Latest news from WHO on COVID-19 and other breaking health stories

The EUL decision on COVAXIN is still pending.  Bharat Biotech  has been submitting data to WHO on a rolling basis and submitted additional information at WHO’s request on 27 September.  WHO experts are currently reviewing this information and if it addresses all questions raised, WHO and an independent group of experts -the Technical Advisory Group (TAG)- will carry out the risk/benefit assessment and come to a final decision whether to grant Emergency Use Listing to the vaccine.  The TAG is expected to convene next week.  Here’s the latest Status of COVID-19 vaccines within WHO EUL evaluation process.

Our Strategic Advisory Group of Experts on vaccination (SAGE) is holding its regular meeting (4 to 8 October), during which it will examine the latest evidence in preparation of policy recommendations for the best use of COVAXIN vaccine, to be issued once the EUL process has been completed.

Emergency Use Listing of (EUL) of a COVID-19 vaccine and SAGE policy recommendations for its use: two complementary but independent processes

A short explainer and helpful background information for reporters writing about the regulation and policy recommendations for COVID-19 vaccines

The EUL process is centred on determining if a manufactured product is quality-assured, safe and effective.

The WHO Strategic Advisory Group of Experts on Immunization (SAGE) is centred on issuing evidence-based policy recommendations for the best use of vaccines against COVID-19.  Such product-specific recommendations are issued once a vaccine is authorized through a regulatory process, including the assessment of safety and efficacy from phase III clinical trials.

Policy recommendations for a vaccine are only of value to a vaccination campaign when the product has been listed or authorized for use, hence the SAGE recommendations follow the announcement of EUL.  In the context of COVID-19 and due the pressing need for vaccines, the Secretariats of SAGE and the EUL team have been working in parallel to ensure that the roll-out of vaccines is not impeded by the lack of policy recommendations or EUL, as long as the evidence supports these.

Emergency Use Listing (EUL)

When a vaccine has gone through established development, manufacturing and clinical testing procedures and is demonstrated to be safe, efficacious, and meets manufacturing standards, the data must be assessed by regulators to authorize its use.

Once manufacturers believe they have the requisite data to secure emergency use authorization, conditional marketing authorization or equivalent, they can submit their product for evaluation to WHO prequalification (PQ) or for WHO emergency use listing (EUL).

WHO EUL or PQ is usually a pre-requisite for a vaccine that will be supplied through procurement partners such as UNICEF and PAHO, and for funding through Gavi for countries who are eligible.

So far, six different COVID-19 vaccine products and multiple vaccine manufacturing sites have been listed for emergency use; several other candidates are in the assessment pipeline.

Dr Mariângela Simão, WHO Assistant Director-General for Drug Access, Vaccines and Pharmaceuticals, explains the process in this episode of Science in 5; here is the explainer and Q&A on the process

WHO Strategic Advisory Group of Experts on Immunization (SAGE)

SAGE develops evidence-based policy recommendations for the best use of vaccines against COVID-19.  It continuously reviews the available evidence on the progress of candidate vaccines, guides vaccine introduction for optimal impact, prepares policy advice on the accelerated use of vaccines (pre-licensure and post-licensure) and recommendations for early allocation of vaccines when vaccine supply is still limited.

Policies on use of specific products are developed once there is sufficient information that will inform authorization and use beyond the clinical trial setting.  These policies will consider product specific attributes related to the safety and efficacy of the products, as well as aspects relates to delivery, handling and storage of the products.  The recommendations may be updated as additional evidence of vaccine effectiveness and safety, and additional vaccines and other interventions become available.

So far, SAGE has issued interim recommendations for the use of six different COVID-19 products, as well as generic guidance for policy-makers, including the Roadmap for Prioritizing Uses of COVID-19 Vaccines in the Context of Limited Supply, the Values Framework for the Allocation and Prioritization of COVID-19 Vaccination.

It has also issued interim statements on COVID-19 vaccines, namely on booster doses, on heterologous priming (mix-and-match schedules) and on dose-sparing strategies (fractionated doses).

Latest updates on EUL status of COVID-19 vaccines

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Episode three of the ‘EYE on Yellow Fever’

Episode three of the ‘EYE on Yellow Fever’ podcast looks at the impact the COVID19 pandemic had on yellow fever vaccination campaigns and resources. Dr Michael Ryan, Executive Director of WHO Health Emergencies Programme and Dr Chikwe Ihekweazu, Director General of Nigeria Centre for Disease Control provide their perspective on fighting this deadly vector-borne disease. 

Listen to the episode here.