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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

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.

TTS: Clot In Blood Vessels Occurs In Rare Cases With Certain Vaccines, Says Medical Expert Amid Reports Over AstraZeneca

Medical expert Dr Rajeev Jayadevan said that Thrombosis Thrombocytopenia Syndrome (TTS) refers to the clot in blood vessels, and it occurs in very rare cases, following the use of certain types of vaccines.

Acknowledging that the Covid vaccines have helped in preventing numerous deaths, Jayadevan, who is the Co-Chairman of National Indian Medical Association (IMA) Covid Task Force in Kerala, stated that reports of such cases have also been highlighted in many reports.

"TTS is thrombosis with thrombocytopenia syndrome, which is basically clot in blood vessels of the brain or elsewhere, along with a low platelet count. It is known to occur in very rare instances following certain types of vaccines and also from other causes. According to the WHO, adenovirus vector vaccines in particular have been rarely associated with this condition," he told ANI.

"Although COVID vaccines have prevented numerous deaths, reports of these extremely rare but potentially serious immune mediated events have also been published in reputed journals," Dr Jayadevan added.

This comes in the wake of a recent admission by AstraZeneca, the pharmaceutical company, that its Covid vaccine Covishield and Vaxzevria "can, in very rare cases, cause TTS."

According to several UK media reports, AstraZeneca has made the admission in court documents in connection with a case that alleges that the vaccine, developed with the University of Oxford, caused death and serious injury in dozens of cases.

The Serum Institute of India produced COVID-19 vaccine named Covishield but not using mRNA platform. It has been prepared using the viral vector platform. In the vaccine, a chimpanzee adenovirus - ChAdOx1 - has been modified to enable it to carry the COVID-19 spike protein into the cells of humans. This cold virus is basically incapable of infecting the receiver, but can very well teach the immune system to prepare a mechanism against such viruses.

The same technology was used to prepare vaccines for viruses like Ebola.

Amid reports about clot in blood vessels in the UK media, the Serum Institute of India did not respond to the query.

Notably in 2023, the World Health Organisation (WHO) said in its report that TTS emerged as a new adverse event following immunisation in individuals vaccinated with COVID-19 non-replicant adenovirus vector-based vaccines.

This refers to the AstraZeneca COVID-19 ChAdOx-1 vaccine and the Johnson & Johnson (J&J) Janssen COVID-19 Ad26.COV2-S vaccines.

"TTS is a serious and life-threatening adverse event. WHO has issued this interim emergency guidance to increase awareness about TTS in the context of COVID-19 vaccination and help healthcare providers in the assessment and management of potential TTS cases," the 2023 statement by WHO read.

However, Union Health Minister Mansukh Mandaviya in March 2024 at 'Dialogues - Navigating India's health sector' said that ICMR has done a detailed study which shows that COVID-19 vaccine is not responsible for heart attacks, and an individual's lifestyle and factors such as binge drinking could be among underlying causes.

Mandaviya said, "If someone has a stroke today, they think it is because of the Covid vaccine. ICMR has done a detailed study that the (Covid) vaccine is not responsible for heart attacks." (ANI)

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