Centre plans strategies for rollout, as some Covid-19 vaccine may get emergency-case license

The Drug Controllers General of India will have to consider the risk-benefit ratio before giving its nod especially under the situation
Centre plans strategies for rollout, as some Covid-19 vaccine may get emergency-case license
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Soon after Pfizer has requested for an emergency permit for their Covid-19 vaccine, Bharat Biotech and Serum Institute have also requested emergency case permission for their vaccines Covaxin and Covishield respectively. Confirming their condition, the Union Health Ministry has informed that “some of the Covid vaccine candidates are likely to get a license in the next few weeks”.

Health Secretary Rajesh Bhushan has announced that the central government has started the preparations alongside the States and Union Territories in the matter of the vaccine rollout. He said, “We cannot predict when the three vaccine candidates — currently with the Drugs Controllers General of India seeking emergency use authorisation — will be cleared. While they have to go through the clearance process, India’s regulatory framework has a specific provision for the grant of emergency use under the New Drugs and Clinical Trial Rule, 2019.” Under the rules, the regulators can consider relaxing procedural time under specific conditions as per situations. However, the emergency-case licensing will only be authorised once the regulator is satisfied with the risk-benefit ratio considering the conditions.

While the government will ramp up production soon after the regulators have issued the license, the next step in consideration is mobilising vaccinators across the nation. This has to be done while considering two things. Firstly, when the vaccinators are engaged in the Covid scenarios, it should not affect the routine immunisation process happening around the country. Currently, India has 2.39 lakh vaccinators otherwise known as Auxiliary Nurse Midwife (ANM) and the plan is to mobilise only 1.54 lakh ANMs for the process.

Secondly, the problem of storage has been a real issue considering how many vaccines require complicated storage mechanisms before they can be used. Such mechanisms are expensive and not easily accessible. However, the ministry has added in the press meet that they are ensuring a cold chain system. “It consists of 85,634 equipment for storage of vaccines at about 28,947 cold chain points across the country. The current cold chain is capable of storing additional quantities of Covid-19 vaccines required for first 3 crore health care and frontline workers,” the ministry said.

According to Bhushan, the National Expert Group on Vaccine Administration for Covid-19 recommended a list of prioritised population groups including healthcare providers, municipal workers, persons above 50 years of age and many more. Adding to this, the collection of data on health workers has started in the states/UTs, which will be uploaded later to Co-WIN. The latter is a mobile application that will be used for “vaccination delivery, recording vaccine data, and real-time monitoring”.

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