Vaccine has ‘potential’ to be part of India’s Covid response: Pfizer

PT Jyothi Datta Mumbai | Updated on November 11, 2020

Pfizer’s vaccine candidate is yet to get approval   -  DADO RUVIC

As countries scramble to get the Pfizer-BioNTech Covid-19 vaccine candidate for its citizens, the American company has said that its vaccine “has the potential” to be part of India’s arsenal to deal with the coronavirus.

Earlier this week, an upbeat Pfizer had revealed that its Covid-19 vaccine candidate had shown 90 percent efficacy, in an interim analysis from late-stage clinical trials. And while more data is expected later this month, the UK and the European Union, among others, have set about procuring the still-to-be-approved vaccine.

Scientific voices have said that the vaccine could be out of bounds for India, given among other things, the distribution challenges Pfizer is likely to face even in its home-base, as the vaccine needs a -70oC cold-chain.

A Pfizer spokesperson clarified that its vaccine candidate, if successful, “certainly has the potential to be an important part of India’s early vaccine response to the pandemic in priority geographies and populations.”

“Once we have a go-ahead from the government, we work with the regulatory authorities to determine the regulatory pathway required for deployment in India as well,” the spokesperson said.

In fact, about 42 per cent of the 43,358 participants in Pfizer’s Phase-III studies are from diverse backgrounds. The company will be making this data available to governments across the world to seek regulatory approvals, it added.

“We remain committed to advance our dialogue with the government to make this vaccine available for use in the country,” the spokesperson added.

Supply agreements

Pfizer had earlier announced that it expected to produce up to 50 million vaccine doses in 2020 and 1.3 billion doses in 2021. And if it has a successful product, it would be allocated to countries where it has existing supply agreements.

Other Covid-19 vaccine-candidates like that from the AstraZeneca-Oxford University combine or Russia’s Sputnik V have aligned with Indian companies like Serum Institute and Dr Reddy’s Laboratories, respectively for production or clinical trials, as the case may be.

Pfizer, however, said its immediate priority was to ensure rapid manufacturing and deployment of the vaccine to cater to a pandemic response scenario. “We are also mindful of the unique mRNA technology that is being utilized in this vaccine. Given these considerations, Pfizer has created two dedicated supply lines with established vaccine capabilities—– one each in US and Europe — to exclusively manufacture this vaccine for use across the world,” the company said.

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

Companies have undertaken “at risk” production of their vaccine-candidates in anticipation that it would make the cut. But public health advocates have cautioned that “vaccine nationalism” could result in effective vaccines not reaching those who need it, especially in economically-weaker countries.

Pfizer said it was committed to ensure the availability of this vaccine for use by governments across the world. “We seek to work with governments to support distribution to their defined priority groups,” the spokesperson said.

Published on November 11, 2020

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