PUNE, India — India on Friday was preparing to launch one of the most ambitious and complex nationwide campaigns in its history: the rollout of coronavirus vaccines to 1.3 billion people, an undertaking that will stretch from the perilous reaches of the Himalayas to the dense jungles of the country’s southern tip.
The toughest part might be persuading doubters like Shankar Patil to roll up their sleeves.
Patil, a 27-year-old state police academy applicant, lives in Pune, the city central to India’s vaccine rollout, which is set to begin on Saturday. Prime Minister Narendra Modi is staking his pride on India’s ability to manufacture enough inexpensive shots to inoculate his country as well as much of the developing world. India aims to do nothing less than “protect humanity,” Modi said at an online address to the Indian diaspora recently.
Stretched out on an exercise mat along a row of pink Mexican lilacs at the top of Parvati, a hillock popular with early-morning joggers, Patil has questions. He and two friends, also aspiring police officers joining him to exercise, are skeptical about the country’s vaccine approval process, which has been criticized by health experts for a lack of disclosure.
“We believe in the government, but nobody should play with our health,” said Patil. “If the vaccines are truly safe, they should make the data public.”
Little data has been published yet from the early trials of one of the two vaccines being rolled out, and the manufacturer has not yet completed the important final trial even as the vaccine is being distributed.
Doubts about transparency only add to the obstacles that officials will face when one of the world’s largest inoculation programs begins. About 300,000 health care workers are set to take the vaccines on Saturday, then millions more health care and front-line workers by spring.
Already, in addition to the logistical challenges, Indian officials must deal with a growing sense of complacency. After reaching a peak in the middle of September of more than 90,000 new cases per day, India’s official infection rates have dropped sharply. Fatalities have fallen by about 30% in the last 14 days, according to a New York Times database.
City streets are buzzing. Air and train travel have resumed. Social distancing and mask-wearing standards, already lax in many parts of India, have slipped further. That attitude alarms experts, who say the real infection rate is probably much worse than India’s official numbers suggest.
Doubts about the effectiveness of the vaccines are making the mission harder still.
At least one state, Chhattisgarh, has refused to accept shipments of the vaccine that is still in its final trial. Experts have expressed wariness. Just days before the mass inoculation was set to begin, Dr. Gagandeep Kang, one of India’s top virologists, was still weighing whether to receive a jab.
“It’s really not a lack of confidence in the vaccine,” Kang said. “It’s a lack of confidence in a process that allowed the vaccine to move forward in such a way. If my taking the vaccine would convince other people to take the vaccine, I’d think that’s not right.”
The rollouts come at a time when new virus variants are spreading alarm around the world.
Modi is looking to two Pune-based powerhouses to fuel his national and global ambitions. The Serum Institute of India, the world’s largest vaccine manufacturer, is making the vaccine developed by AstraZeneca and Oxford University, which has been approved for emergency use in Britain and India, where it is branded Covishield.
The second is the National Institute of Virology, or NIV, which developed an indigenous vaccine called Covaxin with Bharat Biotech, a local pharmaceutical company that will make the doses.
Covaxin, the vaccine still in trials, has been approved for emergency use in India, but neither its creators nor government officials have published data proving that it works.
India’s drug regulator initially said that Covaxin would be available as a backup option. But government officials have since said that both vaccines will be rolled out simultaneously, and recipients will not get to choose between the two.
A group of doctors and public health watchdogs in India has called for an investigation into the ethics of Bharat Biotech’s ongoing clinical trials and a halt to the trial in Bhopal after some participants in that city said they hadn’t been informed that they were receiving a vaccine or a placebo.
Bharat Biotech said it was complying with clinical trial guidelines. Both the company and the government have defended the safety of Covaxin, based on interim data from the first two phases of clinical trials, when the vaccine was administered to 800 participants. They said they would publish efficacy data after the ongoing final clinical trial concludes. Bharat Biotech says it is in talks with a Brazilian company about supplying doses to Brazil, and is looking for other potential export markets.
The pressure on the Serum Institute and the NIV has been immense.
The NIV was the first Indian institution to diagnose COVID-19, in a student who returned to India from the Chinese city of Wuhan. It was also first to isolate and grow a stock of the virus. As a result, it was receiving requests from scientists as well as curious citizens to test potential antidotes.
“People started overwhelming us with candidate drugs, extracts, compounds which they believed had antibody properties,” said Priya Abraham, the NIV’s director.
“That came with political pressure,” Abraham said. “I’ve had ministers calling in.”
Abraham declined to comment on the questions surrounding Covaxin because she was so involved with its development, although she added it was “not at all a bad vaccine.”
Serum Institute CEO Adar Poonawalla must balance commitments to Modi’s government, which has purchased only 11 million of the 100 million doses his company has promised it, with demand in the rest of the world.
AstraZeneca and Oxford agreed to license the vaccine to Serum on a pledge that it would deliver it to the world’s poorest people at cost. The Serum Institute recently applied for World Health Organization certification, which would allow it to start exporting doses it has sold to Covax, an international health group that has negotiated vaccine purchases for less wealthy countries, as soon as the end of January. The institute has promised Covax 200 million doses.
Poonawalla, who aims to distribute a billion doses by the end of 2021, said national pride is at stake.
“The way the world has looked at India now, it’s been overwhelming because we were always ignored and thought about as backward, in many respects,” Poonawalla said in an interview with The New York Times on Thursday, his 40th birthday.
“The world now has to recognize the capabilities of India to service the world and help the world, and that’s exactly what we’re doing,” he said.
Distribution of the vaccine to health centers began Tuesday in Pune, a city of about 3.1 million people southeast of Mumbai, and home of the Maratha warriors who battled the Mughal empire and ruled much of the subcontinent in the 18th century. A police officer performed a puja, a Hindu ceremony seeking divine blessings, on the front fender of a refrigerated truck carrying vaccine doses made by the Serum Institute.
“May all be free from disease,” read a label in Sanskrit and English slapped on every box of vials of COVID-19 vaccine passing through the company’s wrought-iron gates.
As many as 20 Indian government ministries, from railways and defense to civil aviation and education, are involved. The government is leaning on know-how from its mammoth, multiphase general elections exercise and its universal immunization program, which reaches more than 50 million infants and pregnant women annually.
An extensive study of India’s immunization infrastructure jointly carried out by the government of India and UNICEF, the United Nations Children’s Fund, in 2018 showed that India had greatly expanded cold storage capacity and vaccine management. Those two factors will be crucial to India’s ambition of inoculating hundreds of millions of people as soon as possible.
As an epidemiologist and the head of surveillance for the state of Maharashtra, where Pune is, Pradip Awate is relieved that the nightmarish days of peak transmission, when demand for hospital beds and ventilators far outstripped supply, appear to have passed, at least for now. Because of high population density and international connections, Maharashtra has reported the most COVID-19 infections in India since the beginning of the pandemic.
Still, Awate warned against placing too much faith in vaccines.
“The vaccine is not the panacea for this outbreak,” Awate said. “It’s not going to stop it once and for all.”