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With Fresh COVID Vaccine Guidelines, States Now Free to Talk to Global Manufacturers Directly

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Representative image

The central government has allowed open market and private players in the vaccination process, but everyone will have to register on the CoWin app.

Following the government announcement that vaccination will open up for all Indian citizens above the age of 18 from May 1, 2021, few important questions have been raised. The first question is, how will the vaccination happen, logistically, and more importantly, how will we have enough vaccines for everyone? Few have also been concerned about what happens to the priority group after everyone is allowed to get vaccinated.

With outbreaks in various states, and severe demand for vaccines from several quarters, the central government has opened up vaccination for everyone above 18 so that various states are allowed to vaccinate the group(s) they feel appropriate from May 1. They can purchase the vaccines directly from the manufacturers, who are allowed to release up to 50 per cent of their supply at a ‘pre-declared price’ to the states.

States are also free to talk to international players following the current guidelines. If a vaccine, that has not been evaluated among Indians, is put in the Indian market, it is imperative that the first 100 patients will have to be very closely monitored. Following this, as the emergency use authorization is given to that particular vaccine, the states will also have to concurrently run a bridging trial.

However, as far as the central government is concerned, all those above the age of 45 still form the priority group, and they will continue to receive vaccination from the central government, to reduce the burden on the healthcare system, and save more lives.

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Even though the central government has allowed open market and private players in the vaccination process, everyone will have to register through the CoWin app. There will be several vaccines in the market now, so we will have to monitor adverse events very thoroughly. Hence, a centralised registration is essential, so that we can continue to monitor all those events.

As far as vaccine production is concerned, the central government has already rendered financial support to various public sector players to boost the vaccine production capacity. There are currently three public sector manufacturing units—Haffkine, Indian Immunologicals Ltd. and Bharat Immunologicals and Biologicals Corporation Ltd (BIBCOL)—that are ramping up the production of Covaxin. A big plant of Bharat Biotech is also being set up in Bengaluru, which will exponentially enhance their production capacity. As we already know, Serum Institute is also scaling up its production.

The initial few batches of Sputnik V will be imported; meanwhile, there are companies that will also start manufacturing it in India. Johnson and Johnson is also starting its manufacturing unit here. And, another Indian vaccine, Zydus’ Covid-19 vaccine, is already in phase-3 trial stage, so we are hopeful that by May or June, this will be through, and will get the emergency use authorization. Lastly, a clinical trial of mRNA vaccine, Gennova, has also started and I assume by August that too should hit the market as well.

These new vaccines will greatly boost the vaccination drive in the country.

(As told To Simantini Dey)
Disclaimer:Dr N K Arora is heading Operations Research Group, a part of the National Task Force set up by the Indian Council of Medical Research (ICMR) in response to COVID-19. He is also the Advisor to the National AEFI Committee.

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