India embarks on one of the world’s most ambitious vaccine rollouts after emergency use approval

India is embarking on one of the world’s most ambitious mass immunization programs ever undertaken, after regulators approved the country’s first two Covid-19 vaccines for restricted emergency use.

Indian drug regulators on Sunday gave the go ahead for two coronavirus vaccines, one developed by AstraZeneca and Oxford University, and the other conceived locally by Bharat Biotech and a government-run institute.

Both vaccines will be administered in two doses and stored at standard refrigerator temperatures of 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit).

The approval is a crucial step in India’s effort to contain its coronavirus outbreak, which has infected more than 10 million people, trailing only the United States in total caseload.

The country of 1.35 billion is planning to inoculate 300 million frontline workers, elderly and vulnerable people by August, and preparations have been months in the making.

The Serum Institute of India, the world’s largest vaccine maker, is producing the AstraZeneca and Oxford vaccine locally, having taken on a huge risk to manufacture the vaccine months before approval from regulators.

“It’s a great day for India and the world, because this is going to be the most affordable vaccine, that will be equitably distributed as much as possible across the globe,” the institute’s CEO Adar Poonawalla told CNN Sunday.

But the vaccines, locally branded Covishield, won’t be available to other countries until March or April, as the Indian government has restricted them for export, according to Poonawalla.

“This is not going to go to the private market, private hospitals and other places right now. We’re given a restricted license to only give it and provide it to the government of India, because they want to prioritize for the most vulnerable and needy segments first,” he said.

India’s coronavirus vaccines are an important alternative for developing countries, which may not be able to afford the more expensive vaccines made in the West, or have the cold storage capacity to transport vaccines that require ultra-cold temperatures, such as the ones developed by Pfizer and Moderna.

In September, the Serum Institute of India pledged to manufacture and deliver 200 million doses for COVAX — a World Health Organization vaccine alliance set up to ensure fair access to Covid-19 vaccines. But the export of vaccines to “low-and middle-income countries” may not begin until the restrictions ease.

Poonawalla said Covishield would be sold initially to the Indian government for $2.74 per dose — roughly its production cost. It’ll be priced between $3 to $5 per dose for export, and at $13.70 for the private market, he added.

Mass vaccination drive

The Serum Institute of India is expecting to sign a formal deal with the Indian government “imminently,” and people will start getting vaccinated in the “next seven to 10 days,” Poonawalla said.

The institute has already stockpiled 50 million doses of the vaccine ready for distribution this month, and is ready to send them to 30 to 40 government locations across the country. From there, they’ll be distributed to the smaller centers and clinics that have been set up, he said.

India already has a vast, established network under its Universal Immunization Program, which inoculates about 55 million people per year. Analysts have said that means the country’s health system is relatively well geared up for the Covid-19 vaccinations.

Ahead of the mass vaccination drive, the Indian government has also been recruiting and training additional vaccinators and ramping up its stocks of cold-chain storage equipment such as walk-in coolers and freezers, deep freezers and ice-lined refrigerators over the past few months.

On Saturday, it conducted a nationwide Covid-19 vaccine drill at 286 sites across India to familiarize officers on all levels with the operation guidelines, according to the Ministry of Health.

Some 114,100 workers have been trained on tasks such as verifying personal data, conducting cold chain and logistics management, and uploading information using government software, the ministry said in a statement.

Lack of data

India’s drug regulator also approved Covaxin, the country’s first homegrown coronavirus vaccine developed jointly by Bharat Biotech and the government-run Indian Council of Medical Research.

But the government has faced heated criticism from experts and opposition leaders for not revealing the vaccine’s efficacy results or any other data from its clinical trials.

Following Sunday’s announcement, Congress leader Shashi Tharoor said on Twitter that Covaxin’s approval was “premature and could be dangerous” because it has not completed Phase 3 trials.

“Its use should be avoided till full trials are over. India can start with the AstraZeneca vaccine in the meantime,” he tweeted.

Dr. Randeep Guleria, director of the All India Institute of Medical Sciences, agreed.

“I would say that we should in the first phase focus predominantly on the Serum Institute of India — the Astra Zeneca vaccine, and the Bharat Biotech is only as a standby or a backup in case there is a surge in the number of cases,” said Guleria, a member of the national task force on Covid-19 management.

Following the criticism, India’s health minister Dr. Harsh Vardha tweeted late on Sunday that the emergency use authorization (EUA) for Covaxin is “differently conditional — in clinical trial mode.”

“EUA for COVAXIN is different from COVISHIELD because its use will be in clinical trial mode. All COVAXIN recipients to be tracked,monitored as if they’re in trial,” he wrote.

In a news release Sunday, Bharat Biotech said its Phase 3 clinical trial for Covaxin started in mid-November, with a goal to include 26,000 volunteers.

“COVAXIN™ has been evaluated in approximately 1000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity results, with acceptance in international peer reviewed scientific journals,” the release said.

Vaccine rollouts in Asia

Across Asia, a growing number of countries have started vaccinations against Covid-19.

In China, regulators last week approved the country’s first homegrown coronavirus vaccine, developed by state-owned pharmaceutical giant Sinopharm.

The Chinese government aims to inoculate 50 million people against Covid-19 ahead of February’s Lunar New Year celebrations. The country has already administered 4.5 million doses of experimental Chinese vaccines since June under its emergency use program, which included frontline workers such as health care workers and customs officers.

The next step is to inoculate vulnerable groups such as the elderly and people with underlying diseases, before vaccinating the general population, officials said last week.

In Beijing, the municipal government started vaccinating targeted groups of the population, including frontline workers and students and employees who need to go overseas, on January 1. It has set up 220 vaccination sites across the city and inoculated 73,500 people as of Saturday.

Compared with the swift rollouts in India and China, the Japanese government has faced criticism over its slowness in rolling out the vaccines.

Japanese Prime Minister Yoshihide Suga told a news conference Monday that Covid-19 vaccinations will begin in late February. He said frontline medical workers and the elderly would be the first groups to receive the vaccinations, adding that the government has moved forward the timeline amid a surge in coronavirus cases.