The Serum Institute of India’s Covishield is likely to be initially used in India's vaccine drive against Covid-19, with the Drugs Controller General of India formally waving the green flag for the shot’s use along with Bharat Biotech's Covaxin. Vaccination is likely to be launched simultaneously in most states that were part of the dry run on January 2, even as the final contours are being worked out. DCGI V G Somani announced the emergency use approval for the Pune-based SII, which is manufacturing Covishield developed by Oxford University and Astra Zeneca, and the indigenous Covaxin which will have to fulfil additional conditionalities.
In the case of Covaxin, the emergency use authorisation is in clinical trial mode which means that monitoring of recipients will be in the same mode as persons participating in a trial. Though it can be used, Covaxin may be introduced in the vaccination programme a little later. SII and Bharat Biotech have speeded up manufacture of the vaccine and have a substantial stockpile.
For the rollout of the vaccine, the government is likely to follow an election-like process and identify session sites in particular districts in almost all states on particular dates. Depending on vaccine availability, beneficiaries will be called for inoculation on specified dates in a phased manner. “Limited number of beneficiaries may be inoculated during the first few days on each of the identified sites depending on vaccine availability, much like the way elections are conducted,” an official said.
Govt has registered priority beneficiaries
The government has already registered over 75,00,000 priority beneficiaries on Co-WIN - the IT platform developed by the Centre to implement the mega vaccination drive. The nationwide vaccination dry runs were conducted at 286 session sites across 125 districts. The government is likely to place a formal supply order with Serum Institute of India in order to facilitate mobilisation of vaccines to cold chain hubs, another senior official said. The vaccines will be further distributed to particular districts as per the final plan for vaccine administration.
While the plan is to inoculate 300 million “priority population” with anti-Covid vaccine by July, the government aims to vaccinate the first 30 million, including healthcare and frontline workers, over next two months and vaccination process is likely to pick up pace with simultaneous inoculation of the over 50 population and those who are younger but have serious comorbidities.
Since in-principle approvals for SII were in place with the government expecting it to be the first vaccine in the country, it is expected to be easier for the government to procure immediate supplies of Covishield though soon supplies of Covaxin may follow, an official said.
India approves Oxford and Bharat Biotech vaccines
Earlier, India last week formally authorised the emergency use of AstraZeneca and Oxford University, and by Hyderabad-based pharmaceutical firm Bharat Biotech, Somani said at a virtual briefing. It is now expected to start a massive immunisation programme within about a week and hopes to inoculate 300 million of its 1.35 billion people free of charge in the first six to eight months of this year. The AstraZeneca/Oxford shot, already approved in Britain, Argentina and El Salvador, will take the lead and Bharat Biotech's Covaxin will be administered under stricter conditions given no efficacy data has been released for it. Somani said the overall efficacy of the AstraZeneca/Oxford vaccine was 70.42%, while Bharat Biotech's Covaxin was "safe and provides a robust immune response".
The British-developed AstraZeneca/Oxford shot is being made locally by the Serum Institute of India (SII) and will be branded Covishield, while Bharat Biotech has teamed up with the government-run Indian Council of Medical Research. Prime Minister Narendra Modi tweeted that the fast-track approvals were "a decisive turning point to strengthen a spirited fight" that "accelerates the road to a healthier and Covid-free nation". Serum Institutes chief executive Adar Poonawalla tweeted after the approvals that the vaccine would be "ready to roll-out in the coming weeks". The government has already been holding nationwide drills ahead of the mass inoculation drive and 96,000 health workers have been trained to administer the shots.
Somani told reporters that the drug regulator would "never approve anything if there is the slightest safety concern". "The vaccines are 100 per cent safe," he said, adding that side effects such as "mild fever, pain and allergy are common for every vaccine". Somani said the Bharat Biotech vaccine had been approved "in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains".
Both vaccines will be administered in two doses and stored at 2-8 degree Celsius (36 to 48°F), he said, without clarifying the intervals between the shots. A report quoted sources as saying that the doses would have to be given four weeks apart.
