India began its nationwide vaccination program in thousands of centers across the country on Saturday. It aims to immunize 300 million people by this summer, a massive undertaking in a country that has recorded more coronavirus cases than any other place on Earth except the United States. The campaign is based on two locally produced vaccines and India’s previous experience of large-scale vaccination campaigns. But this one is still mainly plagued by controversy.
The Indian government has granted emergency authorizations for 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 completed previous trials of its vaccine but has not provided any data on it. Not even about whether it works. Yet both vaccines are administered and Indians cannot choose which vaccine to receive.
The mysterious ‘clinical trial mode’
To complicate matters further, Indian regulators have said the Bharat Biotech vaccine will be used in what they mysteriously call “ clinical trial mode. ” Even one of India’s foremost vaccine experts, Gagandeep Kang, told an interviewer that she had no idea what that meant.
Kang, like many other experts, fears that the lack of transparency in vaccine approval could undermine confidence in vaccines more broadly. That would be a break with the past in India, a place where vaccine skepticism is low and immunization is seen as an essential tool to reduce mortality.
India starts its vaccination campaign at a time when the virus is withdrawing – unlike in the EU, the United States and Great Britain. The number of new cases has fallen dramatically since its peak in September, with India now registering about 18,000 cases and 200 deaths per day. Indian Prime Minister Narendra Modi urged Indians in a televised address to remain vigilant, adding that the launched vaccination campaign was “living proof of the talent among Indian scientists.”
2.25 euros per vaccine
Vaccinations have begun in 3,000 locations around the country and authorities say the number will increase in the coming weeks. More than 191,000 people were vaccinated on the first day. The Indian government began purchasing 16 million doses of the two vaccines. She paid € 2.25 per dose. The AstraZeneca vaccine is manufactured by Serum Institute of India, the world’s largest vaccine manufacturer by volume. Neither the AstraZeneca vaccine nor the Bharat Biotech vaccine requires ultra-cold storage, a critical asset in a largely subtropical country where refrigeration is scarce.
The first to qualify for vaccinations are 30 million health workers, soldiers and government employees. They receive free vaccinations. The next phase is more ambitious: it will target 270 million people over 50, as well as those under 50 with co-morbidities.
The roll-out of the vaccine program is important not only for India, but for the entire developing world. India has a long track record of mass-producing vaccines at affordable prices. The Serum Institute will be a major supplier of the Covax project, a global initiative supported by the World Health Organization to distribute vaccines fairly to poorer countries. Adar Poonawalla, the CEO of the Serum Institute, has already announced that the company would start supplying doses to Covax by the end of this month.
Signs of unease
The success of the vaccination campaign in India will only become apparent in the coming months. There have been no reports of large-scale problems so far. The state of Maharashtra had to suspend immunizations for two days due to a software glitch. However, there are signs of discomfort, especially in hospitals administering Covaxin.
At JJ Hospital in Mumbai, a government-run facility, 100 health workers were summoned to receive the Bharat Biotech vaccine on Saturday, but only 39 showed up. Unlike the AstraZeneca vaccine, people receiving Covaxin are asked to sign a consent form stating that “clinical efficacy has yet to be established”.
Not only is there skepticism among health professionals about Covaxin – so it is not yet known whether it works – but also about the AstraZeneca vaccine. Where that was administered, up to half of the doctors and nurses did not show up. The AstraZeneca vaccine accounted for the vast majority of vaccinations administered on Saturday, but Covaxin was also an important part of the campaign’s launch.
Anant Bhan, an expert in public health and bioethics, said the government’s approval of the Bharat Biotech vaccine raised many unanswered questions. Government critics went further. “Indians are not guinea pigs,” said Manish Tewari, an opposition spokesman.