Injecting hope

The one-year-long battle against the unknown Coronavirus is likely heading toward a conclusion as some of the vaccine candidates developed to cure the deadly disease have been introduced into the vaccination campaigns of countries like Britain and Russia, while some more are in the pipeline to get the approval for emergency use authorisation in India.

In India, Serum Institute of India, Bharat Biotech and Pfizer have applied for Emergency Use Authorisation approval by the Central Drugs Standard Control Organisation (CDSCO).

However, the proposals of two — Pune-based Serum Institute of India (SII) and Hyderabad-based Bharat Biotech has been put on hold as the subject expert committee of the apex drug regulator has asked both the vaccine makers to submit updated safety data of clinical trials in the country, immunogenicity data from the clinical trial in UK and India and the outcome of the assessment of the UK regulator as well as safety and efficacy data from the ongoing Phase III clinical trials in the country.

Given that the vaccine has been developed on "urgent basis" to put a check on the further spread of the Coronavirus across the globe, the reports of side-effects post-vaccination would not be a surprising development and that is why countries starting vaccination process have advised people to take special precautions such as no alcohol for two months after the administration of Sputnik V vaccine shot in Russia, and allergy warning in Britain for Pfizer-BioNTech Covid-19 vaccine as anyone with a history of anaphylaxis to medicine or food has been advised not to get the shot.

In India too, the Health Ministry has asked individuals to take all COVID-19 related precautionary measures even after vaccination as vaccination is not a "total cure" and people should not start behaving live COVID-19 free.

Monumental effort

The scientists and researchers of the world must be applauded for working tirelessly to find a solution for an unknown virus in a timeframe that defies the traditional logic of vaccine development.

In India, the scientists and researchers of Indian Council of Medical Research (ICMR), Council of Scientific and Industrial Research (CSIR) have done a tremendous job by finding genome sequencing of the virus and simultaneously working on the vaccine against the virus that is very new for the world.

As per experts, developing a vaccine for a year-old highly contagious virus is one of the most difficult tasks that researchers have gone through as there are several risk factors associated with it.

"We must feel proud of our extra-talented researchers and scientists at premier research institutes of the country that a vaccine against the unknown virus is becoming a reality just within a year of the outbreak of the pandemic in India," the experts have stated, adding that the developed vaccine that is in phase three trials have not yet been tested on children and pregnant women.

There are eight Covid-19 vaccine candidates in India, which includes Covisheild, Covaxin, ZY-Cov-D, Russian vaccine Sputnik V, NVX-COV-2373, recombinant protein antigen-based vaccine by Biological E Ltd, HGCO 19 (mRNA vaccine and inactivated rabies vector platform (repurposed vaccine) by Bharat Biotech and Thomas Jefferson University.

The Covisheild (chimpanzee adenovirus platform) manufactured by Serum Institute of India in collaboration with AstraZeneca is currently in phase two/three of trials, though the company has applied for emergency use authorisation.

Covaxin (inactivated virus platform) manufactured by Bharat Biotech in collaboration with ICMR, which is in phase three trials in India, has also applied for emergency use authorisation.

ZY-Cov-D (DNA platform) vaccine is being developed by Cadila Healthcare (Zydus Cadila) in collaboration with the Department of Biotechnology and is presently in the middle of phase two trials.

Russian vaccine Sputnik V (human adenovirus), which is being developed by Gamaleya National Centre Russia in collaboration with Dr Reddy's Lab in India, would start phase three trials next week.

NVX-COV-2373 (protein subunit platform) by Serum Institute of India in collaboration with Novavax and the vaccine is going through phase three trial and is under consideration.

The other vaccine is recombinant protein antigen-based vaccine by Biological E Ltd, Hyderabad in collaboration with MIT USA and phase one, two of trials of the vaccine have started.

The seventh candidate is HGCO 19 (mRNA vaccine similar platform to Modern and Pfizer in the USA), which is being developed by Gennova, Pune with Thomas Jefferson University, USA and phase 1, 2 trial of the vaccine has started.

The eighth candidate is inactivated rabies vector platform (repurposed vaccine) by Bharat Biotech and Thomas Jefferson University, USA and the vaccine is in pre-clinical advanced stages of trials.

Early concerns

The reports of vaccine development have brought a great sense of relief among the countrymen, but a worrying factor is the distribution and efficacy of the vaccine.

While India has achieved the milestone of vaccinating a majority of the population during the pulse polio drive, as per experts, the COVID-19 vaccination process is going to be significantly challenging in comparison due to the need to vaccinate all groups.

"The COVID-19 vaccine would be administered to every age-group ranging from children to senior citizens for two rounds and in a very short span of time. If there would be a delay in vaccination, the transmission of the virus cannot be prevented," the experts stated.

The pillar of vaccine distribution is cold-chain infrastructure, which is going to be very crucial in the streamlining the vaccination process as vaccines are temperature sensitive. The Government has set a target to vaccinate about 30 crore people by August 2021, which means 60 crore doses.

Currently, India has 28,947 cold chain points, 85,634 cold chain equipment, 700 reefer vans, 55,000 cold chain handlers, and 2.39 lakh health workers as part of its vaccine logistics network.

According to Union Health Secretary Rajesh Bhushan, the cold chain system is capable of storing an additional quantity of COVID-19 vaccines for the first three crore people in India. The Government would take care of the additional requirement raised by the states and UTs and the first supply of such equipment would start from December 10.

On the availability of vaccinators, the Health Ministry official said that there are a total number of 2.39 lakh vaccinators in India under the universal immunisation programme (UIP) and out of which the government is planning to deploy 1.54 lakh auxiliary nurse midwives (ANMs) for vaccination purposes.

The country's vaccine distribution network is operated through four government medical store depots (GMSDs) in Karnal, Mumbai, Chennai and Kolkata, which procure vaccines from the manufacturers.

About 53 state vaccine stores get their supplies either from these GMSDs or directly from manufacturers. The state vaccine stores then distribute the vaccines to regional, district and sub-district level cold chain points via insulated vans.

Realising the significant challenges behind identification of individuals for vaccination, the Union Health Ministry has developed a digital platform — Co-WIN — that would help in real-time monitoring of vaccine delivery, recording data and it would enable people to get themselves registered for vaccination. It is available in the mobile app format as well.

"Co-WIN digital platform includes a free downloadable mobile application which can help record vaccine data. One can register themselves on it if they want the vaccine. There are five modules in Co-WIN app — administrator module, registration module, vaccination module, beneficiary acknowledgement module and report module," the Health Secretary said.

Through these modules, they can create sessions and the respective vaccinators and managers will be notified, he said, adding that the registration module is for people to get registered for vaccination.

It will upload bulk data on co-morbidity provided by local authorities or by surveyors. The vaccination module will verify beneficiary details and update vaccination status while the beneficiary acknowledgement module will send SMS to beneficiaries and also generate QR-based certificates after one gets vaccinated.

Target group

The Government has set a target to vaccinate about one crore healthcare workers, including government and private sector workers, on a priority basis. In the second priority list, two crore frontline workers, which include personnel from state and the Central police department, armed forces, home guards, civil defence organisations including disaster management volunteers and municipal workers, would get the shots.

The third priority list of the Government is 27 crore people belonging to the age group of above 50 years and less than 50 years with comorbidities. So in total, the Government would vaccinate 30 crore individuals on a priority basis.

However, the former Deputy Chairman of the erstwhile Planning Commission, Montek Singh Ahluwalia has suggested that the Government should avoid price controls on vaccines supplied to the private sector at least for the first two years.

"Covering 70 per cent would be sufficient to achieve herd immunity to stop the pandemic. That still amounts to over 900 million, but children under 10 and pregnant women should also be excluded because none of the vaccines has been tested for these groups," he said.

On selection of vaccine for vaccination, he said, "Choosing the vaccine to use in the vaccination programme is not as simple as it appears as the in the pipeline are based on very different technologies — messenger RNA, adenovirus, and the traditional approach using an inactivated virus. Each vaccine will differ in its degree of efficacy, side effects, and impact of different age groups depending on the presence of co-morbidities."

According to the WHO, there are currently more than 50 COVID-19 vaccine candidates in trials and WHO is working in collaboration with scientists, business, and global health organisations through the ACT Accelerator to speed up the pandemic response.

"When a safe and effective vaccine is found, COVAX (led by WHO, GAVI and CEPI) will facilitate the equitable access and distribution of these vaccines to protect people in all countries," the WHO said, adding that people most at risk will be prioritised.

The cold chain infrastructure in the country is very discriminatory as there are about four cold chain points to serve 1,00,000 population in Gujarat, while there is just one cold chain point for the same number of people in Jharkhand.

However, Jharkhand has identified 30 new cold chain points for expanding its distribution network and the State is expected to receive 148 ice-lined refrigerators and 57 deep freezers from the Centre.

Further challenges

As may be expected, the process of organising such a large-scale vaccination process is anything but simple. The Government has to carry out the difficult but crucial task of identifying co-morbidities in individuals. As there is no definitive record of such, the authorities in large part will have to rely on the individuals themselves to accurately self-report their health conditions.

Additionally, vaccine developers have been reluctant in sharing important details such as the efficacy of the vaccine as when Dr Krishna Ella, who is the CMD of Bharat Biotech, was asked some important questions related to vaccines, she refused to comment, citing her busy schedule.

The Millennium Post had asked the CMD of Bharat Biotech about the production capacity of vaccine, expected price, how much time would require to start the supply of the vaccine after approval, the efficacy of the vaccine and details regarding any plan to export the vaccine.

Then there is the case of post-vaccination care, a relatively neglected topic in the current vaccine discourse. The Government needs to take the initiative in creating awareness about post-vaccination care.

"There is a need to create awareness about post vaccination care as after the first shot of the vaccine, any individual may experience COVID-19 like symptoms such as fever, headache, respiratory problem for a while, etc. Such post-vaccination effects may create a panic among the people leading to confusion among masses," said Dr Alok K Mishra — a well-known psychologist and chairman of Brain Behaviour Research Foundation of India (BBRFI).

"There are chances that after post-vaccination side-effects, people may not turn up for a second dose that would make the vaccination process more complicated," Mishra said, adding that it would make the vaccination process ineffective.

"India is a country of listeners. If one would say that vaccines are not good enough, people would not trust doctors or findings of the research. They would rely on fellow people. So the Government should make special psychological arrangements by providing counselling facilities about the post-vaccination side effects," said Mishra, who is a post graduate from AIIMS.

As many experts and commentators note, India's success in this vaccination campaign will mean much for the future. This not just for ending this pandemic but also preparing India for any future situations with a similar scale. More importantly, a competent showing here will build a solid case for a socialised healthcare system in India which will go a long way in ensuring the safety of India in the uncertain future.

Views expressed are personal