The three groups in the government’s coronavirus vaccination priority list may get inoculations simultaneously if there are enough supplies, the Union government said on Tuesday, raising hopes that members of the public above the age of 50 or with significant comorbidities could get access sooner than previously thought.
The priority list, which identifies people at most risk, has front line health workers, essential service workers like the police and army, and people above of 50 and those it who have significant comorbidities.
“The immunisation process across the groups will not be sequential; it can also happen simultaneously depending upon the availability of vaccine,” said Union health secretary Rajesh Bhushan, while adding that these were the recommendations from NEGVAC, or the National Expert Group on Vaccine Administration for Covid-19.
The health ministry estimates there are around 10 million health care workers, 20 million frontline workers, and another 270 million people in the last group.
Officials at the routine health briefing held on Tuesday also said that India’s apex drug regulator will likely consider the emergency use authorisation (EUA) applications of all three vaccines that have applied, despite the candidate of Bharat Biotech still undergoing large scale Phase 3 clinical trials and the data from the combined Phase 1/2 trials not being public.
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The other vaccine candidates that have applied for EUA with the country’s apex drug regulator Central Drugs Standard Control Organisation (CDSCO) include the Oxford-AstraZeneca vaccine by Serum Institute of India (SII) and the Pfizer-BioNTech vaccine. The Pfizer vaccine was found to be 95% effective in international trial while the Oxford vaccine showed between 62-90% efficacy.
“The Phase 1 and 2 data has been submitted to the regulator,” said the director general of the Indian Council of Medical Research Dr Balram Bhargav, refusing to comment on when the data would be made public. Bharat Biotech had partnered with ICMR to develop India’s completely indigenous vaccine candidate Covaxin.
According to Bharat Biotech’s filings with the Clinical Trials Registry of India, the first two phases are meant to judge safety and immune response, with Phase 3 being the point where they would check for efficacy – the vaccine’s ability to prevent infections.
The Phase 3 trial of the vaccine started in mid-November and volunteers have so far received only one trial dose, with the other to be administered 28 days after the first. So far, 5,000 volunteers of the total 26,000 planned across 25 sites in India have been enrolled, as per the DG ICMR. Efficacy data is measured only 42 days after first shots, which means it will not be available till the end of this month.
Bhargava suggested that assessments may be made with more preliminary data.
“For temporary licensure, the regulator has to be satisfied with the risk-benefit ratio. In this emergency situation, if the benefit is more than the risk clearly then it may be considered for approval. From phase I and II trial, we get the safety and immunogenecity data, which is available for several months for certain studies. As for efficacy, the WHO says if it is more than 50% it can be used. The phase III data available for other vaccines is for a very small number of people,” said Bhargava.
There are currently nine vaccine candidates in advanced pre-clinical or human trials in India, Bhushan said.
“India’s regulatory framework has a specific provision for EUA, without the particular phrase being used. The new drugs and clinical trial rules mentions that under specific special situations relaxation, abbreviation, omission, deferment of data including local clinical trial data may be considered for approval,” he said.
Bhushan also gave details about vaccine logistics, saying the government has created a digital network called CoWIN, which will help register those eligible for a vaccine, tracking those vaccinated, creating a schedule, and monitoring the availability of resources on a real-time basis.
The platform comes with an app that can be used by people for registering themselves for a Covid-19 vaccine.
For the first phase of vaccination, states have already started collecting details of health care workers who will be the first to be administered the vaccine once it becomes available. A detailed list is being uploaded to CoWIN.