COVID-19 Vaccine AstraZeneca® – conclusion of EMA review of usage safety in reference to the thromboembolic events following vaccination

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has concluded its preliminary review of a signal of thromboembolic events in people vaccinated with COVID-19 Vaccine AstraZeneca® as of yesterday 18 March 2021. The EMA concluded that the benefits of the vaccine in combating the, still widespread, threat of COVID-19 (which itself results in clotting problems and may be fatal) continue to outweigh the risks. Although the vaccine is not associated with an increase in the overall risk of blood clots (thromboembolic events) in those who receive it, the vaccine may be associated with very rare cases of blood clots associated with thrombocytopenia, including rare cases of Cerebral Venous Sinus Thrombosis (CVST). These are rare reports, with 18 cases of CVST and 7 cases of Disseminated Intravascular Coagulation (DIC) assessed as part of the EMA review. Approximately 20 million people in the UK and EEA had received the vaccine as of March 16 2021.Given the vaccine’s proven efficacy in preventing hospitalisation and death from COVID-19, the PRAC concluded that the benefits of COVID-19 Vaccine AstraZeneca® outweighs the extremely small likelihood of developing DIC or CVST. However, given the findings, healthcare professionals and vaccine recipients should be aware of the remote possibility of developing such syndromes. Recipients should be advised to seek immediate medical attention should they develop symptoms as outlined below and should inform healthcare professionals of their recent vaccination.  While further analysis is ongoing, the product information for the vaccine will be updated to include more information on these risks.
For the current time there is no evidence of a problem related to specific batches of the vaccine.

Go back

News

Merry Christmas and Happy New Year

Let the magical night of Christmas Eve bring peace and joy. Let every moment of Christmas live with its own beauty, and bestows the New Year with prosperity and happiness.

Read more …

COVID -19 Antigen Tests:

On 31st of October 2020, the Chief Sanitary Inspectorate confirmed that the antigen cassette tests are the same basis for determining the SARS-CoV-2 ...

Read more …

BRG team participated in BIO-Europe®

On 26th -27th  of October BRG team participated in BIO-Europe® the largest partnering conference in Europe dedicated to the global biotechnology industry. 

Read more …

BRG Team participated in the official opening of the Celon Pharma Research and Development Center

On September 28, 2020 BRG Team participated in the official opening of the Celon Pharma Research and Development Center

Read more …

About Us | Services | Our Site | Partners | Smoking Risk Study | Contact Us

Early Phase Clinical Trials

2021 © Bio Research Group. All rights reserved.

 

scroll to top ▲