ANVISA requests modification of Oxford-AstraZeneca-Fiocruz vaccine package insert

11/04/2021

 


On Wednesday, 4 April 2021, ANVISA reported that it had requested modification of the insert for the Oxford-
AstraZeneca-Fiocruz vaccine, to include in the warnings and precautions section the possibility of very rare cases of
blood clots associated with thrombocytopenia. In addition, ANVISA noted that the recommendation is to continue its
use, as the benefits, to date, outweigh the risks of using the vaccine.


In its statement, ANVISA clarifies that more than four million doses of the Oxford-AstraZeneca-Fiocruz vaccine have
been administered in Brazil, with a total of 47 suspected cases of thromboembolic adverse events, with only one
thrombocytopenia-associated event. In addition, it reported that no causal link between these 47 suspected cases of
thromboembolic events and the use of the vaccine could be established.


In addition, ANVISA emphasizes that most of the side effects that occur with the use of the Oxford-AstraZeneca-
Fiocruz vaccine are mild and transient in nature, lasting only a few days. Thus, while the risk of blood clots is very
low, people receiving the vaccination should be attentive to possible symptoms, and seek immediate medical
attention should they occur. These symptoms include dyspnoea, chest pain, swelling of the leg, and persistent
abdominal pain; in addition to neurological symptoms, such as severe and persistent headaches or blurred vision.
Source: Brazil drug watchdog calls for update in Oxford vaccine package insert. 08 April 2021. Available at:


https://agenciabrasil.ebc.com.br/en/saude/noticia/2021-04/brazil-drug-watchdog-calls-update-oxford-vaccinepackage-
insert

 

 

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