Beyond vaccine introduction: Working together for sustainable, resilient immunization programs Manufacturer perspective

Transcription

1 Beyond vaccine introduction: Working together for sustainable, resilient immunization programs Manufacturer perspective IAIM Regional Meeting for the Americas and Europe 1 February 2017 Anupama Tantri Global Policy and Partnerships Merck Vaccines

2 Forward-Looking Statement This presentation includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of These statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2016 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site ( 2

3 A vaccine lifecycle is governed by a complex, interconnected ecosystem with multiple, people and policies Knowledge and skills Funding Clinical trial infrastructure R&D Industry Academia Patient advocacy groups research institutes Technology Equipment Supply managemen t regulatory agencies Industry Trade associations Ministries of industry / trade / commerce Funding Expertise Human resources Licensure regulatory agencies European Medicines Agency Expertise Human resources WHO prequalification Manufacturing Recommendations technical advisory groups WHO SAGE / global / regional institutions Medical societies Advocacy groups Funding Management Procurement / regional governments Health care providers / Pooled procurement entities UNICEF / Gavi Cold chain Logistics Delivery and Storage immunizatio n programs Health care providers / NGOs Trained workforce Accessible venues Vaccination immunization programs Health care providers School nurses Community health workers Vaccine safety Information Disease surveillance Monitoring and Surveillance Ministries of health Regulatory agencies Industry WHO / global / regional institutions Communication campaigns Funding Scale up and Sustainability Ministries of health Academia Industry WHO / global / regional institutions Advocacy groups and NGO

4 Several trends influence and shape the vaccine ecosystem and vaccine introduction, access, uptake and program sustainability and resiliency Ageing Populations Transforming Health Systems Health Budget Pressures and Economic Crises 4 Emerging Infections and Non- Communicable Diseases Source: Vaccine hesitancy and confidence

5 Working together: Strategies to promote sustainable, resilient immunization programs Create new and optimize existing vaccines Generate and disseminate data about the burden of disease, safety, efficacy and value of vaccines Strengthen program implementation Promote vaccine confidence and resilient vaccine eco Promote evidence-informed immunization policies and best practices

6 Strengthening programs, generating data and building vaccine confidence Nicaragua 1 Philippines 2 Partnership: MoH and MSD ( ) Facilitated introduction of rotavirus vaccine Generated data on effectiveness and evaluated public health impact Supported program implementation (education and training) Achieved >90% national coverage by 3 years Collaboration with public sector, NGOs, medical societies ( current) Supported comprehensive cervical cancer prevention programs Promoted resilient program and vaccine confidence Supported implementation of HPV vaccination program (training, best practices) Achieved >75% coverage for first dose 6 1. Khawja, et al. Evaluating the health impact of a public-private partnership to reduce rotavirus disease in Nicaragua. Human Vaccines & Immunotherapeutics 8:6, ; June

7 Disseminating data, strengthening communications and building vaccine confidence Fig 1: Map showing global transmission of: 1) Information about other countries HPV situation reported in the Japanese media; and 2) reporting and discussion on the Japanese suspension of the HPV vaccine recommendation outside of Japan. (January 2014-July 2014). From: Larson, et al. Tracking the global spread of vaccine sentiments: The global response to Japan's suspension of its HPV vaccine recommendation. Hum Vaccin Immunother Sep; 10(9):

8 Promoting evidence-informed immunization policies and best practices ALOHA: Acting for Longevity and Healthy Ageing Pan-European partnership across 10 countries with 22 public and private partners Aim to inform, educate and engage HCPs, public to prevent infectious diseases in seniors AVAC: Adult Vaccine Access Coalition Coalition of >50 HCPs, vaccine makers, pharmacies, public health orgs, patient and consumer groups Aim to inform and engage policymakers to strengthen and enhance access to and utilization of adult immunization services across health system 8

9 9 Thank you! We cannot step aside and say that we have achieved our goal by inventing a new drug or a new way by which to treat presently incurable diseases We cannot rest till the way has been found, with our help, to bring our finest achievement to everyone. - George Merck