Brazil, Anvisa unanimously approves CoronaVac and Covishield vaccine for emergency use
Authorization is temporary and exceptional to minimize, as soon as possible, the impacts of the disease.
Jan 19, Sao Paulo: The Collegiate Board of the National Health Surveillance Agency (Anvisa) unanimously approved, on Sunday (17), the temporary authorization for the emergency use of the CoronaVac vaccine, developed by the pharmaceutical company Sinovac in partnership with the Butantan Institute, and of the Covishield vaccine, produced by the pharmaceutical company Serum Institute of India, in partnership with AstraZeneca / Oxford University / Fundação Oswaldo Cruz (Fiocruz).
The decisions will be published and communicated to the two institutions today. In relation to CoronaVac, in particular, the authorization was also conditioned to the signing of a Term of Commitment and its publication in the Official Gazette (DOU). This document determines that, until February 28, the complementation of the immunogenicity studies is made and presented to Anvisa, as approved in phase III clinical study design of the vaccine.
So-called immunogenicity is the ability, for example, of a vaccine to encourage the body to produce antibodies against the disease-causing agent. This document, therefore, should complement the information regarding the immunity granted to volunteers who received the vaccine in the third phase of clinical development. The data is essential to conclude the duration of the immune response in vaccinated individuals.
Both Fiocruz and Instituto Butantan must continue their studies and generate data to allow health registration at Anvisa. Likewise, both need to maintain vaccine safety monitoring, which is critical to ensuring that the benefits continue to outweigh the risks for people receiving Covid-19 vaccines. Anvisa, as a federal regulatory body, can review and adjust the conditions for emergency use in the face of results that are considered relevant, including data and information from international regulatory authorities.
Understand
The emergency use authorization procedure assesses the suitability of vaccine candidates against Covid-19 for use during the current public health emergency, in order to minimize, as quickly as possible, the impacts of the crisis. It is important to note that temporary authorizations for emergency use are not permits for placing on the market for marketing, distribution and use. In other words, health registration has not yet been granted.
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