Italian Medicines Agency Agenzia Italiana del Farmaco

AstraZeneca’s COVID-19 vaccine: benefits and risks in context - AstraZeneca’s COVID-19 vaccine: benefits and risks in context

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AstraZeneca’s COVID-19 vaccine: benefits and risks in context

Vaxzevria (formerly COVID-19 Vaccine AstraZeneca) is authorised in the EU to prevent COVID-19, which can cause severe disease and death. The disease can also have long-term consequences in people of all ages, including in otherwise healthy people.
The benefits of Vaxzevria outweigh its risks in adults of all age groups; however, very rare cases of blood clots with low blood platelets  have occurred following vaccination.
To support national authorities making decisions on how to best use the vaccine in their territories, EMA’s human medicines committee (CHMP) has further analysed available data to put the risk of these very rare blood clots in the context of the vaccine’s benefits for different age groups and different rates of infection.
The analysis will inform national decisions on the roll out of the vaccine, taking into account the pandemic situation as it evolves and other factors, such as vaccine availability. The analysis could change as new data become available.
The Committee also considered available data on the use of the second dose.


Published on: 23 April 2021

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