SÃO PAULO – The National Health Surveillance Agency (Anvisa) approved the emergency use gives Covid-19 vaccine produced by Janssen, pharmaceutical subsidiary Johnson & Johnson. The announcement was part of an extraordinary public meeting of the collegiate board of Anvisa, held on Wednesday (31).
Directors Meiruze Sousa Freitas, Rômison Rodrigues Mota, Alex Machado Campos, Cristiane Gomes and Antônio Barra Torres voted in favor of approving the emergency use requested by Janssen, considering the context of the pandemic and agency regulatory guidelines, which include benefit analysis and risks and continuous monitoring of vaccine efficacy and safety.
Janssen (Johnson & Johnson)
Janssen’s Covid-19 vaccine is the only one currently that has a single dose application regimen. The Ministry of Health has an agreement with the pharmaceutical company to acquire 38 million doses of the vaccine, with delivery of 16.9 million doses expected by August 31 and 21.1 million doses by November 31.
Part of the Janssen vaccine studies were done in Brazil, with the results of phase III clinical studies shared with Anvisa on March 15th. Janssen’s request for emergency use was received by the agency on March 24.
Last Tuesday (30), Anvisa had already given a certificate of good practices to three factories involved in the production of the Janssen vaccine. Neighboring Colombia has also recently approved the emergency use of the immunizer.
According to Anvisa, the Janssen vaccine has a significant response after 14 days of application of the dose. The overall effectiveness of the immunizer is 66.9%. No serious adverse reactions have been identified by the agency. The most common effects are headache (headache), chills, muscle pain, joint pain and fatigue.
The agency points out as points to be deepened: effectiveness, safety and protection time considering the long term; the reaction of pregnant women to the vaccine; application with other vaccines; and the effectiveness of the Janssen immunizer against new variants of the coronavirus.
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