Mpox vaccine production: WHO invites expression of interest from manufacturers

By: Modupe Adeniyi. Freelance Health Reporter.

MONDAY, AUGUST 12, 2024. The World Health Organization (WHO) has issued its first call for submission of Expressions of Interest (EOI) from manufacturers of vaccines for the prevention of mpox. This invitation is part of the WHO's efforts to ensure the availability of safe, effective and high-quality vaccines to combat the ongoing public health threat posed by the mpox virus.

The WHO, through its Department of Regulation and Prequalification (RPQ), provides guidance to United Nations (UN) procurement agencies, such as the United Nations Children's Fund (UNICEF), as well as to National Regulatory Authorities (NRAs) and National Control Laboratories (NCLs), on the acceptability of vaccines for purchase.

The primary goal of the WHO vaccines prequalification program is to assure that candidate vaccines meet the WHO recommendations on quality, safety and efficacy, including compliance with Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) standards, as well as the operational specifications required by the relevant UN agencies.

Both the Emergency Use Listing (EUL) and Prequalification assessment processes are utilized by the WHO to ensure that vaccines intended for use in national immunization services are safe, effective, of assured quality and suitable for the target populations at the recommended immunization schedules, with appropriate concomitant vaccines. The EUL procedure has been specifically developed to expedite the availability of unlicensed medical products needed in public health emergency situations, such as the current mpox outbreak.

In this first call for EOI, the WHO is inviting manufacturers of candidate vaccines that fulfill the EUL requirements to submit their expressions of interest. Priority will be given to vaccines that are expected to meet most or all of the WHO Target Product Profile (TPP) characteristics. Only those EOIs that are considered acceptable will be further assessed according to the EUL procedure, prequalification standards and relevant WHO guidance.

Interested manufacturers are required to submit their EOI letters to the Vaccines & Immunization Devices Assessment Team at whoeul@who.int. The letter should include information such as the product name, contact details, vaccine description, status of ongoing clinical trials and interactions with NRAs. Manufacturers must also agree to allow NRAs to share confidential information with the WHO to facilitate collaboration.

Manufacturers who meet the criteria and submit a complete EOI will be contacted by the WHO to schedule a pre-submission meeting. The purpose of this meeting is to discuss the assessment procedure, submission timeline, and data requirements to ensure a smooth and efficient evaluation process.

The WHO's call for EOI is a crucial step in the global efforts to combat the mpox outbreak and ensure the availability of safe and effective vaccines for populations in need. Manufacturers are encouraged to respond to this invitation and work closely with the WHO to make these vital public health tools accessible worldwide.

Source: World Health Organization News.

Click here for more details on the EOI

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Published: August 12, 2024

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