Anvisa confirms rare cases of thrombosis, but emphasizes the safety of vaccination

On Thursday (24), the National Health Surveillance Agency (Anvisa) confirmed the record of rare cases of thrombosis in combination with thrombocytopenia (TTS), associated with vaccines against COVID-19 with an adenovirus vector — such as Covishield ( AstraZeneca/Oxford) — in Brazil. The rare adverse event has already been reported in other countries and, for now, the agency has not detailed the exact number of cases.

In the statement, Anvisa explained that the vaccines against COVID-19, in use in the country, that adopt the adenovirus are Covishield and, more recently, Janssen (Johnson & Johnson). It is worth remembering that the first batch of immunizations from Janssen arrived in the country this week. In addition, “they already contain information about this type of adverse event in their leaflets” and that “early diagnosis and treatment are essential in these cases”.

Anvisa confirms cases of thrombotic events after the use of adenovirus vaccines in Brazil (Image: Reproduction/Mufid Majnun/Unsplash)

“Most occurrences of rare cases of thrombosis associated with vaccines were identified in large urban centers, which indicates the need for greater awareness by health services, especially emergency care, for the proper diagnosis, treatment and notification of cases”, points out Anvisa. In addition, most reported cases occurred with the use of the first dose, but it can also occur after the second.

Specifically in relation to the AstraZeneca/Oxford vaccine, it is important to highlight that Anvisa maintains the recommendation to suspend the vaccination of pregnant women with this vaccine, a measure adopted in May this year. At the time, a suspected case of the adverse event in a pregnant woman was released.

Are Adenovirus Vaccines Safe?

Even with the confirmation of rare cases of thrombosis, Anvisa reinforces that, so far, the benefits of AstraZeneca/Oxford and Janssen vaccines outweigh the risks of using these products. Therefore, “it maintains the recommendation of continuity of vaccination with immunizing agents, within the indications described in the package insert”, according to the text of Communiqué 6/2021.

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According to the document, early identification of cases and the urgent implementation of appropriate therapy for the patient with thrombosis with thrombocytopenia (TTS) is necessary. In addition, Anvisa reinforces that cases of rare adverse events must be notified through VigiMed and Notivisa. Both are tools that allow for the continuous assessment of the benefit-risk balance of immunization agents in use in the Brazilian population.

After all, what does thrombosis with thrombocytopenia mean?

Thrombosis with thrombocytopenia is a rare and serious, potentially fatal condition. Therefore, it requires immediate treatment. According to Anvisa, “patients of all ages and of both sexes can develop this syndrome and, currently, there is no clear sign of risk factors associated with the event”.

Anvisa maintains indication of the use of vaccines with viral vector in Brazil (Image: Reproduction/iLexx/Envato Elements)

In case of suspicion of the condition, a series of symptoms can serve as a warning for the investigation of thrombotic events, such as: shortness of breath; chest pain; swelling or pain in the legs; persistent abdominal pain; and neurological symptoms, including severe headaches.

In addition, complaints about “blurred vision, confusion, seizures, petechiae (small red or brown spots on parts of the body), bruises or other hemorrhagic manifestations in areas of the body other than the vaccination site, after application of the vaccine” should be considered. .

In the current scenario, “health professionals should be aware of the manifestations and check for signs of thrombosis in anyone with thrombocytopenia developed within four to 52 days after the administration of a vaccine with adenovirus in its composition”, the agency completes

To access press release 6/2021 in full, published by Anvisa, click here.

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Source: Anvisa

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