The Union Health Ministry on Tuesday said three Covid-19 vaccine candidates, including those developed by Bharat Biotech, Serum Institute of India and Pfizer, are under the active consideration of India’s drug regulator for their early approval, and there is hope that it would be possible for all of them.

Over the last four days, Pfizer India, Hyderabad-based Bharat Biotech and Pune-based Serum Institute of India have been applying to the Drugs Controller General of India (DCGI) for the emergency use authorisation of their potential Covid-19 vaccine.

Addressing a press conference, Niti Aayog member (Health) VK Paul said that the pandemic situation in India is in a stable condition with the active number of cases exhibiting a “clear-cut declining trend” even though in several countries, the scenario is quite the opposite.

“The concern and anxiety that arose following an increase in daily cases of infection in Delhi has also settled now,” he said.

Asked what steps would be followed by the DCGI in the absence of a water-tight emergency use authorisation law for granting licence to vaccine makers, Union Health Secretary Rajesh Bhushan said not all countries' regulatory framework or rules and acts mention emergency Use authorisation.

“So, the fact that this phrase is not used in the national regulatory framework of any country does not mean that specific country does not have an enabling provision to accord an approval which is early and which is distinct from a regular market approval,” Bhushan said.

“India's regulatory framework has a specific provision for grant of emergency use authorisation. Although this phrase is not used,” he added.

Under the New Drugs and Clinical Trials Rules, 2019, in specific special situations, relaxation, abbreviation, omission, or deferment of data including local clinical trial data may be considered for approval.

“This is our law. Similarly other countries also have their legislations,” Bhushan elaborated.

He mentioned that eight vaccines in India are at various stages of development, while providing a comprehensive view of India’s Covid-19 vaccine scenario.

“Another vaccine, which is in initial stages, is the one being developed by Aurobindo Pharma. So there are a total of nine vaccines out of which six are in clinical trials and three are in pre-clinical stage,” Bhushan said.

“There are multiple vaccine candidates in different stages of development and some may get licensed in the next few weeks. But we cannot foretell at this moment because licensure or market authorisation is the domain of the national regulator,” he added.

Bhushan also revealed that a mobile app, Co-Win, was being developed to monitor the vaccination process.

“Co-WIN digital platform includes a free downloadable mobile application which can help record vaccine data. One can register themselves on it if they want the vaccine. There are five modules in Co-WIN app -- administrator module, registration module, vaccination module, beneficiary acknowledgement module and report module,” he said.

Bhushan said the administrator module is for the administrators who will be conducting these vaccination sessions.

“Through these modules, they can create sessions and the respective vaccinators and managers will be notified,” he added.

About cold chain infrastructure augmentation, the health secretary said presently the system consists of 85,634 equipment for storage of vaccines at about 28,947 cold chain points across the country.

“Data on frontline healthcare workers is being uploaded on Co-WIN software in preparation of Covid-19 vaccination. The current cold chain is capable of storing the first lot of three crore Covid-19 vaccines for healthcare and frontline workers,” he said.

He also informed that while 2.38 lakh auxiliary nurse midwives (ANMs) provide vaccination under universal immunisation programme, only 1.54 lakh such workers will be called in for Covid-19 inoculation.

“The National Expert Group on Vaccine Administration for Covid-19 (NEGVAC) has recommended that around one crore health workers should be given priority in the vaccination drive,” he said.