Cleared in UK, Pfizer first in India to apply for emergency use

In its application to the drug regulator, Pfizer has sought permission to import the vaccine for sale and distribution in the country, besides waiver of clinical trials on Indian population in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019, official sources said.

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“Pfizer India has submitted an application on December 4 to the DCGI seeking emergency use authorisation (EUA) for its Covid-19 vaccine,” a source said. “The firm has submitted the EUA application in Form CT-18 for grant of permission to import and market Pfizer-BioNTech’s Covid-19 mRNA vaccine BNT162b2 in the country,” the source said, citing the application.

V K Paul, who chairs the high-level National Expert Group on Vaccine Administration, had earlier spelled out India’s strategy with respect to candidates like Pfizer and Moderna which have shown positive results in Phase III abroad but are not being tested here. “We know that doses of this vaccine (Pfizer) will not be available in huge quantities… If this vaccine candidate has to come, and if we require it, we are preparing ourselves… we have parallel plans,” Paul had said.

For the vaccine to be considered for use here, the Indian subsidiary of Pfizer will have to approach the regulator and share the data it has submitted to the UK regulator. “They can then ask for an approval and, accordingly, the regulator will take a decision,” an official had told The Indian Express.

The UK on Wednesday became the first country to approve the Pfizer/BioNTech vaccine against Covid-19, with the UK regulator Medicines and Healthcare products Regulatory Agency granting temporary authorisation for its emergency use. The British regulator said the jab, which claims to offer up to 95 per cent protection against COVID-19, is safe for roll-out.

Bahrain on Friday also announced that it has granted an EUA for the two-dose vaccine made by Pfizer and its German partner BioNTech. The pharma company has already applied to the US FDA seeking EUA for the vaccine.

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The extreme low temperature of minus 70 degrees Celsius required for storing the vaccine pose a big challenge for its delivery in a country like India, where maintaining such cold chain facilities would be very difficult, top government officials have said.

When contacted, Pfizer said it remains committed to engaging with the Government of India and exploring opportunities to make this vaccine available for use in the country. “During this pandemic phase, Pfizer will supply this vaccine only through government contracts based on agreements with respective government authorities and following regulatory authorisation or approval,” the global pharma major said in a statement.

Five vaccines are in advanced phases of clinical trials in India.

(with PTI)