to provide more information and will take further action as required.
In its evaluation, the PRAC committee took into account all available information, including the advice of a panel of experts.
The EMA reminds health professionals and people receiving the vaccine "to be aware of the possibility of very rare blood clots in combination with low platelet counts within 2 weeks of vaccination".
EMA clarifies that "so far, most of the reported cases have occurred in women under 60 years of age within 2 weeks of vaccination".
"Based on the available data, specific risk factors have not been confirmed (drugs, or underlying diseases)," says EMA.
"People who have received the vaccine should seek medical help immediately if they develop symptoms of this combination of blood clots and low platelets," he said.
The PRAC Committee noted that blood clots appeared in veins in the brain (cerebral venous thrombosis, CVST) and in the abdomen (splenic vein thrombosis) and arteries, along with low platelet counts and sometimes bleeding.
The committee conducted a thorough review of 62 cases of CVST thrombosis and 24 cases of splenic vein thrombosis reported in the EU Drug Safety Database (EudraVigilance) on 22 March 2021, 18 of which were fatal. 1 mainly from spontaneous EEA and UK reporting systems, where around 25 million people had received the vaccine.
"The scientific evaluation of the EMA supports the safe and effective use of vaccines COVID-19", It is noted.
"The use of the vaccine during vaccination campaigns at national level will also take into account the pandemic situation and the availability of vaccines in each Member State," said Coreper.
The PRAC Committee emphasizes the importance of immediate specialized medical treatment.
"By recognizing the signs of blood clots and low platelets and treating them early, health professionals can help those affected by their recovery and avoid complications."
Finally, the committee clarifies that the probability of these side effects occurring is very low and calls on the public to
seek emergency medical help immediately if you have any of the following symptoms in the weeks after vaccination:
swelling in the legs
persistent abdominal pain
neurological symptoms such as severe and persistent headaches or blurred vision
tiny spots of blood under the skin beyond the injection site.