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India wants Pfizer to do local study for approval: Official

Serum Institute of India, the local manufacturer of the vaccine developed by AstraZeneca Plc and Oxford University, has done a similar study on more than 1,500 people over months before seeking and receiving emergency approval in the country.

January 13, 2021 / 07:26 PM IST

Any vaccine maker, including Pfizer Inc, which has sought emergency-use authorisation for its COVID-19 shot in India, must conduct a local "bridging" safety and immunogenicity study to be considered for the country's immunisation programme, a senior government official told Reuters.

Serum Institute of India, the local manufacturer of the vaccine developed by AstraZeneca Plc and Oxford University, has done a similar study on more than 1,500 people over months before seeking and receiving emergency approval in the country.

Local media have reported that Pfizer had sought an exception when last month it became the first company to seek emergency-use approval in India for its vaccine already in use overseas. The company has not attended subsequent meetings called by India's drugs regulator.

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"As of now, the pre-condition for any vaccine to be implemented in India is that you have to do a bridging trial," Vinod K. Paul, who heads a government panel on vaccine strategy, said in an interview in his office near the parliament building.

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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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A Pfizer spokeswomen did not immediately respond to a request seeking comment.

Paul also said Russia's Sputnik V, a shot undergoing last-stage trials in India, will soon apply for emergency-use approval in the country.

No vaccine maker will be given indemnity by the government should something go wrong, Paul said. Serum Institute had written to the government seeking indemnity. AstraZeneca has said it has received such indemnity in many other countries.

India has also approved for emergency use a vaccine developed locally by Bharat Biotech.

Follow our full coverage of the coronavirus pandemic here.
Reuters
first published: Jan 13, 2021 07:20 pm

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