Clinical Human Trial of Coronavirus Vaccine to start in India soon!

Do the trials really mark the beginning of the end as claimed by the Centre?

Monday, 6th July 2020

Clinical trials on humans for the two country-made COVID-19 Vaccines- ZyCov-D and COVAXIN are soon to begin and the government thinks that it will signal the ‘beginning of the end’ for the deadly pandemic that has so far infected more than 1.12 crores and has killed over 5.3 lakhs worldwide.

A letter from the Union Ministry of Science and Technology stated most optimistically that there were over 100 such vaccine candidates globally of late among which 11 were selected for human trials.

The letter read: "The nod by Drug Controller General of India, CDSCO (Central Drugs Standard Control Organization), for conduct of human trial for vaccines, marks the beginning of the end,"

The ministry further said: "Six Indian companies are working on a COVID-19 vaccine. Along with two Indian vaccines, COVAXIN and ZyCov-D, world over 11 out of 140 vaccine candidates are in human trials,"

The ministry further informed that the makers of 2 of the most prominent vaccine candidates – MRNA-1273 (Moderna; a US-based firm) and AZD1222 (manufactured by AstraZeneca; a British firm) had signed an agreement pertaining to production with various Indian firms should their products turn out to be effective as well as safe for use.

Both the candidates have received approval for the Phase II & Phase III trials.

Typically, the initial two trial phases assess the drug’s safety while the Phase III assesses the efficacy of the drug. Each trial phase may take a couple of months and even many years to get completed successfully.

Indian Council for Medical Research (ICMR) had announced 15th August (Independence Day) as the apt date for releasing of the COVID-19 Vaccine.

The previous version of the letter from ICMR reads: "None of these (the 11 coronavirus vaccines undergoing human trials) are likely to be ready for mass use before 2021". This line was however deleted in the letter’s edited version that was released soon afterwards.

As per the claims made by medical experts as well as the opposition parties the date, 15th August was strategically fixed to let PM Modi get many votes ahead of very important elections in the state of Bihar in the later part of the year. They also tried to alert saying that hurrying with trials could lead dangerous consequences in terms of public health.

COVAXIN, manufactured by Bharat Biotech (Hyderabad-based firm) and ZyCov-D, manufactured by Zydus Cadila got approval for the Phase I & II trials to be executed this week.

 COVAXIN’s Phase I trial, which was manufactured as part of a joint venture with ICMR, are scheduled for completion within 28 days and that would place the candidate on track for release on the 15th of August. However, it isn’t very clear as to how a vaccine could be launched without making it go through Phase II & III trials.

The suspense and the questions surrounding the release of COVID-19 Vaccines & trials still remain and we are yet to find the answers…

Source: NDTV