A message is going viral on social media stating that the vaccine against COVID-19 produced by Bharat Biotech has received permission from the central government and will be available in the market from 15 August. The message is being shared with a letter from ICMR about fast-tracking the clinical trials of the vaccine.
While the letter is real, the message is being shared without the context that there have been clarifications about it stating that 15 August is not actually a deadline for the launch of the vaccine.
The letter is being shared with the following message: “Bharat bio tech vaccine Received permission from central government from 15th August it will be available in market as corona vaccine . Great news today see official permission.”
The Quint received a query on its WhatsApp helpline from one of its readers to check the veracity of the message.
We also found that this message and the letter were also viral on Twitter.
WHAT’S THE TRUTH?
ICMR Issues Letter
While the letter being shared from the Director General of ICMR about the Bharat Biotech vaccine is in no way fake or altered, the viral message along with it lacks the context that came after this letter was issued on 2 July.
In the letter, ICMR says that it has partnered with Bharat Biotech lnternational Limited to fast-track clinical trials of the vaccine produced by the company, which is India’s first indigenous COVID-19 vaccine candidate, named Covaxin.
Further, the letter, addressed to a site chosen for clinical trial, does indeed say that it “is envisaged to launch the vaccine for public health use latest by 15th August 2020 after completion of all clinical trials.” But it also adds that “final outcome will depend on the cooperation of all clinical trial sites involved in this project.”
The issuance of this letter on 2 July was met by huge hue and cry about the difficulties involved and the dangers of fast-tracking to this extent the human trials of such a vaccine. Many questioned how such a feat would be possible in so short a period, especially since BBIL had simply called pre-clinical trial data 'promising' and not shared any details on the kind of success the vaccine has seen in animal testing.
Confusion and Multiple Clarifications
As confusion ensued over the announcement, in an official statement on 4 July, ICMR said 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, also pointing out that other vaccine candidates across the world were being fast-tracked as well. According to the body, the point of the letter was to meant to cut red tape, insulate the vaccine development from slow file movement and speed up the recruitment of participants, “without bypassing any necessary process”.
However, on 5 July, an ICMR official told Livemint that they had not zeroed in on 15 August as a launch date and that the letter was being misinterpreted.
"“Our internal communication is being misinterpreted. We only said that we envisage to have a vaccine by 15 August and it is not a deadline. We have not said that we will launch a vaccine by then. The process can be expedited but the vaccine still will have to undergo all safety clinical trials.”" - ICMR official to Livemint
Further, on 9 July, Rajesh Bhushan, Officer on Special Duty in the health ministry, told PTI that the intent of the ICMR letter was “only to expedite duly approved clinical trials without compromising on safety and security concerns“.
“We want the vaccine to be developed as fast as possible. The aim of the letter was to ask sites to fast-track it. We have the candidate and it should not happen that we miss the bus,” ICMR scientist Nivedita Gupta also told PTI.
While Bharat Biotech remained silent while the confusion raged, in a 26 July interview to The Week, Bharat Biotech founder Dr Krishna Ella said that it is too early to state a date for the launch of Covaxin, “as we are in the beginning phase of human trials. Only after the safety data is established and upon receiving regulatory approvals will we be able to decide to move into the course of licensure.”
Earlier, too, in an interview to The New Indian Express, Dr Ella had said that the vaccine could be available for mass use only by early 2021. “We are hoping all the studies meet the highest safety and efficacy standards, and if the regulators approve of them, we can expect the vaccine to be available early 2021,” he said.
Clearly, it is not true that the vaccine for the novel coronavirus can be expected in the market by 15 August, although efforts are on to make it available as soon as possible, given the seriousness of the disease. The messages being shared are actually lacking context and later updates that took place after the letter was issued.
Meanwhile, the human clinical trials of Covaxin have begun at various sites across the country and has shown "encouraging" results in PGIMS Rohtak, where the first phase of the trial has been completed.
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