HOPE is on the way!
Amid the urgency of rising anticipation to uncontrolled pandemic, The National Institute of Allergy and Infectious Diseases fast-tracked the corona vaccines into human trials almost jumping on animal trials. Limited studies in the mice show promising results, meanwhile a Seattle based volunteer received his first experimental dose on March 16.
While this is just a beginning of phase 1 trial, the vaccine must be cleared through three more stages before being available to the mass. This would mean another one year or more before it can be calibrated at a safe dose for the benefits.
Phase 0 trial (Sample size <15.)
Administration of very small dose of medication to make sure it isn’t harmful to humans before they start using it in higher doses.
Phase 1 trial (sample size 20-100 healthy individuals not expose to the virus) (Duration 6-8 months)
Body interaction and kinetics, affect on the immune system and its ability to create immunity further. This will be observed under short term as well as long term effects. Different dosage is administered to reach the minimum dose concentration for maximum therapeutic advantage. Aim is to figure out the highest dose humans can take without serious side effect.
If an interaction goes well then it observation is focused on the immune response and its ability to create antibodies. These antibodies will act on the proteins found on novel corona virus and neutralize it in case of infection. This will also consider the duration of next therapeutic dosing to maintain the stable concentration of the antibodies in case of future infection.
Phase 2 trial (sample size >100)
(Duration 1-2 years)
Further refining: Vaccines are targeted against most susceptible individual. In this case it is mostly elderly or people with underlying co morbidity.
Phase 3 trial (sample size >300 -3000)
(Duration 1-4 years)
Focus on the benefit as well as side effect over long term. Benefits must outweigh the risk for the drugs to be considered approved for widespread use .
At present the journey of the vaccines is still longer than fast spreading COVID 19 but everyone stays cross fingers for the vaccine to pass all the phases with as little side effects while we hope the world experiences its minimum causalities in days to come.
GAMEFACE 