Analysis

By end-2020, India, which has a population of around 1.3 billion people, had recorded nearly 10.3 million COVID-19 cases and almost 150,000 related deaths. It is the second worst-hit country after the United States in terms of reported infections, although its number of cases per million people is relatively low (see INDIA: Country is playing catch-up on COVID-19 - August 26, 2020). The daily number of new cases is following a broadly downward trajectory.

On January 3, the DCGI approved emergency use of two coronavirus vaccines:

• Covishield, which is being manufactured by the Pune-based Serum Institute of India (SII), the world's largest vaccine manufacturer; and
• Covaxin, which the Hyderabad-based Bharat Biotech (BB) has developed in conjunction with the Indian Council of Medical Research.

Other vaccines are under trial in the country and may become available later in the year.

The first phase of the vaccine roll-out will involve 30 million frontline workers, such as healthcare professionals, and 270 million priority beneficiaries, including people above the age of 50 and younger people with health problems. It is due to be completed by end-July.

No time frame has yet been specified for vaccinating the rest of the population.

Authorisation

The government is facing criticism for its approval of Covaxin. The vaccine is yet to complete a third and final phase of clinical trials, and lacks peer-reviewed efficacy data.

According to official records, the jab has been cleared for restricted use in "clinical trial mode".

BB claims it has the capacity to produce 700 million doses of Covaxin this year. It presently has 20 million doses ready for use.

Delhi says Covishield will be the lead vaccine in the initial stage of its inoculation programme.

The SII has stockpiled 50 million doses. It has packed and readied them for immediate dispatch. It plans to ramp up production to 100 million doses per month by March.

The government has reportedly agreed to buy the first 100 million doses of Covishield at INR200 (USD2.7) per shot, starting with a tranche of 11 million. The SII will thereafter look to sell the vaccine privately at a marked-up price.

All beneficiaries in the first stage of the roll-out will receive vaccination free of charge.

The SII says it has been approached by buyers from across the world. It insists it will reserve 50% of the doses it produces for use in India. The government has yet to clear exports formally.

Both Covishield and Covaxin require storage at 2-8C. The Pfizer/BioNTech vaccine needs to be stored at around minus 70C. This makes it less suitable for India, as it would require drastic upscaling of India's current cold chain infrastructure (see INT: World may turn corner in COVID-19 fight in 2021 - November 17, 2020).

Delivery

The greatest challenge in India's vaccine roll-out will be to overcome infrastructural and manpower constraints. The country's 42-year-old universal immunisation programme is one of the largest health schemes in the world, involving administration of 390 million doses of various vaccines to infants and pregnant women each year, but the task of vaccinating the adult population against COVID-19 is of a much greater magnitude.

In preparation for the first phase of the upcoming roll-out, the health ministry has conducted two rounds of nationwide mock drills. These have put various logistical mechanisms to the test. Special attention was given to management of the cold chain network.

More than 114,000 vaccinators were given training on the process to be followed at vaccination sites.

The COVID Vaccine Intelligence Network is the health ministry's digital platform for managing the inoculation programme. It will track details of vaccine beneficiaries, and provide information on vaccine stocks and storage temperatures. More than 7.8 million people have been registered on it.

A related app is under production.

State governments will be working in close coordination with the federal administration in the vaccine roll-out. Each state will have a control room, with a 24-hour helpline.

India has had to scale up production of key medical items such as needles and syringes ahead of the upcoming programme. The founder of the Bangalore-based biopharmaceutical company Biocon in a recent interview highlighted the difficulty of ensuring sufficient human resources to carry out vaccination on such a large scale.

Systems will be in place to monitor adverse events following immunisation. Strict protocols will be enforced to mitigate the risk of other health problems, such as spread of blood-borne diseases from syringe reuse.

If more vaccines besides the two presently approved become available, it may be possible to begin vaccinating the wider population before completion of the inoculation programme's first phase.

Patents

India is appealing for relaxation of rules regarding pharmaceutical patents as it looks to increase its scope for manufacturing key medical products, including vaccines.

In October, India and South Africa put a proposal before the WTO's Council for Trade-Related Aspects of Intellectual Property Rights to waive intellectual property protection (IPP) in the pharma sector. They argued that this is necessary to facilitate rapid access to affordable medical products amid the pandemic.

The matter was last month deferred due to a lack of agreement among members.

People advocating suspension of IPP during the pandemic say the measure would help remove barriers to vaccine manufacture across the world.

Those against diluting IPP at this time say such a move would act as a disincentive for future investment in pioneering research.

India is keen to step up production of diagnostic kits, medical masks and drugs used to treat COVID-19 symptoms, as well as coronavirus vaccines.