As India embarks this weekend on what may become the biggest national vaccination campaign in the world, some scientists have raised questions about one of the two vaccines the country of 1.4 billion people has authorized for emergency use against COVID-19.
More than 5 million vaccine vials arrived early Wednesday at hundreds of hospitals and clinics across India. Inoculations start Saturday. India aims to vaccinate 300 million people by July.
The shipments consist of two formulas: One developed by Oxford University and the pharmaceutical giant AstraZeneca, and another vaccine developed by an Indian company called Bharat Biotech — billed as India's first "indigenous" vaccine. Both vaccines are being manufactured inside India.
Officials say patients will not be able to choose which of the two vaccines they get.
However, some scientists have expressed concern that the one produced by Bharat Biotech is being deployed prematurely. It still has yet to clear phase three clinical trials, and efficacy data isn't expected until March. Activists also allege unethical practices at one of drug's trial sites.
"Our chief concern is the lack of efficacy data," says Malini Aisola, co-convenor of the All India Drug Action Network (AIDAN), a healthcare watchdog. "It is currently too early for there to be any data. However, the regulator has cleared it for emergency restricted use, in what is being called 'clinical trial mode.' We actually have no idea what this means."
When India's regulator announced the vaccine's approval on Jan. 3, it said it was aimed at offering more options, in addition to the AstraZeneca formula, given that a more infectious COVID strain had been discovered in the UK. But at a news conference, the Drugs Controller of India, V. G. Somani, refused to take questions.
Many scientists, public health experts and opposition politicians are calling for more transparency.
Bharat Biotech's founder & chairman, Krishna Ella, told a Jan. 4 news conference his company's vaccine is "200% safe."
"We are 200% transparent, 200% honest clinical trial! And we get a bashing from everybody," Ella told reporters, accusing them of "bashing" his company.
It's not the first time India's regulator has bypassed the last phase of clinical trials to approve a potentially life-saving medicine. It happened last spring with hydroxychloroquine, a drug President Trump touted without proof as a treatment for COVID-19.
But there's a difference between giving an experimental drug to someone who is already sick, and giving a vaccine to someone who is healthy, says public health activist Dinesh Thakur.
With vaccines, he says, there should be more oversight. In the case of the Bharat Biotech vaccine, "the approval process in India was a secret," Thakur says.
He suspects it may have something to do with a new initiative by Prime Minister Narendra Modi called "Aatmanirbhar Bharat," or self-reliant India. In addition to a vaccine developed by the big multinational company AstraZeneca, India may also have wanted to approve one that was developed in India.
"There seems to be some sense of nationalism. You know, we can also make a vaccine," Thakur says.
Making vaccines — or least, mass-producing them — is something India is actually famous for. It's the world's largest vaccine producer, nicknamed 'the pharmacy to the world.'
TONYA MOSLEY, HOST:
This weekend, India will start what may be the biggest vaccination campaign in the world. It's authorized emergency use of two vaccines against the coronavirus. But some scientists have raised questions about one of them, as NPR's Lauren Frayer reports from Mumbai.
LAUREN FRAYER, BYLINE: This Mumbai hospital is plastered with vaccine posters. There are arrow marks on the floor to guide patients to booths where they'll get their shots. India has an ambitious goal to vaccinate 300 million of its people by July. Dr. Anita Shenoy is eagerly awaiting shipments of vials.
ANITA SHENOY: We are confident that whatever vaccine is given to us is safe - that thorough checking will be done before it is given to us.
FRAYER: But some scientists are worried. The Indian government has granted emergency authorization to two vaccines, one developed by Oxford University and the pharmaceutical giant AstraZeneca, and another homegrown formula from an Indian company called Bharat Biotech. The latter is still in Phase 3 clinical trials, and there's not yet any data on how effective it is.
MALINI AISOLA: Our chief concern is actually the lack of efficacy data.
FRAYER: Malini Aisola heads an Indian health care watchdog.
AISOLA: The Phase 3 trial is still ongoing, and it is currently too early for there to be any data. However, the regulator has cleared it for emergency restricted use in India, but in what is being called the clinical trial mode. We actually have no idea what this means, and it hasn't been clarified.
FRAYER: When the drug controller of India announced the vaccine's approval, he said it was so that India has more options given this mutant COVID strain first discovered in the U.K. But he refused questions from the media, and many are calling for more transparency. At an online news conference, Bharat Biotech's founder and chairman, Krishna Ella, said his company's vaccine is 200% safe.
(SOUNDBITE OF PRESS CONFERENCE)
KRISHNA ELLA: You know, 200% transparent, 200% hardest clinical trial - and we get a bashing from everybody. Everybody...
FRAYER: He accused the media of bashing his company. There have been cases where India's regulator leapfrogs the last phase of clinical trials to approve a lifesaving medicine. But there's a difference between giving an experimental drug to someone who's already sick and giving a vaccine to someone who is healthy. With vaccines, there should be more oversight, says public health activist Dinesh Thakur.
DINESH THAKUR: What happens to adverse reactions if there are any? How are they treated? But the approval process in India was a secret. People don't even know who these experts are who actually sort of recommended that this vaccine candidate get its approval.
FRAYER: He suspects it may have something to do with a new initiative by Prime Minister Narendra Modi called Aatmanirbhar Bharat - self-reliant India. In addition to a vaccine developed by a big multinational company, AstraZeneca, India may have also wanted to approve one that was developed in India.
THAKUR: They're using words like indigenously made vaccine. So there seems to be some sense of nationalism that we can also make a vaccine.
FRAYER: And making vaccines - or at least mass-producing them - is something India is famous for. It's the world's largest vaccine producer. It's often called the pharmacy to the world. And even the AstraZeneca vaccine, while developed abroad, is being mass-manufactured inside India.
Lauren Frayer, NPR News, Mumbai.
(SOUNDBITE OF EDAMAME'S "SPILLED SAND") Transcript provided by NPR, Copyright NPR.