1. Introduction
deaths, fetotoxicity, coronavirus disease 2019, pain
CORONAVIRUS DISEASE 2019, ADVERSE EVENTS, TERATOGENIC EFFECT, MAY, CORONAVIRUS, SEVERE ACUTE RESPIRATORY SYNDROME
These authors contributed equally to this work.We present the results of a randomized, double-blind, placebo-controlled, multi-center clinical trial phase I/II of the tolerability, safety, and immunogenicity of the inactivated whole virion concentrated purified coronavirus vaccine CoviVac in volunteers aged 18–60 and open multi-center comparative phase IIb clinical trial in volunteers aged 60 years and older. The safety of the vaccine was assessed in 400 volunteers in the 18–60 age cohort who received two doses of the vaccine (n = 300) or placebo (n = 100) and in 200 volunteers in 60+ age cohort all of whom received three doses of the vaccine. The studied vaccine has shown good tolerability and safety. No deaths, serious adverse events (AEs), or other significant AEs related to vaccination have been detected. The most common AE in vaccinated participants was pain at the injection site (The ongoing pandemic of coronavirus disease 2019 (COVID-19), which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has claimed more than 6.9 million lives as of May 2023 [While the registered COVID-19 vaccines demonstrate high immunogenicity and high short-term efficacy, it has been shown that post-vaccination antibody levels decrease over time [Despite generally lower post-vaccination neutralizing antibody (nAB) levels as compared to vector and mRNA vaccines, inactivated vaccines have been instrumental in the prevention of severe cases of COVID-19, with tens of billions of doses administered worldwide, showing exceptional safety [We developed a β-propiolactone-inactivated whole virion vaccine CoviVac, which has previously shown no signs of acute/chronic, reproductive, embryo- and fetotoxicity, or teratogenic effects in the antenatal and postnatal periods of development, as well as no allergenic properties in rodents and nonhuman primates in preclinical trials [