India launches what could be the world’s largest vaccination campaign. But it’s unclear if one of the vaccines works.

By Joanna Slater and Niha Masih,

T. Narayan Bloomberg News

A hospital staff member administers a Covishield vaccine, developed by Oxford-Astrazeneca and manufactured by Serum Institute of India Ltd., at the Ganga Ram Hospital in New Delhi.

NEW DELHI — Early on Saturday, Kartik Naik waited in line with doctors, nurses and medical students in a small city on India’s eastern coast, unaware that he was making history.

The 44-year old works as a hospital janitor. When the pandemic swept through the region, he witnessed some of the worst: his job was to shift the dead to the morgue.

Now Naik is part of a leap forward in the country’s long battle against the coronavirus, becoming one of the first Indians to receive vaccines in what is likely the world’s largest vaccination campaign.

“I am told this vaccine will drive covid away,” said Naik. The “rest is up to God.”

India on Saturday kicked off its nationwide vaccination drive at thousands of centers across the country, part of a bold bid to immunize 300 million people by this summer.

It’s a vital undertaking in a nation that has recorded more coronavirus cases than any other place on Earth except the United States.

The effort is being buoyed by two locally made vaccines and India’s prior experience with large-scale immunization campaigns. But what might have been a triumph for the country’s vaccine industry has been dogged by controversy.

The Indian government granted emergency approval to two vaccines — a locally manufactured version of the Oxford-AstraZeneca vaccine and a vaccine called Covaxin developed by Bharat Biotech, an Indian pharmaceutical company.

Only the Oxford-AstraZeneca vaccine has completed a Phase 3 clinical trial for safety and efficacy. Bharat Biotech has finished earlier-stage trials on its vaccine but has provided no data on whether it works. Yet both vaccines are being administered, and people cannot choose which vaccine they receive.

Complicating matters further, Indian regulators said that the Bharat Biotech vaccine will be used in “clinical trial mode,” a phrase that left experts baffled. One of India’s foremost vaccine experts, Gagandeep Kang, told an interviewer that she had “no clue” what it meant.

Dhiraj Singh

Bloomberg News

Government officials pray over a box of vaccines in Mumbai on Friday.

India is starting its vaccination campaign at a moment when the virus is in retreat — unlike in the United States and the United Kingdom. New cases have dropped drastically since peaking in September: India is recording about 18,000 cases and 200 deaths a day.

Indian Prime Minister Narendra Modi urged Indians to remain vigilant in a televised address on Saturday, adding that the vaccine drive was “living proof of India’s talent.” Vaccinations began at 3,000 sites across the country and authorities say the number will grow in the coming weeks. More than 191,000 people were vaccinated on the first day, falling short of the initial target.

The Indian government began by purchasing 16 million doses of the two vaccines, both sold at $2.75 a dose (the Pfizer vaccine, by comparison, costs $19.50). The AstraZeneca vaccine is being manufactured by Serum Institute of India , the world’s largest vaccine maker by volume. Neither the AstraZeneca vaccine nor the Bharat Biotech vaccine requires ultracold storage, a crucial plus in a country where such refrigeration is scarce.

The first in line for vaccinations are 30 million health-care workers, soldiers, and municipal employees. They’ll receive vaccines free of cost. The next stage is more ambitious: it will target 270 million people over the age of 50 as well as those below 50 who have co-morbidities.

The rollout of the vaccine program matters not just for India, but for the entire developing world. India has a long track record of mass-producing vaccines at affordable prices.

Serum Institute will be a major supplier to COVAX, a global initiative backed by the World Health Organization to distribute vaccines equitably to poorer countries. Adar Poonawalla, the chief executive of Serum Institute, said that the company would start delivering doses to COVAX by the end of this month.

The success of India’s vaccination campaign effort will become clear only in the coming months, but there were no reports of large-scale problems on day one. At many vaccination centers, there was joy and relief.

At Delhi’s Lok Nayak hospital, a sprawling facility that has treated more than 10,000 covid-19 patients, chains of marigolds garlanded the pathway leading to the vaccination center. Suresh Kumar, the hospital’s medical director, was beaming. “This menace, this crisis, is over,” he said.

Dhiraj Singh

Bloomberg News

A government official takes coronavirus vaccines from a storage box upon arrival at the BKC vaccination center in Mumbai on Friday.

Along with celebration, however, there were signs of unease, particularly at hospitals administering Covaxin. At JJ Hospital in Mumbai, a government-run facility, 100 people were called to receive the Bharat Biotech vaccine, but only 39 arrived. Ranjit Mankeshwar, the hospital’s dean, said it was too soon to gauge whether health workers were reluctant to get Covaxin. Mankeshwar said he received Covaxin without hesitation on Saturday.

Unlike the AstraZeneca vaccine, people receiving Covaxin were asked to sign a consent form which noted that its “clinical efficacy has yet to be established.” Nupur Abrol, a 35-year old anesthesiologist at Ram Manohar Lohia hospital in Delhi, said she came to the hospital thinking she would refuse to take the shot. She changed her mind after seeing one of the country’s top doctors take Covaxin on television.

“We don’t know the efficacy of the vaccine, but we won’t be eligible for the other vaccine,” Abrol said, adding that she is praying it works. Abrol said the past year had been “horrid.” Her regular stints in the covid-19 intensive care unit meant frequent separations from her three-year-old son.

India managed the towering logistical feat of distributing vaccines across the country for a synchronized national launch. Still, overcoming apprehensions about new vaccines remains a challenge. Lahu Kumethe, the medical superintendent of a rural hospital in Rajora in central India, said 100 recipients were invited to get the AstraZeneca vaccine on Saturday but only half showed up. “People were nervous,” he said, although the mood at the center shifted after the first vaccinations unfolded with no ill-effects.

The AstraZeneca vaccine represented the large majority of vaccines administered on Saturday, but Covaxin was also a key part of the launch. Anant Bhan, a public health and bioethics expert, said that the government’s approval of the Bharat Biotech vaccine raised many unanswered questions. Critics of the government went further. “Indians are not guinea pigs,” Manish Tewari, a spokesman for the opposition party, told Asian News International.

Some experts worry that the lack of transparency in the process of approving vaccines for emergency use could undermine confidence in them more broadly. That would represent a break from the past in India, a place where vaccine skepticism has been low and immunization is seen as an essential tool in reducing mortality.

Such concerns aside, health-care workers welcomed the advent of vaccines. Pragati Raut, a 44-year old nurse in Mumbai, has been on covid-19 duty throughout the pandemic. She has seen patients succumb to the virus. In August, she was infected and hospitalized for 10 days. On Saturday, she was helped administer the first round of shots at BYL Nair Charitable Hospital. “It feels like a full circle,” said Raut.

On the other side of the country in the eastern state of Odisha, a doctor supervising a vaccination drive expressed a similar sentiment. “It is difficult to describe what this day means to doctors like us,” said Amulya Kumar, 53. “For months, we have been on our toes, working day and night to cure covid patients.” Now, he said, this “could be the beginning of the end.”

Tazeen Qureshy in Berhampur, Jyoti Shelar in Mumbai and Taniya Dutta in New Delhi contributed to this report.

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Source: WP