AstraZeneca: The National Health Surveillance Agency (Anvisa) recommended on Monday (10) the “immediate suspension” of the application of the vaccine against covid-19 by AstraZeneca in pregnant women. The product had been used in some states to immunize pregnant women with comorbidities.
According to the regulatory agency, the decision was made after the “monitoring of adverse events” carried out on the immunizers used in the country. The guidance is that the National Immunization Program (PNI) follows the indication of the package leaflet for vaccine shipped in Brazil by the Oswaldo Cruz Foundation (Fiocruz).
Also according to the Anvisa note, the off-label use of the vaccine (in situations not provided for in the package insert) should be restricted to cases evaluated by health professionals, taking into account the risks and benefits for the patient. It is worth mentioning that the Oxford vaccine package insert does not provide for the use of the product in pregnant women without medical guidance.
Since April, pregnant women and women who have recently given birth (women in the postpartum phase) have been included in the PNI priority group, due to the increased risk of hospitalization for covid-19. In addition to the AstraZeneca vaccine, the formulas of Pfizer and CoronaVac are also being used, which continue to be applied normally in this public.
In response to the guidance given by Anvisa, the British pharmacist clarified that pregnant women and breastfeeding women did not participate in the clinical trial of the vaccine. However, animal studies have not found “direct or indirect harmful effects” to pregnancy or fetal development, according to the company.
Despite this, local authorities are following Anvisa’s guidance regarding the suspension of the use of the AstraZeneca vaccine. According to a survey by G1, the application of the product in pregnant women was halted in 22 states, while in the others, pregnant women were being immunized with doses of Pfizer to protect against the new coronavirus.