Medical experts from around the world estimate that a coronavirus vaccine could be developed in as many as 12-18 months
Dr. Ranbir Singh Dahiya, Ex- Senior Professor (PGIMS Rohtak)
Truths You Must Know-Russian COVID 19 Vaccine.
Point 1: Is Russian COVID -19 virus vaccine first vaccine?
Answer: It is the first coronavirus vaccine to be approved, though a Chinese vaccine has been cleared for ‘limited use’ much earlier, to be administered only on soldiers of the People’s Liberation Army.
Point 2: Why Russia’s Covid-19 vaccine claims are being questioned?
Answer: Russia’s approval for the vaccine comes even before Phase III of its trials are over. The phase involves testing the vaccine on a large number of people.
Point 3: Is any other vaccine available?
Answer: Over 100 possible vaccines are in various stages of development around the world, WHO data show, with at least four in final Phase III human trials stage.
Point 4: How much time is required to develop corona virus vaccine ?
Answer: Medical experts from around the world estimate that a coronavirus vaccine could be developed in as many as 12-18 months.
Point 5: What is the development cycle of corona virus vaccine ?
Answer: The development cycle of a vaccine consists of six stages —
Point 6: Would you tell something about clinical development stage of tha virus vaccine?
Answer: Clinical development phase consists of three sub-phases in which vaccine is tested on a different number of humans. This is also the phase where The majority of promising potential vaccines may fail in this stage.
Point 7: How many stages are there in clinical development of the virus vaccine?
Answer: There are following stages.
Phase I trial is performed on a limited number of humans, 20 to 100 healthy volunteers with conditions that a vaccine can treat. Phase I assess the safety of the candidate vaccine and also tries to determine the “type and extent” of immune response that it provokes. Generally, phase I trials take two months to complete.
In this phase, a candidate vaccine is tested on several hundred people. In this phase, the people are segregated according to their age to determine the impact of the vaccine on different age groups. Like Phase I, in this phase too, the scientists try to determine a vaccine’s safety and its ability to provoke the immune system.
In this phase, scientists also try to determine immunogenicity, proposed doses, schedule of immunizations, and method of delivery.
This phase can take from months to years to complete. All the phase II trials are randomised and placebo-controlled.
In this phase, thousands of people are vaccinated. Scientists wait to see how many people are infected compared to people who received a placebo.
In this phase, scientists also try to determine any random side effects of the vaccine. This is the final step before a candidate vaccine is approved for public use.
Some manufacturers may opt for Phase IV of trial after the vaccine has been released. During this phase, a manufacturer may continue to test the vaccine for safety, efficacy, and other potential uses.
Point 8: What about approval stage then?
Answer: Approval stage
Approval can be accelerated if there has been a similar vaccine approved in the past. However, in the case of a novel coronavirus, no such vaccine exists in the market and hence, it is unlikely that the process would be hastened.