These WHO interim recommendations for use of the Sinovac-CoronaVac were developed on the basis of advice issued by the Strategic Advisory Group of Experts on Immunization (SAGE) and the evidence summary included in the background document and annexes referenced below.
This document has been updat...ed: version 15 March 2022.
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orientaciones provisionales, primera publicación: 24 de mayo de 2021, actualización: 21 de octubre de 2021, actualización: 15 de marzo de 2022
Вакцина против COVID-19 CoronaVac производства компании Sinovac (Sinovac-CoronaVac) July 2021
This quick guide offers basic information about COVID-19, the Sinovac-CoronaVac COVID-19 vaccine and what to
expect following vaccination: ...
Временное руководство (Первый выпуск 24 мая 2021 г., Обновлено 21 октября 2021 г., Обновлено 15 марта 2022 г.
24 September 2021. The vaccine has been authorized by the Chinese National Regulatory Authority (NRA) – the National Medicinal Product Administration (NMPA) – as well as other regulatory authorities. Because WHO has granted Emergency Use Listing (EUL) for the COVID-19 Vaccine BIBP/ Sinopharm, th...e Africa Union and Africa CDC’s Regulatory Taskforce has endorsed the Emergency Use Authorization for the vaccine (see scenario #1) and the specification is 0.5ml/dose, 1 dose/vial; or 2 doses/vial; or 5 doses/vial. As such, African Union Member States are recommended to waive any review processes and rely directly on the WHO EUL via the AVAREF managed pathway described in Scenario #1.
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24 September 2021. The vaccine has been authorized by the Chinese National Regulatory Authority (NRA) – the National Medicinal Product Administration (NMPA) – as well as other regulatory authorities. Because WHO has granted Emergency Use Listing (EUL) for the Sinovac COVID-19 vaccine (Vero Cell ...[Inactivated]) – CoronaVac, the Africa Union and Africa CDC’s Regulatory Taskforce has endorsed the Emergency Use Authorisation for the vaccine (see scenario #1). As such, African Union Member States are recommended to waive any review processes and rely directly on the WHO EUL via the AVAREF managed pathway described in Scenario #1
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This chronology of facts has challenged public health systems worldwide and regulatory bodies are no exception. Regulatory authorities with mechanisms in place to authorize the use of investigational products had to development guidelines and procedures, create task forces and alliances to maximize ...the efficiency of assessment, review and authorizations of medical products. Vaccines are undoubtedly the most complex medical products to develop, from concept to a stage where sufficient evidence of quality, safety and efficacy are collected to provide an assurance that their use will provide more benefits than risks when used in the context of a public health emergency.
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These WHO interim recommendations for use of the COVID-19 vaccine BIBP produced by Sinopharm were developed on the basis of advice issued by the Strategic Advisory Group of Experts on Immunization (SAGE) and the evidence summary included in the background document and annexes referenced below.
Th...is document has been updated: version 15 March 2022.
more
27 September 2022
These WHO interim recommendations for use of the Novavax NVX-CoV2373 vaccine were developed on the basis of advice issued by the Strategic Advisory Group of Experts on Immunization (SAGE) and the evidence summary included in the background document and annexes referenced below.
9 Febr. 2022
The COVID Covovax™ (SIIPL) and Nuvaxovid™ (Novavax) vaccine explainer includes key vaccine specific information on the vaccine specific requirements.
Vaccinator's Manual SINOPHARM Vaccine - 28 FEBRUARY 2021
O SAGE aplica os princípios da medicina baseada em evidências e estabeleceu um processo metodológico completo para emitir ou atualizar recomendações. Especificamente para vacinas contra a COVID-19, uma descrição detalhada dos processos metodológicos pode ser encontrada no esquema de evidênc...ias do SAGE para vacinas contra a COVID-19. Esse esquema contém orientações sobre como levar em consideração os dados provenientes de ensaios clínicos em apoio à emissão de recomendações baseadas em evidências específicas para vacinas.
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first issued 18 August 2022