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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 . . .

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