New Delhi, India – India prepares to embark on its biggest ever immunisation drive after the drug regulator approved the emergency use of two coronavirus vaccines.
The Drugs Controller General of India (DCGI) on Sunday gave the green light to two vaccines, one developed by British-Swedish pharmaceutical company AstraZeneca with Oxford University, and another by local pharmaceutical firm Bharat Biotech.
The Bharat Biotech’s vaccine, called Covaxin, was granted a conditional nod despite a lack of a critical phase-three trial, raising concerns about its efficacy.
Covaxin is being developed indigenously in collaboration with the government research body, Indian Council of Medical Research (ICMR), as part of the government’s push for “atmanirbhar” or self-reliance.
The Oxford-AstraZeneca vaccine will be produced by its Indian partner, the Serum Institute of India (SII) – the world’s largest vaccine maker – under the name, Covishield.
Indian Prime Minister Narendra Modi took to social media to declare that the development made “every Indian proud that the two vaccines” are made in India.
But health experts and opposition politicians have questioned the lack of transparency in the approval process.
American drugmaker Pfizer was the first to apply for emergency use authorisation in India in early December, but it continues to be under review.
Pfizer and its German partner BioNTech have been the COVID-19 vaccine trailblazers, becoming the first vaccine to receive WHO validation for emergency use.
Ahmedabad-based Zydus Cadila and Dr Reddy’s Laboratories are among other domestic manufacturers with vaccine candidates under consideration. Dr Reddy’s is partnering with Sputnik V, the Russian vaccine.
Second-worst hit nation
With more than 10.3 million recorded COVID-19 cases and nearly 150,000 deaths, India is the second-most infected country after the United States.
Vaccinating the second most populous country, health experts say, will not be an easy task.
The government has released an elaborate vaccine roll-out plan with the vaccination of 300 million of the most vulnerable people in the first phase running from January to August.
Those eligible in the first round include 10 million healthcare workers, 20 million front-line workers – policemen, soldiers, municipal and others – and 270 million people above the age of 50.
“Nothing has ever been attempted at this scale,” said K Srinath Reddy, President, Public Health Foundation of India (PHFI).
The health ministry on December 28 released the updated COVID-19 operational guidelines, a 148-page document detailing different aspects involved in vaccinating the population.
It cites India’s experience with the Universal Immunization Program (UIP) which vaccinates more than 50 million people every year against diseases such as measles-rubella and adult Japanese encephalitis (JE).
PFHI’s Reddy said that vaccinating healthcare and front-line workers, who can be quickly identified and assembled, is an easier task.
“These [UIP campaigns] were done in limited areas and didn’t cover a large part of the population. Japanese encephalitis is limited largely to eastern Uttar Pradesh and Bihar while measles-rubella is generally given to pregnant women,” said Reddy.
To test and prepare for the seamless delivery and administration of the vaccine, the government first conducted a two-day dry run in four states on December 28 and 29. On January 2, another exercise was conducted at select hospitals across state capitals and major cities across the country.
The government guidelines say India’s successful conduct of the election process will be used as a template to run the vaccination drive. The 2019 general elections saw 900 million voters across the country casting their ballot in seven phases over six weeks.
Similar to voting centres, district administrations will identify vaccination session sites to gather those eligible for vaccination. Every session site will be managed by a five-member team of vaccination officers to authenticate identity, administer vaccines and monitor the vaccinated.
Instructions suggest that each session will inoculate 100 people daily, increasing the number to 200 if adequate vaccines and logistics are available. The number of such vaccination sites to be set up has been left to the district administrations who will rely on their area’s electoral roll. India has more than 700 districts.
Since both the vaccines require two full doses administered around four to six weeks apart, the vaccination sessions will have to be set up twice.
About 114,100 vaccinators were trained for the country-wide mock drill. Delhi and Mumbai, major hotspots last year, are gearing up for the task. While Delhi plans to set up 500-600 vaccination sites, Mumbai has identified major hospitals to start gradually increasing the sites to 100.
A digital platform, the Covid Vaccine Intelligence Network (Co-WIN), will also be put to use to allow beneficiary registration, session microplanning, real-time reporting of vaccination and issuing of vaccination certificates.
More than 7.5 million health officials have already registered on Co-WIN. The app is not yet accessible for other citizens.
And to get these databases up and running, state authorities have been instructed to ensure the completion of data collection of “age-based priority groups”.
Health is a state responsibility but the pandemic forced the state governments to heavily depend on the central government due to budgetary, capacity and even technical expertise constraints.
At the start of the pandemic, the tussle between states and the central government was reflected in difficulties procuring testing kits and financial aid requests.
Rajiv Nath, Managing Director of India’s biggest syringe manufacturer, Hindustan Syringes and Medical Devices, says vaccinating 300 million people in the first round is a tough task but not an impossible one.
“I was thinking a more probable date would be September but India is like a huge elephant. When it gets up and starts running and charges, there’s no stopping it,” he told Al Jazeera.
Nath’s company, which produces 700 million pieces annually, estimates that India would require 1.8 billion different kinds of syringes if 60-70 percent of the population is vaccinated with two shots.
Experts say that supply chain logistics and storage are significant challenges, as different vaccines require different storage.
Pfizer’s vaccine, for instance, requires storage at -60°C to -90°C, a challenge acknowledged by WHO, making it a tough candidate for distribution in remote areas while significantly increasing the cost.
Reddy from PHFI says cold-chain challenges with Pfizer’s vaccine limits its use in more remote areas, perhaps the reason the government is reluctant to purchase it. The two approved vaccines require regular fridge storage.
While the health ministry claimed that sufficient storage facilities have been arranged for the first phase of vaccinations until August, there is no clarity on the capacity when the general population will be vaccinated.
In mid-December, Union Health Secretary Rajesh Bhushan told reporters that 29,000 cold-chain points, 45,000 ice-lined refrigerators, 41,000 deep freezers, among others, have already reached the states.
Pricing is another concern. While Health Minister Harsh Vardhan has said that the vaccines will be free in the first phase, it is not clear what might happen for the general population.
It was reported that SII planned to charge the government Rs 200 ($2.70) per dose for the first 100 million doses, and price it at Rs 1,000 [$13.70] for the general public in the open market. Bharat Biotech has not revealed a price for its vaccine yet.