Astitav Khajuria
It must be kept in mind that just developing, approving and subsequently manufacturing a vaccine is not enough to ensure that it will be of quality when administered
In 2003, when the SARS Coronavirus (SARS-CoV) epidemic hit the world, it was managed and practically finished within eight months by employing measures like isolation, physical distancing, containment and quarantine. Now, despite the fact that SARS-CoV and COVID-19 have many similarities – and of course, characteristic differences with regards to their infectiousness, clinical manifestation community spread, etc. – the public health measures utilised in 2003 when deployed for COVID-19 were only able to merely slow it or in some cases, suppress the peak thereby providing countries necessary space to scale up their responses.
Shifting our focus to India, we have had about 15 lakh cases and about 30 thousand deaths. The peak shows no sign of flattening, and records with respect to daily cases and deaths are being broken every few days. Every now and then there are debates about herd immunity as being an exit strategy for the country from the pandemic while ignoring the intolerable death toll it will result in. Going by the current stats while writing this article, the death rate in the country stands at about 2.21%.
As per a Johns Hopkins study herd immunity requires about 70% of the population to have developed antibodies for a disease. For India that would mean that about 94 crore people out of the 135 crore population get infected with COVID19 and at a case fatality rate of 2.21 percent it would mean about 2.1 crore deaths.
We must not forget that this is the best case scenario for herd immunity. Recent studies have shown that antibodies for SARS COVID19 remain in the body for about 4 months. What this simply means is that we don’t know if after 4 months from recovering the patient will remain in the ‘immune’ category or practically lose all the acquired immunity.
All this makes the availability of a safe and effective COVID19 vaccine a critical need. But a mere invention of the vaccine will not turn the tables on the pandemic. A bigger test for humanity and specifically for India, given its inadequate infrastructure would be the storage, distribution and vaccination of citizens.
The development of vaccines are the centre of attention for everyone. Never before in the history have we seen such a blazing fast scientific endeavour. To put into perspective, the BCG vaccine given for TB took at least 13 years to be developed. As of 30 July 2020, the WHO draft COVID-19 vaccine candidate landscape indicates 6 candidates in phase 3, 25 candidate vaccines in at least active phase 1 and/or phase 2 clinical trials, and 139 in preclinical evaluation.
Getting a Vaccine is only the First Step
It must be kept in mind that just developing, approving and subsequently manufacturing a vaccine is not enough to ensure that it will be of quality when administered. A vaccine spends significant time at storage facilities, inside transport vehicles and all final administration points like clinics, hospitals etc. To ensure that the effectiveness of vaccines remain intact India needs to start investing right now in a robust storage, transport and a well trained workforce for management down to the village level.
Even though we know the type of vaccine candidates that are in advance stages of development, as of now we have no information on the time and temperature sensitivity of the vaccines, distribution prerequisites, and transport conditions. This information is critical for developing the infrastructure for a quick and effective vaccination of the country. Even though India has considerable experience in vaccination programs and a good supply chain infrastructure, the cold storage capacity for vaccines in transport and storage is unlikely to be sufficient for covering everyone at all the corners of the country. Depending on the vaccine needs, specialised temperature monitoring devices and storage capacity is needed for administration at the rural-level.
The government must keep in mind that if the vaccine has an extreme cold chain requirement (which is the case with the Ebola vaccine), India has negligible capacity to handle it. The fact that the Ebola vaccine requires -80 degrees Celsius storage conditions helps put things into perspective. Achieving and maintaining such temperature at a remote village is a matter that the government needs to start preparing for.
Another big issue to tackle is the global shortage of glass vials. If we want to immunise the whole of India – or even a considerable part thereof – the biggest concern should be the safety of administration. Single dose vials are better suited for safe and effective administration as their exposure to temperature fluctuations and needle punctures is minimal but given the shortages of glass vials, it might become practical to go for multi-dose vials. Multi-dose vials are also prone to mishandling. That is, administration of less dosage by not filling the injection up to a required dosage and so on.
Pre-emptive preparations for handling the enormous environmental waste the vaccination program are also required. Setting up of incineration facilities in every district proportional to the population should be planned.
In this regard, I call upon all the research institutions, developers and manufacturers of SARS-CoV-2 vaccines to make publicly available detailed information of the temperature stability and target product profile (vaccine presentation details) even before clinical trials are completed. These aspects cannot be considered as trade secrets or critical business knowledge at times like these.
Lastly, there is a pressing need for commitments at national levels to make vaccines equitably available through the length and breadth of the country. The Government of India has to dispense a critical role in the fair distribution of the SARS-CoV-2 vaccines when available.
Astitav Khajuria is currently studying for his Master’s degree of Public Policy from National Law School, Bangalore. He has a background in Biotechnology from his undergraduate studies.
Astitav likes to explore science and technology’s interplay with government and society at large. He can be reached at astitavkhajuria@nls.ac.in