Scientists bust ICMR’s claim for COVID-19 vaccine by August15

ICMR's claim to launch COVID-19 vaccine by 15 August has been busted by the scientists. A day after it drew flak for setting what was seen as an impossible deadline for developing a vaccine for COVID ICMR has faced criticism from the experts.

1. ICMR's unrealistic claims busted by scientists

After the claims made by ICMR to launch a vaccine in just 38 days , the experts raised concerns on non-compliance of participating institutes seriously

2.ICMR announced the launch of vaccine in unbelievably impossible deadline

After being pointed out on the superfluous theory, ICMR had to issue clarification saying that the letter was meant to “cut unnecessary red tape” and speed up recruitment of participants for trials without bypassing necessary process.

3. ICMR had to issue clarification after the superfluous theory was pointed out

The clarification from the government’s apex medical research body comes in the wake of concerns in the medical and scientific community for ICMR setting August 15 as a target for developing a vaccine

4. Medical and scientific community raised serious concerns over the target setting for vaccine

The letter was written by ICMR director general Dr Balram Bhargava. While timelines were strongly questioned by the scientific community, ICMR said the effort was to speed up recruitment for human trials

5. DG-ICMR Dr. Balram Bhargava said in a letter that the effort was to speed up the human trials

Amar Jesani, editor of Indian Journal of Medical Ethics and a public health advocate, said,“Firstly, I wish today’s ICMR statement was signed by its DG because it was his letter to investigators of the vaccine that created the storm."

6. Experts are not satisfied by the clarification given by ICMR

"Most of the issues raised in that letter still remain hanging without any answer. ICMR is silent on the timeline, the statement does not mention August 15. How have they arrived at this date? Do they plan to waive off Phase 3 trials?",asked Jesani

7. Scientists question the intentions of ICMR on trial norms

"The DG must also apologise for threatening the institutions, ethics committee and the scientific community by saying that not adhering to timeline will attract action.”

8. The DG must apologise for threatening the institutions to meet deadline: Experts

Anant Bhan, researcher on biotech and ethics said, “It is good to see ICMR clarify its intent to conduct the trial scientifically. However, the concerns raised with regards to the timelines, the instructions to the sites to comply have not been clarified, including on the ethical red flags these raise.

9. Researchers said ICMR's instructions raise ethical red flags

According to scientists ideal time period required for the development of a vaccine is two and a half years. In the fast-track mode, it will take eight months to a year for completing the process of clinical trials, data testing, accuracy and efficacy of vaccine.

10. Development and clinical trials,data testing is a long process: scientists

Human trials of the inactivated BBV152 or Covaxin, a vaccine candidate being developed by Bharat Biotech along with ICMR and the National Institute of Virology, Pune, that begin on July 7 will be required to follow these processes.

11.Human trials of Covaxin will begin on July 7

The globally accepted ‘fast-track mode’ allows for eliminating one or two steps that are repetitive in nature but does not allow for any process or data to be sidelined.

12. No process and data can be sidelined

The adverse effects of vaccine, discrepancies in human body reactions and antibody studies will make the basis of going forward in every step.

13. Each step of trial takes time and cannot be completed in a haste

All of this may not be completed in the 38-day timeline set by ICMR, and may put paid to its plan of secure a vaccine by August 15, Independence Day.

14. It is impossible to complete all the steps of the vaccine trials in 38 day timeline

ICMR's announcement has not only questioned the compliance of ethics but also indicated bypassing of scientific norms by the highest medical body

15. ICMR's announcement has raised serious concerns over scientific ethics and norms