Pfizer Seeks India Approval For Covid Vaccine, First To Do So: Sources

American pharma giant Pfizer has sought approval from the country's drug regulator - the DCGI (Drugs Controller General of India) - for emergency use authorisation of its coronavirus vaccine, say sources. The vaccine is ready to be rolled out in the United Kingdom and Bahrain. This is the first such request received by the DCGI amid the race to find a vaccine for the deadly virus, which has affected over 96 lakh people in India.

The drug regulator may give emergency approval if it is satisfied by the results of the trials conducted outside India, sources have added.

On Wednesday, the United Kingdom became the first western country to clear the Covid-19 shot developed jointly by Pfizer and German biotechnology partner BioNTech, which has reported an efficiency of 95 per cent in the third stage of trials.

In its application submitted on Friday, Pfizer India 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," sources have been quoted as saying by news agency PTI.

The DCGI has "discretionary power to waive localised clinical trials for a vaccine", officials say. "Pfizer's CT-18 application for grant of permission to import new drug (Covid vaccine) for sale in India is under process. As per New Drugs and Clinical trials Rules 2019, the application has to be decided within 90 days," sources told NDTV.

A spokesperson from the pharma firm said: "Pfizer is dedicated to ensure the availability of this vaccine for use by governments across the world. During this pandemic phase, Pfizer will supply this vaccine only through government contracts based on agreements with respective government authorities and following regulatory authorization or approval. We remain committed to engaging with the Government of India and explore opportunities to make this vaccine available for use in the country."

However, experts have been raising concerns about the logistical issues linked to the distribution of this vaccine, which needs to be stored at a temperature of minus 70 degrees Celsius. Most vaccines in India can be stored at temperatures between 2 and 8 degrees.

Pfizer told NDTV in a statement that it has "developed detailed logistical plans and tools to support effective vaccine transport, storage and temperature monitoring" and will be using different options for storage, ranging from temperature-controlled thermal shippers to refrigeration units that are commonly available in hospitals. It also said that the pricing of the vaccine will depend on the doses ordered and the advance commitments with the government.

The drug regulator recently approved three drugs - Favipiravir, Itolizumab and Remdesivir - for 'restricted emergency use' for treating coronavirus.

Dr D Roy, Former Deputy Drugs Controller, Central Drugs Standard Control Organization, today told NDTV, "Recently antiviral drug - Favipiravir - was allowed in India for Covid-19 on emergency use basis. So vaccines can also be approved for emergency usage. Prior consent of each individual who is being vaccinated will be must."

In November, NITI Aayog member (Health) Dr VK Paul, who also heads the National Task Force on COVID-19, said sufficient doses of the Pfizer vaccine, as required for the Indian population, will not be available, but the government is looking at the possibilities and will work out a strategy for its procurement and distribution in case it gets the regulatory approvals.

Elaborating on various aspects, Dr Rommel Tickoo, Associate Director, Internal Medicine, Max Healthcare today said: "Emergency use authorisation does not mean there will be no trials at all. Usage will start in a restricted way on one end but in a parallel way the trials will also start simultaneously. As far as resources are concerned, we might have a challenge when it comes to rural areas but bigger cities already have advanced facilities and India has decades of experience with inoculation programmes. If we can vaccinate even if a fraction of the population, especially our frontline workers, then its good."

Across India, "three indigenous vaccines are already in the final stages of trial", Prime Minister Narendra Modi on Friday. "Vaccines for COVID are likely to be ready within few weeks. Indian health agencies and manufacturers are working in tandem with global agencies. We are fully prepared for the roll out," he said after an all-party meet.

(With inputs from PTI)