We present a self-amplifying RNA encoding the SARS-CoV-2 spike protein, encapsulated within a lipid nanoparticle, as a vaccine. [We] demonstrate [the] induction of robust neutralization of a pseudo-virus, proportional to quantity of specific IgG, and of higher quantities than [in] recovered COVID-19 patients.
These data provide insight into the vaccine design and evaluation of immunogenicity to enable rapid translation to the clinic.
EDITOR’S NOTE: ‘preprints’ are released prior to publication, and in many cases, prior to peer review.
CEPI has moved quickly and collaboratively to rapidly develop vaccines against the COVID-19 virus. CEPI is also collaborating with GSK and will use their pandemic vaccine adjuvant platform technology to enhance the development of an effective vaccine.
Help CEPI develop a COVID-19 vaccine
CEPI estimates that it will cost $2 billion to develop this vaccine within the next 12-18 months. So far they have raised over $750 million towards this goal. They are seeking further contributions from individuals and institutions.
We developed a pilot-scale production of a purified inactivated SARS-CoV-2 virus vaccine candidate (PiCoVacc), which induced SARS-CoV-2-specific neutralizing antibodies in mice, rats and non-human primates. These antibodies potently neutralized ten representative SARS-CoV-2 strains, indicative of a possible broader neutralizing ability against SARS-CoV-2 strains circulating worldwide.
Immunization with two different doses (3μg or 6 μg per dose) provided partial or complete protection in macaques against SARS-CoV-2 challenge, respectively, without any antibody-dependent enhancement of infection.
Systematic evaluation of PiCoVacc via monitoring clinical signs, hematological and biochemical index, and histopathological analysis in macaques suggests that it is safe. These data support the rapid clinical development of SARS-CoV-2 vaccines for humans.
Editor’s note: ‘preprints’ are released prior to publication, and in many cases, prior to peer review.
The National Institutes of Health and the Foundation for the NIH (FNIH) are bringing together more than a dozen leading biopharmaceutical companies, the Health and Human Services Office of the Assistant Secretary for Preparedness and Response, the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration and the European Medicines Agency to develop an international strategy for a coordinated research response to the COVID-19 pandemic.
The planned Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership will develop a collaborative framework for prioritizing vaccine and drug candidates, streamlining clinical trials, coordinating regulatory processes and/or leveraging assets among all partners to rapidly respond to the COVID-19 and future pandemics.
EDITOR’S NOTE: vaccine timeline discussion @ 3:43.