APR January/February 2022 - 70

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FORMULATION AND DEVELOPMENT
»
mRNA: A New Frontier in
Vaccines and Medicine
Vanessa Elharrar
Vice President
PPD Clinical Research Services
Thermo Fisher Scientific
Martina Kovac
Vice President
PPD Clinical Research Services
Thermo Fisher Scientific
Anusha Streubel
Executive Medical Director
PPD Clinical Research Services
Thermo Fisher Scientific
Overview
Vaccines have revolutionized the world's ability to prevent, mitigate the
impact of and, in some cases, eliminate the threat of certain infectious
diseases and improve overall health. The clinical development of a
conventional vaccine is a complex and lengthy process involving
rigorous safety and efficacy testing that can take 10-15 years to
complete.
Prior to the COVID-19 pandemic, the mumps vaccine was the fastest
vaccine developed - going from viral sampling to licensure - in
four years. The global COVID-19 pandemic, occurring six decades
later, provided an acute need to accelerate vaccine development to
previously unimaginable speeds - less than one year from sequencing
of the viral genome to emergency use authorization. This achievement
has forever changed the landscape of vaccine development and brings
with it hope that vaccines for other pathogens can be developed on an
accelerated timeline.
The emergence of the SARS-CoV-2 virus and the resulting COVID-19
global health crisis highlighted the need for vaccines that could safely
protect from severe disease while reducing infection rates in vaccinated
populations, eliciting long-term memory immune responses and
offering the potential for rapid and cost-effective manufacturing in
extremely large quantities, all while providing global accessibility. To
answer this unmet need, messenger ribonucleic acid (mRNA) vaccines
quickly surged to the forefront of COVID-19 vaccine candidates.
Potent inducers of both cellular and humoral adaptive immune
responses, mRNA vaccines are very fast to deploy and, because of the
quick degradation of nucleic acid within the body, were expected to
have a favorable safety profile. Further, since the primary ingredient
required for production is the genetic sequence that encodes for
a viral antigen, design and production could be fast-tracked. Less
than 10 weeks after the first genetic sequences were released, one
prominent biotech company's mRNA-based SARS-CoV-2 vaccine
candidate entered Phase I trials.
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| January/February 2022

APR January/February 2022

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