Since the emergence of SARS-COV-2 in 2019, two mRNA vaccines, Moderna mRNA-1273 and Pfizer-BioNTech BNT162b2, were developed most rapidly and proved to be most efficacious 3, 4, 5. New vaccines that can be manufactured rapidly and stored without complex cold-chain requirements and result in long-term, robust, multi-variant immunity are urgently needed to protect people across the globe against SARS-CoV-2. Although multiple SARS-CoV-2 vaccines have been developed and over 12 billion SARS-CoV-2 vaccine doses have been administered globally 1, only 21% of people in low-income countries have received a dose 2. More than 609 million confirmed cases of coronavirus disease 2019 (COVID-19) and 6.5 million related deaths have occurred worldwide due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as of September 2022 1. Taken together, this saRNA delivered by NLC represents a potential improvement in RNA technology that could allow wider access to RNA vaccines for the current COVID-19 and future pandemics. Notably, the saRNA/NLC platform demonstrated thermostability when stored lyophilized at room temperature for at least 6 months and at refrigerated temperatures for at least 10 months. Robust Th1-biased T-cell responses were also observed after prime or homologous prime-boost in mice. In preclinical studies, this saRNA/NLC vaccine induced strong humoral immunity, as demonstrated by high pseudovirus neutralization titers to the Alpha, Beta, and Delta variants of concern and induction of bone marrow-resident antibody-secreting cells. This saRNA vaccine is formulated with a nanostructured lipid carrier (NLC), providing stability, ease of manufacturing, and protection against degradation. We have developed an easily-manufactured, potent self-amplifying RNA (saRNA) vaccine against SARS-CoV-2 that is stable at room temperature. However, limitations in these vaccines have been recognized due to their requirement for cold storage, short durability of protection, and lack of access in low-resource regions.
MRNA vaccines were the first to be authorized for use against SARS-CoV-2 and have since demonstrated high efficacy against serious illness and death.
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