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Ficci demands PLI-like scheme for vaccine makers, clinical trial waiver for foreign jabs

Flagging vaccine shortage across states, Ficci said to meet the government's target of vaccinating 30 crore people by August at the current pace of 30 lakh daily vaccinations, as much as 38 crore doses would be required. But reports show that the Centre has just 2.04 crore doses in the pipeline, it added.

April 13, 2021 / 13:10 IST
Representative Image. Health workers at the tiny village of Bahakajari along the Brahmaputra River in Assam preparing to vaccinate the nearly 9,000 residents. (Image: AP)

Industry body Ficci has asked the government to extend financial help to vaccine makers like it does under the performance-linked incentive (PLI) scheme to ramp up production as new coronavirus cases continue to surge at a furious pace in the country.

The industry body also suggested that foreign vaccines already in use in other countries be quickly approved for emergency use and strenuous domestic clinical trials be waived. Several states have complained of vaccine shortage in recent days as they struggle to check the spread of the virus.

"There is an urgent and critical need to encourage vaccine manufacturers to substantially augment their capacities for production. Since the cost of vaccines has been capped by the government, the vaccine manufacturers need to be provided with appropriate incentives for ramping up the production," Ficci said on April 13.

The demand comes a day after the Drug Controller General of India (DCGI) approved the Sputnik V COVID-19 vaccine for emergency use.  The Russian vaccine is the third to have been granted emergency use authorisation in the country after Covishield, developed by Oxford University-AstraZeneca and manufactured by the Serum Institute of India (SII), and Bharat Biotech’s Covaxin.

India has been hit hard by the new wave of coronavirus with infections growing at a much fast clip than the last time. The country added 1,61,736 new cases in the last 24 hours, the health ministry’s April 13 update shows. This the seventh straight day that the cases have topped one lakh.

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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Ficci also asked the government to make provisions for immediate grants and subsidies for the companies developing or manufacturing COVID-19 vaccines. The money can be routed through the government's COVID-19 funds, it said, citing the PM CARES Fund that created for this purpose in March 2020.

Vaccines that are proven and successful in other markets should be brought into India at the earliest to maintain supply chains, the chamber said.

"This should be considered for import and sale of international vaccines as well as initiate manufacturing of such vaccines in the country. Given that most of these vaccines have extensive dossier and data on their safety and efficacy for large populations, including for Indians living abroad, we should waive off the need for Indian clinical trial data," the chamber said.

Severe shortage 

The industry body also said many states continue to face a vaccine shortage including Punjab, Rajasthan, Uttarakhand, Uttar Pradesh, Jharkhand and Bihar, forcing state governments to scale down their daily vaccination targets. The Centre has repeatedly said there is no shortage of vaccines.

"India intends to vaccinate a priority population of 30 crore by August 2021. Given that 10.85 crore people have received at least first dose of COVID vaccination and going with the current rate of 30 lakh vaccinations per day, we would need more than 38 crore doses (of two-dose vaccines) to fully vaccinate this priority group," the industry body said. It added that reports showed the government had only 2.04 crore doses in the pipeline for the next few days.

Since the duration of immunity provided by the vaccines was yet not known, the government would need to factor in repeat vaccination and maintain the momentum of manufacturing for at least the next couple of years, Ficci said.

With the current strategy and vaccination rate, India would miss vaccinating "super-spreaders" in the 18-45 year age bracket, it said, adding the group also constituted the majority of the workforce needed to sustain economic activities.

Click here for Moneycontrol’s full coverage of the coronavirus pandemic

Subhayan Chakraborty
first published: Apr 13, 2021 12:55 pm

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