The risk of thrombosis at 11 excess events per 100 000 vaccinations are higher than estimated by the European Medicines Agency. The EMA estimates the risk of thrombosis to be between 1 and 2 per 100 000 people, depending on age. Among the venous thromboembolic events, the most notable was cerebral venous thrombosis, which was about 20 times more common after the Oxford-AstraZeneca vaccine than expected with an excess risk of 2.5 per 100 000 vaccinations. Venous thromboembolic events were more common in women than in men and were also more common in people aged 18-44 than in those aged 45-65. Thrombocytopenia and bleeding were mildly increased after vaccination, but not significantly.
Study Paper here: Arterial events, venous thromboembolism, thrombocytopenia, and bleeding after vaccination with Oxford-AstraZeneca ChAdOx1-S in Denmark and Norway: population based cohort study
“Up to 5 April 2021, the MHRA had received Yellow Card reports of 100 cases of major thromboembolic events (blood clots) with concurrent thrombocytopenia (low platelet counts) in the UK following vaccination with COVID-19 Vaccine AstraZeneca. These events occurred in 61 women and 39 men aged from 18 to 85 years and the overall case fatality rate was 22% with 22 deaths.
Of these, 99 reports were associated with the first dose of the vaccine and a single report followed a second dose, although this individual had medical conditions that could have caused the events. Fifty individuals had cerebral venous sinus thrombosis (average age 46 years) and 50 had other major thromboembolic events (average age 52 years) with concurrent thrombocytopenia.”
“As part of our enhanced surveillance of thromboembolic disorders, 3 new cases of thrombosis of the large veins of atypical locations associated with thrombocytopenia and/or coagulation disorders were analyzed during the weekly monitoring committee of the ANSM with the network French CRPVs (12 cases in total since the start of vaccination, including 4 deaths).
These cases, mainly located in the brain, occurred within a median time of 9 days after vaccination, mainly in women and with no specific common history identified to date (9 vaccinated people under 55 years old, 3 people over 55 years).”
ANSM report The seventh pharmacovigilance report on adverse reactions reported with the AstraZeneca vaccine (Vaxzevria) covers data validated from March 19 to 25, 2021
Information from the previous (sixth) ANSM report:
“The sixth pharmacovigilance report on adverse reactions reported with the AstraZeneca vaccine covers data validated from March 12 to March 18, 2021 . Since the start of vaccination with the AstraZeneca vaccine, 5,693 cases of adverse effects have been analyzed by the CRPV reporters (Amiens and Rouen). The vast majority of these cases concern flu-like syndromes, often of high intensity (high fever, body aches, headaches). More than 1,430,000 injections have been performed as of March 18, 2021.
As part of our enhanced surveillance of thromboembolic disorders, a total of 16 new cases were analyzed during the weekly ANSM monitoring committee with the French CRPV network, for a total of 29 cases since the start of vaccination. The majority of thromboembolic events have occurred within 15 days of vaccination in patients with risk factors.
Among all these cases, 9 cases of thrombosis of the large veins, atypical by their location (mainly cerebral, but also digestive), which may be associated with thrombocytopenia or coagulation disorders were reported, including 2 deaths. These cases occurred within a median of 8.5 days after vaccination in people with no specific history identified to date (7 patients under 55 years old, 2 patients over 55 years old).”
ANSM report The sixth pharmacovigilance report on adverse reactions reported with the AstraZeneca vaccine covers data validated from March 12 to March 18, 2021
Lithuania is the latest to suspend use of AstraZeneca’s Covid vaccine as “a precaution” until the European Medicines Agency gives a final evaluation of its safety, the country’s health minister Arturas Dulkys has said.
“We are taking the decision now, because over the previous few hours we have received three reports about serious, unexpected, unwanted thromboembolic cases in patients who were given the AstraZeneca vaccine in Lithuania”, the head of the country’s medicine authority Gytis Andrulionis said. “We do not have proof whether this is a coincidence or due to the vaccine.”