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Pfizer says it told India there is no safety concern with its COVID-19 vaccine

Pfizer, which produces the COVID-19 vaccine with German partner BioNTech, reiterated that it would supply doses only through government contracts.

May 04, 2021 / 07:48 AM IST
Pfizer’s vaccine is based on genetic material or mRNA.

Pfizer’s vaccine is based on genetic material or mRNA.

Pfizer Inc said on Monday it told the Indian government that there was no concern over the safety of its COVID-19 vaccine, as the country insists on small local trials for foreign shots despite a record surge in infections and shortage of doses.

The government in mid-April made it easier for foreign vaccines approved in the West and Japan to sell in India, though companies would still have to initiate a local clinical trial within 30 days of receiving emergency use authorization. Previously, companies were required to do the trial prior to approval.

India has invited Pfizer, Johnson & Johnson and Moderna Inc to sell their vaccines to the country but none have applied to do so yet.

Pfizer, however, said it is holding fresh talks with the government after having withdrawn its initial application in February over the earlier local trial rule.

"Pfizer's application for emergency use authorization was supported with data that shows an overall efficacy rate of 95 percent with no safety concerns," a company spokeswoman told Reuters, when asked if it had sought an exception even to the current trial rule in its discussions with the government.

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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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She added that the safety and efficacy data had been backed by regulatory authorities in the United States, Britain, Japan and the World Health Organization – agencies that India endorses.

Pfizer, which produces the vaccine with German partner BioNTech SE, reiterated that it would supply doses only through government contracts.

Asked about the vaccine's ultra-low temperature storage requirements – minus 70 degrees Celsius (-90 F) – Pfizer said the company could deliver the shot to vaccination centers using its specially designed, temperature-controlled thermal shippers.

It said doses could be stored in ultra-low-temperature freezers for up to six months, in the shippers for up to 30 days by refilling them with dry ice every five days, or in common refrigeration and freezer units for five days.
Reuters
first published: May 4, 2021 07:48 am

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