Four days after India's first indigenous COVID-19 vaccine candidate got approval for human clinical trials by the drug regulator, the Indian Council of Medical Research (ICMR) on Thursday announced that it wanted to "launch the vaccine for public health use latest by August 15".
The ICMR has set the ambitious launch date in partnership with Hyderabad-based Bharat Biotech.
Bharat Biotech is the maker of the world's cheapest Hepatitis vaccine and was also reportedly the first firm to develop a Zika virus vaccine in the world.
ICMR'S Push To Fast-Track Process
On July 2, the apex medical research body's director-general Balram Bhargava wrote to a dozen institutions involved in the trial to "fast-track all approvals", adding that participants for the trial should be enrolled "no later than July 7".
Bhargava warned that non-compliance will be viewed very seriously. "Therefore, you are advised to treat this project on highest priority and meet the given timelines without a lapse," he wrote in the letter.
Public health experts, medical experts have raised serious safety concerns over the ICMR's desperate and sudden push to fast-track development of the vaccine and make it available for public use by the Independence Day.
Several medical institutes chosen to conduct the trials have also referred to the timeline of vaccine development as 'impossible'.
Expert's Concerns Over Safety
Many have raised ethical concerns over the ICMR's decision to develop the vaccine for a disease about which the world is still learning.
"For a vaccine for which pre-clinical development is still ongoing, how can clinical trial recruitment be starting on July 7 and the vaccine be launched on August 15? A vaccine trial completed in little over a month, efficacy pre-decided?" Anant Bhan, researcher at the Global Health, Bioethics and Health Policy said in a series of tweets.
Some experts have also raised questions on the selection of the institutes chosen for the trials.
"How were the clinical trial sites mentioned in the appendix chosen--on what criteria? What was their eligibility? From which list was this selection done by ICMR? Some of these institutes seem to be small nursing homes/hospitals. Are they the apt place to run a pandemic vaccine trial?" Bhan asked on Twitter.
Some even termed the ICMR's push to fast-track the development of the vaccine as threatening.
"This reads more like a threat than a letter. 'Get everything done by July 7 (in a letter dated July 2) and start clinical trial participant recruitment', otherwise non-compliance will be viewed seriously? By whom? By the ICMR? Under what powers?" Bhan tweeted.
"Vaccines have to be safe for children, adults etc. The bar for a COVID-19 vaccine is much higher because it has to be tested across different age groups as both young and adults will use it. All this will take 2-2.5 years and we should calibrate our expectations accordingly," Prof Ramana Laxminarayan, director of the Center for Disease Dynamics, Economics & Policy (CDDEP) told India Today.
Throwing light on the dangers of fast-tracking the process, the professor said, "if we roll out a vaccine which harms even one in a thousand person, it still will have terrible effect on public confidence on any COVID-19 vaccine."
Dr Davinder Gill, vaccine expert and former CEO of Hilleman Labs said: "Developing a full-fledged vaccine by August 15, 2020, was scientifically not possible. "ICMR should admit it was a typo. (The date) should be 2021...that will take away the hysteria and make people focus on real work."
Stages Of Vaccine Development
The Clinical Trial Registry of India for human trials of 'Covaxin' reveals that the trial was registered on July 1 for Phase 1 and 2. The details shows that it plans to test 1,125 people in these trials and plans to enroll people on July 13.
As per the registry, the firm could take one year and three months. Of this, Phase 1 trials alone will take at least a month. This implies that there is very less time to look into the safety and efficacy of these trials.
As per the global average, a drug candidate in a lab normally takes 12 years to reach the market and a vaccine takes 8-10 years.
- Phase 1 is conducted on 1,000-3,000 patients and takes about 2 years
- Phase 2 is conducted on 1,000-3,000 patients and takes at least 2 years
- Phase 3 is conducted on 15,000 to 30,000 patients and takes a minimum of 3-5 years
In the case of the ongoing deadly pandemic, fast-tracked trials are preferred to move fast in the direction of vaccine development which include:
- Phase 1 is for safety studies and conducted on 50 to 500 people. It takes about four months.
- Phase 2 is for dosage of the vaccine. It is conducted on 500 to 1,000 people and takes additional four months.
However, in case of India's first COVID-19 vaccine, these two phases will now happen together.