Till a few weeks ago, Prime Minister Narendra Modi had hoped to announce India’s own indigenously produced Covaxin from the ramparts of the Red Fort on August 15.
He had been hoping to be the first world leader to make such an announcement but these plans were pipped to the post by President Vladimir Putin, who obviously wanting the numero uno position went on to announce on Tuesday morning that Russia was all set to register the world’s first Covid 19 vaccine developed by Gamaleya Research Institute and the Russian Defence Ministry.
Putin had in April ordered state officials to shorten the time line of the trials. His order was immediately complied with and strangely, the crucial Phase 3 trials that last for several months and involve thousands of people will follow after the registration.
Our government did try and arm twist the Indian scientific community to follow the same approach but they could not pull it off. Dr Balram Bhargava heading ICMR shot off a diktat to the Principal Investigators (PIs) at the twelve hospitals selected for Covaxin trials warning that all trials be fast tracked so that the potential vaccine be launched on August 15. The missive drew massive public criticism and the government was forced to retract its stand.
Covaxin, the potential vaccine against COVID-19 is being developed by Bharat Biotech with support from the National Institute of Virology. Prncipal Investigators involved in its trial have gone public to state that Phase one of the trial has yet to be completed. Dr Prabhakar Reddy, the PI for the trial at the Nizam’s institute of Medical Sciences, Hyderabad, pointed out that the vaccine has to be given in two doses at a gap of two weeks and after 28 days the blood samples of the volunteers is to be evaluated mainly to assess for safety, efficacy as also to see if it is generating the proper immunogenic response.
`We are keeping in mind all safety procedures and the Covaxin is presently being tried on 750 volunteers,’ he said adding that it would take some time to complete the interim analysis.
The trial at AIIMS began only on July 23 and the PI there, Dr Sanjay Rai, said that it would take about a month for the phase 1 study to be completed. Dr Rai has stated that phase 2 will start only after the blood samples from the volunteers are thoroughly evaluated for crucial health parameters. At present, the regulator has still to study the data.
Explaining the entire testing process, Dr Shahid Jameel, leading virologist with Welcome Trust and the DBT National Alliance said, ` The Phase 1 level lasts for around two months and involves testing of a small group of healthy adults who are neither young or very old and have no co-morbidities. At this stage, the dosage of the vaccine is set in order to ensure just how much is to be given.
Phase 2 involves testing a larger group of people from different age groups and Phase 3 will involve testing of an even larger group,’ said Dr Jameel going on to add that the Oxford vaccine has entered Phase 3 and is being presently tested on over 10,000 people across several countries.
`Phase 3 is based on the principle of natural infections. It is given to half the people to check how many get naturally infected and then administered to the others,’ said Dr Jameel.
The Russians have gone ahead and registered their vaccine after having completed Phase 1 trial and the other two Phases have still to be completed.` Therefore for President Putin to announce that his daughter has taken the vaccine is rather silly since the testing process has still to be completed,’ said Dr Jameel.
The WHO has spoken out against these Russian shortcuts pointing out that all established practices must be put in place before claiming to come up with a vaccine. Public health experts have decried this move warning that ` by cutting corners, the vaccine may not only be ineffective but also unsafe.’
One of the frontrunners in the race is the Oxford-AstraZeneca vaccine which in India will go by the name of Covidshield. The Drugs Controller General of India has green signalled the application of the Serum Institute of India to conduct Phase 3 trials with 1600 participants at 18 sites in India. Already, the vaccine is being tested in the UK, South Africa and Brazil, with participants being administered two doses nearly a month apart.
Dr K. Srinath Reddy, heading the Public Health Foundation, pointed out, `Though the Oxford group has claimed that it will have a tested vaccine available by September, evidence of efficacy and safety still need to be examined. Bharat Biotech has said it will probably provide the vaccine early next year. It is unlikely that any of these vaccines will be available for public use this year. ICMR has clarified that it had set the August 15 deadline only for speeding up recruitment for Phase 3 trials.’
The global race to develop a vaccine has hotted up. Public concern is justified given that the number of worldwide cases have crossed 20 million. In India cases have crossed the 23-lakh mark with the number of fatalities having crossed 25,000.
Scientists have expressed apprehension that this race can end up damaging public perception on the vaccine. Several organisations have gone public to state that this entire exercise seems like one big marketing gimmick. They cite the example of Russia which has announced the registration of the vaccine without releasing accompanying data. The US has nicknamed this as Operation Warp Speed where speed is being given priority over public health.
Already apprehensions are building up around this vaccine. Some doctors point out that protection from the vaccine will last only a couple of weeks and then an individual will have to get another shot. Details regarding the immunisation schedule and the issue of temperature stability are not being looked at adequately. If the first- generation vaccine fails to meet the mark, then who will be interested in getting a second jab?
The extent to which corporates are willing to gamble on the COVID-19 vaccine is best highlighted by the example of Pune -based billionaire Adar Poonawala heading the Serum Institute, who has gone ahead and set up a coronavirus producing facility where millions of doses of this vaccine are being produced in anticipation of the success of the ongoing Oxford trials. Poonawala is confident his gamble will pay off in the long run.
Speaking at a recent conference on COVID-19, Dr. Ella, the MD of Bharat Biotech has clarified that the earliest the Covaxin will be released will be in 2021. He has also given an assurance that the cost of the vaccine will be kept low - `lower than the cost of a water bottle’ whatever that may mean. Dr Ela also expressed confidence that the vaccine would be mass produced in large quantities, citing how two companies Biological E and Indian Immunologicals are engaged in cutting costs so that it can reach the common man.
The key question of fair distribution of the vaccine is also going to plague policy makers with the richer countries known to exert pressure to buy over the vaccines even before mass production starts. Governments have already invested more than 10 billion dollars on this vaccine but many researchers feel this is not enough and the amount should be much higher.