No, There is no Russia Covid Vaccine yet
Russia Covid Vaccine: Indian news media is agog with a cleverly worded article claiming Russia has created a Coronavirus Vaccine. This vague headline from respected business magazine Mint did not clarify if they agreed if this was indeed a Covid Vaccine
The Russians completed what is called Phase I of the trial. The Russia Covid Vaccine was tested on a small group of Volunteers in the University. To quote Mint –
The clinical trials of the world’s first coronavirus vaccine on volunteers at Sechenov First Moscow State Medical University has been successfully completed, Vadim Tarasov, the director of the Institute for Translational Medicine and Biotechnology, according to Russian news agency Sputnik, adding that the first group of volunteers would be discharged on 15 July and the second on 20 July.
By calling it a clinical trial and not mentioning the stage, the reader is confused. It is therefore important to understand which stage of approval the vaccine is and when to expect a vaccine. According to CrowdWisdom360’s predictions, a vaccine can be expected closer to December 2020. However, mass availability would take time. Here are various stages of trials before a vaccine is approved (Source: nccn)
Phase I: Main Agenda, Test Safety of the Drug
In Phase I trials drug is tested in a small group of 15 to 30 patients. Doctors start by giving very low doses of the drug to a few patients. Higher doses are given to other patients until side effects become too severe or the desired effect is seen. If a drug is found to be safe enough, it can be tested in a phase II clinical trial.
Phase II – Safety and Efficacy
Phase II trials further assess safety as well as if a drug works. The drug is often tested among a variety of patients. Phase II trials are done in larger groups of patients compared to Phase I trials. Often, new combinations of drugs are tested. Patients are closely watched to see if the drug works. However, the new drug is rarely compared to the current (standard-of-care) drug that is used. If a drug is found to work, it can be tested in a phase III clinical trial.
Phase III – Efficacy
Phase III trials compare a new drug to the standard-of-care drug. These trials assess the side effects of each drug and which drug works better. Phase III trials enroll 100 or more patients.
Often, these trials are randomized. This means that patients are put into a treatment group, called trial arms, by chance. Randomization is needed to make sure that the people in all trial arms are alike. This lets scientists know that the results of the clinical trial are due to the treatment and not differences between the groups. The control group gets the standard-of-care treatment. The other groups get a new treatment.
Every patient in a phase III study is watched closely. The study will be stopped early if the side effects of the new drug are too severe or if one group has much better results. Phase III clinical trials are often needed before the FDA will approve the use of a new drug for the general public.
Phase IV – Drug Approval
Phase IV trials test new drugs approved by the FDA. The drug is tested in several hundreds or thousands of patients. This allows for better research on short-lived and long-lasting side effects and safety. For instance, some rare side effects may only be found in large groups of people. Doctors can also learn more about how well the drug works and if it’s helpful when used with other treatments.
At the moment, only a couple of vaccines are in Stage III of the vaccine.