GACVS statement on rare thrombotic events with the AstraZeneca vaccine in Europe


The COVID-19 subcommittee of the Global Advisory Committee on Vaccine Safety (GACVS) met in March 2021 to
review available data on cases of thromboembolism and thrombocytopenia reported following administration of the
AstraZeneca COVID-19 vaccine. The data were obtained from clinical trials and reports on safety of the vaccines
from Europe, the United Kingdom, and India, and from WHO's VigiBase reporting safety in individual cases, from
which it concluded and recommended that:

- The benefits of the vaccine continue to outweigh the risks, with enormous potential to prevent SARS-CoV-2
infection and reduce mortality worldwide.

- Administration of COVID-19 vaccines does not result in an overall increase in disorders such as deep vein
thrombosis or pulmonary embolism. The rates of such occurrences are consistent with the expected number
of diagnoses of these disorders, which are not uncommon and occur naturally, and can also occur as a
result of COVID-19 itself. The observed rates of these events have been lower than expected.
- Of the 18 cases of cerebral venous sinus thrombosis reported after more than 20 million vaccinations with
the AstraZeneca vaccine in Europe, no cause-and-effect relationship has at present been established,
though this remains a possibility.
- GACVS recommends that all countries continue to monitor the safety of all COVID-19 vaccines, and
encourages reporting of any suspected adverse effects.


Additional information concerning the events and studies being conducted on this topic can be found at:
PRAC Report,

Source: Østergaard SD, Schmidt M, Horváth-Puhó E, Thomsen RW, Sorensen HT. Thromboembolism and the Oxford–
AstraZeneca COVID-19 vaccine: side-effect or coincidence? The Lancet 2021 doi: 10.1016/S0140-6736(21)00762-5

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