Price and capacity, key areas as Pfizer applies for license in India
India is yet to discuss the price of the Pfizer / BioNTech vaccine and the company’s ability to deliver the orders placed by the country, even as the Central Standard Drug Control Organization or CDSCO reviews the emergency authorization requested by the developer of the vaccine.
A senior government official said there will be a negotiation on price and availability after the vaccine is approved for use in India. This person pointed to the $ 20 price tag for the vaccine in the US and compared it to the $ 3-4 price that the AstraZeneca / Oxford vaccine will be available for locally manufactured by the Serum Institute of India.
A second office confirmed it. “(The) (vaccine) Pfizer not only poses a great logistical challenge, since it has to be stored at Antarctic temperatures, but it also comes at a high price. There is room for negotiation. “
The company has reached an agreement with the EU for $ 18.34 a dose, added the second person.
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 searched in geographies other than those where clinical trials are conducted, presenting detailed trial data.
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However, there is another problem with the Pfizer / BioNTech vaccine: supply.
“If they get emergency clearance, they must tell us how they are going to provide the required vaccine,” said the first official.
None of the officials wanted to be identified.
While the EU has reserved 200 million doses of Pfizer, India will require 580 million doses for 290 million people or the top three priority groups comprising healthcare workers, front-line staff and older people with comorbidities. These three groups are expected to receive vaccinations between January and July 2021.
Pfizer also has agreements with the US, UK and Japan.
“The government is studying a set of vaccines to immunize the Indian population. While our focus continues to be Made in India vaccines, we have not closed our doors to imported ones, ”said the first official.
Without a doubt, the only locally made vaccine that is close to being approved is the AstraZeneca / Oxford one made by IBS.
Still, pricing and supply discussions will have to wait until the CDSCO, led by the Comptroller General of Drugs, Dr. VG Somani, reviews the company’s files. You can even seek a virtual meeting with Pfizer for clarification.
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The company has submitted detailed data from its trials to the Indian authorities.
“But it wasn’t easy either,” said the first official. “Pfizer had insisted on a nondisclosure agreement with the Union government. As a sovereign country, we signed that pact with a company that is also based in the US, so we had to ask an agency of the biotechnology department to sign the nondisclosure pact. “
According to first-line data published by Pfizer, its vaccine is 95% effective.
Russia’s Gamaleya Center also obtained a similar promise of secrecy by sharing test data for its Sputnik V vaccine.