8:20 am Chair’s Opening Remarks

Future Directions & Adapting to COVID-19

8:30 am Developing Vaccines at Pandemic Speed

  • Kay Hunsberger Director of Infrastructure for Biological Clinical Manufacturing,, Merck

Synopsis

  • Highlighting approaches in vaccine development to be prepared for future potential pandemic infectious diseases and share our historical experiences with Ebola and Coronavirus
  • How Merck responded to the Ebola outbreak, share our experience partnering with other companies, government, health, and regulatory agencies, and non-government organizations to develop and implement a vaccine to address the outbreak
  • How Merck’s development efforts for our COVID-19 program were significantly accelerated by using the previously-developed Ebola platform
  • Lessons learned and future preparations to respond to the next global infectious disease

9:00 am Clinical & Operational Challenges of COVID-19 Vaccine Development & Future Opportunities

Synopsis

  • Vaccine efficacy against disease versus infection / transmission: Defining clinical trial endpoints for a new pathogen with limited pre-existing evidence
  • Establishing vaccine efficacy when placebo-controlled trials become more and more difficult as vaccines are being licensed and deployed
  • Need for correlates of protection, newly emerging variants and vaccine adaptation, and vaccine safety and pharmacovigilance

9:30 am Clinical Development of AAVCOVID: A Single Dose AAV-Based Vaccine for COVID-19

Synopsis

  • Understanding how AAVCOVID induces potent neutralizing SARS-CoV-2 antibodies following a single dose intramuscular injection
  • Developing insight into how AAVCOVID can be manufactured at scale with established industry AAV production processes
  • The AAVCOVID vaccine has minimal cold-chain requirements, with stability at room temperature for at least 1 month

10:00 am Establishment of a COVID-19 mRNA Vaccine Technology Transfer Hub to Scale Up Global Manufacturing

  • Martin Friede Coordinator, Initiative for Vaccine Research, World Health Organisation
  • Birgitte Giersing Technical Officer, Initiative for Vaccine Reseach, World Health Organisation

Synopsis

  • Expand the capacity of low- and middle-income countries (LMICs) to produce COVID-19 vaccines and scale up manufacturing to increase global access to these critical tools to bring the pandemic under control
  • Enabling production of mRNA-based COVID-19 vaccines in LMICs through unprecedented partnerships and creation to technology-transfer hubs

10:30 am
Morning Refreshments & Networking

11:00 am Clinical Burden of Severe RSV Infection During the First 2 Years of Life

Synopsis

  • 12-year study is the first to estimate the burden of RSV hospitalisation (RSVH) and included all live births from 2000-2011 and followed > 600,000 children until 2 years old
  • Investigation into verall RSVH rates

11:30 am Systems Serology to Define Updated Correlates of Immunity to SARS-CoV-2

  • Galit Alter Professor of Medicine, Harvard Medical School

Synopsis

  • While neutralization has been linked to protection against other pathogens, whether neutralization alone will be sufficient to drive protection against SARS-CoV-2 in the broader population remains unclear
  • Dissecting the early evolution of the humoral response in a cohort of hospitalized individuals ranging from moderate-to severe
  • Highlighting distinct humoral trajectories associated with resolution of SARS-CoV-2 infection and the need for early functional humoral immunity

12:00 pm Conception, Construction, Pre-Clinical & Clinical Testing of COH04S1 Vaccine with Activity Against SARS-CoV-2

  • Don Diamond Professor, Cancer & Viral Vaccines, City of Hope

Synopsis

  • COVID-19 variants have arisen with different biologic properties culminating in the most recent and frightening variety referred to as Omicron. Development of a vaccine that would have prophylactic activity against a variety of SARS-CoV-2 strains by expanding the antigen cargo two
    include both the Nucleocapsid and Spike antigens
  • Describing the development process of a vaccine including a proprietary synthetic viral platform, laboratory and animal studies, culminating with an overview of ongoing and completed Phase 1 and Phase 2 trials in healthy adults and immunocompromised cancer patients and stem cell
    transplant recipients
  • Sharing results from Phase 1b trial (NCT046339466) and ongoing Phase 2 trials (NCT04977024) to demonstrate the capacity of a vaccine to stimulate protective humoral and cellular immunity in healthy persons and cancer patients

12:30 pm Exploring Vaccine Adjuvant R&D Within RSV Models

  • Simon van Haren Research Associate, Division of Infectious Diseases, Precision Vaccines Program, Boston Children’s Hospital

Synopsis

  • Preclinical studies showing effectiveness in neonates
  • Clinical development of the CAF®01 adjuvant
  • Immune profile of correct Th1/Th2 and antibody responses for optimal protection against RSV

1:00 pm
Networking Lunch

2:00 pm Developing a Live Attenuated RSV Vaccine for Infants Newborns & Toddlers

  • Sanie Sesay Global Director Clinical Development, Vaccines , Sanofi Pasteur

Synopsis

  • Recent advances in the understanding of RSV gene function and reverse genetics have led to the rational design of promising new-generation replication-competent live attenuated RSV vaccines
  • Live attenuated RSV vaccines do not cause enhanced disease
  • Live attenuated RSV vaccines are expected to induce innate immunity, durable local and systemic immunity
  • Development of a live attenuated RSV vaccine could substantially reduce the global burden of disease in infants and toddlers

2:30 pm Observational Maternal COVID-19 Vaccination Clinical Data

  • Geeta Swamy Associate Vice President for Research Vice Dean for Scientific Integrity Professor, Obstetrics & Gynecology, Duke University

Synopsis

  • Injection-site (local) and systemic reaction data will be discussed and second vaccination
  • Analyzing maternal serum samples to compare for antibody titers relevant to COVID-19 at time points that include: prior to vaccination, ~29 days post second vaccination, and at delivery
  • Maternal and infant cord blood analyzed for the same antibody titers

3:00 pm Global Technology Transfer & Commercialization of Next-Gen mRNA Vaccines

3:30 pm Afternoon Refreshments & Networking

4:00 pm The Canadian Registry of Palivizumab (CARESS): Outcomes Following Twelve Seasons of RSV Prophylaxis

  • Bosco Paes Professor Emeritus, Pediatrics, McMaster University

Synopsis

  • Review the CARESS study protocol and enrolment
  • Examine the indications for prophylaxis, palivizumab utilization and adherence
  • Review the respiratory and RSV-related hospitalizations across the indications from 2005-2017

4:30 pm Updated RSV Epidemiology of High-Risk Infants & Toddlers

  • Leonard Krilov Chairman, Department of Pediatrics, NYU Long Island School of Medicine

Synopsis

  • Updated overview of the morbidity in developed countries and in high-risk neonates and potential implications
  • Potential targeted prevention of RSV infection based on current epidemiology
  • Short term burden of RSV infection

5:00 pm The Burden of RSV Infection on Healthcare Systems, Children & Families

  • Ian Mitchell Professor Emeritus, Department of Pediatrics, University of Calgary

Synopsis

  • RSV infection remains most common cause of respiratory admissions in infancy
  • Abrupt onset of RSV epidemics creates annual resource problems
  •  Effective, safe RSV vaccine immediate system impact

5:30 pm Chair’s Closing Remarks & Close of Summit