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Pfizer & Indian Government May Collaborate for Vaccine Availability in India

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The 90 percent efficacy of the COVID-19 vaccine created by US-based Pharma giant Pfizer and German Biotech company, BioNTech has ignited a ray of hope in many to defeat the virus after a long wait. In this scenario, the Indian government has also expressed its interest, as the Health Ministry has indicated that they are open to a dialogue with the vaccine manufacturer Pfizer.

“The National Expert Group on vaccines is in touch with both domestic and international manufacturers of all vaccines. We look at regulatory approvals for all vaccines. And also look at the resources they require for refrigeration. This is a continuously changing equation. As and when the approvals come and situation changes we will inform,” stated Rajesh Bhushan, Secretary in the Union Ministry of health. In the same line, Pfizer is in talks with the Indian government to sell its COVID-19 vaccine candidate, according to a company spokesperson who stated the same in an email response. “We remain committed to advance our dialogue with the government of India to make this vaccine available for use in the country,” the spokesperson said. The Pfizer spokesperson said it expects to produce up to 50 million doses in 2020 and up to 1.3 billion doses in 2021. “If our vaccine candidate is successful, Pfizer would allocate the available doses across the countries where we have fully executed supply agreements,” he said.

Pfizer does not have a distribution agreement so far with any firm in India. It also does not have a formal pact with Covax, the COVID vaccine access initiative of Gavi, the Vaccine Alliance and World Health Organization. Though India is yet to sign an agreement with Pfizer, the union health ministry indicated that they are open for talks. The vaccine would also have to go through India’s regulatory authority - the Drug Controller General India (DCGI) via clinical trials in the country before getting approval for mass manufacturing.

The biggest roadblock for the vaccine, like most other messenger RNA candidates, is it requires a storage temperature of within a range of -90°C to -60°C. In fact, the requirement for ultra-low temperature freezers, which is not available in India, is one of the reasons why the government is not enthused about procuring the vaccine, which is being developed by Pfizer and German partner BioNTech, a government official said seeking anonymity. However, the Pfizer spokesperson said that the company has developed detailed logistical plans and tools to support effective vaccine transport, storage and continuous temperature monitoring. “We have experience working with customers in all markets and have developed comprehensive solutions to partner with countries to help in the deployment of this vaccine,” he added.

India is keeping a close watch on the outcome of the trials of Russia’s Sputnik and University of Oxford’s Covishield vaccine candidates, even as the early data from Pfizer’s vaccine efficacy trial spurred sentiments across the globe. The interim efficacy data of both Sputnik and Covidshield are expected within a month.