The Oswaldo Cruz Foundation (Fiocruz) deeply regrets and sympathizes with the relatives of the patient who died in Rio de Janeiro from a suspected serious adverse event of hemorrhagic stroke. There is still no confirmation of the relationship between this case and the vaccine, which is still under investigation by the health authorities and is supported by the Foundation, which is responsible for monitoring the pharmacovigilance of the vaccines produced by the institution.

Vaccination in pregnant women has been recommended in several countries under different conditions. This is a complex issue because of the failure to include this population group in phase 3 clinical trials of all Covid-19 vaccines. Fiocruz understands that the temporary suspension of immunization of pregnant and postpartum women with the AstaZeneca/Covid-19 Fiocruz vaccine by the National Immunization Program (NIP) is a precautionary measure until the investigation of the case is concluded and an evaluation of the epidemiological context and available data can be made. 

Fiocruz reinforces the benefits of immunization with the AstraZeneca/Covid-19 Fiocruz vaccine, as evidenced by effectiveness studies in different countries. This research demonstrates the vaccine's impact in controlling the pandemic and avoiding hospitalizations, while overcoming the possible risks, considered extremely rare, of thrombosis associated with thrombocytopenia (low levels of platelets in the blood). 

The Foundation will follow the case investigations, reaffirming its commitment to the pharmacovigilance of the vaccine in Brazil. Fiocruz seeks to clarify the population and reinforces the role of regulatory agencies around the world, along with vaccine producers, in the follow-up and permanent monitoring of these immunizers.

Source: Oswaldo Cruz Foundation (Fiocruz) portal.