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The Impact of Vaccination on the Health of the World’S People Is Hard to Exaggerate

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The Impact of Vaccination on the Health of the World’S People Is Hard to Exaggerate “The impact of vaccination on the health of the world’s people is hard to exaggerate. With the exception of safe water, no other modality has had such a major effect on mortality reduction and population growth” Susan and Stanley Plotkin “The impact of vaccination on the health of the world’s peoples is hard to exaggerate. With the exception of safe water, no other modality has had such a major effect on mortality reduction and population growth” “What looks simple on retrospective, it was much complicated than you thought Susan and Stanley Plotkin WE NEED BETTER VACCINES WE NEED SAFER VACCINES WE NEED BETTER & SAFER VACCINES FASTER WE NEED THE VACCINE TO BE ADMINISTERED WE NEED TO BETTER ASSESS VACCINE IMPACT WE NEED BETTER VACCINES Understand burden of disease and clinical course Identify target population Understand the immunological response (B, T, mucosal) Identify specific vaccine antigen Improved vaccine design (next generation vaccines) Do we need to include an adjuvant to enhance/skew immune response? WE NEED BETTER VACCINES “Design vaccines for older adults, not college age kids” Keipp Talbot “There is nothing wrong with the early life immune system. It is different and we have to learn to adapt to its specificities” Claire-Anne Siegrist “Maternal immunization can benefit both the mother and the baby. Closes the window of vulnerability” Janet Englund WE NEED BETTER VACCINES Understand the immunological response “Germinal Center is the key to a successful party!!” Claire-Anne Siegrist “Structure based vaccine design will change things moving forward” Barney Graham Cristina Cassetti “Do not use an adjuvant unless you need to!! Make the antigen immunogenic” Martin Friede ASO1 Adjuvanted vaccines WE NEED SAFER VACCINES We need to develop safer vaccines We need to improve how we assess vaccine safety We need to better communicate about vaccine safety “Immunization safety encompasses ensuring and monitoring the safety of all aspects of immunization, including: vaccine quality, transport, storage and handling, vaccine administration, and the disposal of sharps” Philippe Duclos “Many adverse events are preventable by following recommended guidelines” Neal Halsey “We need to understand on how do vaccines cause adverse events and how to determine causal association” Neal Halsey ”Temporal associations are frequently assumed to be causal” “Be careful with temporal associations” Paul-Henri Lambert “Teach and demand good science in the evaluation of vaccine safety concerns” Neal Halsey “Large linked data bases are the future BUT we need to understand how do we use them best” Nick Andrews “We need to do much more safety “science”. The “science of vaccine safety” . What can we say from the data, and what we are unable to say because we have not done the studies. We need to understand what studies need to be done. As a medical community we need to show that we have taken such issues seriously” Stanley Plotkin “Learn to better communicate uncertainty” Hannah Nohynek “Anticipatory advice helps a lot” Neal Halsey Communication – vaccine advocacy Attitudinal Research Addressing vaccine hesitancy – Increasing vaccine uptake Training of health care workers in vaccine safety is KEY We need to get out from our comfort zone and communicate Media Training – Learn communication skills! WE NEED TO EVALUATE VACCINES BETTER & FASTER Vaccine evaluation is a long and challenging process Myron Levine “Endpoint selection should focus on public health importance” “The size of a trial is not how many people are in the trial, it is how many have the primary endpoint! NUMBER OF ENDPOINTS NOT NUMBER OF PEOPLE” Peter Smith “Understanding the case definition is critical for the success of the trial” Penny Heaton Large-scale Phase 3 trials…LOGISTICS is key! And its all about partnerships . Myron Levine “Controlled Human Challenge studies are important to understand wild type infection and vaccine immune response” Anna Durbin Regulatory challenges Discussed utility for: -Vaccine candidate selection -Identifying a correlate of protection to design phase II/III trials “Cluster-randomized clinical trials offer the opportunity to assess herd protection before the vaccine is licensed and inform decision” John Clemens “Acknowledge the full range of ethical resources that are available to provide ethical directions” Catherine Slack Ensuring welfare of study participants Community engagement is KEY! “Science” of community engagement and guidelines. Need to know when a DSMB is needed and how does it work. ”I worry about the delivery! We have great vaccines and people don’t want to receive them” Myron Levine WE NEED THE VACCINE TO BE ADMINISTERED “The best vaccines are useless unless they are delivered” Stanley Plotkin Access and availability of vaccines Vaccine uptake WE NEED THE VACCINE TO BE ADMINISTERED Access and availability of vaccines In-Country decisions to include a vaccine in the NIC Planning and implementation of Immunization Programs - COVERAGE Manufacturing process Vaccine supply and logistics Vaccine delivery technologies Epidemic and pandemic preparedness Delivery of vaccines in LIC – equity Vaccine uptake = Communication – vaccine advocacy Attitudinal Research Addressing vaccine hesitancy – Increasing vaccine uptake Get out from our comfort zone and be a communicator! Learn communication skills! Immunization programs need to think about ethical principles "Measures of vaccine efficacy and safety data do not capture the full public health value of vaccine. A broader evaluation of vaccines should include the vaccine preventable disease incidence” Annelies Wilder-Smith “Explicitly understand the questions and assumptions that drive the decisions” Mark Miller “PRIME, PRIME, BOOST!” Mandatory vs. Voluntary Claire-Anne Siegrist Vaccination Program “Don’t stop challenging the paradigms of vaccination schedules” Edwin Asturias Philippe Duclos For those involved with NITAGs please make sure to capitalize on the Global NITAG Network and the NITAG resource centre on the web Philippe Duclos NITAGs are about making evidence-based decisions, transparency, and national cohesion and can bring credibility and trust in the program based. COVERAGE “Without national ownership and political commitment there will be no progress” Philippe Duclos To move forward and improve vaccine coverage we need: sharing of experiences between countries and regions, adequate training for all heath care providers, quality implementation of activities, thinking in social versus physical distance, engaging communities to understand and deliver vaccines, and adapt to the evolving situation such as taking migrations into consideration and weak health systems. “Some approaches towards reaching left out and dropped out children: small changes, big impact! Every health contact is an opportunity to vaccinate!” WE NEED THE VACCINE TO BE ADMINISTERED Access and availability of vaccines In-Country decisions to include a vaccine in the NIC Planning and implementation of Immunization Programs - COVERAGE Manufacturing process Vaccine supply and logistics Vaccine delivery technologies PROGRAM MANAGEMENT IS KEY! Supply Chains systems “optimization” WE NEED THE VACCINE TO BE ADMINISTERED Access and availability of vaccines In-Country decisions to include a vaccine in the NIC Planning and implementation of Immunization Programs Manufacturing process Vaccine supply and logistics Vaccine delivery technologies Epidemic and pandemic preparedness - CEPI Delivery of vaccines in LIC – equity Half of the children born in the world each year receive a GAVI-funded vaccine” GAVI is a development model – Ownership depends on the country. Aurelia Nguyen “Commitment from the government is important. Every country has their own requirements and regulations. We need regulatory harmonization when want to go global” Suresh Jadhav Communicate, Advocate!! “We all need to work collectively! All with the same message” Noni McDonald Teaching the value of vaccines to young children, high school students and medical students is critical to improve vaccine acceptance WE NEED BETTER VACCINES WE NEED SAFER VACCINES WE NEED BETTER & SAFER VACCINES FASTER WE NEED THE VACCINE TO BE ADMINISTERED WE NEED TO BETTER ASSESS VACCINE IMPACT “Pneumococcal vaccine should be evaluated by the impact, not by the efficacy, taking all endpoints together. Benefit would be much more than predicted” Ron Dagan “Understanding the detailed epidemiological impact of vaccination programs is not optional – it is essential. Calculation is required” Roy Anderson “We urgently need adequately-sized rigorous randomised controlled trials to provide definitive evidence whether non-live vaccines have any detrimental effects and to determine whether a change in the schedule (sequence) of vaccines can optimise the benefits of NSE and minimise any detrimental effects.” Nigel Curtis RSV VACCINES New era of vaccinology and technology opportunities could transform vaccine development into an engineering exercise Barney Graham Pre-F specific antibodies have higher potency Stabilized RSV pre-F candidate trimeric subunit vaccine (DS- Cav1) provides a clinical proof-of-concept for structure-based vaccine design. New long acting MAb Medi15887 being studied in clinical trials Pregnant women – International phase 2, 3 trial completed with > 4000 women (Novavax with support from B&M Gates).. MALARIA VACCINE “Its not just science, its commitment and collaboration that makes this possible” Mary Hamel • The RTS,S malaria vaccine is a partially effective vaccine currently introduced
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