Stating that some of the COVID-19 vaccine candidates may get a license in the next few weeks, with preparatory activities for the roll-out of the vaccine being carried out simultaneously by the Central government in collaboration with States and UTs, the Union Health Ministry on Tuesday at a press conference said that getting vaccinated is a voluntary exercise and that vaccination cannot just be a State’s or the Centre’s responsibility, “it has to be people’s participation”.
Three COVID-19 vaccine candidates have currently applied for emergency use authorisation, according to the Health Ministry. Rajesh Bhushan, Secretary-Health, speaking at the conference, cautioned that COVID-19 appropriate behaviour should not see any relaxation with several countries across the world now witnessing another surge of the virus.
“While we cannot predict when the three vaccine candidates currently with the Drugs Controllers General of India (DCGI) seeking emergency use authorisation will be cleared as they have to go through the due clearance process, India’s regulatory framework has a specific provision for the grant of emergency use authorisation under the New Drugs and Clinical Trial Rule, 2019. This provides that under specific special situations mentioned in the Rule, relaxation, abbreviation, omission, or deferment of data, including local clinical trial data, may be considered for approval. Similarly, other countries also have laws. The timeline for issuing licence is under the national regulator’s domain,” said Mr. Bhushan.
He added that once a green signal was obtained from scientists, the Centre “will launch massive production of the vaccine”.
“The Central government has made elaborate preparations and drawn an outline to ramp up production of vaccines to make it available to each and every person in the shortest possible time. We will be running parallel vaccination programmes for several priority groups,” said Mr. Bhushan.
The Health Ministry explained that, at present, there are around 2.39 lakh vaccinators (auxiliary nurse midwife or ANM) across the country, but only 1.54 lakh ANMs will be used for COVID-19 vaccination to ensure that the COVID-19 vaccination drive would have minimal impact on routine health services, including routine immunisation.
It added that the National Expert Group on Vaccine Administration for COVID-19 has made recommendations on prioritised population groups, including healthcare providers, personnel from State and Central police, Armed Forces, Home Guards, civil defence and disaster management volunteers, municipal workers, and persons above 50 years of age.
Mr. Bhushan added that the process of collecting databases of health workers has started across all States and UTs and Central Ministries. “This data is being uploaded on CO-WIN software which will be used for the vaccination process. CO-WIN platform is a mobile application, which can be downloaded for free by all, for vaccination delivery. The mobile app will record vaccine data and will be used for remote real-time monitoring,” he added.
Giving details of the current cold chain system, the Ministry said that it consisted of 85,634 equipment for storage of vaccines at about 28,947 cold chain points across the country. “Current cold chain is capable of storing additional quantities of COVID-19 vaccine required for first 3 crore health care and frontline workers. Additional supplies would be available to States/UTs beginning 10th December 2020,” stated the Ministry
Asking the people to have faith in vaccines cleared by Indian regulators, V.K. Paul, Member (Health), NITI Aayog, speaking at the conference, said: “This is a scientific, technical body with vast experience. Don’t succumb to contrary opinion, have faith in these institutions. Take into consideration only accountable transparent information from the government, otherwise we will not find ourselves standing strong against the pandemic. We are chasing the virus and we need to make sure that the virus doesn’t chase us.”
He added that besides the three vaccine candidates that are before the regulator seeking permission for emergency use, other vaccines may also arrive.
Replying to a question on the data being relied upon for possible issue of emergency use approval, Indian Council of Medical Research head Balram Bhargava added that the regulator probably has to be satisfied with risk-benefit ratio in this emergency situation.
The Health Ministry, meanwhile, giving information on the current COVID-19 situation in India, said that while cases are increasing around the world, there had been a steady and continuous decline in new cases in India since mid-September. “Maharashtra, Kerala, Karnataka, West Bengal and Delhi contribute to 54% of the total active cases in the country. Today, the active cases in the country are less than 4 lakh and case positivity rate is decreasing,” Mr. Bhushan said.
