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Pfizer in talks with govt to expedite vaccine delivery, donates $70 million worth COVID-19 drugs to India

Last month, the pharmaceutical major had offered a not-for-profit price for its COVID-19 vaccine for the Indian government's immunisation programme.

May 03, 2021 / 03:09 PM IST
Pfizer’s vaccine is based on genetic material or mRNA.

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

Global pharma major Pfizer is in talks with the Indian government to establish an expedited approval pathway to make Pfizer-BioNTech vaccine available for use in the country, the company's Chairman and CEO Albert Bourla said on May 3.

"Pfizer is aware that access to vaccines is critical to ending this pandemic. Unfortunately, our vaccine is not registered in India although our application was submitted months ago. We are currently discussing with the Indian government an expedited approval pathway to make our Pfizer-BioNTech vaccine available for use in the country," Bourla said in a mail sent to Pfizer India employees.

Last month, the pharmaceutical major had offered a not-for-profit price for its COVID-19 vaccine for the Indian government's immunisation programme. "We continue to be in discussions with the government and remain committed to make our vaccine available for deployment in India’s immunisation programme,” a Pfizer company spokesperson had told Moneycontrol.

The drug manufacturer had also said its priority would be to exclusively support governments by supplying its vaccine only to governments for their immunisation programmes.

In February, the company had withdrawn an application for emergency-use authorisation (EUA) of its COVID-19 vaccine in India, after failing to meet the drug regulator’s demand for a local safety and immunogenicity study.

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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But circumstances have changed now, with Pfizer becoming eligible to directly seek EUA from the Drugs Controller General of India (DCGI) to import its COVID-19 vaccine, as the government recently waived the requirement of submitting local bridge trial data upfront for vaccines approved by the USFDA, European Medicines Agency (EMA), UK MHRA, PMDA Japan or those listed with the WHO under Emergency Use Listing. All these regulatory agencies have approved the Pfizer vaccine.

In his mail, Bourla also said Pfizer would be sending medicines worth $70 million (over Rs 510 crore) to India from its distribution centres in the US, Europe and Asia. These are medications that have been identified as part of India''s COVID-19 treatment protocol.

"We are deeply concerned by the critical COVID-19 situation in India, and our hearts go out to you, your loved ones and all the people of India," he said in the mail, which he has shared on his post.

"We are donating these medicines to help make sure that every COVID-19 patient in every public hospital across the country can have access to the Pfizer medicines they need free of charge," Bourla said.

These medicines, valued at more than $70 million, will be made available immediately, and "we will work closely with the government and our NGO partners to get them to where they are needed most," he added.
Moneycontrol News
first published: May 3, 2021 12:19 pm