COVID-19 Vaccines are in limited supply globally, and companies have their own priorities, game plans, and compulsions in allocating finite stocks
The Central Government has come out with a press release after various allegations were levelled against it concerning the vaccination process to fight the pandemic of COVID-19.
“Several myths on India’s Covid-19 vaccination program are doing the rounds. These myths are arising due to distorted statements, half-truths and blatant lies, a statement from PIB Delhi said in this connection.
Member (Health) in NITI Aayog and Chair of the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC), Dr Vinod Paul addresses, what the government calls, myths and gives out ‘facts’ on all these issues.
Concerning the allegation that Centre was not doing enough to buy vaccines from abroad, the government said that it 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. 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,” it said.
It added that 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 & 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,” the government stated.
On why Centre has not approved vaccines, which are available globally, the Central government contended that it 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,” it said.
On the allegation that Centre was not doing enough to ramp up domestic production of vaccines, it responded by saying that the Central Government is playing the role of an effective facilitator to enable more companies to produce vaccines from the early 2020.
“There is only 1 Indian company (Bharat Biotech) which has the IP. GoI has ensured that 3 other companies/plants will start production of Covaxin apart from enhancing Bharat Biotech’s own plants, which have increased from 1 to 4. Covaxin production by Bharat Biotech is being increased from under 1 Cr per month to 10 Cr month by October. Additionally, the three PSUs will together aim to produce up to 4.0 Cr doses by December,” the statement said.
Giving more details, it said that with constant encouragement of the Government, Serum Institute is ramping up Covishield production of 6.5 crore doses per month to 11.0 crore doses per month.
“GoI is also ensuring in partnership with Russia that Sputnik will be manufactured by 6 companies coordinated by Dr Reddy’s. The Union Government is supporting efforts of Zydus Cadila, BioE as well Gennova for their respective indigenous vaccines through liberal funding under Covid Suraksha scheme as also the technical support at national laboratories,” the government said.
It was given out that development of Bharat Biotech’s single dose intranasal vaccine is proceeding well with GoI funding, and it could be a game-changer for the world. “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. How many countries can even dream of such an enormous capacity, and that too across conventional as well as cutting-edge DNA and mRNA platforms? GoI and vaccine manufacturers have worked as one Team India in this mission with seamless engagement on daily basis.”
About why Centre was not invoking compulsory licensing, it said that the 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. 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?” it said in the statement.
Responding to the allegation that Centre has abdicated its responsibility to the states, the government said it 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. All this is very much in the knowledge of the states. 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. In fact, GoI ran the entire vaccine program from January to April & 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 decentralization,” the statement said.
Stating that health is a state subject & the liberalized vaccine policy was a result of the incessant requests being made by the states to give states more power, the government said that global tenders have not given any results which only reaffirms what they 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.
“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 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. 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,” it said while reacting to the accusation that Centre was not giving enough vaccines to the states.
About why the Centre is not taking any steps to vaccinate children given the prediction of a third wave, the government stated that no country in the world is giving vaccines to children.
“Also, WHO has no recommendation on vaccinating children. There have been studies about the safety of vaccines in children, which have been encouraging. Trials for children in India are also going to begin soon. However, vaccinating children should not be decided on the basis of panic in WhatsApp groups and because some politicians want to play politics,” the GoI said while adding that a decision in this regard will be taken by scientists after adequate data is available based on trials.