Pfizer may make its vaccine in India if assured faster clearance: Report

Pfizer was the first company to apply for emergency use authorisation in India

pfizer-vaccine-covid-19-vaccine-reuters FILE PHOTO: A woman holds a small bottle labelled with a "Coronavirus COVID-19 Vaccine" sticker and a medical syringe in front of displayed Pfizer logo in this illustration taken, October 30, 2020 | REUTERS/Dado Ruvic/File Photo

The Pfizer vaccine against COVID-19 may yet make its way to India. The US-based company, Pfizer Inc, has told the government it would be willing to produce its vaccine locally in India if it was assured of faster regulatory clearance as well as freedom on pricing and exports, Reuters reported sources saying.

Last month, the company withdrew its application for emergency use clearance of its COVID-19 vaccine, developed with Germany’s BioNTech SE, in India after the DGCI declined its request to skip a local safety trial.

“U.S. companies want to produce vaccines in India under joint ventures,” Reuters quoted a source as saying, citing Pfizer and fellow U.S. drugmaker Moderna Inc.

“They want faster approvals for clinical trials and emergency authorisation use. They fear the government will introduce price control policies.”

At present, only two COVID-19 vaccines have been approved for use in India: The Oxford-AstraZeneca ‘Covishield’ vaccine made by the Serum Institute of India, and the Bharat Biotech Covaxin.

The successful deployment of the Pfizer vaccine in Israel, where it was used to inoculate the majority of the country;’country’s population, helped the nation emerge from lockdown. The Israel case was considered the vaccine’s biggest “real-world” test and showed that it was 92 per cent effective at preventing severe disease after two shots and 62 per cent after one.

One of the biggest hurdles to deploying the Pfizer vaccine in India was its ultra-cold freezer storage requirements, which would be difficult to implement in India given the current cold-chain capacity. However, the US FDA recently reviewed data submitted by both Pfizer and Moderna showing the stability of their vaccines at normal freezer temperatures (-25°C to -15°C) and said it could be stored at these temperatures for up to two weeks at a time.

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