As the world struggles to address the vast demand for, and limited supply of, regulatory-approved COVID-19 vaccines, experts
are investigating scientific approaches to maximize those precious resources.
Biosimulation, which integrates computer-aided modeling and simulation with pharmaceutical science, provides potent
intelligence to support decision making on these crucial issues. It can help answer questions like:
• Do elderly people require a higher dose of the COVID-19 vaccine because their immune system becomes less effective
with age?
• Might a lower vaccine dose be effective for young people?
• Can the interval between doses be increased to free up vaccine to allow more people to get their first dose earlier?
• Can people receive their first dose of one vaccine and their second dose of a different vaccine?
• How long does a vaccine’s antibody response last? Will a booster shot be required in a year?
• If people have had COVID-19, should they still get a vaccine, and do they need the full dose?
• Are the answers to these questions the same for populations of different ethnicity?
The beauty of Certara’s biosimulation models is that they allow researchers to study how a drug or a biologic is handled by
the human body in computer-generated, virtual patients. They enable virtual computer-based trials to be conducted that may
be impractical or unethical to perform with real subjects due to a range of recruitment challenges such as age, concurrent
diseases, comedications, or an impaired hepatic or renal system. They generally yield results much faster and at a lower cost
than actual clinical studies and are often used to streamline, optimize, and sometimes replace studies. This speed factor is
pivotal for COVID-19, especially as we grapple with how to optimize the vaccine supply chain.
Biosimulation is a powerful and proven technology. Certara and our partners have been using biosimulation to support
the development of drugs and biologics, including new modalities such as gene therapies, and to optimize immunooncology combinations for many years. These biosimulation technologies have been adopted by major pharmaceutical and
biotechnology companies, academia and global regulatory agencies.