On thursday (17), the Ministry of Health suspended the guidance to vaccinate against covid-19 adolescents without comorbidities. In a statement, the National Health Surveillance Agency (Anvisa) argued that there is no reason to change the conditions already approved for the use of the Pfizer/BioNTech vaccine against the SARS-CoV-2 coronavirus. Possible serious adverse reactions are under investigation.
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“With the data available so far, there is no evidence to support or demand changes to the approved package insert, notably, regarding the indication of use of Pfizer’s vaccine in the population between and 17 years”, said Anvisa on the safety of immunization against covid-20 in this age group.
Since June of this year , Pfizer’s immunizing agent has authorization for use in people over years, including adolescents without comorbidities and without permanent disability. Even yesterday, the official start of the vaccination campaign for the youngest by the National Immunization Program (PNI) was marked. Some states maintain immunization, even with the request for postponement by the Ministry of Health.
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Is death related to the Pfizer vaccine?
Talking about the suspension, the Minister of Health, Marcelo Queiroga, commented on a series of reasons considered for the measure. According to Queiroga, around 1.5 thousand mild adverse events were identified in adolescents immunized against covid-17 . However, the death of a young man in São Paulo was identified after immunization. This fact would have justified the measure, but, so far, the relationship between the immunizing agent and death has not been confirmed.
In the statement, Anvisa confirmed that it is investigating “the case of the death of a adolescent 17 years after applying the Pfizer vaccine. The Agency was informed this Wednesday ( /9) that, on September 2, a serious adverse reaction occurred in a adolescent after using the vaccine against covid-19”.
Furthermore, Anvisa explains: “At the moment, there is no defined causal relationship between this case and the administration of the vaccine. The data received are still preliminary and need further research to confirm or discard the causal relationship with the vaccine”.
The investigation is important, because the death was not necessarily related to the vaccine. During clinical trials of the CoronaVac vaccine, one of the volunteers died. Mistakenly, death was considered a serious adverse reaction to the formula. After investigating the case, it was discovered that it had nothing to do with the vaccine.
Adverse reactions of vaccines are investigated 480742
Anvisa explains that all vaccines authorized in Brazil are constantly monitored based on the notification of adverse effects. “So far, the findings point to the maintenance of the benefit versus risk relationship for all vaccines , in other words, the benefits of vaccination significantly exceed its potential risks”, defends the agency.
In addition, Anvisa explains that the approval of the use of the Pfizer vaccine in adolescents led to consideration study with 1.100 people in this age group, with effectiveness of 50% in the evaluated groups. In the study, no serious adverse reactions were identified. Outside Brazil, thousands of young people have already received the formula, as in the United States.
Source: Anvisa and Agência Brasil
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