The first scientific study on Russia’s controversial new crown vaccine approved a few weeks ago has come out,media BGR reported. The early authorization for emergency use prompted a lot of criticism from experts in the field because Russia failed to provide any evidence that the experimental drug was safe and whether its effects were as expected. On Friday, the 1/2 trial study, published in a leading journal, provided the first data around its efficacy and safety.
The results show that the drug works as scheduled to induce an immune response that may prevent COVID-19 infection. The candidate vaccines used in Russia provide both a medium and antibody, as well as a T-cell response, a two-pronged protection that is also shown in other candidate vaccines. The researchers do agree that the phase 1/2 trial has limitations and needs more research to answer all the outstanding questions.
The study appears to have reached the same conclusion as similar studies in the United States, Europe and China. In addition to the Russian vaccine, at least six new crown vaccines are currently in Phase 3 trials around the world, including three candidates for the New Crown vaccine in China and Phase 3 cutting-edge drugs being tested in countries such as the United States and Europe. They are Modelna, Pfizer/BioNTech and AstraZeneta/Oxford Vaccine Candidates.
Early results from Russia were published in the authoritative medical journal The Lancet in the form of peer reviews. Doctors concluded that there were two different versions of their vaccine candidates to meet the needs of different regions of Russia, providing the expected response in 76 patients who were included in the limited Phase 1 and Phase 2 trials. The volunteers, aged between 18 and 60, did not experience any serious adverse reactions. The most common reactions are pain, fever, headache, wheezing, muscle and joint pain at the injection site. These side effects are mild and short-lived, which seems to be consistent with other studies.
The paper notes that antibodies and T-cell reactions have occurred in all patients. “These results from two open, phase 1/2 non-randomized studies of the isogenous primary COVID-19 vaccine based on recombinant adenovirus vectors rAd26-S and rAd5-S showed that the vaccine was safe, well-to-bear, and induced strong body fluids and cellular immune responses in 100 percent of healthy participants,” the researchers said. “
The study also referred to preclinical studies of non-human primates conducted by scientists. The data has not yet been released, but scientists say the vaccine shows “a strong body fluid and cellular immune response in non-human primates, providing protection against SARS-CoV-2 infections.” In addition, the vaccine showed “100% protectiveness in the lethal model of the immunosuppressed hamster SARS-CoV-2 challenge.” In vaccinated animals and SARS-CoV-2 challenge animals, no increase in antibody-dependent infections was seen. “
If it hadn’t been for the emergency approval of the vaccine, the Russian study would have been like other early new crown vaccine studies. Moderna has been criticised for the way it produced the early stage 1 data, while others have questioned the Oxford data for preclinical trials. That’s the benefit of transparency in vaccine research. This is not the case with Russian vaccines, so the paper will invite experts in the field to conduct more reviews. The limitations of the study described by Russian researchers also require attention.
Limitations of our study included short follow-up times (42 days), only male volunteers in some parts of the first phase, a small number of participants (n-76), no placebo or control vaccine. Although we plan to recruit healthy volunteers between the ages of 18 and 60, in general, our study includes quite young volunteers. Further research is needed to assess the use of vaccines in different populations, including older groups, individuals with potential medical conditions, and high-risk groups. Participants in these phase 1/2 trials will be followed up for 180 days after initial immunization.