A pilot-scale inactivated SARS-CoV-2 vaccine candidate, PiCoVacc, was developed and tested. The vaccine induced SARS-CoV-2-specific neutralizing antibodies in mice, rats, and nonhuman primates, neutralizing 10 representative SARS-CoV-2 strains. Three immunizations with doses of 3 or 6 micrograms per dose provided partial or complete protection in macaques against SARS-CoV-2 challenge without antibody-dependent enhancement of infection. These results support the clinical development of PiCoVacc for human use. The World Health Organization declared the outbreak of COVID-19 a Public Health Emergency of International Concern and classified it as a pandemic. SARS-CoV-2, a member of the Betacoronavirus genus, is a highly contagious virus that causes severe respiratory illness. Currently, no specific treatments or vaccines are available for SARS-CoV-2, making vaccine development urgent. Multiple vaccine types, including DNA- and RNA-based formulations, recombinant subunits, adenovirus vectors, and inactivated virus, are under development. Inactivated virus vaccines have been used successfully for influenza and poliovirus. To develop preclinical models, SARS-CoV-2 strains were isolated from patients, and the CN2 strain was selected for vaccine development. The CN2 strain was propagated in Vero cells and inactivated with β-propiolactone. The vaccine was purified and characterized, showing intact, oval-shaped particles with crown-like spikes. PiCoVacc induced strong S-specific and RBD-specific IgG responses in mice, with high neutralizing antibody titers. The vaccine also elicited neutralizing antibodies against 10 SARS-CoV-2 strains, suggesting broad neutralizing activity. In macaques, PiCoVacc provided protection against SARS-CoV-2 challenge, with no signs of antibody-dependent enhancement. Safety evaluations in macaques showed no adverse effects, with no notable changes in hematological or biochemical parameters. Histopathological evaluations also showed no significant pathology. The study provides evidence for the safety and efficacy of PiCoVacc in nonhuman primates, supporting its clinical development for human use. Phase I, II, and III clinical trials are expected to begin later this year.A pilot-scale inactivated SARS-CoV-2 vaccine candidate, PiCoVacc, was developed and tested. The vaccine induced SARS-CoV-2-specific neutralizing antibodies in mice, rats, and nonhuman primates, neutralizing 10 representative SARS-CoV-2 strains. Three immunizations with doses of 3 or 6 micrograms per dose provided partial or complete protection in macaques against SARS-CoV-2 challenge without antibody-dependent enhancement of infection. These results support the clinical development of PiCoVacc for human use. The World Health Organization declared the outbreak of COVID-19 a Public Health Emergency of International Concern and classified it as a pandemic. SARS-CoV-2, a member of the Betacoronavirus genus, is a highly contagious virus that causes severe respiratory illness. Currently, no specific treatments or vaccines are available for SARS-CoV-2, making vaccine development urgent. Multiple vaccine types, including DNA- and RNA-based formulations, recombinant subunits, adenovirus vectors, and inactivated virus, are under development. Inactivated virus vaccines have been used successfully for influenza and poliovirus. To develop preclinical models, SARS-CoV-2 strains were isolated from patients, and the CN2 strain was selected for vaccine development. The CN2 strain was propagated in Vero cells and inactivated with β-propiolactone. The vaccine was purified and characterized, showing intact, oval-shaped particles with crown-like spikes. PiCoVacc induced strong S-specific and RBD-specific IgG responses in mice, with high neutralizing antibody titers. The vaccine also elicited neutralizing antibodies against 10 SARS-CoV-2 strains, suggesting broad neutralizing activity. In macaques, PiCoVacc provided protection against SARS-CoV-2 challenge, with no signs of antibody-dependent enhancement. Safety evaluations in macaques showed no adverse effects, with no notable changes in hematological or biochemical parameters. Histopathological evaluations also showed no significant pathology. The study provides evidence for the safety and efficacy of PiCoVacc in nonhuman primates, supporting its clinical development for human use. Phase I, II, and III clinical trials are expected to begin later this year.