New Delhi: The Government of India hasn’t received any requests or applications for the conduct of phase III clinical trials of the Russian Covid-19 vaccine Sputnik V, and the vaccine also didn’t figure in the deliberations of the National Expert Group on Vaccine Administration for coronavirus that took place Wednesday, ThePrint has learnt.
However, the central government is trying to obtain data about the safety and efficacy of the vaccine using “alternate channels”, top sources in the government told ThePrint.
“While we do not want to comment on claims made by others, what is a fact is that nobody has so far approached the Government of India or the Drug Controller General of India, which is the competent authority for giving permissions for trials, to conduct a phase III (trial) in India of the Sputnik V,” said a senior government official on condition of anonymity.
“However, now that an announcement has been made about the vaccine, we are looking at accessing some of that data on safety and efficacy through alternate channels,” added the official.
Russia earlier this week came out with the world’s first Covid vaccine Sputnik V, and among its first recipients was one of the daughters of President Vladimir Putin. Mass production of the vaccine is set to start by September.
The Sputnik V website says: “RDIF (Russian Direct Investment Fund) sees strong global interest in the vaccine and plans to conduct Phase III clinical trials in different countries, including Saudi Arabia, UAE, Brazil, India and the Philippines, and start mass production in other countries in partnership with local sovereign wealth funds, including India, South Korea and Brazil, as well as in Saudi Arabia, Turkey and Cuba. The plan is to ramp up the vaccine production to 200 million doses by the end of 2020, including 30 million doses in Russia.” The RDIF is financing the production.
Expert Group not looking at Sputnik V
Sources in the government told ThePrint that during the deliberations of the National Expert Group on Vaccine Administration Wednesday, it looked at all vaccines that are in Phase II or III trials.
These include the vaccines from Oxford University being manufactured in India by Serum Institute of India (SII), the indigenous Indian vaccines of Bharat Biotech and Zydus Cadila, the one from Moderna and two Chinese ones.
However, in the list of vaccines that the group was looking at, Russia’s Gamalaya Institute vaccine is still marked to be in Phase I.
“This is probably because they have not shared the safety and efficacy data with WHO so far. The expert group is looking at only those vaccines, which are in Phases II or III,” said a member of the group.
Meanwhile, there is increasing clarity in the government that the first vaccine to be released in India may not be an indigenous one at all. It will most likely be the vaccine developed by Oxford University and manufactured by the Pune-based Serum Institute, said sources.
“They are three months ahead of us (the two Indian vaccines). We are expecting to see the results of the Phase III trials of the Oxford vaccine before the year ends. There is also clarity about the dosage and price, unlike the others. For the Indian versions, there are some internal reference points on pricing but they are still in Phases I and II. So it is unlikely that they can beat the Oxford one,” said a second senior government official.
Two doses of the Oxford/SII vaccine need to be administered, but whether it will be yearly or not is still not clear as it has not yet been a year since the trials started.
For the indigenous vaccines, there is no clarity yet on how many doses will be needed, officials said.
The Covid vaccine developed by Oxford University uses the spike protein of the SARS-COV-2 to trigger an immune response in the body, using a chimpanzee common cold virus as a vector. The vaccine, Covishield, is currently in phase III trials in several countries, including Brazil and South Africa.
The Serum Institute of India has just got clearance for a 1,600-participant phase III trial in India for Covishield.
The SII has entered into a partnership with Gavi, the Vaccine Alliance and the Bill & Melinda Gates Foundation to accelerate the manufacture and delivery of up to 100 million doses of the vaccine for India and low and middle-income countries.
Availability key to access
Sources in the government also clarified that while there have been multiple discussions on who will get the vaccine first, the key question is the availability of the vaccine.
In the meeting on 30 June of the National Expert Group, chaired by Prime Minister Narendra Modi, he had laid down four “guiding principles” on vaccines.
“First, vulnerable groups should be identified and prioritised for early vaccination, for example doctors, nurses, healthcare workers, non-medical frontline Covid warriors, and vulnerable people among the general population. Second, that vaccination of ‘anyone, anywhere’ should take place, i.e. without imposition of any domicile related restrictions for getting the vaccine.”
“And third, that vaccination must be affordable and universal — no person should be left behind; and fourth, that the entire process from production to vaccination should be monitored and supported in real time with the use of technology,” according to a government statement of that day.
The second government official explained that there are currently two options on vaccine access, but that is linked to whether it is an Indian or a foreign vaccine.
“We can look at either giving it to frontline workers and health staff first or we could give it to people with comorbidities. The strategy will depend on how much vaccine we get. If millions and millions of doses are available, we can cover many groups. But if limited amounts are available — which is possible if we are looking at the Oxford vaccine — we will need to rationalise. There again we have no clarity,” said the official.
The other concern is the mode of administration. Most vaccines now are intramuscular injections and, therefore, they will need to be given by trained people.
The Moderna vaccine is an IV injection that requires higher skill levels.
“We are talking about a long period of time. If an oral or a nasal version comes, there will be a lot of easing out,” the official added.