RIO DE JANEIRO, BRAZIL – Brazil’s Health Regulatory Agency (ANVISA) recommended that the administration of the anti-Covid vaccine developed by AstraZeneca laboratory in association with the University of Oxford be “immediately” suspended in pregnant women.
The regulatory agency recommends that “the indication of the vaccine’s package insert,” which includes the potential for the formation of blood clots, be followed by the Ministry of Health’s National Immunization Program.
“The guidance is the result of adverse event monitoring conducted on an ongoing basis on Covid vaccines in use in the country,” ANVISA said in a technical note released Monday, May 10.
The note does not mention specific adverse events detected in pregnant women, but the Ministry of Health confirmed that it is investigating the case of a pregnant woman who developed thrombosis a few days after being inoculated with the AstraZeneca vaccine in Rio de Janeiro.
ANVISA also alerted that the use of vaccines in situations that are not foreseen in the package insert should only be done after “individual assessment” by a health professional “who considers the risks and benefits of the vaccine for the patient.”
“AstraZeneca’s current Covid vaccine package insert does not recommend its use without medical guidance,” it added.
Following the regulator’s advice, some states in the country, including São Paulo and Rio de Janeiro, on Tuesday announced the preventive suspension of pregnant and puerperal women’s immunization on a temporary basis.
Last April, Brazil, one of the countries hardest hit by the pandemic, with more than 423,000 deaths, included all pregnant and puerperal women in its national vaccination program priority groups, considering that they “have a high obstetric risk irrespective of age.”
By Monday, about 17% of the country’s population of about 210 million had been administered the first dose of the vaccine, while 8.5% had been inoculated with the second dose.
AstraZeneca’s vaccine accounts for 26.4% of the doses administered in Brazil since the beginning of the national immunization campaign, last January, according to Ministry of Health data.
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