Identifying 12 clinical trial sites (medical institutions and hospitals), ICMR had asked them to ensure that the subject enrollment was initiated no later than July 7. The trial sites included AIIMS, New Delhi, AIIMS, Patna and SRM Medical College Hospital and Research Centre in Tamil Nadu.
Corona vaccine candidate Covaxin is developed by the Hyderabad-based Bharat Biotech International Limited (BBIL) in collaboration with the ICMR and the National Institute of Virology (NIV), It was given the nod for human clinical trials by the Drug Controller General of India (DCGI) in June.
Meanwhile, Zydus, the part of Cadila Healthcare Ltd., had also received approval from authorities to start human trials for its Corona vaccine contender.The vaccine candidate, ZyCoV-D, showed a "strong immune response" in animal studies, and the antibodies produced were able to completely neutraliz the wild type virus, Zydus claimed.
However, it was not clear how the clinical trials would be completed and the vaccine released on August 15 when the minimum normal period for a vaccine to be approved is 12 to 18 months. Many experts questioned the timeline of the announcement and said "we were rushing too much".
With more than 50,000 daily corona cases reported in the country this month, India desperately needs a vaccine or drug to control the killer virus.
Normally, it takes 10 to 12 years for a vaccine to be in use. However, the tremendous pressure of pandemic outbreak, the time period has been cut down to 12 to 18 months if all necessary approval are fast-tracked. But clinical trials take time. Under any circumstances, it can't be reduced further .Clinical development of a vaccine is a three-phase process. During Phase I, small groups of people receive the trial vaccine. In Phase II, the clinical study is expanded and vaccine is given to people who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended. In Phase III, the vaccine is given to thousands of people and tested for efficacy and safety.Besides.Many vaccines undergo Phase IV formal, ongoing studies after the vaccine is approved and licensed.
It was quite far-fetched idea for a vaccine for which pre-clinical development was still ongoing, to start clinical trial recruitment from 7th July? And vaccine to be launched on 15th August? A vaccine trial completed in little over a month, looks as if efficacy was pre-decided, argued experts. Excess pressure could kill the efficacy of the vaccine.
ICMR knew all the implications of rushing too much. Then why did India's top medical body made an exasperated announcement? It looks, the announcement was made under political pressure. ICMR is a central govt body and is highly prone to political pressure.
Russia has become first country to develop a vaccine for coronavirus. Russian President Vladimir Putin on Tuesday announced that the country has granted regulatory approval to a Corona vaccine after less than two months of human testing. The vaccine is named as ‘Sputnik V’ in homage to the world’s first satellite launched by the Soviet Union.
However, the vaccine, developed by Moscow’s Gamaleya Institute in collaboration with the country’s defence ministry, has led to scepticism regarding its safety and effectiveness since it is being approved for civilian use even before clinical trials were completed.
German Health Minister Jens Spahn on Wednesday said Russia's COVID-19 vaccine had not been sufficiently tested, adding the aim was to have a safe product rather than just being first to start vaccinating people. “It can be dangerous to start vaccinating millions, if not billions, of people too early because it could pretty much kill the acceptance of vaccination if it goes wrong, so I'm very sceptical about what's going on in Russia,” Mr. Spahn told radio broadcaster Deutschlandfunk.
As per reports, Russia’s corona vaccine is based on the DNA of a SARS-CoV-2 type adenovirus, a common cold virus. The vaccine uses the weakened virus to deliver small parts of a pathogen and stimulate an immune response. Speaking to Sputnik News, Alexander Gintsburg, director of the Gamaleya National Research Centre, maintained that the coronavirus particles in the vaccine cannot harm the body as they cannot multiply.
So far, Russia has only made public the results of phase-I of the clinical trials, which they claimed were successful and produced the desired immune response. In mid-July, Russia’s TASS news agency said the Defence Ministry had claimed that none of the volunteers had reported any complaints and experienced no side-effects.
Phase I human trials started on June 17 among 76 volunteers, with most being recruited from the military. Half were injected with a vaccine in liquid form and the other half with a vaccine that came as soluble powder.
The phase-II trials were started on July 13. On August 3, Russian media reported that Gamaleya Institute had completed clinical trials. The reports, however, did not specify whether all the three stages of clinical trials were over, or only stage-II was completed. Phase II trials usually take a few months to be completed.
Interestingly, Russia had earlier indicated that Phase III human trials, where a candidate vaccine is tested on tens of thousands of people for its effectiveness in real-life situations, will be completed after the shot received regulatory approval.
According to an AP report, Russia has promised to start “industrial production” of the Gam-COVID-Vac Lyo vaccine in September. However, the website of the State Register of Pharmaceuticals showed the vaccine would appear in circulation starting on January 1, 2021. “Date of introduction to the civilian circulation – 01.01.2021,” the site noted.
Is India going the Russia way? We are still to hear from ICMR over the latest status of vaccine development. Prime Minister Modi has announced in his Independence Day address that three Corona vaccines are in trial stage, and India is ready to mass produce. But no word on when?