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India’s COVID-19 vaccine puzzle: Bharat Biotech, Serum set to start human trials; but big questions remain unanswered

With no benefit of funding or prior orders unlike their European and American counterparts, Indian companies largely remain on their own when it comes to the risk of failure.
Jul 12, 2020 / 06:14 PM IST

While the global efforts to develop a safe and affordable coronavirus vaccine are going on in full swing, a big question remains unanswered: how and when India, one of the world's most populous countries and is only behind the United States and Brazil in infections numbers, will be able to make it available to the public.

Since the government is yet to announce a national policy on COVID-19 immunisation, public health experts believe that Ayushman Bharat, the central government's flagship health insurance scheme, to be the way forward to undertake the vaccination programme for the poor with possible price control on the vaccine for people outside the government's universal healthcare programme.

However, this massive and potentially multi-year immunisation programme, which is expected to start with the elderly and the other vulnerable segments, including frontline workers, needs to have a proven vaccine before addressing other uncertainties like timelines and availability.

In India, Hyderabad-based Bharat Biotech and Pune-based Serum Institute have initiated human trials on their respective vaccine candidates, which are among close to 170 vaccines currently under various stages of clinical development globally.

COVID-19 Vaccine

Frequently Asked Questions

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How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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Bharat Biotech is working on an initial capacity of 200 million vials of the vaccine while the Serum Institute said it would be able to produce 400 million doses of the vaccine before December 2020 for India and other markets licensed from its European partners. Like any potential COVID-19 vaccine, the regulatory approval for these vaccines and their entry into the government vaccination programme ultimately depend on the degree of intended outcomes that the Phase-3 trials would establish in terms of safety and efficacy.

While the developed countries like the US, the UK and Germany have made advance purchase agreements with vaccine makers in order to stock up the potential COVID-19 vaccines to make them available to their people at the earliest if proved successful, the approach of India largely remained open-ended, leaving scope for different possibilities.

With no benefit of funding or prior orders unlike their European and American counterparts, Indian companies largely remain on their own when it comes to the risk of failure.

The Public Health Foundation of India president K Srinath Reddy said that even if India was unable to produce a successful vaccine for COVID-19 initially or ran third or fourth in bringing a vaccine, it did not matter much owing to the country's capability as a low-cost manufacturer of medicines and vaccines. "As we are a low-cost producer of vaccines globally, it is likely that other countries also seek our help to produce a vaccine for them," Reddy told Moneycontrol.

On the early timelines of a particular vaccine candidate in India, Prime Minister Narendra Modi in his recent address categorically said the country would produce the vaccine in large volumes when it was ready.

One of the possibilities, according to a vaccine industry spokesperson, could be the ongoing efforts of the GAVI (formerly Global Alliance for Vaccines and Immunisation) and the Bill and Melinda Gates Foundation towards funding the COVID-19 vaccine manufacturing across geographies for equitable distribution and overcoming logistics issues. "These agencies have been in the process of identifying 10 vaccine companies in 10 different countries to produce COVID-19 vaccines for which they have raised about $4 billion. It is even going to be a challenge to find vendors capable of supplying billions of glass vials and other packaging material to support the vaccine production," the spokesperson said, while refusing to elaborate on whether India was on their radar.

The scale of production is as important for India as for the global agencies considering the size of the country’s population and many people have already experienced the adverse effects of low supply of the prescription COVID-19 drug Remdesivir in the market. Reports suggest that a Rs 5,400-priced Remdesivir was sold for as much as Rs 1 lakh in the black market. Thankfully, other Indian generic drug makers, who had signed a similar non-exclusive agreement with the innovator company, Gilead Sciences, have also started launching the drug to help increase the supply of the antiviral medication.

"Instead of looking at the price, you should focus on ensuring adequate supplies in the market, which would in turn take care of the problems associated with the availability. The same would apply to the future vaccine," said Madhukar Gangadi, founder and CEO of pharmacy chain Medplus. If there is enough supply of the product in the market the companies would eventually approach pharmacy chains like Medplus to use them as their retail distribution channel and keep the product available at every nook and corner of India, according to him.

The question of when the vaccine is expected to be available for Indian people is still unclear as the timelines of these vaccines have become a subject matter of big debate all over the world, not just in India, even though a reasonable time frame of 12-18 months was indicated by many at the beginning.

When the Indian Council of Medical Research (ICMR) hinted at August 15-timeline for Bharat Biotech's Covaxin, which is now considered as a remote possibility, Serum Institute's Adar Poonawala said they do not want to rush anything. "We are confident of a safe and good vaccine for India and the world; we would certainly announce it when we are licensed by the Drug Controller (DGCI), but that is still at least six month away," Poonawalla said at a recent press conference.

Bharat Biotech chairman Dr Krishna Ella also clarified that they would go ahead with all the regulatory trials before concluding the safety and efficacy for the use of the vaccine. Only late last month, the company had announced that it has successfully developed India's first candidate for coronavirus vaccine in collaboration with ICMR and also received DGCI approval for Phase I and Phase II clinical trials.

Noted virologist Dr T Jacob John goes a step ahead and warns against creating false hopes about the vaccine. "We don't expect a vaccine until the first or the second quarter of 2021. Therefore the vaccine should not be there in the equation of COVID-19 management. Creating false hopes is nothing but hiding behind good stories," he says.

Speaking to Moeycontrol, Dr John said high hopes about the vaccine would particularly push the country's senior citizens into the brink of depression if they do not find one as had been promised. "While facing the pandemic, we are looking backwards," he noted.

The pandemic vaccine is not expected to be included in the country's universal immunisation programme (UIP) schedule, which is basically meant for the children's immunisation programmes involving BCG, MMR, etc. Last year the Ministry of Health and Family Welfare had released a multi-year immunisation plan with an estimated budget of Rs 52,220 crore for the period between 2018 and 2022, a 52 percent increase over the budget of 2013-17 period, as the external funding was unlikely to continue, according to reports.

A potential Covid-19 vaccination would add more to the government's healthcare expenditure on top of testing and treatment costs, depending on the price and the policy. However, it would be a little early to guess the price of a potential vaccine even though an Indian vaccine maker earlier indicated a price of up to Rs 1,000 per vial.

Apart from the crucial safety and efficacy aspects, the vaccines would also require a number of other studies to determine the parameters like the exact quantity of a dose, the shelf life of the vaccine, need for a single or a double dose among other things, according to an industry expert. "The shelf life of a vaccine should remain at least one year. If the shelf life is enhanced using excipients, there is a danger of side effects also," he observed.
B Dasarath Reddy
first published: Jul 12, 2020 06:14 pm
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