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Pfizer seeks emergency licensure for mRNA vaccine from DCGI

Vials with a sticker reading, Premium
Vials with a sticker reading, "COVID-19 / Coronavirus vaccine / Injection only" and a medical syringe are seen in front of a displayed Pfizer logo in this illustration taken October 31, 2020. REUTERS/Dado Ruvic/Illustration/File Photo (REUTERS)

The US-headquartered firm is seeking permission to import the vaccine for sale and distribution in the country as well as skip a phase 3 bridging study

New Delhi: Pfizer became the first company to approach the Drug Controller General of India V.G. Somani to seek an emergency use authorisation for its messenger RNA vaccine, a source in the know said. The vaccine had shown robust efficacy data against covid-19 in a recently concluded US trial.

The US-headquartered firm is seeking permission to import the vaccine for sale and distribution in the country as well as skip a phase 3 bridging study, the source said.

Under clinical trial rules, a company can seek an import license for a drug not approved in India if it has been approved in by a prominent regulator of another country.

Last week, the UK Medicines & Healthcare Products Regulatory Agency (MHRA) became the first regulator to grant a temporary authorisation for use of the covid-19 mRNA vaccine, which Pfizer has co-developed with German company BioNTech.

The EUA followed a worldwide Phase 3 trial of a vaccine, involving over 40,000 participants, which demonstrated a vaccine efficacy rate of 95% seven days after the second dose. The second and final dose is given 21 days after the first dose.

In its statement, a spokesperson for Pfizer said that the company “remains committed to engaging with the Government of India and explore opportunities to make this vaccine available for use in the country". However, the spokesperson did not comment on whether it has sought an EUA for import and distribution, as well as waiver on the clinical trial.

DCGI Somani also did not reply to messages or calls seeking comment on the application by Pfizer.

A crucial bottleneck cited by government officials of the vaccine is its storage temperature of -70°C, which requires ultra-low-temperature freezers and do not exist in India.

However, the company said that it has developed solutions which would make it feasible for transport to the country, and then it would require last mile delivery at normal refrigerator temperatures of 2 to 8 degree Celsius.

“The Pfizer specially-designed, temperature-controlled thermal shippers, in which doses will arrive, that can be used as temporary storage units. The shipper can maintain the recommended storage condition -70°C±10°C for 10 days unopened which allows for transportation globally to ensure all patients have access. Once opened, and if being used as temporary storage by a vaccination centre, then it can be used for a total of 30 days with re-icing every five days," the spokesperson said.

The spokesperson added that the vaccine can be stored for five days at refrigerated 2-8°C conditions, adding that it will utilise GPS-enabled thermal sensors in every thermal shipper that will enable us to track their location and temperature across their pre-set routes..

However, despite the assurances, government officials have not appeared keen on using Pfizer’s mRNA vaccine for mass vaccinations due to its logistical and financial challenges.

Pfizer has priced the vaccine at $19.5 per dose ( 1,440) in the US after a deal with the country’s government under Operation Warp Speed.

This is around six times the $3 per dose that Serum Institute of India plans to charge for the vaccine from COVAX and the Indian government. The company plans to sell the vaccine, originally developed by the University of Oxford and AstraZeneca plc, at 500-600 per dose.

Serum Institute of India’s vaccine, branded ‘Covishield’, can be stored at 2 to 8 degree Celsius, and the company also plans to approach the DCGI this month, with an emergency licensure expected as early as the end of this month.

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