Vaccine / Pfizer offers 5 cr vaccine doses to India with pre-conditions: Report

Pfizer is ready to offer 5 crore doses of its COVID-19 vaccine between July and October this year to India, PTI reported citing sources. However, the company reportedly wants regulatory relaxations, including indemnification, and it will deal only with the government. Meanwhile, Moderna plans to launch its single-dose vaccine for the Indian market only in 2022, the report said.

Vikrant Shekhawat : May 26, 2021, 09:52 AM
New Delhi: Top American pharma companies Pfizer and Moderna have offered their respective COVID-19 vaccines to India at a time when the country is trying to ramp up its indigenous production of anti-Coronavirus jabs. As per PTI sources, Pfizer is ready to offer 5 crore COVID-19 vaccine shots this year, however, it has set a pre-condition. Pfizer has sought significant regulatory relaxations in India including indemnification, sources say.

According to the reports, Pfizer, the US pharma giant has indicated availability of 1 crore in July, 1 crore in August, 2 crore in September and 1 crore in October –for supply to India in 2021 and that it will deal only with the Government of India and payment for vaccines will have to be made by GOI to Pfizer India.

The central government will make its own arrangement for further channelization of procured vaccines in the domestic market.

According to another source, for the supply of vaccines to India, Pfizer has asked for indemnification from the Government of India and a document in this regard has been received from Pfizer Inc.

Further, Pfizer has also sought certain relaxations in the regulatory regime, including relaxation in the requirement of post-approval bridging trials and dispensing the requirement of testing their vaccines in CDL (Central Drugs Laboratory).

Taking into consideration the track record of the company, similar arrangements done with other countries in the world and the current pandemic situation, an overall view may be taken to indemnify the company by the government, officials said but flagged that in case a view is taken to indemnify the company, similar demands may be made by other companies.

As per the information furnished by Pfizer, around 116 countries in the world including the USA have signed the indemnification document.

Further, considering that over 14.7 crore doses of Pfizer had been administered worldwide without any significant reports of adverse effects, a view needs to be taken to indemnify the company in order to supplement the availability of vaccines in India, officials discussed at one recent meeting.

It was suggested that a decision on the issue of Pfizer Inc may be taken at the earliest and that NEGVAC (National Expert Group on Vaccine Administration for COVID-19) may hold a meeting immediately on these issues.

At a press conference on Monday, in response to a question on states being unable to procure vaccines directly from Moderna and Pfizer, Health Ministry Joint Secretary Lav Agarwal had said, “Whether it is Pfizer or Moderna, at the Centre-level, we have been coordinating with them.”

“Also, the order book of both Pfizer and Moderna is full so it depends on their surplus that how much they can provide in India… they will come back to the Centre and we will help in facilitation to states,” he said.