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Emergency use authorisation for COVID vaccine only after detailed analysis

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New Delhi, Dec 12: The emergency use authorisation for COVID-19 vaccine would be given by the country's drug regulator after analysing all aspects of safety and efficacy, Niti Aayog member V K Paul said on Saturday.

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Addressing the 93rd annual convention of industry body FICCI, he said that management of the immunisation programme and election process in the country gives the government confidence that even the vaccine initiative could also be successfully imparted to the target groups.

"We have three applications today for the emergency use authorisation on sound principles. We have Pfizer, we have Bharat Biotech and we have Serum and they have not only met the deadline, they have overtaken the deadline," Paul said.

Terming the current period as an inflection point, he said that decisions regarding the vaccine would roll out in a matter of a few days.

COVID-19: US allows emergency use of vaccineCOVID-19: US allows emergency use of vaccine

'Importantly, these decisions will be science-based, evidence based, rules based. Our regulator will make the right decision. Safety, immunogenicity and efficacy will drive the decision,' Paul noted.

He further said, 'We have absolutely no pressure on the regulator to do the decision one way or the other; I can say this with authority. We have insulated that system. We respect their decision making process.' Paul said taking the right decision was important for the nation.

'There is a reputation to be kept. Our vaccines go to half of the world. If we compromise today we will be hurting ourselves,' he noted.

He also said that DCGI was in touch with the UK regulator.

'We are trying to work together irrespective of a particular vaccine which is common to both the nations," Paul said.

On starting the process of imparting the vaccine, he added that the process would have to be regulated so that the most needy get the dosage first.

Paul said that conventional cold chains have been built up to store the vaccine and so has been the capacity of syringes and needles.

'We have vaccinators being lined up, partly from the government system because we don't want to load the government system because if we depend totally on the government system their other priorities like primary health care, particularly immunisation will suffer, so therefore additional elements are being brought up,' he added.

Paul also informed that an IT platform for vaccination purposes has been built.

"We have also built a strong IT platform which will be doing the logistics management..it will also give messages for appointments and inform which day a person needs to go for the vaccination. It is almost ready, testing is being done. We also believe that once ready we will also offer it to the world for any country which would like to adopt it," he noted.

He said preparations till block level was being done for effective imparting of the vaccine.

"What gives us confidence is not only the experience of universal immunisation programmes where you have more than 9 million sessions each year and where 650 million dosages are given to children and women every year, but also we have the experience of conducting elections," Paul said.

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