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Montevideo, January 30th 2023 - 13:44 UTC



Brazil's Anvisa advises against AstraZeneca vaccines for pregnant women after one fatal case

Wednesday, May 12th 2021 - 09:33 UTC
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It is not yet proven that vaccination has caused the fatal complications It is not yet proven that vaccination has caused the fatal complications

Brazil's Health Ministry Tuesday announced that vaccination of pregnant women and mothers in Brazil against Covid-19 will be restricted only to patients with comorbidities (pre-existing diseases) and they would only be given CoronaVac or Pfizer vaccines, following a death which might be linked to the AstraZeneca immunizer.

For that reason, authorities have advised pregnant women who have already received the AstraZeneca medication to seek proper follow-up, after the National Health Surveillance Agency's (Anvisa) recommendation pending a probe into the rare death on May 10 of a 35-year-old pregnant woman due to a hemorrhagic stroke that may be linked to the use of the AstraZeneca vaccine.

The case is still under investigation and, according to the federal government, it is not yet proven that vaccination has caused fatal complications. “This case is being closed, some details are missing concerning laboratory tests that are under investigation for the conclusive closing of this case,” said Franciele Francinato, a Coordinator of the National Immunization Program

Jorge Kalil, an immunology expert, and consultant to the National Vaccination Program said that the relationship between the case and the vaccine has not yet been confirmed and that adverse events of this type are rare. “In no way would we like to have the idea that this vaccine causes problems in pregnant women. It's not like this. This vaccine can have cases of thrombosis, are very rare cases, occur in women of childbearing age and varying from 1 to 100 thousand or 1 to 500 thousand vaccinated people,” he said.

But Anvisa has nonetheless recommended the suspension of the use of the AstraZeneca vaccine against Covid-19 in pregnant women. According to Anvisa, the “serious adverse event of hemorrhagic stroke was assessed as possibly related to the use of the vaccine administered to pregnant women”.

“Case of thrombosis with thrombocytopenia is a very rare adverse event, potentially related to vaccines that use adenovirus as a platform such as the Oxford / AstraZeneca / Fiocruz and Janssen vaccines, approved for use in Brazil,” Anvisa said.

“The label for the Oxford / AstraZeneca / Fiocruz vaccine is Category C, that is, the data presented so far are insufficient to substantiate a risk associated with the vaccine. Therefore, as a precautionary measure, vaccination of pregnant women is not recommended,” Anvisa also explained.

“Anvisa strongly recommended to the Ministry of Health the suspension of vaccination of pregnant women with the Oxford / AstraZeneca / Fiocruz vaccine, as a precautionary measure and based on the insufficient data related to the safety of use by pregnant women available so far.”

“Anvisa maintains the recommendation to continue vaccination with the aforementioned immunizer within the indications described in the package insert, since, so far, the benefits outweigh the risks.”

Meanwhile, Argentine Health Minister Carla Vizzotti announced Tuesday that almost 5 million doses of the AstraZeneca vaccine are to be received during May. Vizzotti explained 3,960,000 doses are from the contract signed last year while 861.600 will arrive through the Covax mechanism, for a total of 4,821,000 doses.

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