15 January 2021
Several groups representing scientists and doctors have expressed concerns over India's vaccine approval process.
The concerns come after India approved a vaccine by Indian drugmaker Bharat Biotech. The vaccine was approved for emergency use on January 3, before it had completed late clinical trials.
Late clinical trial data gives evidence about how effective a vaccine is in preventing illness from coronavirus infections.
Many scientists have warned that approving a vaccine without evidence from late trials is risky. And a lack of clarity in the approval process could lead many people to delay getting the vaccine or to refuse to get it at all.
More than 10.4 million coronavirus cases have been reported among India's nearly 1.4 billion people.
Two Vaccines
Bharat Biotech's vaccine was one of two that India approved for emergency use. The second was a form of the AstraZeneca vaccine. It is made by the world's largest vaccine manufacturer, Serum Institute of India. Serum Institute's vaccine was approved because of partial results from studies in Britain and Brazil that showed it was about 70 percent effective.
At first, a member of India's COVID-19 task force said the Bharat Biotech vaccine would be used as a "backup."
Backup is a term that means something can be used to replace or support another person or thing.
But on January 5, health officials said Bharat Biotech's vaccine would be made available to people who give their permission. People given the vaccine will also need to get follow-up visits.
The move suggests India will send out both vaccines. But it remains unclear which states will receive which vaccine and for what reasons.
On January 16, India will begin giving vaccines to an estimated 30 million doctors, nurses and other front line workers.
After that, the shots will start going to around 270 million Indians who are either over age 50 or have other health issues, sometimes called "co-morbidities."
China and Russia have also released vaccines while late clinical trials were still going on. But India, which is the world's largest manufacturer of vaccines, has drawn criticism for not being clear in its approval process and for using two different standards. A standard is a level of quality that is considered acceptable.
The group of experts that approved the vaccines met three times. In the first two meetings, on Dec. 30 and Jan. 1, they were not pleased with Bharat Biotech's application. They asked for more data on its ability to prevent illness from COVID-19, notes from the meeting show. The AstraZeneca vaccine, meanwhile, was approved on Jan. 1.
Notes from the Jan. 2 meeting show that the company presented "updated data." But it is not clear what new evidence led the experts to change their minds.
Dr. Vineeta Bal of India's National Institute of Immunology noted the need for transparent approvals that include data to confirm vaccine effectiveness.
"This is a process that Indian government officials are themselves sabotaging," she said.
India's top drug official would not comment on the issue. The identities of the experts that approved the vaccines have not been made public.
Balram Bhargava heads the Indian Council of Medical Research. He said the "restricted use" of a vaccine on the basis of data from early clinical trials is legally possible in a pandemic. The group is a co-sponsor of the clinical trials.
I'm John Russell.
Aniruddha Ghosal and Sheikh Saaliq reported on this story for the Associated Press. John Russell adapted it for Learning English. Bryan Lynn was the editor.
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Words in This Story
clinical trial – n. a kind of research study in which human subjects are assigned to one or more treatments in order for researchers to study the effects of those treatments.
task force – n. a group of people who deal with a specific problem
application – n. an official request for something, usually made in writing
update – v. give someone the most recent information
transparent – adj. open an honest, without secrets
sabotage – v. to destroy or damage (something) so that it does not work correctly
sponsor – n. a person or organization that pays the cost of an activity or event
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