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EMA for AstraZeneca: Thrombosis is possible but rare – No change in its use

The European Medicines Agency (EMA) diagnosed possible association of AstraZeneca vaccine with very rare cases of unusual low platelet blood clots, but confirms that the overall benefit balance – risk remains positive.

Specifically, the head of the organization Emer Cook at a press conference of Coreper on Wednesday afternoon, announced that the EMA Security Committee (WASH) concluded that “Unusual blood clots with low platelets should be listed as very rare side effects of Vaxzevria (former COVID-19 Vaccine AstraZeneca).”

“The benefits outweigh the side effects”, stressed Emer Cook, making it clear that the vaccine saves lives and should continue to be used.

The director clarified that COVID-19 is associated with a certain risk of hospitalization and death. The reported combination of blood clots and low platelets is very rare and the overall benefits of the COVID-19 vaccine outweigh the risk 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 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..

During its evaluation, the PRAC committee took into account all available data, including the advice of a panel of experts.

The EMA reminds health professionals and people receiving the vaccine “remain aware of the possibility of very rare cases of blood clots in combination with low platelet levels within 2 weeks after vaccination”.

Coreper clarifies that “so far, most of the reported cases have occurred in women under 60 years within 2 weeks after vaccination”.

“Based on available data, specific risk factors have not been confirmed (medicines, or underlying diseases)”, reports Coreper.

“People who have received the vaccine should seek medical help immediately if they experience symptoms of this combination of blood clots and low platelets.”, emphasizes.

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 in the arteries, along with low platelet levels and sometimes bleeding.

The committee conducted a thorough review 62 cases of CVST thrombosis and 24 cases of splenic vein thrombosis listed in the EU Drug Safety Database (EudraVigilance) at 22 Of March 2021, 18 of which were lethal. 1 mainly from spontaneous EEA and UK reporting systems, where approximately 25 millions of people had received the vaccine.

“EMA scientific evaluation supports safe and effective use of COVID-19 vaccines”, is noted.

“Vaccine use during vaccination campaigns at national level will also take into account the pandemic situation and the availability of vaccines in each Member State.”, reports Coreper.

The PRAC Committee emphasizes the importance of immediate specialized medical treatment.

“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”, refers.

Finally, the committee clarifies that the possibility of these side effects occurring is very low and calls on the public to seek emergency medical help immediately if they have any of the following symptoms in the weeks after vaccination.:

  • breathing difficulty
  • chest pain
  • 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.

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