[ti:Some Experts Express Concern over Vaccine Approval Process in India] [by:www.51voa.com] [00:00.00]更多听力请访问51VOA.COM [00:00.04]Several groups representing scientists and doctors [00:06.08]have expressed concerns over India's vaccine approval process. [00:11.84]The concerns come after India approved a vaccine [00:17.00]by Indian drugmaker Bharat Biotech. [00:20.96]The vaccine was approved for emergency use on January 3, [00:27.36]before it had completed late clinical trials. [00:31.96]Late clinical trial data gives evidence about how effective [00:37.36]a vaccine is in preventing illness from coronavirus infections. [00:43.68]Many scientists have warned that [00:47.08]approving a vaccine without evidence from late trials is risky. [00:52.92]And a lack of clarity in the approval process [00:57.88]could lead many people to delay getting the vaccine [01:01.96]or to refuse to get it at all. [01:05.32]More than 10.4 million coronavirus cases [01:09.68]have been reported among India's nearly 1.4 billion people. [01:15.40]Bharat Biotech's vaccine was one of two [01:20.16]that India approved for emergency use. [01:24.44]The second was a form of the AstraZeneca vaccine. [01:29.68]It is made by the world's largest vaccine manufacturer, [01:34.60]Serum Institute of India. [01:37.28]Serum Institute's vaccine was approved [01:40.76]because of partial results from studies in Britain and Brazil [01:46.36]that showed it was about 70 percent effective. [01:51.68]At first, a member of India's COVID-19 task force [01:57.08]said the Bharat Biotech vaccine would be used as a "backup." [02:03.24]Backup is a term that means something can be used [02:07.68]to replace or support another person or thing. [02:12.08]But on January 5, health officials said Bharat Biotech's vaccine [02:18.72]would be made available to people who give their permission. [02:23.16]People given the vaccine will also need to get follow-up visits. [02:28.80]The move suggests India will send out both vaccines. [02:34.16]But it remains unclear which states will receive [02:38.40]which vaccine and for what reasons. [02:41.84]On January 16, [02:44.40]India will begin giving vaccines to an estimated [02:48.48]30 million doctors, nurses and other front line workers. [02:54.80]After that, the shots will start going to around 270 million Indians [03:01.84]who are either over age 50 or have other health issues, [03:07.12]sometimes called "co-morbidities." [03:10.64]China and Russia have also released vaccines [03:14.64]while late clinical trials were still going on. [03:18.88]But India, which is the world's largest manufacturer of vaccines, [03:25.04]has drawn criticism for not being clear in its approval process [03:30.36]and for using two different standards. [03:34.04]A standard is a level of quality that is considered acceptable. [03:40.40]The group of experts that approved the vaccines met three times. [03:45.48]In the first two meetings, on Dec. 30 and Jan. 1, [03:51.92]they were not pleased with Bharat Biotech's application. [03:57.20]They asked for more data on its ability to prevent illness [04:02.20]from COVID-19, notes from the meeting show. [04:07.08]The AstraZeneca vaccine, meanwhile, was approved on Jan. 1. [04:13.52]Notes from the Jan. 2 meeting [04:16.92]show that the company presented "updated data." [04:21.24]But it is not clear what new evidence led the experts to change their minds. [04:28.64]Dr. Vineeta Bal of India's National Institute of Immunology [04:34.44]noted the need for transparent approvals [04:38.24]that include data to confirm vaccine effectiveness. [04:43.60]"This is a process that Indian government officials [04:47.48]are themselves sabotaging," she said. [04:51.20]India's top drug official would not comment on the issue. [04:57.12]The identities of the experts that approved the vaccines [05:01.80]have not been made public. [05:04.00]Balram Bhargava heads the Indian Council of Medical Research. [05:09.88]He said the "restricted use" of a vaccine on the basis of data [05:16.36]from early clinical trials is legally possible in a pandemic. [05:22.56]The group is a co-sponsor of the clinical trials. [05:28.12]I'm John Russell. 更多听力请访问51VOA.COM