As the race for manufacturing the Covid-19 shot gathers pace, the World Health Organization (WHO) has called on vaccine makers to submit an expression of interest (EOI) for its evaluation.
Priority will be given to candidate vaccines that are expected to meet all or most of the WHO-published Target Product Profile (TPP) characteristics, said the WHO in a statement, adding that those EOIs that are considered acceptable to proceed with the submission of a dossier, will be assessed according to either the Emergency Use Listing (EUL) procedure or Prequalification.
Interested manufacturers can submit expressions of interest for vaccines evaluation by a letter to the vaccines and immunisation devices assessment team. “The letter should include name of the product, contact person, email address, description of the vaccine, presentation, indication, current phase of clinical trial, date of initiation and completion, high level details of interactions with national regulatory authorities, agreement in principle to allow national regulatory authorities to share confidential information with WHO to facilitate collaboration, status of interactions with COVAX,” as per the statement from the global health agency.
Manufacturers that meet the criteria and have submitted a complete EOI will be contacted to schedule a pre-submission meeting to discuss the assessment procedure to be used (EUL/PQ), assessment pathway, date of submission of the dossier, readiness of submission package, upcoming availability of supplemental data and other important information that will help the manufacturer make decision on the submission and will help WHO coordinate resources to assess the dossier within the shortest possible timeline, details of rolling submissions and general requirement for data to be submitted.
The purpose of the WHO prequalification assessment is to provide assurance that candidate vaccines meet the WHO recommendations on quality, safety and efficacy, including compliance with WHO recommended good manufacturing practice (GMP) and good clinical practice (GCP) standards; and meet the operational specifications for packaging and presentation of the relevant United Nations (UN) agency.
“This is to ensure that vaccines provided through the UN for use in national immunization services in different countries are safe and effective, and are suitable for the target populations, at the recommended immunisation schedules, and with appropriate concomitant products,” the WHO added.