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Saturday, June 12, 2021

Some Pfizer doses could come in July, but no call on indemnity request: Govt

The Indian drug regulator has not granted indemnity against the costs of compensation for severe side effects to the manufacturers of any of the three Covid-19 vaccines to which it has issued emergency use authorisation (EUA).

Written by Kaunain Sheriff M | New Delhi |
Updated: May 28, 2021 1:09:18 pm
Israel sees probable link between Pfizer vaccine and myocarditis casesCOVID-19 vaccine developed by Pfizer and BioNTech. (File)

The head of the country’s Covid-19 Task Force on Thursday said that Pfizer has indicated that it would be able to make available a “certain amount” of its mRNA Covid-19 vaccine to India, “possibly starting in July”.

However, the government is still examining the American pharma giant’s request for indemnity against the cost of compensation for any severe side effects, Dr V K Paul said.

The ongoing discussions with Pfizer are also taking place around issues related to the cold chain, as the vaccine — developed by Pfizer along with the German biotechnology company BioNTech — requires ultra-low temperatures during transport and storage, he said.

“Yes, we are engaged with Pfizer because they have indicated availability of a certain amount and volume of vaccines in the coming months, possibly starting in July.

“We are looking at what Pfizer’s expectations from the government are, and they are looking at what our expectations from them are. That is the process in which it will move because they have to come into India; they have to apply for licensure, that is one part…

“There are imperatives of the cold chain that are being looked at,” Dr Paul, who also heads the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC), said.

The Indian drug regulator has not granted indemnity against the costs of compensation for severe side effects to the manufacturers of any of the three Covid-19 vaccines to which it has issued emergency use authorisation (EUA).

However, Pfizer, which has received EUA in several countries, obtained indemnity before rolling out its vaccine. “…They have requested indemnity from all nations. It is their expectation that liability should be indemnified. They have expressed this in legal language. We are examining this request and we will take a decision in the larger interest of the people and on merits. This is under discussion, but there is no decision as of now,” Paul said.

Hours before he made these statements at the media briefing, Paul had issued a separate, written statement on “Myths & Facts on India’s Vaccination Process”.

“Myth 1”, the statement said, was that “Centre is not doing enough to buy vaccines from abroad.” However, the statement said, “The Central Government has remained engaged continuously with all the major international vaccine manufacturers right from mid-2020. Multiple rounds of discussions have happened with Pfizer, J&J & Moderna. The government offered all assistance to have them supply and /or manufacture their vaccines in India. However, it is not that their vaccines are available in free supply.”

“We need to understand that buying vaccines internationally is not similar to buying ‘off the shelf’ items. Vaccines are in limited supply globally, and companies have their own priorities, game-plans and compulsions in allocating finite stocks. They also give preference to countries of their origin just as our own vaccine makers have done unhesitatingly for us,” Paul said in the statement.

At the media briefing, Paul was asked whether any vaccine manufacturer had cited “preference to countries of their origin” as the reason to deny vaccines to India.

Paul replied: “The context of that observation is that the vaccines developed in other countries, a large part of those vaccines were supplied to the same country. The US-made vaccines went in a big way to the US; that was taken for them as a priority. This is nothing surprising because when we look upon our vaccine manufacturers, they also unhesitatingly offered the vaccines to our nation.”

However, “Now that the vaccine availability for the country of origin has been met to a large extent, and their own production capacities are rising because they are aware of the market and the success of the vaccine, there will be vaccine for others to take, partly through Covax and partly through bilateral arrangements,” Paul said.

“Myth 2”, the written statement said, was that “Centre has not approved vaccines available globally.”

In fact, “The Central Government has proactively eased entry of vaccines approved by US FDA, EMA, UK’s MHRA and Japan’s PMDA, and WHO’s Emergency Use Listing into India in April. These vaccines will not need to undergo prior bridging trials,” the statement said.

“The provision has now been further amended to waive off the trial requirement altogether for the well-established vaccines manufactured in other countries. No application of any foreign manufacturer for approval is pending with the drugs controller.”

“Myth 4”, according to the written statement, was that the “Centre should invoke compulsory licensing”.

To this, Paul said in the statement: “Compulsory Licensing is not a very attractive option since it is not a ‘formula’ that matters, but active partnership, training of human resources, sourcing of raw materials and highest levels of bio-safety labs which is required.

“Tech transfer is the key and that remains in the hands of the company that has carried out R&D. In fact, we have gone one step ahead of Compulsory Licensing and are ensuring active partnership between Bharat Biotech & 3 other entities to enhance production of Covaxin.”

The statement added: “Similar mechanism is being followed for Sputnik. Think about this: Moderna had said in October 2020 that it will not sue any company which makes its vaccines, but still not one company has done it, which shows licensing is the least of the issues. If vaccine-making was so easy, why would even the developed world be so short of vaccine doses?”

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