COVID-19 vaccine update | Pfizer wants India to order coronavirus vaccine before pursuing approval

India's CDSCO says Pfizer officials failed to turn up to meetings after the company's application was made in early December. The regulator has also declined to accept the company's request for approval without a small local trial on the vaccine's safety and immunogenicity for Indians

January 27, 2021 / 08:28 AM IST
Pfizer covid-19 vaccine

Pfizer covid-19 vaccine

Pfizer Inc will pursue its request for India to approve its COVID-19 vaccine if the government commits to buying shots, the U.S. drugmaker told Reuters on Monday, even as global supplies tighten.

Pfizer was the first company to seek emergency-use authorisation (EUA) for a COVID-19 vaccine in India, but the government this month approved two much cheaper shots – one from Oxford University/AstraZeneca and another developed at home by Bharat Biotech with the Indian Council of Medical Research.

Pfizer, Moderna COVID-19 vaccines could possibly be available in India through COVAX route

India's Central Drugs Standard Control Organisation (CDSCO) says Pfizer officials failed to turn up to meetings after the company's application was made in early December. The regulator has also declined to accept the company's request for approval without a small local trial on the vaccine's safety and immunogenicity for Indians, Reuters has reported.

Pfizer says its application is supported by data from a global study that shows an overall efficacy rate of 95% with no vaccine-related, serious safety concerns. It also says that, based on the same data, the vaccine developed with German partner BioNTech has been approved in Britain, the United States, the European Union and Canada.

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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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"The data collected has been endorsed by various regulatory agencies (including the most evolved) and they have given EUA [based on] … that data," the firm said in an emailed response to questions, including on India's demand for a local trial.

"Given our exclusive priority to government supply, we look forward to a confirmation from the government on necessary supplies, [on the] basis [of] which we will take the regulatory process forward, as we have done across the world," it added.

Last week, government officials in some EU countries said Pfizer had slashed in half deliveries to them, causing frustration and hampering vaccination drives.

Indian officials have had discussions with both Pfizer and its U.S. rival Moderna Inc about making their shots in India, given its large pharmaceutical capacity.

However, India, the world's biggest vaccine maker, says it is mainly relying on shots already approved or tested at home to run its massive immunisation campaign that began on Jan. 16.

Pfizer said its current focus was on distributing the vaccine around the world using manufacturing capacity in the United States and Europe.

"Once the pandemic supply phase is over and we enter a phase of regular supplies, Pfizer will evaluate all additional opportunities available," it said.

Asked why it did not attend meetings called by the CDSCO, Pfizer said its officials had not been given enough notice.

"The company representatives have been unable to participate in previous meetings due to extremely short notices of a few hours or less and time-zone limitations," the company said.

"We remain committed to engaging with the Government of India to make this vaccine available for use by the government in the country."
Reuters
first published: Jan 25, 2021 08:56 pm

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