“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 SAFER VACCINES

WE NEED BETTER 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

ASO1 Adjuvanted vaccines

“Do not use an adjuvant unless you need to!!Make the antigen immunogenic”

Martin Friede

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

“Teach and demand good science in the evaluation

of vaccine safety concerns”

Neal Halsey

”Temporal associations are frequently assumed to be causal”“Be careful with temporal associations”

Paul-Henri Lambert

“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

“Large linked data bases are the future BUT we need to understand how do we use them best”

Nick Andrews

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!

“Learn to better communicate uncertainty” Hannah Nohynek

“Anticipatory advice helps a lot”Neal Halsey

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

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.

“Acknowledge the full range of ethical resources that are available to provide ethical directions”

Catherine Slack

Access and availability of vaccines

Vaccine uptake

WE NEED THE VACCINE TO BE ADMINISTERED

”I worry about the delivery! We have great vaccines and people don’t want to receive them”

Myron Levine

“The best vaccines are useless unless they are delivered”

Stanley Plotkin

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

WE NEED THE VACCINE TO BE ADMINISTERED

"Measures of vaccine efficacy and safety data do not capture the fullpublic health value of vaccine.

A broader evaluation of vaccines shouldinclude the vaccine preventable disease incidence”

Annelies Wilder-Smith

“Explicitly understand the questions and assumptions that drive the

decisions” Mark Miller

“PRIME, PRIME, BOOST!”Claire-Anne Siegrist

Mandatory vs. Voluntary Vaccination Program

“Don’t stop challenging the paradigms of vaccination schedules”

Edwin AsturiasPhilippe 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!”

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

WE NEED THE VACCINE TO BE ADMINISTERED

GAVI is a development model – Ownership depends on the country. Aurelia Nguyen

Half of the children born in the world each year receive a GAVI-funded vaccine”

“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 SAFER VACCINES

WE NEED BETTER 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

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)..

RSV VACCINES

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 in 3 countries in implementation pilots. If safety signals are positively resolved, the vaccine could be an important addition to current malaria control tools.

• Pilot implementations may be more common as vaccines come forward with modest efficacy. Lessons learned from the MVIP can be applied to those future pilots.

• Bringing a vaccine through clinical development is particularly challenging when the vaccine is intended solely for resource poor countries.

POLIO

The only wild type polio strain that is still circulating is polio Type 1

Polio is on the brink of being the second human disease to be ever eradicated, thanks to a global partnership and intense vaccination efforts.

Innovations in vaccine research can further strengthen the strategies to overcome unique challenges of the Endgame, to complete and sustain eradication for long-term.

Ananda Bandyopadhyay

DIPHTHERIA, MEASLES AND RUBELLA

Remember the challenges and principles of outbreak control elimination and eradication.

Measles eradication is biologically, technically and epidemiologically feasible.

The time of vertical disease eradication efforts is questioned. We are going towards to universal health coverage and primary healthcare where measles is a driver for

focusing good programs and the indicator of immunity gaps.

“Measles is the canary in the coal mine and an indicator of where we have a lack of immunity”

Ann Lindstrand

“Take advantage of all opportunities. Don’t let them pass you by because you think they

are too hard”

Stanley Plotkin

"Vaccinologists must remain optimists, reminding all at every opportunity that vaccines are medicine's most powerful

weapons of mass protection."

Myron Levine

“Be open minded and continue to learn.”

“Don’t be afraid to expand your horizons and try other jobs.”

“Follow your passion. Only do a job you are passionate about.”

“Never stop asking. Keep boosting.”

“Learn and try to find everyday something new.”

“Think outside the box!”

“Use your network, and use this network.”

“Network. Stay In Touch in one another.”

“Network and identify multiple mentors.”

“Networking is key. Learn networking skills.”

“Choose a good mentor.”

“Aim to work for and to collaborate with the very best researchers/mentors.”

“Use your network, and use this network.”

“Network. Stay In Touch in one another.”

“Network and identify multiple mentors.”

“Networking is key. Learn networking skills.”

“Choose a good mentor.”

“Aim to work for and to collaborate with the very best researchers/mentors.”

DENGUE VACCINES

Partial immunity to dengue is BAD.

CHIM studies are important to understand wild type disease and protective immunity to guide vaccine development

We have one licensed Dengue vaccine and two other candidate vaccines are currently in Phase 3 clinical trial.

“For a live vaccine to protect against dengue all four components have to infect and replicate within the host to produce homotypic response” Anna Durbin

TUBERCULOSIS VACCINES

ASO1 Adjuvanted vaccine had significant VE so we can develop TB vaccines that work!

Other vaccines under evaluation: VPM1002, MTBVAC

Inhaled TB Vaccine would be a good idea to enhance mucosal immunity

Human mycobacterial challenge models important for vaccine selection

There has been a huge progress in TB vaccine development, we need

To continue this momentum.

Helen McShane

ZIKA VACCINES

Synthetic vaccinology. wherever you are in the world and you can isolate and sequence the virus, understand the structure and how they express the antigens to synthetize a vaccine quickly

Platform technologies shorten manufacturing timelines

Will require global infrastructure for surveillance, virus discovery, and surge capacity

INFLUENZA VACCINES

• There are many new vaccines on the market. Still require yearly administration and are strain specific.

• Vaccination programs in LIC should consider burden of disease and feasibility.Pregnant woman and HCW might be initial targets groups

• We need to learn from the studies that don’t work

“Influenza is a serious disease and even moderately efficacious vaccines will have impact .”

Kathleen Neuzil

ROTAVIRUS VACCINES

“You don’t need more strains to get better protection.”

Umesh Parashar

• Rotavirus vaccines provide good protection against vaccine and non-vaccine strains.

• There is a lower risk of intussusception, but benefits clearly outweighs the small risk

• We have seen evidence of indirect benefits - Community Immunity!

PERTUSSIS VACCINES

“You have to love your pathogens. You need to be immerse in what they do and how they do”

Kathy Edwards

• Is very important to understand the fundamentals of the immunology of the pathogen and the vaccine.

• Maternal immunization protects young infants.

• We need a new vaccine.

Can antigens be added to acellular pertussis vaccines to make them more effective?

Can new vaccine approaches restore protection?

Can the accelerated waning of protective immunity with repeated aP doses be averted?

How can sterilizing immunity as seen with natural pertussis be obtained with vaccines?

MENINGICOCCAL VACCINES

More people should become vaccinologistsbecause it crosses through many different

“ologies”Ray Borrow

• Conjugate vaccines against A, C, Y and W are proving highly effective, especially by interruption of acquisition of carriage.

• A pentavalent ACWYX conjugate is proceeding well through Phase 2.

• We have a safe, efficacious and broad coverage meningo B vaccine .

CMV VACCINE

“We will know in next couple of years if it’s feasible”Stanley Plotkin

• CMV is he most important cause of congenital abnormalities and most common infection in transplanted patients.

• The pathogen is much different from most infectious diseases therefore prevention is more difficult .

• We have many experimental candidates and the path to licensure has been defined by the FDA.

HPV VACCINES

“We need them, they work and they are safe.That is what the parents want to know”

Margaret Stanley

• HPV vaccines are the first vaccines to be delivered to adolescents, they target a sexually transmitted infection the most serious disease consequence of which is cervix cancer which develops 15-40 years after the infection. The challenges are to persuade governments, health professionals and parents that.

• The vaccines work – impact and effectiveness have been demonstrated in countries that have implemented HPV immunisation and achieved high coverage.

• The vaccines are safe all the evidence from trials, Phase IV studies, large pharmacovigilance studies have not given any evidence of an adverse safety signal. WHO and all regulatory bodies continue to recommend the vaccine.

“If we can convince people worldwide we can eliminate cervical cancer”

HIV VACCINE“Antibody mediated vaccine induces protection against HIV”

Brigitte Autran

New Hopes for preventative HIV vaccines ? Combined strategies inducing: • Neutralizing or Non-neutralizing antibodies : in progress

• T cells : induction with replication deficient or competent vectors

There is increasing hope to develop antibody mediated HIV vaccine efficacy but this development is still facing huge challenges in terms of ideal immunogens, protective efficacy and implementation.