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India to treat homegrown COVID-19 vaccine same as AstraZeneca's

“No vaccine is a backup to the other - both vaccines are equally important, both vaccines are hugely immunogenic,” said Vinod K. Paul, who heads a government panel on vaccine strategy.

January 14, 2021 / 10:36 PM IST
Covaxin, Bharat Biotech

Covaxin, Bharat Biotech


India will treat a domestic COVID-19 vaccine “equally” with a prominent global one, even though the homegrown drug’s efficacy has not been proven, and people will have no choice which they one they get, a top government vaccine official told Reuters.

The government on Saturday will launch one of the world’s biggest vaccination programmes with shots manufactured in India - one developed by Oxford University and AstraZeneca Plc, the other by Bharat Biotech International Ltd with a state-run institute.

Administering Bharat Biotech’s COVAXIN, a move cheered by nationalist politicians, has worried some health experts who consider it rushed, as the vaccine has only limited, “clinical-trial mode” approval. In addition to efficacy concerns, the close monitoring required for its use will be a massive challenge in a country of 1.35 billion people.

Also Read: Coronavirus LIVE Updates: Delhi govt extends extends '14-Day Quarantine' order on UK passengers

Controversy over COVAXIN - similar to what China and Russia faced for pushing through their own shots before their efficacy was known - risks undermining India’s position as the vaccine capital of the world, medical ethics groups say.

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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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“No vaccine is a backup to the other - both vaccines are equally important, both vaccines are hugely immunogenic,” Vinod K. Paul, who heads a government panel on vaccine strategy, said in an interview. They excite immunity against the virus.”

“There is no choice to the individual at this point of time” as India ramps up production of the vaccines, he said.

Also Read: Covaxin vs Covishield | Bharat Biotech’s COVID-19 vaccine may cost lower than Serum Institute's: Report

This marks the government’s clearest statement that recipients may not choose their vaccine. The health secretary said this week that no other country allows a choice but stopped short of saying India would do the same.

Experts at India’s drug regulator this month recommended stricter monitoring for COVAXIN, as is done during clinical trials, especially if cases of infection by mutant strains of the virus spread fast. At the same time, the government wants to inoculate as many people as possible as demand for vaccines outstrips supply.

Indian health advocacy groups, watchdogs and opposition politicians have questioned the local vaccine’s approval, which came just a day after the authorities asked Hyderabad-based Bharat Biotech for more evidence it would work.

“This achievement will indeed be hailed as a major Indian scientific achievement once efficacy data are released, but by this hasty approval without evidence, the government has shot itself in the foot,” the All India People’s Science Network, a network of science advocacy groups, said in a statement.

“Whatever prestige India may gain abroad for an indigenously developed vaccine will be outweighed by the damage caused to the credibility of COVAXIN in particular, and of Indian science, research and regulatory institutions.”

Also Read: COVID-19 Vaccine Update: Recipients cannot choose between Covishield and Covaxin initially

Paul defended moving ahead with the drug, which Bharat Biotech developed with the Indian Council of Medical Research, saying all COVID-19 vaccines in the world, including those by Pfizer Inc and Moderna Inc, are administered under emergency authorisation.

“The scientific rigour under the circumstances of the pandemic has been respected in a robust manner,” Paul said. “There is no pressure” on India’s regulator, the Central Drugs Standard Control Organization. “They take decisions based on science and regulatory norms.”

PROUD POLITICIANS, RELUCTANT REGULATORS

Prime Minister Narendra Modi has said every Indian should be proud of the made-in-India COVAXIN, calling its approval a sign of a “self-reliant” country.

Brazil this week became the first foreign country to sign a deal to buy the Indian shot.

India’s emphasis on the domestic vaccine comes as the government asks Pfizer and Moderna to make their highly efficacious shots in India for local and global distribution

Paul said Pfizer would have to do an additional safety and immunogenicity trial in India.

Also Read: Big Story | How Pfizer, Moderna, AstraZeneca COVID-19 vaccines are placed in terms of availability?

He said it is the responsibility of government officials like himself to answer questions about COVAXIN. All required protocols - such as closer proactive monitoring of recipients for any adverse effects - will be followed, he said.

The government has already bought 11 million doses of the AstraZeneca COVISHIELD shot and 5.5 million of COVAXIN - whose efficacy results from last-stage trials are expected by March.

Paul declined to say whether the government, which wants about 600 million vaccine doses in the next six to eight months, would buy an equal number of doses of both vaccines. Bharat Biotech did not respond to requests for comment.

The drug regulator believes COVAXIN will be more effective on new strains of the coronavirus as it is designed to act against the whole body of a virus, not just its “spike-protein” tip.

Some of its experts, nevertheless, were reluctant to give the emergency nod to COVAXIN for much of the hours-long meetings they had late last month and early this month, said a person with direct knowledge of the deliberations.

Published minutes here of the meetings also showed that the initial position of the panel - which had wanted to wait for some sort of efficacy data - changed in a matter of days.

Also Read: India wants Pfizer to do local study for approval: Official
Reuters
first published: Jan 14, 2021 10:36 pm

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