In a concerted effort to ensure global health security, the World Health Organization (WHO) has released the Vaccines Prequalification Priority List 2024 - 2026, offering a roadmap for the prioritization of vaccines eligible for WHO prequalification. This comprehensive list, updated every two years, serves as a strategic guide for channeling limited resources towards vaccines crucial for international public health initiatives.
The priority categorization, established by the WHO in collaboration with UNICEF and the Revolving Fund of the Pan American Health Organization, is based on four key criteria. These criteria include demand in UN-supplied markets, suitability for WHO programmatic needs, recommendations from the WHO's Strategic Advisory Group of Experts on immunization, and supply security indicators.
Supply Security: Safeguarding Global Immunization Efforts
Maintaining supply security is a cornerstone of the WHO's prequalification strategy. This involves active monitoring and response to potential factors leading to vaccine shortages. Issues such as production challenges, batch failures, risks associated with complex biological products, and production planning intricacies are vigilantly addressed to ensure a steady and reliable vaccine supply. Additionally, the limited supplier base for certain products, often influenced by market entry barriers and supplier decisions based on factors like profitability, is also considered in securing the vaccine supply chain.
Vaccines Prequalification Priority List 2024 - 2026: Key Highlights
High-Priority Vaccines:
- Cholera
- Dengue Tetravalent
- Hexavalent (DTwP - HepB - Hib – IPV)
- Human Papilloma Virus (HPV)
- Malaria
- Measles-Rubella (MR)
- Measles-Mumps-Rubella (MMR)
- Meningococcal ACWY containing conjugate
- Meningococcal ACWYX conjugate
- Pneumococcal conjugate
- Novel Oral Polio type 2 (nOPV2)
- Rotavirus
- Respiratory Syncytial Virus (RSV)
- Typhoid conjugate
- Yellow Fever
Medium-Priority Vaccines:
- BCG
- Ebola
- Hepatitis A
- Hepatitis B
- Hepatitis E
- Measles
- Polio (bivalent live, oral type 1,3) (bOPV 1,3)
- Polio (monovalent live oral type 1) (mOPV1)
- Rabies
- Varicella
- Chikungunya (For production from seeds)
Low-Priority Vaccines:
- Diphtheria-Tetanus for children (DT)
- Diphtheria-Tetanus for adults (Td)
- DTwP-based tetravalent combination fully liquid (DTwP - Hep B - Hib)
- DTaP-Hepatitis B-Hib-IPV
- Influenza seasonal NH & SH
- Japanese encephalitis
- Meningococcal A containing conjugate
- Pneumococcal polysaccharide
- Polio (inactivated) (IPV)
- Polio (inactivated-Sabin) (sIPV)
- Polio (monovalent live oral type 2) (mOPV2)
- Polio (monovalent live oral type 3) (mOPV3)
- Polio (trivalent live oral) (tOPV)
No-Priority Vaccines:
- Diphtheria - Tetanus - (whole cell) Pertussis (DTwP)
- Diphtheria - Tetanus-(acellular) Pertussis (DTaP)
- DTwP + Hib (liquid-lyophilized)
- DTwP - Hib (fully liquid)
- DTwP - Hepatitis B
- DTwP-based pentavalent combination (liquid-lyophilized) (DTwP-Hep B +Hib)
- Haemophilus influenza type b (Hib)
- Influenza H1N1 for stockpile
- Meningococcal CW containing conjugate
- Meningococcal AC Polysaccharide
- Meningococcal ACWY polysaccharide
- Rubella
- Tetanus Toxoid (TT)
- Typhoid polysaccharide
Potential Candidate Vaccines:
- Covid-19
- Novel OPV1, 3, and combinations with type 2
- Monkeypox
- Tuberculosis (TB)
- Shigella
- Group B strep
- S19-IPV
Note: Priority for certain vaccines could be upgraded to medium if produced using a different platform, ensuring faster supply availability.
Advancing Global Health Through Strategic Vaccine Prioritization
The Vaccines Prequalification Priority List 2024 - 2026 reflects a commitment to strategic planning and global cooperation to safeguard public health. By prioritizing vaccines based on demand, programmatic suitability, expert recommendations, and supply security, the WHO aims to streamline resources and strengthen immunization efforts worldwide. As we navigate the evolving landscape of global health challenges, the prioritization of vaccines remains a cornerstone in our collective journey towards a healthier and more resilient future.
Vaccines Prequalification
WHO vaccines prequalification is a service provided to UNICEF and other UN agencies that procure vaccines.
The goal of WHO vaccines prequalification is to ensure that vaccines used in immunization programmes are safe and effective. Prequalification also supports the specific needs of national immunization programmes with regards to vaccine characteristic such as potency, thermostability, presentation, labelling and shipping conditions. As a result, more people can be vaccinated with safe, effective and quality vaccines because immunization programme managers can plan, select and procure appropriate products.
In prequalifying vaccines, WHO applies international standards to comprehensively evaluate and determine whether vaccines are safe and effective. WHO also ensures the continued safety and efficacy of prequalified vaccines through regular re-evaluation, site inspection, targeted testing and investigation of any product complaints or adverse events following immunization.
National regulatory agencies (NRAs) and national control laboratories (NCLs) play a vital role in WHO vaccines prequalification since they are responsible for regulatory oversight, testing and release of WHO-prequalified vaccines.
WHO vaccines prequalification contributes to innovation when there is a compelling unmet public health need for new products. This is achieved by supporting vaccine innovation and by providing technical support to vaccine manufacturers in collaboration with other organizations and networks. Demand forecasting is also supported: WHO vaccines prequalification, in partnership with UNICEF and Gavi, makes a significant contribution to the creation and maintenance of a healthy market for vaccines.
