As the centre gears up to vaccinate Indians for Covid-19, it has to keep in mind a number of parameters and give it to those who need it the most. India’s cases are among the lowest and the drive could see it on top of the game.
By Dr KK Aggarwal
As India gears up to tackle the deadly Covid-19 virus through vaccines, the last few months of lockdowns and high morbidities seem like a nightmare. With vaccines giving hope, the common man is spoiled for choice and has little knowledge of how these work.
The Covid-19 virus has two main components—the genetic component and the protein one. When a genetic component is used to make the vaccine, the said component (mRNA) inside the candidate’s (the person who receives the vaccine) cell produces viral proteins against which the body produces antibodies. In protein-based vaccines, the protein directly makes neutralising antibodies in the body.
All genetic mRNA-based vaccines will potentially cause more allergic reactions as RNA is highly inflammable. But these vaccines will be highly antigenic and will produce a strong immunity response.
Examples of the genetic-based material vaccines are Pfizer BioNTech and Moderna. India’s Zydus Cadila is also working on a DNA-based genetic vaccine and is in Phase 3 trials. Other competing vaccines are based on the S protein segment of the virus which is introduced in the body by way of a vector virus (which does not produce infection in humans) and this protein then makes the antibodies.
On the other hand, protein-based vaccines’ efficacy may be lower (around 60 percent to 70 percent) as Covid-19 is a mucosal-based disease. The side effects of these vaccines may also be similar to other mucosal-based vaccines, with possible neurological manifestation as has been seen in the recent past.
Currently, there are eight vaccine candidates in India in various stages of clinical trials—Covishield manufactured by Serum Institute of India (SII), Covaxin by Bharat Biotech, ZyCoV-D by Zydus Cadila, Sputnik V by Dr Reddy’s Laboratories and NVX-CoV2373, another vaccine by SII. Out of these, Covishield and Covaxin have also applied for Emergency Use Authorisation. This apart, a Recombinant Protein Antigen-based vaccine by Biological E Ltd, mRNA-based HGCO 19 vaccine by Genova, Pune and an inactivated rabies vector platform vaccine by Bharat Biotech are in various stages of pre-clinical trials. Vaccines require 2-3 doses at intervals of three to four weeks.
All genetic material containing vaccines will require –20 degrees centigrade to –70 degrees centigrade for storage, transfer and point of care. The vaccine by Zydus Cadila, if successful, may be a single dose one and may not require rigid temperature control. Bharat Biotech’s indigenous vaccine, on the other hand, is an inactivated one.
Other countries where vaccines are successful are China and the UAE where mass vaccination is on the way.
Such vaccines are safer, but require multiple doses to produce adequate antibodies. India had a chance of launching this vaccine on August 15 based on China’s results, but preferred to go the safer way of introducing it only when it has a proven efficacy and safety record. If I was on the committee deciding this, I would have voted for its introduction much earlier based on the experiences of early inactivated vaccines.
Presently, it makes political sense to introduce the vaccine within the pandemic year (before December 31, 2020). India may consider emergency use of the Pfizer, Oxford and Bharat Biotech ones. If so, by the end of this month, the vaccines will be ready for distribution. The Delhi government has said that if the vaccine was given to it, it would ensure that the entire population of the capital is vaccinated within 48 hours.
India, unlike western nations, seems to be recovering from the pandemic. On December 8, 2020, the Ministry of Health and Family Welfare said that while the Covid-19 situation around the world was getting worrisome, India was seeing a steady and continuous decline in new cases since mid-September. India’s cases per million at 7,031 is still amongst the lowest in the world, while the number of deaths per million at 102 is also among the lowest. At the same time, case positivity rate is continuously declining and cumulatively stands at 6.5 percent now.
The government is now setting up a huge vaccination drive and an institutional mechanism in states, districts and blocks that will inspect and supervise the entire process. Preparatory activities for roll-out of the vaccine in collaboration with states/UTs include:
- A new digital platform for Covid-19 vaccination delivery called CO-WIN is being used. This user-friendly mobile app for recording vaccine data is working as a beneficiary management platform having various modules. A database of healthcare workers is being formed and is in an advanced stage across all states/UTs and is being uploaded on the CO-WIN platform.
- Line-listing of prioritised population groups for vaccination. Every Indian who needs to be vaccinated will be vaccinated. Prioritised population groups include about one crore healthcare workers in both government and private healthcare facilities, two crore frontline workers (including personnel from state and central police departments, armed forces, Home Guard, civil defence organisations, disaster management volunteers and municipal workers) and also about 27 crore people in the prioritised age group, which includes those above 50 and with co-morbidities.
- Strengthening of the cold chain infrastructure. The current system, consisting of 85,634 equipment for storage of vaccine at about 28,947 cold chain points across the country, is capable of storing additional vaccines required for the above-mentioned three crore population. The health ministry, in consultation with states/UTs, has assessed the additional requirement for cold chain storage (walk-in coolers and freezers, deep freezers, ice-lined refrigerators, etc.) Additional supplies would be available to states/UTs from December 10, 2020.
- Around 2.39 lakh vaccinators (auxiliary nurse midwives) across India provide vaccination under the Universal Immunisation Programmes (UIP). So as not to disturb the ongoing UIPs, only 1.54 lakh ANMs will be used for Covid vaccination. Additional vaccinators for the purpose are being arranged in collaboration with states/UTs.
- This apart, there has to be a communication strategy on vaccine safety, effectiveness, etc. Transparent, effective and sustained communication for Covid vaccination is crucial for educating people and explaining the implementation plan to them. It will also prepare them to accept some adverse effects, as happens with all vaccines, as well as address doubts and challenges like disinformation campaigns and rumours and tackling the anti-vaccine lobby.
There are some issues regarding Covid-19 vaccine administration.
- Can the vaccine be mandated in view of the broader good of society (UNESCO ethics)? Or under Article 231, can a person have the choice to accept the vaccine?
- In emergency use authorisation, a compensation clause may not be in place and people may have to take the vaccine at their own risk.
- No trial has been done on children less than 16 years, pregnant women and immune-compromised persons.
- No data is available on giving the vaccine to those who have recovered from Covid-19. These people were excluded from the trials.
- No data is available on giving the vaccine to asymptomatic people.
- Should healthcare workers undergo pre-vaccine RT-PCR and Covid antibodies testing?
- What should be the protocol to know whether a person has developed antibodies or not?
- The Haryana health minister developed Covid-19 after the first dose of the vaccine. What should be the protocol for such cases?
- The government is in the process of framing rules and procedures for the administration of emergency authorisation of the Covid-19 vaccine.
- While framing the rules, the government has to keep in mind that the right to health is a fundamental right of all citizens irrespective of caste, creed, gender, religion, health condition, etc.
- Since the news of the side effects of vaccines, many people are apprehensive about the vaccination.
- While framing the rules for vaccine administration, the government should make sure that a proper written informed consent of the patient is taken as without it, the judiciary will be flooded with multiple litigations.
- Also, it is important that the government provide for no-fault compensation to the healthcare industry.
- Adult vaccination will involve natural happenings of a large number of adult diseases, which people may link to the vaccine.
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—The writer is President, Confederation of Medical Associations in Asia and Oceania, and former National President, IMA