Pfizer ready to give India 5 cr vaccine doses in 2021, wants significant regulatory relaxations

Moderna is expecting to launch a single-dose Covid-19 vaccine in India next year and is in talks with Cipla among other Indian firms, while another US giant Pfizer is ready to offer five crore shots in 2021 itself, but it wants significant regulatory relaxations including indemnification, sources said on Tuesday. While Moderna has conveyed to Indian authorities that it does not have surplus vaccines to share in 2021, there are limited prospects of Johnson & Johnson exporting its jabs from the US to other countries in the near future, the sources privy to discussions added.

Two rounds of high-level meetings chaired by the Cabinet Secretary were held last week on the availability of vaccines in the global as well as domestic markets as it was felt that there is an urgent need to procure the jabs at a time the country is reeling under an unprecedented second wave of Covid-19 and a widening gap between supply and requirement.

Currently, the country is using two 'made-in India' jabs -- Covishield and Covaxin -- to inoculate its billion-plus population and has administered 20 crore doses since launching the world's largest vaccination drive in mid-January.

A third vaccine, Russian-made Sputnik V, has been approved by the government and is being used on a smaller scale at present.

In the high-level meeting, officials from the Ministry of External Affairs, NITI Aayog, Department of Biotechnology, Law Ministry and Health Ministry were present.

It was discussed that Moderna doesn't have surplus vaccines to share in 2021 and that it plans to launch its single-dose vaccine for the Indian market only in 2022, for which, they are in discussion with Cipla and other Indian companies, a source said.

It is learnt that Cipla has already evinced interest in procuring 5 crore doses from Moderna for 2022 and has requested confirmation from the central government in respect of stability in regulatory requirements/policy regime.

The Health Ministry has also been asked to take an early decision on Cipla's request regarding support required by them for procurement of Moderna vaccines.

In the case of Pfizer, the US pharma giant has indicated availability of 5 crore vaccine doses -- 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 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 channelisation 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.

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