The WHO provides advice to the United Nations Children’s Fund (UNICEF) and other United Nations (UN) agencies on the acceptability, in principle, of vaccines considered for purchase by such agencies for vaccination programs they administer. The WHO does so through its vaccine prequalification program. An important part of the program is the WHO’s reliance upon the national regulatory authority (NRA) of the country of manufacture of the vaccine if the NRA is determined to be “functional” based on assessment performed by a WHO team. This assessment uses WHO established indicators (i.e., critical indicators defined by WHO experts) to ensure there is consistency in the standards applied when evaluating level of functionality of national regulatory systems. In order for WHO to designate an NRA as being “functional”, the NRA must meet a set of criteria defined by critical indicators in the NRA assessment tool. The regulatory authority, supported by legislation, should be able to fulfill the following functions: licensing; post-marketing surveillance; lot release; laboratory access; regulatory inspections; and authorization/evaluation of clinical trials.
WHO assessed CBER’s functionality as an NRA in 2007 and concluded it met the pre-specified indicators. The NRA is commonly referred to as the “reference” NRA when the WHO relies on that regulatory authority for vaccine prequalification.
On July 8, 2008, the FDA and WHO entered into a mutual confidentiality arrangement that included a commitment not to publicly disclose non-public information shared by and between the FDA and the WHO. The commitment satisfies the requirements of 21 CFR § 20.89 (c)(1)(i) and enables CBER to serve as the reference NRA under the WHO vaccine prequalification program.
CBER has affirmed its willingness to serve as the reference NRA for the following U.S. licensed vaccines:
- Rotavirus Vaccine, Live, Oral, Pentavalent (Tradename: RotaTeq®; Manufacturer: Merck & Co., Inc.); Prequalified by WHO October 7, 2008
- Influenza Virus Vaccine (Tradename: Fluvirin®; Manufacturer: Novartis Vaccines and Diagnostics Limited); Prequalified by WHO December 4, 2009
- Influenza A (H1N1) 2009 Monovalent (No tradename; Manufacturer: Novartis Vaccines and Diagnostics Limited); Prequalified by WHO December 9, 2009
- Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
- (Tradename: Prevnar®; Manufacturer: Wyeth Pharmaceuticals Inc.); Prequalified by WHO December 28, 2009
- Influenza Virus Vaccine (Tradename: Fluzone®; Manufacturer: Sanofi Pasteur, Inc.); Prequalified by WHO January 21, 2010
- Influenza A (H1N1) 2009 Monovalent (No tradename; Manufacturer: Sanofi Pasteur, Inc.); Prequalified by WHO January 27, 2010
- Influenza A (H1N1) 2009 monovalent (No tradename; Manufacturer: MedImmune LLC); Prequalified by WHO February 25, 2010
- Meningococcal ACYW-135 Polysaccharide, 10 dose vial (Tradename: Menomune; Manufacturer: Sanofi Pasteur), Prequalified by WHO May 22, 2013
- Meningococcal (Serogroups A, C, Y, and W135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Tradename: Menactra; Manufacturer: Sanofi Pasteur); Prequalified by WHO March 21, 2014
