Fees for prequalification

Fees for vaccines prequalification are levied according to:

  • whether the vaccines is classified as simple/traditional or combination/novel as described in the table Vaccines categorization for fee payment 
  • vaccines which are considered as urgent public health need but no (or very small) commercial market.

For a vaccine, a single product is defined as a vaccine of a unique strength and dose form. However, a single vaccine product may have several presentations.

                        

Screening fee

US$

Reduced assessment

fee1 US$

Assessment fee

US$

Site inspection fee

US$

Simple/traditional vaccines

  2,500    25,000 100,000 30,000

Combination/novel vaccines
 
5,000 66,000 232,750 30,000

 1 For products for which there is urgent public health need but no (or a very small) commercial market.

Invoicing of screening & evaluation fee

WHO will issue an invoice for screening and evaluation after the application has been screened and accepted or rejected for assessment. Payment should be made within 30 days of receipt of the invoice.

Annual maintenance fee

The annual maintenance fee is tiered and applied per prequalified vaccine. Determination of the annual payable for vaccines is a two-step process.

  1. Vaccine manufacturers are required to submit, by 30 June each year, a declaration of their tier: I, II, III or IV.
  2. Determination of manufacturer-tier, based on a rolling average of total sales of the prequalified vaccine to UN agencies (including the PAHO Revolving Found) and GAVI, hereinafter referred to as "PQ-enabled sales", over the previous, completed three-year period. The manufacturer tiers, defined according to average yearly total sales value, are given in Table 1 below.

Table 1: Vaccine manufacturer-tiers for annual fee calculation

Tier

 Average annual PQ-enabled sales over the previous, completed three-year period (US$)

1

 US$ 0 to US$ 1 million

2

 >US$ 1 million to US$ 20 million

3

 >US$ 20 million to US$ 300 million

4

 >US$ 300 million

A different annual fee applies according to whether the vaccine is a simple/traditional, combination or novel vaccine, as indicated in the table below.

Table 2: Annual maintenance fees for prequalified vaccines.

 

Tier 1

US$

Tier 2

US$

Tier 3

US$

Tier 4

US$

Simple/traditional vaccines

4,800

19,200

41,500

140,000

Combination/novel vaccines

8,400

33,600

72,500

250,000

Based on the manufacturer’s declared tier, WHO will invoice the manufacturer for each eligible prequalified vaccine, in accordance with the announced fee schedule. The annual fee will be applied to all vaccines that, on 1 September each year, have been prequalified for 12 months or more.

Payment of the annual fee should be made before 30 November of the calendar year in which the invoice was issued.

Enquires regarding the fees schedule can be emailed to: prequalfees@who.int