“Rare thromboses should be listed as very rare side effects of AstraZeneca’s Vaxzevria vaccine.” This is what the EMA safety committee (Prac) established in the conclusions of the meeting that took place today. “In reaching its conclusion – reads the note – the committee took into consideration all the evidence currently available, including the opinion of a group of experts”. The EMA reminds health professionals and people “who receive the vaccine that they must be aware of the possibility that rare thrombotic events associated with low levels of platelets in the blood may occur within two weeks of vaccination – continues the note – So far, the Most of the reported cases occurred in women aged less than 60 years and within 2 weeks of vaccination. Based on the evidence currently available, the specific risk factors have not been confirmed. ‘ According to Ema experts, “people who have received the vaccine should seek medical assistance immediately if they develop symptoms.”
However, the EMA confirms “that the risk / benefit balance remains positive”, underlining that “the benefits of the vaccine continue to outweigh the risks for the people who receive it. The vaccine is effective in the prevention of Covid-19 and in the reduction of hospitalizations and deaths », underlines the agency. In addition, Ema stressed, “there are no generalized risks in the administration of the vaccine, so we did not consider it necessary to recommend specific measures to reduce the risk”.
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Ema’s verdict is expected after the hypothesis of a link between the vaccine produced by the Anglo-Swedish company and the very rare cases of thrombosis in certain age groups. Some countries, such as Germany and the Netherlands, had already set partial or total restrictions on the administration of the drug.
Ema, analyzed 86 total cases of rare thrombosis after AstraZeneca, 18 fatal
The Ema Prac Pharmacovigilance Committee carried out «an in-depth analysis on 62 cases of cerebral thrombosis and 24 of venous thrombosis, reported in the European database EudraVigilance up to 22 March. Of these cases, 18 were fatal. Rare events have been reported in the EAA systems and in the UK, where around 25 million people have received the vaccine. ‘ This was reported by the EMA in a note released on the conclusions of the Prac pharmacovigilance committee. “The reported combination of blood clots and very low platelets is rare – experts warn – while the overall benefits of the vaccine in preventing Covid-19 outweigh the risk of side effects”.
According to experts, “the combination of blood clots and low platelets could be linked to the body’s immune response – the committee suggests – which leads to a condition similar to that sometimes seen in patients treated with heparin (heparin-induced thrombocytopenia)” . The committee requested new studies and changes to those in progress “to provide more information and take any further necessary action.” EMA technicians warn of the importance of promptly recognizing the signs of adverse events related to thrombosis. “By recognizing the early signs of blood clots and low platelets and treating them early, health professionals can help those affected by these events recover and avoid complications,” they note. Among the warning sirens, the committee lists: shortness of breath, chest pain, swelling of the legs, persistent abdominal pain, headache and blurred vision.