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Vaccine: A Mother of All Doses

All conversations have come to be centred around the Covid-19 vaccine – from the extent and pace of the economic recovery that it is expected to help foster to its very own safety and efficacy

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Act I, Part I: Once upon a time, in Wuhan in the Hubei province of China, someone got very sick, and the ailment was identified as Covid-19. And then, it made more and more people sick every day, in Wuhan and in other parts of the world, quickly turning into a pandemic. Tens of millions came to be afflicted by the deadly coronavirus, in country after country, including India, with more than two million people succumbing to it. Today, more than a year since the first case surfaced, tens of thousands of new cases continue to be reported from different parts of the globe, fuelling neverending conversations around Covid.

Act I, Part II: The pandemic and subsequent lockdown brought the major economies of the world barring China to a standstill, fuelling the charge of conspiracy and sabotage. China has repeatedly denied the virus originated there and even counter-charged that it had appeared in multiple places across the world. The WHO is due to send a team to China to probe the origin and subsequent transmission of Covid.

Act II, Part I: The pandemic has disrupted economies, businesses and the lives of people in unimaginable and unprecedented ways. Businesses shut down, people lost their jobs and economies collapsed. Reports by the World Bank estimated 5.2 per cent contraction in global GDP for 2020. As per an IMF report, since May 1, 2020, it has approved $165 billion in loans to 83 countries in an effort to support countries fight off the devastation caused. Act II, Part II: Meanwhile, as the businesses and people sought to come to terms with the disruption caused by the pandemic and adjust to the new normal, a spate of innovative practices came to be adopted. Work from home, Zoom meetings, online classes, and  edtech tools were some of the key trends that emerged to counter the limitations imposed by the pandemic. Life as we knew it came to a standstill. Social distancing and wearing a mask for the near future did not seem like a viable solution. Herd immunity was the answer - and to achieve that a large percentage of the population would have to get inoculated and so the vaccine looked like the only saviour. As a result, the world embarked on the process of developing one. As per WHO reports, there are currently more than 60 vaccines in clinical trials and 172 vaccines in pre-clinical trials to establish their safety and efficacy.

At least three vaccines received authorisation / approval for use in December. The first off the approval block was the Moderna vaccine which was authorised for emergency use in the United States and Canada. This was followed by the clearance for the Oxford University/ AztraZenca vaccine in the UK. Then on the last day of 2020 the WHO approved the Pfizer/ BioNTech vaccine for emergency use.

The Status in India 
Quick on the heels of the December approvals, the Indian government green signalled the Bharat Biotech and the Serum Institute vaccines right in the beginning of January but not without generating a heated debate. Some experts believe that the approval for the Bharat Biotech vaccine was rushed especially since efficacy data was still being gathered for it. However, VG Somani, Drugs Controller General of India (DCGI), assured everyone that the vaccine was absolutely safe.

Bharat Biotech's Covaxin is an indigenous Covid-19 vaccine developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). Referring to the debate, Krishna Ella, Founder and Chairman of Bharat Biotech said that it was irresponsible on part of people to say that the vaccine was a backup or not safe enough. In his address he stressed that Covaxin is extremely safe and the backlash is undeserved. He mentioned that the Covaxin Phase 3 trials were being handled by an American multinational IQVIA and that patients in Phase 3 trials would be monitored for a year after dose administration.

Even so, some experts are still uneasy about the rushed approval this vaccine got but as Arvind Sharma, Partner, Shardul Amarchand Mangaldas & Co points out, only an emergency authorisation has been granted for restricted use in 'public interest'. As we inch closer to the vaccination drive, it is expected that there will be clarity on these issues, and the government would allay all fears.

Such an approval, however, is not totally surprising, Archana Chatterjee, Dean, Chicago Medical School and Vice President for Medical Affairs, Rosalind Franklin University, United States is of the view that weighing the risks of the pandemic versus the risks and benefits of the vaccines some countries have decided to forego Phase III clinical trials, or collapsed the various phases of clinical trials to fast-track vaccine development. "Public health authorities in each country need to be able to assure the population that vaccines are safe and effective in order to have adequate uptake. Transparent and clear communication in language that is understandable to the lay public will go a long way in achieving this goal," she believes.

Time is of Essence 
With the approval starts the mammoth task of vaccinating a population of 1.3 billion people in India. Prior to the official nod of approval various states conducted a pilot inoculation drive to iron out any training or logistical issues.  

"While prevention being better than cure may be a trite aphorism, it is incredibly appropriate for India during a pandemic. India's healthcare resources are constrained and will be stretched beyond breaking point if Covid-19 is not contained. The Indian economy cannot sustain another lockdown either. Therefore, it is imperative that vaccinations be carried out expeditiously and methodically to ensure the health and prosperity of all Indians," says Ketan Desai, MD Immunology, Easton, Pennsylvania, United States.

The vaccine will in the first phase be administered to frontline workers. In fact, Union health minister Harsh Vardhan has tweeted that free vaccination will be provided to one crore healthcare workers and two crore frontline workers. This is a significant step on the part of the government given the expanse of the country and the sheer number of people that would constitute the first phase. As other priority groups are considered, supply chain and logistics to ensure smooth delivery, storage and handling will have to be kept in mind.

"The government should ensure that the vaccine is affordable for and accessible to the Indian populace. Safety is paramount, as are swift transportation and adequate cold storage facilities. The government may consider conducting the vaccination exercise on the lines of the nationwide elections, where thousands of booths are set-up across the country," says Sharma of Shardul Amarchand Mangaldas.

In addition to the logistics of vaccination, proper care and communication are key to make this exercise successful. Bishnu Panigrahi, Head - Medical Strategy and Operations Group, Fortis Healthcare, while stating that they are ready to extend support to the government during the vaccination drive says, "Care needs to be taken to ensure at least a 30-minute stay for those vaccinated before they leave the centres to ensure no adverse events occur. There should be in-house areas with equipment and personnel for taking care of anyone having an adverse reaction to the vaccine. Proper communication is essential for persons who have been vaccinated to make it mandatory for them to come back for the second dose. Also, detailed vaccination data must be maintained by all designated health centres and these must be collated on a common server under government supervision."

For the time being, all eyes are on how effectively the government will handle the vaccination drive for the entire country.