Authorization is temporary and exceptional to minimize, as soon as possible, the impacts of the pandemic.
Last Sunday, January 17th, the Board of Directors of Anvisa (Diretoria Colegiada da Anvisa – Dicol) unanimously approved the temporary authorization for emergency use of the CoronaVac vaccine, developed by pharmaceutical Sinovac in partnership with the Butantan Institute, and the Covishield vaccine, produced by pharmaceutical Serum Institute of India, in partnership with AstraZeneca / University of Oxford / Fiocruz.
Regarding CoronaVac, in particular, the authorization was conditioned to the signature of a Term of Commitment and its respective publication in the Official Journal of the Union (D.O.U.). This Term of Commitment determines that, until February 28th, the complementation of immunogenicity studies is performed and presented to Anvisa, as approved in the clinical study design phase III of the vaccine.
Both Fiocruz and the Butantan Institute must continue the studies and the generation of data to allow the sanitary registration at Anvisa. Similarly, both need to maintain monitoring of vaccine safety, critical to ensuring that the benefits continue to outweigh the risks to people receiving Covid-19 vaccines.
As a federal regulatory agency, Anvisa can review and adjust conditions for emergency use against outcomes that are deemed relevant, including data and information from international regulatory authorities.
The emergency use authorization procedure assesses the suitability of Covid-19 vaccines for use during the current public health emergency to minimize, as soon as possible, the impacts of the pandemic. It is important to note that temporary permits for emergency use are not permits for commercialization, distribution and use purposes. In other words, the sanitary registration has not yet been granted.
Approved vaccines may be used in an emergency context, following the vaccination phases below:
Health professionals, elderly people aged 75 and over, elderly people over 60 living in asylums and psychiatric institutions, bedridden people and indigenous peoples.
People between 60 and 74 years old.
People with chronic comorbidities, transplants and obesity.
Education professionals, people with severe disabilities, first-aiders, employees of the prison systems, public transportation workers, road cargo transporters, and people deprived of their liberty.
On 03/18/2020, Anvisa published a new regulation (RDC 348/2020), that defines the conditions of the priority review for the registration of covid-19 Vaccines .
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Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations. To learn more, please contact us at email@example.com