ICMR Aug 15 deadline: Dr Soumya Swaminathan said it’s not possible to develop a Covid-19 vaccine within six weeks. She said the clinical trail phase itself may take 6-12 months.

New Delhi, July 9:

Developing a vaccine is a time-taking process which involves several complex steps, because of which it is not possible to make a vaccine with a deadline of six weeks, said World Health Organisation’s (WHO) chief scientist Dr Soumya Swaminathan.

Dr Swaminathan was speaking to India Today TV’s Consulting Editor Rajdeep Sardesai in an exclusive interview where she was asked what she thinks about the Indian Council of Medical Research’s (ICMR) recent move to set August 15 as the deadline for developing a vaccine to fight Covid-19.

“No, it is not possible to do it (develop vaccine) in six weeks,” she said, adding that generally this process takes several years.

However, since the world is currently facing a global pandemic, the WHO has shortened the timeline of vaccine development to some extent, she said.

“Most vaccines developments projects take years to complete. But since we are in the midst of a pandemic, we have shortened the timelines. A very optimistic estimate is that it will take about 12-18 months to a develop a vaccine against Covid-19, from the time you start your vaccine development process,” Dr Swaminathan said.

She said the clinical trail phase may itself take 6 to 9 to even 12 months, depending on how smoothly things are carried out.

“The timeline of the vaccine development can be shortened but the processes that need to be followed can’t be circumvented. This is especially in case of Covid-19 vaccines because these are all new vaccine candidates,” Dr Swaminathan said.

Last week the ICMR triggered a major controversy when a letter written by its Director General, Balram Bhargava leaked into the public domain. In the letter, Bhargava said human trials for the coronavirus vaccine (Covaxin, that is being developed by ICMR and Bharat Biotech) should be “fast-tracked” and set a deadline of August 15, which experts said was unrealistic.

The letter said, “It is envisaged to launch the vaccine for public health use latest by August 15, 2020, after completion of the trial.”

It further stated that Bharat Biotech is strictly “advised to fast-track all approvals needed to ensure subject enrolment is initiated no later than July 7”, and that “non-compliance will be taken very seriously”.

Ever since this letter came out in the public domain, public health experts raised ethical and safety concerns over this move to fast-track vaccine development for a disease about which the world is still learning. (Read more on the controversy and what experts said.)

Responding to these concerns, Dr Swaminathan said she believes that the August 15 deadline is not for the complete vaccine but for Phase 1 trails. “The Phase 1 may be completed by August 15 if everything goes well. Then you need to go into Phase 2 and eventually into Phase 3. Realistically speaking, we are looking at the first quarter of 2021 for a Covid-19 vaccine,” the WHO chief scientist said.

Meanwhile, speaking about the Indian vaccine development projects, Dr Swaminathan said it is “incredibly encouraging” to see these projects coming up in India and elsewhere. “India is very much at the forefront of developing vaccines, not just in terms of manufacturing them and scaling up the production of generic vaccines, but also developing them through local research and development.”

She said the Indian vaccine development system is “robust and strong”, and this this is not the first time that a vaccine is being developed and manufactured in India. “There are mechanisms in place and institutions to protect and oversee the process,” she said.