Request to Submit a Vaccine Prequalification Dossier
The manufacturer must communicate its intention to submit a vaccine for evaluation ‒ as early as possible ‒ by sending an official request to WHO. TEXT NEEDS TO BE REVIEWED AND ADDRESS INCLUDED. This request should take the form of an application letter to be sent to the Coordinator, Quality, Safety and Standards, Department of Essential Medicines and Health Products in WHO, with copies to the vaccines prequalification manager and the relevant national regulatory authority (NRA), giving details of country and sites of manufacture, licensing status and the presentations put forward to United Nations agencies for procurement.
WHO will acknowledge receipt and acceptance of the application letter by e-mail, with a copy to the NRA. It will respond with an official letter only in those cases where the vaccine will not be accepted because it is not a priority. In such cases, the applicant and the NRA will be advised of the rejection of the application within two weeks of receipt of the official request.
A manufacturer whose request to submit an application for evaluation of a candidate vaccine is accepted will be requested to prepare and submit a product summary file (PSF) in one hard copy and five electronic copies or an electronic common technical document (CTD).
For initial product assessments, a PSF or CTD must be submitted for each vaccine to be assessed.
For combination vaccines, information must be submitted on each of the component vaccines and on the combination itself. If a combination vaccine is being evaluated and the monovalent versions of the antigens contained in the combination are also being evaluated, the information provided for the monovalent vaccines (up to concentrated bulk) can be used for the assessment of the combinations or, conversely, the information on each antigen provided in the PSF OR CTD????? of the combination vaccine can be used to assess the monovalent vaccines (up to concentrated bulk level).
Note: WHO does not assess novel vaccines for which there is insufficient test data on which to base a decision.
Product summary file or CTD
Manufacturers may now submit their applications in the common technical document (CTD) format, rather than as a PSF, provided that:
- a detailed cross-referencing of contents is presented
- information required by WHO but not included in the CTD requirements is included.
Where a PSF cross-references to the CTD format, the documentation may be submitted in electronic form only. Electronic documents should be in searchable text where possible.
As of 1 January 2021 CHECK DATE, all applications for full assessment will be required in CTD format.
A pre-evaluation meeting including representatives of the manufacturer, the responsible NRA and WHO may be scheduled if considered necessary or desirable by either party. Such meetings are important for discussing programmatic suitability issues and can be scheduled when requested by the manufacturer. Additional meetings may be held during the evaluation process, as required.