8:20 am Chair’s Opening Remarks
Future Directions & Adapting to COVID-19
8:30 am Developing Vaccines at Pandemic Speed
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
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
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
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
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
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
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
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
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
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