Janssen vaccine may cause new adverse effects, according to Anvisa

After analyzing records of adverse effects of vaccine against covid-19, the National Health Surveillance Agency (Anvisa) requested that the pharmaceutical Janssen (Johnson & Johnson) update the package insert of its formula. The order was released last Friday (19) and until 19 days, the Brazilian package insert for the immunizing agent against the SARS-CoV-2 coronavirus must be updated.

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“With the passage of time of marketing and use of any drug worldwide, including vaccines, new adverse events can be identified. That is why there is pharmacovigilance, which systematically monitors and evaluates the benefit profile -risk of vaccines”, emphasizes Anvisa, in a note on the procedure that is considered standard.

Anvisa asks for the inclusion of new adverse effects in the package insert of Janssen’s vaccine against covid-19 (Image: Reproduction/Rthanuthattaphong/Envato Elements)

By ordering, Anvisa requests the inclusion of the following possible adverse effects of the vaccine against covid-19, considered mild:

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  • Lymphadenopathy (increase in the size and/or number of lymph nodes, such as the appearance of lumps in the neck);
  • Paresthesia (feeling of numbness in some part of the body);
  • Hypoesthesia (decreased skin sensitivity);
  • Tinnitus (tinnitus in the ear);
  • Diarrhea;
  • Vomiting.

    It is worth noting that, so far, “the benefits of all vaccines approved by Anvisa outweigh their risks”, informs the agency .

    How to report adverse effects of vaccines?

    To facilitate the notification of adverse effects of vaccines and medications, Anvisa has launched a new form. In this way, the agency seeks to facilitate and streamline the citizen’s report on suspicions of these events. This is because people who are not health professionals can access the channel.

    The space is intended for users to report “suspected problems during treatment, such as adverse reactions, absence or reduction of the effect , medication errors, interactions between different medications and use with a different purpose than indicated in the package insert (off label)”. In addition, those who write can notify a fact even without the certainty that it was a drug or vaccine that caused the problem.

    To access the Anvisa form, click here.

    Source: Anvisa

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