The WHO, through the Quality Safety and Standards (QSS) Unit of the Department of Immunization, Vaccines and Biologicals (IVB), 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 meets the WHO indicators that gauge its functionality. That is, critical indicators have been defined by WHO experts to ensure the level of functionality of national regulatory systems. In addition to a national regulatory system, supported by legislation, the regulatory authority 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 NRA 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 QSS/IVB of 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
- Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) (Tradename: Prevnar®; Manufacturer: Wyeth Pharmaceuticals Inc.); Prequalified by WHO September 9, 2010