Amid the ongoing controversy over the Indian Council of Medical Research (ICMR)‘s letter to clinical trial partners, which said an indigenous COVID-19 vaccine was to be launched “latest by 15 August 2020”, the research body and the Ministry of Science gave out confusing messages over the weekend about the timeline.
ICMR director general Balram Bhargava had written a letter on Thursday, 2 July, to those working on a ‘Made in India’ vaccine being developed with with Bharat Biotech International Limited, saying all approvals for clinical trials had to be fast-tracked, and the vaccine was to made available for public use by 15 August.
The letter also noted that “non-compliance will be viewed seriously” – this, along with the compressed timeline, had led to criticism from experts in the medical and scientific community.
This is a letter which has been sent out by the ICMR DG yesterday. Now that multiple folks have confirmed genuineness, let me raise some issues with this letter on #vaccine #trials during a pandemic, in this case #COVID19— Anant Bhan (@AnantBhan) July 3, 2020
What are the ethical issues in this letter? Read on. pic.twitter.com/EaJkeaHjmV
Here’s what the ICMR and the Ministry of Science said, and why this has only created more confusion over the claim, which has immense public significance.
What did the ICMR Say?
Official Statement on 4 July
The ICMR initially appeared to be doubling down on the claim, saying on Saturday, 4 July, that its process was “exactly in accordance with the globally accepted norms to fast-track the vaccine development for diseases of pandemic potential wherein human and animal trials can continue in parallel.”
The research body said that the Drugs Controller General of India had given permission to conduct phase 1 and phase 2 clinical trials for the vaccine, based on in-depth scrutiny of the available data from preclinical studies.
They also pointed out that other vaccine candidates being developed around the world were also being fast-tracked (though it should be noted that no other vaccine candidate has made a claim that it could be launched this soon).
The key point that the ICMR statement sought to make was that the director general’s letter was about cutting red tape, to speed up the recruitment of participants, “without bypassing any necessary process”.
The letter was meant to insulate the vaccine development from slow file movement, the ICMR said, much like the fast-track approval for indigenous testing kits and other related drugs.
However, it did not dial down the 15 August timeline, and appeared to stick by it, adding that while issues raised in the public domain by commentators were welcome, “the best of India’s medical professionals and research scientists should not be second guessed”.
Comments by ICMR Official to Mint
In comments to Mint on Sunday, 5 July, however, ICMR officials sought to tamp down the controversy. Speaking on condition of anonymity, an official told Mint that the director general’s letter was being misinterpreted, and that the ICMR has not said that they will launch the vaccine by 15 August.
The official also told Mint that all safety clinical trials will be conducted, even though the process can be expedited.
What did the Ministry of Science and Technology Say?
The Ministry of Science and Technology only made matters worse on Sunday, 5 July, with a statement of its own about the development of indigenous COVID-19 vaccines.
The Science Ministry’s statement, released via the government’s Press Information Bureau, talks about two vaccines being developed in India – COVAXIN by Bharat Biotech (in partnership with the ICMR) and ZyCov-D by Zydus Cadila.
The ministry said that now that the Drug Controller General of India had approved the conduct of human trials for these vaccines, this “marks the beginning of the end” for the coronavirus crisis.
In its fourth paragraph, the Science Ministry noted that along with these two Indian vaccines, 11 out of 140 vaccine candidates from around the world have entered the human trials stage.
Interestingly, however, the original version of the statement by the ministry qualified this by saying:
While the wording is not the clearest, it appears that the Government of India had itself recognised that none of the COVID-19 vaccines in the human trials phase would be ready for public usage till 2021 – in line with the view of Bharat Biotech’s own MD, Krishna Ella.
Ella (one of those to whom the ICMR letter was sent on 2 July), had told India Today on 1 July that the vaccine would be available by the end of the year.
However, as soon as eagle-eyed journalists and commentators began to pick up on this line in the Science Ministry statement, an amended version of the statement was put up on the PIB website, without the qualifier about the vaccines only being available in 2021.
Interestingly, the Ministry of Science and Technology statement was written by Dr TV Venkateswaran, a scientist at Vigyan Prasar, an autonomous organisation under the Ministry.
He had previously written an article in The Federal, in which he had noted that Bharat Biotech’s submission to the Clinical Trial Registry of India said it would need to conduct follow ups for six months for its trials, and that the whole effort could take up to 15 months.