Govt, Pfizer are working together for the earliest possible import of vaccines: NITI Aayog's VK Paul

The central government has proactively eased entry of vaccines into India and waived off the requirement of conducting trials for the well-established vaccines manufactured in other countries, VK Paul, member (health), NITI Aayog said while urging international vaccine makers to come and make vaccines in India.

“Vaccines approved by USFDA, EMA, UK's MHRA and Japan's PMDA, and WHO's Emergency Use Listing vaccines will not need to undergo prior bridging trials,” Paul who is also chair of the national expert group on vaccine administration for COVID-19 (NEGVAC) said while addressing the several myths doing rounds in India in relation to Covid vaccines.

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

Stating facts about Centre’s initiatives to buy vaccines from abroad, Paul 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. Government offered all assistance to have them supply and or manufacture their vaccines in India,” Paul said.

According to Paul, vaccines are in limited supply globally and companies have their own priorities, game-plans and compulsions in allocating finite stocks. “As soon as Pfizer indicated vaccine availability, the central government and the company are working together for the earliest possible import of the vaccine,” he said.

Paul further said that it is the result of the government's efforts that 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. “We reiterate our request to all international vaccine makers to come and make in India – for India and for the world,” he said .

On domestic production of vaccines
The government and vaccine manufacturers have worked as one Team India in this mission with seamless engagement on a daily basis. “The estimate of production of over 200 crore doses by our vaccine industry by the end of 2021 is the result of such efforts and unstinted support and partnership,” he said, adding that along with private players the three PSUs will together aim to produce upto 4 crore doses by December.

On compulsory licensing
As per Paul, 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.

“Infact, we have gone one step ahead of compulsory licensing and are ensuring active partnership between Bharat Biotech and three other entities to enhance production of Covaxin,” he said, adding a similar mechanism is being followed for Sputnik.

On centre abdicating its responsibility to the states
“Health is a state subject and the liberalised vaccine policy was a result of the incessant requests being made by the states to give states more power. The fact that global tenders have not given any results only reaffirm what we have been telling the states from day one that vaccines are in short supply in the world and it is not easy to procure them at short notice,”Paul said.

According to Paul, 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,” he added.

On centre not giving enough vaccines to the states
Paul said the Centre 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 vaccine availability,” he said assuring that the vaccine availability is going to increase in near future and much more supply would be possible.

On centre is not taking any step to vaccinate children
“As of now, no country in the world is giving vaccines to children. Also, WHO has no recommendation on vaccinating children,” he said. According to Paul, trials in children in India are also going to begin soon. “However, vaccinating children has to be a decision taken by our scientists after adequate data is available based on trials,” he added.