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Monday, November 30, 2020

Vaccines are almost ready, but is India ready to use them for its huge population?

As we all know already that potential vaccine candidates across the world are in the race to become a reality against the highly-infectious coronavirus which has claimed innumerable lives around the globe so far. Recently, Pfizer and Moderna released the results of clinical trials of their respective experimental coronavirus vaccines. Both the candidates have reportedly shown an efficacy rate of over 90 per cent. Meanwhile, the first batch of Russia’s Sputnik V vaccine for Covid-19 is expected to reach Kanpur’s Ganesh Shankar Vidyarthi Medical College by next week wherein the vaccine’s Phase 2 and Phase 3 human clinical trials will be conducted. The decision was taken after Dr Reddy Laboratories got approval from the Drugs Controller General of India (DCGI). But with major promising vaccine candidates coming to the fore, multiple challenges come with it that we cannot ignore.

Right from cold storage infrastructure to equal and effective distribution of vaccines, the task ahead of all stakeholders is humongous. In this article, we shall address the concerns related to potential vaccine candidates of India and how our country is preparing to overcome those challenges.

The background

According to the Ministry of Health and Family Welfare data updated on Thursday, the total coronavirus cases in the country have mounted to 89,25,467 with over 38,000 infections being reported in a day while the death toll climbed to 1,31,130. The number of active cases remained below 4.5 lakh for the eighth consecutive day. There are 4,46,805 active cases of coronavirus infection in the country. The total recoveries have surged to 83,35,109 pushing the national recovery rate to 93.52 per cent while the COVID-19 case fatality rate stands at 1.47 per cent.

Vaccines are almost ready, but is India ready to use them for its huge population?

1. Which potential vaccine is best for India?

According to RDIF CEO Kirill Dmitriev, Sputnik-V coronavirus vaccine is safer than others. He said it is one of the three vaccines in the world backed by published preliminary clinical trial results. Russian President Vladimir Putin recently called for a joint effort by the BRICS nations on the development of the coronavirus vaccines as he suggested that Sputnik-V vaccine could be produced in India and China. Both India and China are members of the five-nation bloc. Dmitriev said that the vaccine shows very high efficacy of 92 per cent. “The number is calculated very simply – 75 percent of clinical trial participants received the vaccine but only four out of 20 infected were administered Sputnik-V while the remaining 16 were on placebo,” he said. He also cited a poll conducted by the RDIF that revealed about 60 per cent of people across India know about Russia’s vaccine.

On the other hand, clinical trial results of Moderna and Pfizer have also shown promising results. Reports say that Moderna’s study was small but enough to draw a statistical conclusion. But researchers still need to know that for how long the immune response will be effective. Another factor is the cost of Moderna and Pfizer in India. It is believed that these two would be more expensive than others.

Reports say that AstraZeneca and the University of Oxford’s coronavirus vaccine could be the first to be made available in India by the first quarter of 2021. But the country needs additional cold storage facilities for the distribution of a coronavirus vaccine. Also, the cold-chain requirement for the anti-coronavirus vaccine candidate developed by Pfizer at a temperature of minus 70 degrees Celsius poses a big challenge. The government has said that it examining the possibilities if at all the vaccine has to be obtained by India.

2. Are we doing enough for effective distribution?

The main challenge would be related to the distribution. India produces more vaccines than any country but it lacks a delivery system, specially for adults apart from pregnant women. NITI Aayog member (Health) Dr VK Paul, who also heads the National Task Force on COVID-19, said sufficient doses of the vaccine, as required for the Indian population, will not be available, but the government is looking at the possibilities and will work out a strategy for its procurement and distribution in case it gets the regulatory approvals.

It would be a challenging task for the government to put in place a strategy to ensure vaccine reaches every nook and corner of the country. The country may need repeated waves of vaccination based on priority groups and it could take at least two years for all Indians to receive doses. Prime Minister Narendra Modi has already assured citizens that everyone in the country will be inoculated once a vaccine for the highly-infectious coronavirus becomes available. According to him, a digital platform was being prepared to enroll, track and reach the beneficiaries. He has suggested developing a vaccine delivery system that is on the lines of how elections are conducted in the country.

3. Hope over Pfizer grows, but…

Pharmaceutical giant Pfizer on Wednesday said that its Covid-19 vaccine candidate was found to be 95 per cent effective in the final analysis of the Phase 3 trial, adding it had the required two-months of safety data and would apply for emergency US authorization within days. The drugmaker said the efficacy of the vaccine developed with German partner BioNTech SE was consistent across age and ethnicity demographics, and that there were no major side effects, a sign that the immunization could be employed broadly around the world. The study reached 170 confirmed cases of COVID-19, with the vaccine candidate BNT162b2 demonstrating 95 per cent efficacy beginning 28 days after the first dose, Pfizer said.

Pfizer vaccine, which was shown to be more than 90% effective in preventing Covid-19 based on initial data, must be shipped and stored at freezing temperatures of -70 degrees Celsius from the moment they are bottled to the time they are ready to be injected. This is significantly lower than the standard 2-8 degrees Celsius storage requirement.

4. Can India store the vaccine at -70 degree?

Pharmaceutical giant Pfizer on Wednesday said that its COVID-19 vaccine candidate was found to be 95 per cent effective in the final analysis of the Phase 3 trial, adding it had the required two-months of safety data and would apply for emergency US authorization within days.

The drugmaker said the efficacy of the vaccine developed with German partner BioNTech SE was consistent across age and ethnicity demographics, and that there were no major side effects, a sign that the immunization could be employed broadly around the world. The study reached 170 confirmed cases of Covid-19, with the vaccine candidate BNT162b2 demonstrating 95 per cent efficacy beginning 28 days after the first dose, Pfizer said.

5. Should India just forget Pfizer vaccine?

Many working in the country’s public health and the pharmaceutical industry have already voiced concern that India lacks the necessary capacity and capability to deliver a vaccine across its vast rural hinterland and population of over 1.3 billion people at the breakneck speed now expected. “Most of these vaccines need minus 70 degrees, which we just can’t do in India, just forget it,” said T Sundararaman, a New Delhi-based global coordinator of the People’s Health Movement, an organization that brings together local activists, academics and civil society groups working on public health. “Our current cold chains are not able to cope with some districts’ need for measles vaccines, and that’s only for children below the age of 3,” he said. “That’s a really trivial number of people compared to the numbers that will need a Covid-19 vaccine.”

When asked at a Tuesday briefing if the government would look to buy any of the Pfizer vaccine, Rajesh Bhushan, the secretary at the health ministry, said New Delhi is in talks with all vaccine manufacturers. He added that India was in a position to “augment and strengthen” its existing cold-chain capacity, but declined to release any purchase details immediately. Pfizer already has orders from some developing countries like Peru, Ecuador and Costa Rica. It’s unclear how widely those nations plan to distribute the shots, but their small orders of less than ten million doses suggest limited deployment. After the release of their positive preliminary data, some governments have rushed to finalize orders and start negotiations with Pfizer and BioNTech. The European Union confirmed an order of up to 300 million doses on Tuesday, while the Philippines, Singapore and Brazil said they were in talks.

6. Lack of logistics support

Even without the subzero issue, rolling out a vaccine in a short space of time will be a “major challenge” requiring mass paramedical training to administer two-shot doses, said Pankaj Patel, chairman of Indian drugmaker Cadila Healthcare Ltd., which is developing its own experimental plasmid DNA Covid-19 shot. This is especially so in areas where people are not easily contactable or have to travel long distances to reach vaccination centers. Past vaccination campaigns show that many simply never show up for the second shot, said public health experts. The mounting obstacles mean that some developing countries may pass on the Pfizer vaccine, despite early signs of its exceptional efficacy.

Only time will tell whether India can surpass these challenges and come up with an effective and trusted vaccine for its 138 crore population in the next few months.

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