Price, capacity key areas as Pfizer files for licence in India

India is yet to discuss the pricing of the Pfizer/BioNTech vaccine and the ability of the company to deliver orders placed by the country even as the Central Drugs Standard Control Organization or CDSCO reviews the emergency authorisation sought by the vaccine developer.

A senior government official said there will be a negotiation on the price and availability after the vaccine is approved for use in India. This person pointed to the vaccine’s $20 price tag in the US and compared it with the $3-4 at which the AstraZeneca/Oxford vaccine being made locally by the Serum Institute of India will be available.

A second office confirmed this. “(The) Pfizer (vaccine) not only poses a major logistical challenge as it has to be stored at Antarctic temperatures but it also carries a hefty price tag. There is scope of negotiation.”

The company has struck a deal with the EU for $18.34 a dose, the second person added.

The mRNA vaccine was approved for use by the UK last week and may be approved by the US this week. Regulatory approvals can be sought in geographies other than those where clinical trials are carried out, presenting detailed trial data.

There is another problem with the Pfizer/BioNTech vaccine though: supply.

“If they get the emergency authorisation, they need to tell us how they will provide the required vaccine,” said the first official.

Neither official wished to be identified.

While the EU has booked 200 million doses from Pfizer, India will require 580 million doses for 290 million people or the first three priority groups comprising health workers, frontline staff and old people with co-morbidities. These three groups are expected to be administered vaccines between January and July 2021.

Pfizer also has deals with the US, UK, and Japan.

“The government is looking at a bouquet of vaccines for immunising Indian population. While our focus remains on Made in India vaccines, we have not shut our doors to imported ones,” said the first official.

To be sure, the only locally made vaccine anywhere close to being approved is the SII-manufactured AstraZeneca/Oxford one.

Still, discussions on pricing and supply will have to wait till the CDSCO, headed by Drugs Controller General Dr VG Somani goes through the company’s filings. He may even seek a virtual meeting with Pfizer for clarifications.

The company has submitted detailed data from its trials to the Indian authorities.

“But it too, didn’t come easily,” pointed out the first official. “Pfizer had insisted on a non-disclosure agreement with the Union government. As a sovereign country, we sign such pact with a company that too, a US-based one, so we had to ask an agency under biotechnology department to sign the non-disclosure pact.”

According to top-line data released by Pfizer, its vaccine has 95% efficacy.

Russia’s Gamaleya Center too, extracted a similar promise for secrecy while sharing trial data for its Sputnik V vaccine.

By Hindustan Times

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