It’s been a year since a mere 50-200 nanometers -sized virus has been holding man hostage. Making him appear helpless, vulnerable and without a clue before its relentless march across the globe. The ‘viral march’ which commenced in the wet markets of China’s Wuhan continues unabated.
The spiked single-stranded RNA virus has already infected 87.2 million and taken 1.88 million lives globally, and infected 10.4 million and taken 150,000 lives in India.
India has taken the worst beating after America. India therefore somehow needed to douse the viral cauldron before it consumed her further. With a population of 1.3 billion India resembled a heap of gun powder before the viral onslaught, with a potential to explode. And explode badly. Realizing this, she joined nations queuing up before laboratories demanding a vaccine.
Though Herd immunity acquired through natural infection was reported in large numbers in serosurveillance studies in Mumbai and Delhi, it looked long time to achieve, and its shelf-life uncertain. Therefore, a vaccine appeared the only logical ‘messiah’ that would liberate the nation from the viral stranglehold.
Nations including India witnessed a mad race for the vaccine forgetting that the gestation period of a vaccine, especially against a pandemic has been ten years historically.
Before the first anniversary of COVID-19, nations produced their vaccine candidates. The apparently premature emergence of vaccines was considered by healthcare workers with considerable skepticism and suspicion. Before vaccines rolled out beneath the shutters of laboratories, they were lapped up by politicians. They had a new toy to play a new game. The game of vaccine politics, which promised them rich dividends.
As part of the game, UK approved the Pfizer-BioNTech vaccine for ‘emergency’ use just seven months into clinical trials. How did the country pin the vaccine with efficacy of 95% without properly conducted trials? A concerned scientific world wondered.
USA too approved the same vaccine, closely followed by approving a second one- Moderna, which submitted its safety profile only with two months of follow-up data. Understandably the FDA hasn’t given its full or wholehearted approval for human use, deciding to ‘review more data on safety and efficacy’ at a later date.
India wasn’t far behind among nations queuing up to seek approval to use ‘half-baked’ vaccines putting lives at risk.
The Drug Controller General of India announced on January 3 that the Central Drugs Standard Control Organization has decided to accept recommendations of its Subject Expert Committee and approved two vaccines for ‘emergency’ use in India. 80 million doses have already been stockpiled.
The two vaccines are (1) Covishield, the Indian variant of the AZD1222 vaccine developed jointly by Oxford University and pharma giant AstraZeneca. This vaccine is being manufactured by Serum Institute of India.
And, (2) Covaxin, manufactured by Hyderabad-based Bharat Biotech in collaboration with The Indian Council of Medical Research.
Approval of these vaccines by concerned authorities for ‘emergency use’ in India has surprised Indian medical fraternity for more reasons than one;
- The first and the foremost concern has been the fast-tracking of clinical trials before human use. The Serum Institute conducted a phase II/III ‘bridge trial’ on 1,600 people, while Bharat Biotech conducted its entire phase I/II trials on 800-1,000 participants. Its Phase III trial is only ongoing on 26,000 participants. Vaccines have thus been approved in the country before completion of proper trials on larger number of volunteers- a crucial prerequisite before issuing license for human use. There are some who argue that vaccines have been used in thousands in other nations like the USA and UK, equating short-circuited use in humans to crucial phase IV trial. Something which is unethical, and which amounts to making guinea pigs of human beings.
- Indian vaccines are live attenuated, containing attenuated infecting virus, making full-fledged, well-conducted human trials mandatory before licensing them for human use.
- India hasn’t been spared of the self-centered politician meddling with the vaccines’ licensing, and administration. The ruling BJP spared no efforts to play ‘vaccine politics’ to the gallery. The Modi government in India has clearly short-circuited well laid out procedures and protocols before rolling out the vaccines for political mileage.
- The Finance Minister promising the vaccine free of cost to poll-bound Biharis is still fresh in our minds. While the opposition Congress frolicked in what they are best at-blame game, the Samajwadi party’s president Akhilesh Yadav went to the abysmal extent of labeling Indian vaccines ‘BJP vaccines’, and would therefore not use it personally. How crude as the homegrown vaccines themselves! Vaccines in the politicians’ hands resemble the proverbial garland in the monkey’s hand, which doesn’t know what to do with it! Surely something as dangerous as poorly developed Indian vaccines must not be allowed to remain within wrong hands- that of the politician.
- Following authorization for Emergency use in India, verbal spat broke out between the chiefs of Barat Biotech and the Serum Institute of India over pricing, quality, efficacy and short-circuited clinical trials of their respective vaccine candidates. The unhealthy public sparring cast a dark shadow on the vaccines themselves, making mockery of the whole exercise of development of vaccine against COVID-19 in India.
- Though in small numbers, which might not be statistically insignificant, sporadic side effects have been reported across the globe. These included anaphylaxis, and toxicity involving the nervous system viz; encephalomyelitis, and Bell’s palsy, Trigeminal Neuralgia and Transverse myelitis, which need to be monitored closely. Among many others, Dr.Vishal Rao, well-known oncologist and member of an expert Committee of the Covid task force, Government of Karnataka, has flagged the neurological complications reported with Covid vaccines, apart from duration of protection offered by the vaccines, safety in pregnant and lactating women, effectiveness in children below 18 years, which remain in the grey zone for safe use in humans.
- Vaccines against the Corona virus demand stringent cold chain requirements. They need to be stored and transported in 2-8 degree Celsius. Does India have facilities to ensure the extremely heat-labile vaccine reach citizens in her hinterlands in prescribed cold chain requirements?
As things stand, the government must rise above egoistic national prestige at the altar of which India cannot afford to sacrifice her citizens.