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

Completion of a single-center phase I study of the safety and pharmacokinetics of CPL207280

We have just completed a phase I study of safety and pharmacokinetics (part B) of an innovative therapy that could be used...

Read more …

GcLP quality certificate for laboratory procedures

The BRG Clinical Site received the GcLP quality certificate for laboratory procedures and is in the process of obtaining GMP certification for pharmaceutical procedures.

Read more …

Study for healthy people with a drug against Covid-19

In BRG we are currently performing a study for healthy people with a drug against Covid-19 .
In the project we are comparing experimental injectable drug called...

Read more …

Phase I study finished

Our site has just succesfully finished clinical stage of phase I (two parts) study with JAK kinase inhibitors.

Read more …

Safety and Pharmacokinetics of JAK/ROCK Inhibitor in Healthy Volunteers

In BRG we are just starting Study for Healthy People with an Immune Drug - Part B. The aim of the following clinical trial...

Read more …

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

Early Phase Clinical Trials

2024 © Bio Research Group. All rights reserved.

 

scroll to top ▲