PremiumRefuting allegations of delay in importing covid-19 vaccines, the central government on Thursday clarified that it has remained engaged continuously with all the major international vaccine manufacturers --Pfizer, J&J and Moderna right from mid-2020.
In strong defence to its covid-19 vaccine procurement policy, Dr Vinod Paul Member (Health) in NITI Aayog and Chair of the National Expert Group on Vaccine Administration for covid-19 (NEGVAC) issued a statement titled--Myths and Facts on India’s Vaccination Process in which he said that multiple rounds of discussions have happened with Pfizer, J&J and Moderna.
“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," the statement said.
The government further asserted that 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.
“As soon as Pfizer indicated vaccine availability, Central Government and the company are working together for the earliest possible import of the vaccine. As a result of GoI’s efforts, Sputnik vaccine trials got accelerated and with timely approval, Russia has already sent two tranches of vaccines and accomplished tech-transfer to our companies that would start manufacturing very soon," the statement said.
The central government has also been drawing flak for initially not approving vaccines available globally after it had asked Pfizer and all other foreign vaccine manufactures to undergo a bridging trial, if they want to introduce their vaccines in India. Clarifying its move, Paul in the statement said that 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 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," the statement said.
Further on debate on if Centre should invoke compulsory licensing, the NITI Aayog member stated that it 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 and 3 other entities to enhance production of Covaxin. 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?, “ the statement said.
On criticism of decentralising its vaccine policy and giving states the power to bargain with the vaccine manufacturing companies, Paul said that the Central Government is doing all the heavy-lifting, from funding vaccine manufacturers to giving them quick approvals to ramping up production to bringing foreign vaccines to India.
“The vaccine procured by the Centre is supplied wholly to the states for free administration to people. GoI has merely enabled states to try procuring vaccines on their own, on their explicit requests. The states very well knew the production capacity in the country and what the difficulties are in procuring vaccines directly from abroad," the statement said adding that in fact, GoI ran the entire vaccine program from January to April and it was quite well-administrated compared to the situation in May. But states, who had not even achieved good coverage of healthcare workers and frontline workers in 3 months wanted to open up the process of vaccination and wanted more decentralisation.
Amidst states’ complaints on shortage of vaccines and the Centre is not giving enough vaccines to the states, Paul said that the central government is allotting enough vaccines to the states in a transparent manner as per agreed guidelines. In fact, states are also being informed in advance of the vaccine availability. “Vaccine availability is going to increase in near future and much more supply would be possible. In the non-GoI channel, states are getting 25% of the doses and private hospitals are getting 25% doses," said the statement.
“However, the hiccups and issues faced by the people in the administration of these 25% doses by the states leave a lot to be desired. The behaviour of some of our leaders, who in spite of full knowledge of the facts on vaccine supply, appear on TV daily and create panic among the people is very unfortunate. This is not the time to play politics," the statement said.
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