SAGE Working group on pertussis vaccines

Last updated: 9 December 2025

Background

The Strategic Advisory Group of Experts (SAGE) on Immunization was established in 1999 to provide policy and strategy advice on vaccines and immunization to the Director-General of the World Health Organization (WHO). SAGE is the principal advisory group to WHO for vaccines and immunization. All vaccine and immunization-related topics of public health relevance for which WHO requires strategic and policy advice need to be reviewed by SAGE.

This SAGE Working Group on Pertussis Vaccines (from now on referred to as SAGE WG) will be established by the WHO SAGE Secretariat as a resource intended to support WHO in the preparation of SAGE deliberations by reviewing and providing evidence-based information and options for policy or strategy recommendations to be decided by SAGE.

Terms of reference

The SAGE WG will be requested to work on specific issues and address critical questions related to pertussis vaccination. It will review the scientific evidence and relevant programmatic considerations to formulate draft recommendations on the use of pertussis vaccines. The draft recommendations will be submitted for consideration by SAGE to inform the global policy on pertussis vaccine use, and for subsequent issuance of an updated WHO Position Paper on pertussis vaccines.

Specifically, the Working Group will be asked to address the following areas, among other, in its review:

Infant schedule

• What are the schedules/products used globally and what is the impact of wP and aP vaccines on pertussis infant mortality and disease.

   

  Maternal immunization

• In which setting (epidemiology, coverage, product, schedules used) will maternal aP vaccination have the greatest impact.
• What is the safety and effectiveness of maternal immunization.

   

  Booster doses

• What is the impact of pertussis vaccine booster doses (wP or aP) during childhood,  adolescence and adults by setting on disease resurgence, epidemics and infant mortality.

   

  Countries facing resurgence/ outbreaks

• What are the potential mitigation measures for countries facing current outbreaks/resurgence of pertussis.

Composition

SAGE Members

• Karron, Ruth (Chair). Johns Hopkins University, USA.
• Dbaibo, Ghassan. University of Beirut, Lebanon.

Experts

• Bosire, Nelly. Africa Health Governance Institute, Kenya          
• Muloiwa, Rudzani. University of Cape Town and Red Cross War Memorial Children’s Hospital, Vaccines for Africa Initiative (VACFA), South Africa.
• Halperin, Scott . Dalhousie University and Canadian Center for Vaccinology, Canada.
• Klein, Nicola. Kaiser Permanente Bernard J. Tyson School of Medicine, USA.
• Knoll, Maria, Research professor, Johns Hopkins University, USA.
• Maldonado, Herberth. Universidad del Valle de Guatemala, Guatemala.
• Al Lami , Faris. Baghdad University, Iraq.
• Domenech de Cellês, Matthieu. Max Planck Institute, Germany.
• Gayatri Amirthalingam, United Kingdom of Great Britain and Northern Ireland (UK) Health Security Agency, UK.
• Heininger, Ulrich. University of Basel Children’s Hospital, Switzerland.
• Giles, Michelle. Monash University, Australia.
• Wood,  Nicholas. University of Sydney, Australia.
• Zheng, Hui. Chinese Center for Disease Control and Prevention, China.
• Winsley, Rose.  Christian Medical College, Vellore, India.

WHO focal point

Melanie Marti

Declarations of Interest

All members completed a declaration of interests form. One SAGE member and 10 Working Group members reported relevant interests. Rudzani Muloiwa was asked to recuse himself from the discussion and recommendation-making on pertussis booster doses. It was assessed that the remaining SAGE members could participate fully in the deliberations of the Working Group. The reported relevant interests are summarized below:

Dbaibo, Ghassan

• Serves as a member of the advisory board of COVID-19 vaccines in pediatric populations for Pfizer. This interest was perceived as non-personal, specific, and financially insignificant*.
• Serves as a member of the Pneumococcal vaccine advisory board in pediatric populations for MSD. This interest was perceived as non-personal, non-specific, and financially insignificant*.
• Served as principal Investigator until 2024 for meningococcal conjugate vaccine in elderly, funded by Sanofi. This interest was perceived as non-personal, nonspecific and financially significant*
• He received the honorarium in May 2025 for giving the lecture on the following topics. These interests were perceived as non-personal, specific and financially insignificant*
  • COVID vaccine in pediatrics at ESPID, funded by Pfizer
  • Pneumococcal 15 in pediatric patients funded by MSD

Muloiwa, Rudzani

• Serves on the Global Pertussis Initiative Steering Committee. This interest was perceived as personal, specific and financially significant*
• Serves on the DSMB of PATH on GBS (Phase 2 trial). This interest was perceived as personal, non-specific and financially insignificant*
• Serves on the Scientific Advisory Board of the Gates Foundation on RSV (GBS Phase 4). This interest was perceived as personal, non-specific and financially insignificant*
• Served until 2025 on the MSD/Merc advisory board on RSV monoclonal antibodies. This interest was perceived as personal, non-specific and financially insignificant*
• Serves on the South African NITAG. This interest was perceived as personal, non-specific and financially insignificant*
• Serves on the WHO AFRO RITAG. This interest was perceived as personal, non-specific and financially insignificant*
• Served as PI on Tdap Booster clinical trial in adolescents funded by Sanofi until 2023. This interest was perceived as non-personal, specific and financially significant*

  Halperin, Scott

  • Serves as member of the Aramis Clinical Advisory Committee. This interest was perceived as non-personal, non-specific and financially insignificant*
  • Serves on the Safety Monitoring Committee, Emory intramuscular rotavirus vaccine study “A Phase 1 study to evaluate the safety and immunogenicity of inactivated rotavirus adjuvanted vaccine for intramuscular administration in healthy adults. This interest was perceived as non-personal, non-specific and financially insignificant*
  • Serves on the Safety Monitoring Committee, Emory transcutaneous rotavirus vaccine study “A Phase 1 Study to Evaluate the Safety and Immunogenicity of an Inactivated Rotavirus Vaccine for Intradermal Administration by Microneedle Patch in Healthy Adults. This interest was perceived as non-personal, non-specific and financially insignificant*
  • Serves on the Safety Monitoring Committee, Marburg vaccine clinical trial (IAVI C104) “A Phase 1 Randomized, Double-blind, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSVΔG-MARVGP Vaccine in Adults in Good General Health. This interest was perceived as non-personal, non-specific and financially insignificant*
  • Served until 2023 on the Safety Monitoring Committee, Phase 1 Sudan Ebola Virus vaccine study, International AIDS Vaccine Initiative, Inc. (IAVI). This interest was perceived as non-personal, non-specific and financially insignificant*
  • Provides ad hoc consultation support to industry advisory boards & committees (GSK, Pfizer, Novavax, Moderna, Malaika VX, Sequirus IMV, Sanofi Pasteur, AstraZeneca, Merck). This interest was perceived as non-personal, non-specific and financially insignificant*
  • Provides ad hoc consultation support to NGO and governmental organizations (Nova Scotia Dept of Health Infectious Diseases Expert Group, PATH, Gates Foundation, VIDO Intervac, Nova Scotia Vaccine Expert Panel, COVID-19 Immunity Task Force, Forum on Major COVID-19 Initiatives, Vaccine Surveillance Reference Group. This interest was perceived as non-personal, non-specific and financially insignificant*
  • Serves as PI for Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH) trial on establishing a human infection model of Bordetella pertussis. This interest was perceived as non-personal, specific and financially significant*
  • Serves as PI for Centers for Disease Control and Prevention (CDC)  trial on establishing a human infection model of pertactin-deficient Bordetella pertussis. This interest was perceived as non-personal, specific and financially significant*
  • His research unit received a grant by GSK in 2023 to strengthen the Canadian Center for Vaccinology by allowing for increased employment opportunities and bolstering top-quality research and pandemic preparedness locally and nationally. This interest was perceived as non-personal, non-specific and financially significant*
  • Consulted with legal team for GSK between November 2024-March 2025 on pertussis vaccine and the cocoon strategy. This interest was perceived as non-personal, specific and financially in insignificant*
  • Consulted with legal team for the province of Ontario in 2023 on general mandatory vaccination. This interest was perceived as non-personal, non-specific and financially insignificant*

     

    Klein, Nicola

    • Safety Expert Panel panel member until 2023. Advised on a planned Hepatitis E Phase II vaccine clinical trial among pregnant women in Pakistan. International Vaccine Institute. This interest was perceived as non-personal, non-specific and financially insignificant*
    • Research support (observational studies). One study related to pertussis vaccines (study/analyses completed in 2023); all other studies were unrelated. Sanofi and GlaxoSmithKline. This interest was perceived as non-personal, specific and financially significant*
    • Additional info on remaining DOIs requested-forthcoming

      Knoll, Maria

• Serves on Scientific Advisory Board for Inventprise. This interest was perceived as personal, non-specific and financially significant*

• Served until 2024 on the Scientific Advisory Board for Merck. This interest was perceived as personal, non-specific and financially insignificant*
• Serves on DSMBs for several trials for the National Institute of Dental and Craniofacial Research (NIDCR), one for a Gates-funded nutrient supplementation trial, one on a bivalent RSV pre-fusion vaccine conducted by Witwatersrand, Johannesburg, South Africa and one funded by the National Institute of Allergy and Infectious Diseases on a Shigella vaccine. These interest was perceived as personal, non-specific and financially insignificant*
• Served until 2024 as Scientific advisor committee for Pfizer.  These interests was perceived as personal, non-specific and financially significant*
• Serves as consultant for WHO on PCV dosing schedule. This interest was perceived as personal, non-specific and financially significant*
• Serves ad investigator for NIH on multi-component INTERLUNG intervention to protect lung health in Nepal that will provide licensed vaccines (COVID-19, influenza, PCV) as part of a package of lung health interventions. This interest was perceived as personal, non-specific and financially significant*
• Conducted a study evaluating impact of PCV in India, sponsored by Pfizer & the Gates Foundation (completed 2023). This interest was perceived as non-personal, non-specific and financially significant*
• Conducted a systematic review and analysis of PCV10 and PCV13 impact on disease, sponsored by WHO (completed 2023). This interest was perceived as non-personal, non-specific and financially significant*
• Assessed Age effects on pneumococcal vaccine immunogenicity in older adults, sponsored by WHO (completed 2023) This interest was perceived as non-personal, non-specific and financially significant*
• Support GAVI with coordination, tracking, evaluation and communications related to their targeted assessments of PCV and Rotavirus vaccines, sponsored by Gavi (completed 2023) This interest was perceived as non-personal, non-specific and financially significant*
• PCV Impact study in Nepal, sponsored by Gavi (completed 2022). This interest was perceived as non-personal, non-specific and financially significant*
• Global and national pneumococcal, Hib and meningococcus etiology estimates, sponsored by The Bill & Melinda Gates Foundation (completed 2022). This interest was perceived as non-personal, non-specific and financially significant*
• Modelling Mortality and morbidity disease burden estimates for childhood pertussis, sponsored by the Gates Foundation (ongoing). This interest was perceived as non-personal, specific and financially significant*
• Strengthening capacity in China for the real-world vaccine efficacy study of PCV, sponsored by the Gates Foundation (ongoing). This interest was perceived as non-personal, non-specific and financially significant*
• COVID-19 vaccine landscape of efficacy, effectiveness and neutralization studies , sponsored by Coalition for Epidemic Preparedness Innovations (CEPI) (ongoing). This interest was perceived as non-personal, non-specific and financially significant*
• Reduction in downstream disease due to vaccination against adult VPDs, sponsored by Merck Sharp & Dohme Corp (completed 2024). This interest was perceived as non-personal, non-specific and financially significant*
• COVID-19 vaccine support to countries in Asia regarding implementation logistics, hesitancy, target groups, efficacy, effectiveness and safety, sponsored by Asian Development Bank (completed 2023). This interest was perceived as non-personal, non-specific and financially significant*

Domenech de Cellês, Matthieu

• Received a research grant  from Sanofi (2021-2024) for a project on pertussis vaccines to develop mathematical models to estimate the properties of pertussis vaccines and predict optimal vaccination strategies, based on pertussis data in Sweden and Denmark. This interest was perceived as non-personal, specific and financially significant*
• Provides consulting services on varicella vaccines in France. This interest was perceived as non-personal, non-specific and financially insignificant*

Gayatri, Amirthalingam

• Member of trial steering committee, ‘A phase IV, multi-centre, randomised controlled trial to assess immunogenicity and safety of COVID-19 and seasonal influenza vaccines given to healthy adults or those with underlying medical conditions when co-administered with a recombinant herpes zoster vaccine with adjuvant’. This interest was perceived as non-personal, non-specific and financially insignificant*
• Her department has provided in 2024/2025 vaccine manufacturers (GSK, Sanofi, Merck, Pfizer) with post-marketing surveillance reports on vaccine preventable diseases (Pneumococcal and  Meninognoccal disease) which the companies are required to submit to the UK Licensing authority in compliance with their Risk Management Strategy. A cost recovery charge is made for these reports. This interest was perceived as non-personal, non-specific and financially significant*
• Research funding is provided to her unit by the National Institute of Health Service Research (NIHR). This interest was perceived as non-personal, non-specific and financially significant*

Heininger, Ulrich

• Served until 2023 on the DSMB for Hillevax, USA, Norovirus vaccine. This interest was perceived as personal, non-specific and financially insignificant*
• Serves on the DSMB for LG Chemicals, South Korea, hexavalent DTPa-IPV-Hib/HBV infant vaccine. This interest was perceived as personal, specific and financially insignificant*
• Serves on the DSMB for Helmholtz Institute, Germany, Diabetes mellitus vaccine. This interest was perceived as personal, non-specific and financially insignificant*
• Serves on the Meta-DSMB for CEPI on various vaccines such as COVID-19, Mpox, Rift Valley Fever. This interest was perceived as personal, non-specific and financially significant*
• Served until 2023 on the Advisory Board for Takeda, Switzerland, Zika virus vaccine. This interest was perceived as personal, non-specific and financially insignificant*
• Serves on the Advisory Board for Takeda, Switzerland, Dengue virus vaccine. This interest was perceived as personal, non-specific and financially insignificant*
• Served until 2022 on the Advisory Board for varicella vaccination strategies. This interest was perceived as personal, non-specific and financially insignificant*
• Serves on the Global pertussis initiative by Sanofi France, steering committee member. This interest was perceived as personal, specific and financially insignificant*
• Serves on the  MSD Switzerland Advisory Board for pneumococcal vaccination strategies. This interest was perceived as personal, non-specific and financially insignificant*
• Serves as ad-hoc consultancy with vaccine dossiers for the Swissmedic, Regulatory authority, Switzerland. This interest was perceived as personal, non-specific and financially insignificant*
• Served until 2025 on Pfizer’s Advisory Board for pneumococcal vaccination strategies. This interest was perceived as personal, non-specific and financially insignificant*
• Served until 2025 on Pfizer’s Advisory Board for Lyme disease vaccination strategies. This interest was perceived as personal, non-specific and financially insignificant*
• Served until 2023 on GSK’s Advisory Board for pertussis vaccination strategies. This interest was perceived as personal, specific and financially insignificant*
• Provided until 2024 adhoc consultancies with interpretation of influenza vaccination response study data to Novarits Switzerland. This interest was perceived as personal, non-specific and financially insignificant*
• Attends the global pertussis initiative annual meeting funded by Sanofi. This interest was perceived as personal, specific and financially significant*

Giles, Michelle

• Served until 2025 on the Australian NITAG. This interest was perceived as non-personal, non-specific and financially insignificant*
• Serves on the IVI DSMB Board for Hecolin. This interest was perceived as non-personal, non-specific and financially insignificant*
• Served until 2025 as PI for the vaccine trial on Covid vaccines funded by Arcturus until 2025. This interest was perceived as non-personal, non-specific and financially significant*
• Served until 2025 PI for the vaccine trial on RSV vaccines funded by GSK. This interest was perceived as non-personal, non-specific and financially significant*
• Serves as PI for the vaccine trial on Covid-influenza vaccines funded by Novavax. This interest was perceived as non-personal, non-specific and financially significant*
• Serves as PI for the vaccine trial on norovirus vaccines funded by Moderna. This interest was perceived as non-personal, non-specific and financially significant*
• Serves as PI for the vaccine trial on CMV vaccines funded by Moderna. This interest was perceived as non-personal, non-specific and financially significant*

Winsley, Rose 

• Serves as consultant for MSD Pharma on the monoclonal antibody Clersovimab. This interest was perceived as personal, non-specific and financially insignificant*
• Served as PI on the Mixed Covid Vaccines trial involving Covishield and Covaxin funded by the Gates Foundation and the Azim Premji Foundation. This interest was perceived as non-personal, non-specific and financially significant*

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* According to WHO's Guidelines for Declaration of Interests (WHO expert), an interest is considered "personal" if it generates financial or non-financial gain to the expert, such as consulting income or a patent. "Specificity" states whether the declared interest is a subject matter of the meeting or work to be undertaken. An interest has "financial significance" if the honoraria, consultancy fee or other received funding, including those received by expert's organization, from any single vaccine manufacturer or other vaccine-related company exceeds 5,000 USD in a calendar year. Likewise, a shareholding in any one vaccine manufacturer or other vaccine-related company in excess of 1,000 USD would also constitute a “significant shareholding”. As per the WHO assessment of conflicts of interests, “Institution” relates only to the expert’s research/or work unit as a subdivision of the department. Funding going to the SAGE Working Group member’s research unit needs to be declared.