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Open up licensing to develop vaccines and accelerate vaccination drive, demand medical experts

Companies other than Bharat Biotech must be given contracts to manufacture the indigenously developed Covaxin in bulk. This is the time to open licensing to any company that wants to produce vaccines and for anyone who wants to take a jab, per doctors.

May 05, 2021 / 12:43 PM IST

The trillion-Rupee question haunting COVID-19-ravaged India today is this: why are companies other than Bharat Biotech [Bharat Biotech International or BBIL] not been given contracts to manufacture the indigenously developed Covaxin in bulk?

After all, that should have been the natural response of any government, instead of continuing with a tiny, 12.5-million-doses-a-month that the Hyderabad-based Bharat Biotech is coughing out at the present movement.

It hardly needs a rocket scientist to calculate that India, now the second worst-hit nation by the COVID-19 pandemic after the US, as some naysayers had dourly predicted earlier, is in dire need of mass immunisation, perhaps the biggest the world has ever seen, if it is to counter the COVID tsunami, not just the Second, but potentially a Third Wave as well.

The ability to carry out the world’s largest mass vaccination exercise in record time will depend on keeping vaccine supplies of hundreds of millions of doses flowing uninterruptedly for months.

Epidemiologist Dr Giridhar R Babu puts forward some numbers. “To vaccinate everyone over the age of 18, we would need a billion vaccine doses straight away,” he told Moneycontrol. The reality is too real.

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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The Department of Biotechnology recently informed the Parliamentary Standing Committee on Science and Technology, Environment, Forests and Climate Change that the estimated manufacturing capacity of Covishield is 70-100 million doses every month while Covaxin has a planned production capacity of 12.5 million doses a month.

What India Needs Now

India is going to increase its vaccine production significantly. SII is going for a month-on-month vaccine increase of 10 to 15 percent and by July this year is expected to touch the 100-million doses mark.

Yet, even that is far from ideal. Experts say that covering 70 percent of India’s population may come close to achieving herd immunity from COVID-19. That still amounts to inoculating over 900 million people in a few months – a task that the government, now, has no option but to follow, irrespective of the consequences.

Bhramar Mukherjee, a biostatistician at the University of Michigan, told the BBC that the country needed to administer 10 million shots daily "instead of being complacent with three million".

India is expected to receive more than 45 crore doses of vaccines by July, enough to fully vaccinate about a quarter of the country’s adult population with both the mandatory doses. This obviously means that 70 percent is not just a very tall order but will require extraordinary political and administrative coordination and acumen at various levels to even get somewhere near the intended goal.

Says Dr Alex Thomas of the Association of Healthcare Providers (India): “It is utterly mystifying. Mass vaccination is the only way out. We have been stressing on the urgent need for increasing the number of jabs for the last six months. Companies need to be pushed into mass manufacturing the vaccine, yet there seems to be no urgent rush. The army and paramilitary has to be called in.”

Interestingly, Covaxin is, in large measure, a product of publicly funded research in India. Scientists say it is based on the SARS-CoV-2 strain, which was isolated in the National Institute of Virology in Pune. This Institute functions under the Indian Council for Medical Research (ICMR). The ICMR had transferred this strain to Bharat Biotech for development and manufacture.

The ICMR-Bharat Biotech Partnership

An ICMR official told the media last year that the “ICMR and BBIL (Bharat Biotech) are jointly working for the pre-clinical as well as clinical development of this vaccine.” ICMR also announced that it had selected 12 institutes to conduct clinical trials of the vaccine.

There are indicators that suggest ICMR’s considerable involvement and control in developing Covaxin. On July 3 last year, a letter written by ICMR Director General Balaram Bhargava was reported in the media. “It is envisaged to launch the vaccine for public health use latest by 15th August 2020 after completion of all clinical trials. BBIL [Bharat Biotech International Limited] is working expeditiously to meet the target. However, the final outcome will depend on the cooperation of all clinical trial sites involved in this project,” said the letter.

Dr MC Mishra, former Director AIIMS, says that developing the Covaxin is a good aatmanirbhar (self-reliantplan, but it has come too late. ``Everyone has missed the bus. The government should have started planning last year for the vaccines. It did not. The two vaccine-producing companies, Serum Institute of India, and Bharat Biotech, instead of getting into a slanging match with each other, should have put their combined heads down. And the people who should have got the vaccine backed away. In the first phase of the vaccination, about half of the intended people took their jabs, citing fear of the consequences. And these, mind you, were educated people,” he told Moneycontrol.

He raises another pertinent point. ``If the Serum Institute could tie-up with Swedish-British firm AstraZeneca from which it has licensed its vaccine, why couldn’t other companies get the same privilege?’’

India could do with more companies producing vaccines. Dr Giridhar Babu lays out the plan of action. ``Pfizer wants to come to India. Sputnik has plans for over 800 million doses, which it wants to produce in India.  Even if India gets half, we would be on a good wicket. Moderna has shown interest. The government should facilitate their vaccine production in India. That would be the best way to really scale up and inoculate the population.”

Moving as quickly as it can, the government is still seen to be dragging its feet to cut through the maze of bureaucratic red tape and get things moving at an express pace.

Already, alliances are being firmed up across the world. The Covax global vaccine equity programme said on May 2 that it has struck a deal to buy 500 million doses of Moderna's COVID-19 jabs. These are the straws that India needs to pick up. The consequences of a potential Third Wave could be difficult to visualize.

Ranjit Bhushan is an independent journalist and former Nehru Fellow at Jamia Millia University. In a career spanning more than three decades, he has worked with Outlook, The Times of India, The Indian Express, the Press Trust of India, Associated Press, Financial Chronicle, and DNA.