印度专家质疑新冠疫苗审批程序，称关键信息必须公开

Covid-19: Experts question vaccine approvals, say key info must be made public

印度专家质疑新冠疫苗审批程序，称关键信息必须公开

Several experts have raised questions on the approval process of the two Covid-19 vaccines, Covishield of Serum Institute and Covaxn of Bharat Biotech by the drug controller general of India (DCGI).

几位专家对印度药品管理总局(DCGI)审批两款新冠疫苗的程序提出了质疑，这两款疫苗为血清研究所的Covishield和巴拉特生物技术公司的Covaxn。

Former president of the International Association of Bioethics, Dr Anant Bhan, pointed out that the only other countries to approve vaccines without making the efficacy data public were Russia and . "It is important to build confidence in the regulatory process. But here, a lot of clinicians are unsure and they are asking which vaccine actually works. There is no confidence in the way the approvals were done and in a language that seems to be more creative writing than based on any law," said Dr Bhan.

国际生物伦理协会前主席Anant Bhan博士指出，其他批准疫苗而没有公开药效数据的国家有俄罗斯和。Bhan博士说：“在监管过程中建立信心非常重要。但许多临床医生并不确定哪种疫苗真正有效。人们对审批的方式没有信心。”

Dr Gangandeep Kang, noted vaccine expert and AIDAN have questioned the claim that Covaxn would work against the UK strain of Covid pointing out that there was no data or scientific basis to back the claim.

著名疫苗专家Gangandeep Kang博士和AIDAN质疑Covaxn可以抵抗英国新毒株的说法，指出没有数据或科学依据支持这一说法。

"What is the local efficacy data on the basis of which the expert committee recommended approval for the two vaccines? It is shocking that while Bharat Biotech is struggling to complete recruitment of volunteers for phase-3 trial, the approval was given. So what did the SEC base the approval on?" asked Dr Amar Jesani, editor of the Indian Journal of Medical Ethics.

《印度医学伦理学杂志》的编辑Amar Jesani博士问道：“专家委员会建议批准这两种疫苗的本土疗效数据是什么? 令人震惊的是，当巴拉特生物技术公司正在努力完成第三阶段试验的志愿者招募时，疫苗已经获批了，批准的依据是什么?”

"We need to wait for at least the early results from that Bharat Biotech phase-3 trial before approval. Yes, there is a pandemic, and we need vaccines. But it is equally important that the public have absolute trust in a vaccine that is approved," said Dr JN Rao, an independent public health physician, researcher, and visiting professor at Staffordshire University.

独立公共卫生医师、研究员、斯塔福德郡大学客座教授JN Rao博士说：“在批准之前，我们至少需要等待巴拉特生物技术公司第三阶段试验的早期结果。这是一场大流行，我们需要疫苗。同样重要的是，要让公众绝对信任已获批的疫苗。”

印度时报读者的评论：译者：Jessica.Wu

vibh

Who are these jokers being called experts??

这些被称作专家的小丑是谁?

Rishi Acharya

When country is in hands of an arrogant, illiterate person then these things will happen. We r going towards dark ages, that's sure.

当国家由一个傲慢的文盲掌控时，就会发生这种事情。我们正在走向黑暗时代，这是肯定的。

Logical view

Modi and his gang is hell bent on taking the credit for vaccine through fake propoganganda from thier godi media channels, though they are no way related to development of these vaccines, they are putting lives of millions on stake for thier ego.

莫迪及其团伙通过他们的喉舌做虚假宣传，一心要把研发疫苗的功劳占为己有，尽管他们与这些疫苗的研发毫无关系，他们为了出风头，正把数百万人的生命置于危险之中。

Narayan Acharya

Public do not understand the technicalities.

We don't want the details. We believe in DCGI and IMCR and the PM. The experts who raise the questions already have vested interests.

公众不懂技术细节，也不想知道细节。我们相信DCGI、IMCR和总理。提出质疑的专家肯定有自己的目的。

viru

There is excessive enthusiasm to prove India is leading just like other super powers in vaccine efforts. An apparent nationalistic approach which can put millions at risk.

印度过分热衷于证明自己在疫苗研发方面跟其他超级大国一样处于领先地位。这种明显的民族主义做法可能会让数百万人处于危险之中。

Be Indian

My dear experts..hitler reborn in india... so don't expect anything

亲爱的专家们，希特勒在印度重生了，大家不要抱任何指望

Prakash Velu

Relevant authorities understands everything and they are experts.

TOI should stop suchb articles and should not add confusion to people!

有关部门什么都懂，他们是专家。印度时报不要再发表这类文章了，人们会感到困惑的!

Sanjeev Nandwani

I have full confidence on Indian researchers and technicians, though they might be working when BJP or Congress is in center. doubters can have vaccines or go to Italy to get a shot of it

我对印度的研究人员和技术人员充满信心，持怀疑态度的人可以买的疫苗，也可以去意大利打疫苗

Anjan Kesh

Govt has said there are no side effects, what more proof we need. The govt has not lied to you before, has it?

印度政府已经说过没有副作用，我们还需要什么证据。政府以前没有对你们撒过谎吧，有吗?

Mithilesh Gupta

Those who don't believe the vaccine may opt not to take the vaccine. This will save some tax payer's money and the vaccine will be available to those who want it.

那些质疑疫苗的人可以选择不接种，还可以节省纳税人的钱，想要打疫苗的人可以打。

Pranav Kumar Jha

let's politicians first get the vaccine ..

让印度政客先接种…

Guest

even in crises periods, we ,Indians, cannot come together

即使在危机时期，我们印度人也不能团结一致

viru

Now there will be some wishy-washy answer by government!

政府将做出一些模棱两可的回应!

Rakesh Mitra

Do these idiots understand emergency approval? Why so much fuzz! The vaccine has been approved for emergency use unlike and Russia where they have released for public administration.

这些白痴知道什么叫紧急审批吗?

印度已批准新冠疫苗用于紧急使用，而和俄罗斯已经批准为公众接种了。

Rahul Jalan

no credentials in these people to call them expert...

Attention seeking behaviour...don't spread rumours

这些人没资格被称为专家，就想博眼球……不要散布谣言