Is India’s war on COVID-19 losing steam?

As the vaccination drive continues, India is faced with a shortage of vaccines considering the population of the country, which currently stands at a staggering 1,390,605,073, as per Worldometer elaboration of the latest United Nations data. The Indian government, to address this stark reality, has opened its doors to foreign vaccines and are fast-tracking their approval.

As the COVID-19 pandemic rages on, vaccines offer a glimmer of hope in these dark times. The world has moved swiftly in unison to develop COVID-19 vaccines, with India leading from the front in terms of COVID-19 vaccine production and supplying it to the rest of the world.

India had approved the indigenously developed COVAXIN by Bharat Biotech and COVISHEILD (AstraZeneca) manufactured by Serum Institute of India (SII) on January 3, 2021. The Drug Controller General of India (DGCI) had approved the vaccines on the basis of ‘restricted’ use in an ‘emergency’ situation, with the vaccination drive commencing on January 16, 2021. The Sputnik V developed by Gamaleya Research Institute of Epidemiology and Microbiology and the Russian Direct Investment Fund (RDIF) received the nod on April 12, 2021. The centre procured 1.10 crore doses of COVISHEILD at the cost of Rs 200/dose (excluding taxes) and 55 lakh doses of COVAXIN. The cost of 38.5 lakh doses of COVAXIN was Rs 295/dose (excluding taxes) but the company provided 16.5 lakh doses of COVAXIN free of cost to the central government reducing the cost to Rs 206/dose. The central government was able to procure the vaccines at this price by putting a price cap on the vaccine. The cost of Sputnik V hasn’t been announced as yet. This is a two-dose vaccine that costs approximately $10 per dose in the global market.

The DCGI has approved the vaccines after scrutinising the data that was submitted to the Subject Expert Committee of Central Drugs Standard Control Organisation. SII submitted data on safety, immunogenicity and efficacy data generated on 23,745 participants aged ≥ 18 years or older from overseas clinical studies. The overall efficacy was found to be 70.42 per cent. Further, SII was granted permission to conduct PhaseII/III clinical trials on 1600 participants within the country. The firm also submitted the interim safety and immunogenicity data generated from this trial and the data was found comparable with the data from the overseas clinical studies.

Bharat Biotech conducted Phase I/II clinical trials on approximately 800 subjects and the results demonstrated that the vaccine is safe and provides a robust immune response. The Phase III efficacy trial was initiated in India in 25,800 volunteers and on January 3, 2021, ~22,500 participants had been vaccinated across the country and the vaccine was found to be safe as per the data available. Bharat Biotech came out with the first interim analysis of COVAXIN on March 3, 2021 with an efficacy of 80.6 per cent.

Dr Reddy’s presented the safety profile for Sputnik V, with Phase II study, and interim data of the Phase III study to the government. The vaccine is currently undergoing the Phase III clinical trial in India. Interim data analysis of the Sputnik V vaccine has demonstrated 91.6 per cent efficacy.

As the vaccination drive continues, India is faced with a shortage of vaccines considering the population of the country which currently stands at 1,390,605,073 (based on Worldometer elaboration of the latest United Nations data). The Indian government, to address this stark reality has opened its doors to foreign vaccines and is fast tracking the approvals for these vaccines.

As per the data

shared by the Health Ministry on April 13, 2021, all the states and Union Territories have received 13,10,90,370 doses with a total consumption of 11,43,69,677 doses (including wastage of 8-9 per cent), remaining doses with the states and UTs are 1,67,20,693 and the doses that are in the pipeline are 2,01,22,960. India has administered a total of 11,11,79,578 doses as per the data mentioned on the Ministry of Health and Family Welfare website (April 14). The vaccines that have been administered till date are COVAXIN and COVISHEILD as the Sputnik V has just been approved and till date, it was only used for Phase II-III clinical trials by Dr Reddy’s.

The COVID-19 vaccines that are available in India currently have a vial capacity of 10 doses (COVISHEILD), (COVAXIN) and 20 doses (COVAXIN initial consignment). Currently there are no details about the vial capacity of the Sputnik V. The vaccines that are currently available have a shelf life of six months. Notably, the shelf life of COVISHEILD was increased from six months to nine months recently. Once the vaccine vials are opened they can only be preserved for four hours. The ideal temperatures to store the Indian vaccines are 2-8 degrees Celsius as was also mentioned by Dr Renu Swarup, Secretary, Department of Biotechnology during a media briefing. Sputnik V can be stored at the same temperature as COVISHEILD and COVAXIN.

Roadblocks ahead

India’s vaccination drive, also being the world’s largest COVID-19 vaccination drive, has been ongoing for the last three months. The vaccination drive has hit several roadblocks in the last few months. Firstly, the

vaccines that have been approved are far from perfect, with each having their own flaws. COVISHEILD also known as Vaxzevria (name change implemented by European Medicines Agency on March 25, 2021) globally has proven to be less effective against the South African strain of the virus and there are reported cases globally about the vaccine causing blood clots. Thankfully, no such cases have been reported so far in India. Several countries have gone ahead and halted the use of Vaxzevria till there is more concrete data on whether the vaccine is indeed, causing blood clots.

COVAXIN has also come under fire from experts who believe that the approval process for the vaccine was rushed. Brazil has refused emergency use authorisation (EUA) to the vaccine as it didn’t meet manufacturing standards. Gagandeep Kang, Professor, Department of Gastrointestinal Sciences, Christian Medical College, Vellore, India voiced her opinion on COVAXIN approval, stating that she couldn’t understand how approval was given to Bharat Biotech without the submission of Phase III clinical trials, as at the time of approval Phase III data had not been submitted to DCGI. All India Drug Network as well were left shocked with the hasty decision at the time, due to the lack of efficacy data and lack of transparency. The All India Drug Network stated that the decision would raise more questions than answers and that could lead to losing faith in scientific decision making bodies.

Unanswered questions

As India has opened its doors to all vaccine manufacturers there are a lot of unanswered questions. Questions pertaining to the process in

which the approvals will be granted, what is going to be the price of the vaccines and will Indian citizens have the option of choosing a vaccine, can be cited.

Johnson & Johnson currently is in talks with the Indian government, to start clinical trials of its singledose COVID-19 vaccine. This vaccine is compatible with standard vaccine storage and distribution channels with ease of delivery to remote areas. The vaccine is estimated to remain stable for two years at -20°C, and a maximum of three months at routine refrigeration at temperatures of 2-8°C.

Crunch time

As we gear up for an influx of various COVID-19 vaccines in the Indian market, the Indian government needs to address the concerns of Indian vaccine manufacturers as well. Indian vaccine manufacturers’ production capacities are highly stressed due to massive demands. European countries and the US are withholding raw materials required to manufacture COVID-19 vaccines. Indian vaccine manufacturers need to ramp up production capacities for which surplus funds are required, they also need to be incentivised so that it further leads to innovation, higher efficacy, quality control, higher production capacities. There is also the issue of wastage of vaccines which needs to be addressed if we want to go ahead and win the war against COVID-19, as there aren’t enough vaccines currently available.

Various states and UTs across India have been reporting shortage of vaccines. Shortage of vaccines can derail the entire vaccination drive against the Coronavirus. The Indian government also needs to iron out flaws in the vaccination drive infrastructure to reduce wastage as there have been reports of CoWin app (COVID-19 vaccine registration application) servers being down and not enough people turning up for vaccinations due to the chaos and miscommunication as the vial capacity of the vaccines of currently available are ten doses.

Cost of jabs

There also needs to be a regulation in pricing of the vaccine as Covshield and COVXAIN are available for Rs 150 currently per dose. Sputnik V has been approved but the price of the vaccine is still unclear. Experts like KV Balasubramaniam, Former Managing Director, Indian Immunologicals Ltd and NK Mehra, ICMR emeritus scientist and Former Dean, AIIMS, New Delhi are of the opinion that the cost can be reduced further to Rs 60-70. However, the crucial question is whether it will be sustainable for foreign manufacturers to compete with COVISHEILD and COVAXIN, as the Sputnik V and Johnson & Johnson COVID-19 vaccine retail for $10 per dose in the global market.

Unsustainable model

Kiran Mazumdar-Shaw, Chairperson and Managing Director, Biocon has voiced her opinion on the price cap of the vaccine. She tweeted, “COVID-19 vaccine price is too low to sustain. She also provided further insights by breaking down the cost that private hospitals can charge for administering a COVID-19 vaccine, vaccine administration at government hospitals are going to be free of cost. Private hospitals empanelled with PM Ayushman Bharat Yojana and the Central Government Health Scheme (CGHS) will also offer vaccination, where Rs 250 can be charged for vaccination, where the vaccine manufacturer would get Rs 150 and the hospital would get Rs 100 for administering it. She also referenced the WHO’s price cap for COVID-19 vaccines at $3, but in India the cost has been brought down further to $2.

A feasible solution

As newer vaccines come to Indian shores, the scope to vaccinate more citizens increases, but foreign vaccines cannot fulfil the vaccine deficit that we might face in the coming months. The feasible solution, or at least a part of it, rests with Indian vaccine manufacturers who must skyrocket their manufacturing capacities right away, so that India’s ambitious vaccine drive isn’t derailed. Vaccine diplomacy and ramping up production of vaccines will have a global impact, leading to a new normalised world. Nobody is safe till everybody is safe.