Brazil’s health regulator requests changes in Janssen and AstraZeneca vaccines package inserts

RIO DE JANEIRO, BRAZIL – Brazil’s health regulator ANVISA has requested vaccine manufacturers Janssen/Johnson & Johnson and AstraZeneca/Fiocruz to include in their Covid-19 immunizers’ package inserts the counter-indication for use in people with a history of capillary leak syndrome.

In a statement, ANVISA explained that capillary leak syndrome is a “very rare and serious condition” that causes leakage of fluid from small blood vessels (capillaries), resulting in swelling mainly in the arms and legs, low blood pressure, thickening of the blood, and low levels of albumin, an important blood protein.

ANVISA received reports of suspected syndrome after vaccination and is analyzing cases. “Healthcare professionals should be aware of the signs and symptoms of capillary leak syndrome and the risk of recurrence in people who have been diagnosed with the disease.”

According to the regulator, people who have been administered the vaccine should seek immediate medical attention should they experience swelling in the arms and legs or sudden weight gain in the days following vaccination. “These symptoms are often associated with feeling faint (due to low blood pressure),” it added.

According to the regulator, some cases evaluated by the European Medicines Agency (EMA) relate to a history of capillary leak syndrome.

Source: Exame

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