Eyebrows raised over India’s COVID-19 vaccine approval

[NEW DELHI] India’s approval for emergency use of a locally developed COVID-19 vaccine that is still undergoing clinical trials has raised a storm of criticism by medical experts and organisations involved in public health.

1月3日（星期日），主要监管机构的印度毒品控制者（DCGI）宣布批准Covaxin。开发了疫苗本土经过Bharat Biotechin partnership with the state’sIndian Council of Medical Research尽管它仍在进行第三阶段的人类试验，但仍未发布有关免疫原性和功效的数据。

DCGI特别将Covaxin部署限制在“临床试验模式”中，许多专家的类别有问题。“从来没有听说过这样的类别，”研究方法学家和公众Manu Rajhealthresearcherattached to theAmrita Institute of Medical Sciences and Research Centrein Kochi, Kerala, tellsscidev.net。

“这可能是一种很好的疫苗，但这种认可方式会在其图像上蒙上阴影”

Manu Raj, Amrita Institute of Medical Sciences and Research Centre

正式的澄清请求scidev.net到印度Department of Biotechnology， 这governmentagency supporting the indigenous production ofCOVID-19疫苗被拒绝。

Also approved for emergency use was the Oxford University-AstraZeneca’s Covishield that uses a weakened adenovirus as a vector to carry the COVID-19 spike protein. The Indian version of Covishield is being manufactured in India by the privately-ownedSerum Institute of India。

DCGI宣布后，总理纳伦德拉·莫迪（Narendra Modi）在一次tweet: “It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India! This shows the eagerness of our scientific community to fulfil the dream of an Aatmanirbhar Bharat (self-reliant India), at the root of which is care and compassion.”

It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India! This shows the eagerness of our scientific community to fulfil the dream of an Aatmanirbhar Bharat, at the root of which is care and compassion.

- Narendra Modi（@narendramodi）January 3, 2021

在另一个tweet, Modi wrote: “A decisive turning point to strengthen a spirited fight! DCGI granting approval to vaccines of Serum Institute of India and Bharat Biotech accelerates the road to a healthier and COVID-free nation. Congratulations India. Congratulations to our hardworking scientists andinnovators。”

India Prime Minister Narendra Modi. Image credit:www.kremlin.ru（（CC BY 4.0).

Poonam Khetrapal Singh, regional director for谁东南亚, said in atweet该组织欢迎印度决定为Covid-19疫苗提供“紧急使用授权”的决定。

她在推特上说：“在优先人群中使用疫苗，以及继续实施其他公共卫生措施和社区参与，对于减少Covid-19的影响至关重要。”

WHO welcomes India’s decision giving emergency use authorization to＃冠状病毒-19＃疫苗-
区域总监Poonam Khetrapal Singh博士
谁东南亚Regionpic.twitter.com/jyQGI6Gymp

- 谁东南亚（@whosearo）January 3, 2021

但medicalscientists and voluntary agencies involved in public health and the rational use of drugs are alarmed at the bypassing of clinical trial protocols and the release of the indigenously developed Covaxin without publishing or publicising trial results.

T. Sundararaman, global coordinator for thePeople’s Health Movement国际基层卫生组织网络说：“仓促的科瓦辛仓促批准是非常不必要的 - 当数据和信息可能可用时，他们很容易再等两个月才能完成3阶段试验。当该国的案件发病率很低时，撕裂的急促是什么？”

迄今为止，一个有13亿人口的国家报告了1,030万次Covid-19案件，世界第二高，其中15万人致命。但是9月中旬达到顶峰后，感染率一直在下降。

“It might have been better to take scientists and the public into confidence before releasing it in this manner,” Sundararaman, a former executive director of the国家卫生系统资源中心of India’s central卫生与家庭福利部, tellsscidev.net。He says releasing the vaccine minusdatawould undermine its credibility and relegate it to a “poor man’s alternative,” even if its efficacy is as good as that of other vaccines.

拉吉说：“这可能是一种不错的疫苗，但是这种认可的方式在其形象上蒙上了阴影。”但是，他补充说，随着两种不同的疫苗的可用性，印度可能会更好地实现其在接下来的六个月内免疫三分之一人口的目标。

这全印度药物行动网络（AIDAN）, an influential drug activists’ group issued a statement asking the DCGI to release all data and analyses on which the decision to launch COVID-19 vaccines was based.

“In the interest of transparency and public welfare, we ask that the regulator [DCGI] share the detailed rationale for the decision along with disclosure of the data, evidence and information that was reviewed by the SEC [subject experts committee] and the data and analysis on the basis of which the REU [restricted emergency use] approval is granted,” the AIDAN statement said.

Mira Shiva, a physician and leader of AIDAN, tellsscidev.net该小组“对仍处于临床试验模式的同时，尤其是在突变菌株感染报告的背景下，对Bharat Biotech的Covaxin批准的决定感到震惊”。

“In contrast, the Oxford University-AstraZeneca vaccine that is being manufactured here by the Serum Institute, was approved in the UK and other countries on the basis of data from rigorous clinical trials,” she says.

According to Shiva, what is at stake is India’s reputation as a major source of reliable and cheap vaccines for the developing world and one controlled by regulatory institutions known for strict conformance to protocols and for carrying out science-based assessments before granting approvals.

Bharat Biotech的董事总经理克里希纳·埃拉（Krishna Ella）在周一的虚拟新闻发布会上为他的产品辩护。“许多人只是在闲聊。这只是对印度公司的强烈反对。那不适合我们。我们不值得。Covaxin显示出比10％的不良反应。”

Covaxin is produced using a whole inactivated virus, the oldest vaccine technique, by which the live virus is killed to so that it can no longer replicate but is still capable of stimulating an immune response in the recipient. Partial phase 1 and 2 trial results for the vaccine are available on company’s网站。

Meanwhile, Adar Poonawalla, chief executive officer of Serum Institute of India said in atweet：“ @SeruminStindia的所有风险都带来了储存疫苗，最终都得到了回报。印度首款Covid-19-19疫苗Covishield获得了批准，安全，有效且随时准备在未来几周内推出。”

Poonawalla had earlier announced that his firm, among the world’s largest vaccine manufacturers, had stockpiled close to 50 million doses of Covishield, ahead of clinical trials, and was prepared to make 300 million doses by July 2021.

印度土著COVID管道另一个-19 vaccine candidate, approved by DCGI for phase 3 clinical trials — a plasmid DNA vaccine called ZyCoV-D developed byZydus Cadila。DNA vaccines rely on agenetically engineeredplasmid (DNA molecule separate from chromosomal DNA and capable of copying itself) that contains the DNA sequence encoding the antigen(s) against which immune response is sought.

“ Zydus cadila在印度在1,000多名参与者中完成了该DNA疫苗候选者的I期/II期临床试验，并且临时数据表明，当疫苗内部服用三剂时，该疫苗是安全的，免疫原性的，”生物技术部”media release周日说。

这件作品由Scidev.net的亚太桌子制作。

*该文章于2021年1月6日编辑以修复印刷错误。