The Path to a SARS-CoV-2 Vaccine

Paul A. Offit, MD
Division of Infectious Diseases
Vaccine Education Center
The Children’s Hospital of Philadelphia
Perelman School of Medicine
The University of Pennsylvania
Aug. 10, 2020
Typical Vaccine Timeline
3
Developing SARS-CoV-2 Vaccine
Rapid Development of SARS-CoV-2 Vaccine

• 120 Investigational New Drug (IND) applications to the

FDA.
• More than 70 companies across the globe are interested.
• BARDA (Biomedical Advanced Research and
Development Authority), the World Health Organization,
and the Gates Foundation have given billions of dollars
toward this effort.
Rapid Development of SARS-CoV-2 Vaccine

• No or limited animal model studies.

• Small dose-ranging studies in people.
• Skip FDA licensure but approve vaccines under
Emergency Use Authorization.
• Manufacturing and scale-up at Warp Speed
• The one thing you can’t truncate: Phase 3 trials, which
are currently planned for roughly 30,000 participants.
The Virus
SARS-CoV-2 Vaccine Strategies
 SARS-CoV-2 Vaccine Strategies

• Whole, killed virus

• Live, attenuated virus
• Purified viral protein
• Replicating viral vectors
• Replication defective viral vectors
• mRNA
• DNA
Managing Expectations
Regarding Safety
15
Regarding Efficacy
 Inducing Herd Immunity
• Dependent on two factors: Ro and vaccine efficacy.

• Ro- 1/Ro divided by percent vaccine efficacy.

• For example, if Ro is 2.0 and vaccine efficacy is 75

percent then 2–1 divided by 2 = 0.5 divided by .75
equals .67. Therefore, about 67 percent of the population
would need to be vaccinated to stop spread.
• If vaccine efficacy was 100 percent, then 50 percent of
the population would need to be immunized; if vaccine
efficacy was 50 percent, then 100 percent of the
population would need to be immunized.
Regarding Availability
Regarding an October Surprise
“Given the widespread potential use of a COVID-19
vaccine, transparent discussion of FDA’s Vaccines and
Related Biological Products Advisory Committee will be
needed prior to vaccine authorization or licensure to
ensure clear public understanding of the evidence
supporting vaccine safety and efficacy.”