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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 ... Listing (EUL) for the COVID-19 Vaccine BIBP/ Sinopharm, the 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.
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 ... 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
The purpose of this document is to stop to irrational use/ over prescription of this reserve/
experimental/ emergency use ... drug Remdesivir. For this reason, Joint
Monitoring Group under Chairmanship of DGHS took into consideration findings of the
following studies to issue this advisory:
African Union and the Africa Centers for Disease Control and Prevention’s Africa Regulatory Taskforce has endorsed the Emergency Used Authorization for Janssen COVID-19 Vaccine
10 March 2021
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 proced...
The conduct of COVID-19 vaccine trials in the context of a candidate vaccine being issued with Emergency Use Designation raises challenging ethical questions, including in relation to the ... of placebo controls and unblinding of trial participants in current and future COVID-19 vaccine trials. This policy brief was developed by the WHO Access to COVID-19 Tools (ACT) Accelerator Ethics & Governance Working Group, to provide guidance for researchers, sponsors, regulators, research ethics committees, and policy-makers, on these and related issues.
Taking the whole of Africa approach to fighting the COVID-19 pandemic has and will continue to require coordinated efforts from multiple stakeholders from across the continent. Africa CDC would like to acknowledge the deep partnership and continued support of AUDA-NEPAD, AVAREF, WHO AFRO, the Bill a...
These WHO interim recommendations on the use of the Pfizer – BioNTech BNT162b2 vaccine against Covid-19 were developed on the basis of advice issued by the Strategic Advisory Group of Experts on Immunization (SAGE) and the evidence summary include...
7 June 2021
The Africa Regulatory Taskforce is a joint effort established by the Africa Centres for Disease Control and Prevention (Africa CDC), the African Union Development Agency (AUDA-NEPAD) coordinated African Medicines Regulatory Harmonization (AMRH) Initiative, and the World Health Organisat...
The domestic regulation of public health emergencies (PHEs) is inextricably linked to the regulation of other types of disaster. PHEs are usually governed at least partly by general disaster and emergency laws. Moreover, there is significant overlap...
Refugee Health
recommended
An approach to emergency situations. Relief workers face rapidly changing and complex environments, new disease patterns, enormous humanitarian needs and relatively limited resources. The authors of this book ... their experience in the area to produce an operational manual of the issues involved in refugee health programs. This book is aimed at professionals involved in public health assistance to refugees and displaced persons. It deals with a variety of specific refugee health issues at the decisional level, and discusses the priorities of intervention during the different phases of a refugee crisis, from emergency to repatriation.
The "Primary Healthcare Standard Treatment Guidelines and Essential Medicines List" by the South African National Department of Health provides evidence-based guidelines for diagnosing and managing common medical conditions at the primary healthcare level. This document includes treatment protocols ...
3rd edition. In 2001, Uganda adapted the Integrated Disease Surveillance and Response (IDSR) developed by World Health Organization (WHO) for member states in African region. The Ministry of Health has been implementing the IDSR strategy since then with success across the country. This strategy prov...
AstraZeneca-SKBio in South Korea and Serum Institute of India
Declarations of interests were collected from all external contributors and assessed for any conflicts of interest. Summaries of the reported interests can be found on the SAGE meeting website and SAGE Covid-19 Working Group webpage. This guidance should be considered along with the broader COVID-...
