ANVISA recommended immediately suspending use of the AstraZeneca/Fiocruz COVID-19 vaccine in pregnant women

10/05/2021

On Monday, 5 May 2021, Brazil's National Health Surveillance Agency (ANVISA) issued a statement recommending immediate suspension of the use of the AstraZeneca/Fiocruz COVID-19 vaccine in pregnant women. This recommendation is based on the results of ongoing monitoring of adverse events associated with COVID-19 vaccines being used in Brazil, as a precautionary measure. The action was taken after suspicion of a severe adverse event of hemorrhagic stroke that resulted in the death of the fetus. Up until 5 May, ANVISA had not received any other reports of serious adverse events in pregnant women.

According to the current package insert for the AstraZeneca COVID-19 vaccine, the vaccine is not recommended for use in pregnant women, absent a medical indication.

The ANVISA statement states that the use of this vaccine in situations not provided for in the package insert should only occur based on an individual evaluation by a health care professional that takes into account the comparative risks and benefits to the patient of receiving the vaccine. In addition, it provides guidance to pregnant women and health professionals on the issue. 

Link: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2021/comunicado-suspensao-da-vacina-da-astrazeneca-para-gestantes

 

  • Share: