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Statement of the WHO Global Advisory Committee on Vaccine Safety (GACVS) COVID-19 Covid-19 vaccines: safety surveillance manual

As of March 17, 2021, more than 120 million cases of COVID-19 infections, with more than two million deaths, have been reported worldwide. Vaccination remains a critical tool to help prevent ongoing illness and death and to control epidemics.
To date, more than 20 million doses of AstraZeneca vaccine have been distributed in Europe and more than 27 million doses of Covishield (AstraZeneca vaccine by the Serum Institute of India) have been developed in India.
Statement of the WHO Global Advisory Committee on Vaccine Safety (GACVS) COVID-19

The subcommittee reviewed clinical trial data and reports based on safety data from Europe, the United Kingdom, India and Vigibase, the WHO's global database of individual safety case reports.
The GACVS COVID-19 sub-committee met on 16 and 19 March 2021 to review available data on thromboembolic events (blood clots) and thrombocytopenia (low platelets) after vaccination with the AstraZeneca COVID-19 vaccine. Based on a careful scientific review of the available information, the subcommittee reached the following conclusions and recommendations:
The available data do not suggest any complete increase in thickening conditions such as venous thrombosis or pulmonary embolism following the administration of COVID-19 vaccines. The reported rates of thromboembolic events after COVID-19 vaccination are consistent with the expected number of diagnoses of these conditions. Both of these conditions are natural and rare. And they occur as a result of COVID-19. Visual rates have been lower than expected at such events.
The AstraZeneca COVID-19 vaccine (including Covishield) continues to have a good profit profile, with great potential to prevent infection and reduce deaths worldwide.
Although rare and unique thromboembolic events are associated with thrombocytopenia, such as cerebral venous sinus thrombosis (CVST), also reported after vaccination with the AstraZeneca COVID-19 vaccine in Europe, it is uncertain whether it was caused by vaccination. The European Medicines Agency's Pharmacovigilance and Risk Assessment Committee has reviewed 18 CVST cases of more than 20 million vaccines with the AstraZeneca COVID-19 vaccine in Europe. The causal relationship between these rare events has not yet been established at this time (1).
Adequate education should be provided to health care professionals and vaccinated individuals to identify the signs and symptoms of all serious adverse events after vaccination with all COVID-19 vaccines, so that people can seek and receive prompt and appropriate care and treatment. The GACVS subcommittee recommends that countries continue to monitor the safety of all COVID-19 policies and encourage the reporting of suspected incidents. The GACVS subcommittee also agrees with the European Medicines Agency's plans to further investigate and monitor these events.
The GACVS COVID-19 subcommittee will continue to review safety information from all COVID-19 policies and update any recommendations as and when required. The WHO COVID-19 safety manual provides international guidance on safety monitoring and the sharing of negative information on new COVID-19 policies, and can be found

Vaccine Safety (GACVS) COVID-19 Covid-19 vaccines: safety surveillance manual
Vaccine Safety (GACVS) COVID-19 Covid-19 vaccines: safety surveillance manual


Covid-19 vaccines: safety surveillance manual

Overview

The 42nd Global Advisory Committee on Vaccine Safety (GACVS) virtual meeting in May 2020 addressed pharmacovigilance preparedness for the launch of the future COVID-19 vaccines. One of their recommendations was that infrastructure and capacity for surveillance of the safety of COVID-19 vaccines should be in place in all countries and existing infrastructure be reactivated and engaged before a vaccine is introduced. This will require local, national, regional and global collaboration. Countries should include preparedness plans for COVID-19 vaccine safety in their overall plans for vaccine introduction, building on WHO guidance. The COVID-19 vaccine safety guidance manual has been developed upon recommendation and guidance of GACVS members, as well as by experts incorporating current and available information critical to all stakeholders when COVID-19 vaccines will be introduced.

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