Two days after announcing a deadline of August 15 for completing clinical trials and launching India's indigenious COVID-19 vaccine COVAXIN, the Indian Council of Medical Research (ICMR) claimed it is following international guidelines for fast tracking this vaccine. BOOM spoke to experts as well as compared the timelines of two other vaccine candidates and found that vaccine approval takes longer than only a month of human trials.
BOOM contacted Vineeta Bal, immunologist at IISER Pune and Anant Bhan, researcher, global health and bioethics who both stated that the international norms do not allow sidestepping of any of the important procedures even when there is an urgent need to launch a vaccine.
"Vaccine approval is a long process anywhere in the world. In their trial registration, Bharat Biotech has mentioned that they would require three months for the first phase. The ICMR needs to show which international guidelines they are referring to," said Bal.
Similarly, Bhan stated, "Internationally, everybody is speaking and exploring ways to speeden the process, but that does not mean you have to go about things in a less ethical manner."
In its July 2 letter to the 12 clinical trial sites, the ICMR had asked the trials to be expedited so that the vaccine could be available for public use by August 15. The ICMR warned that there would be consequences if this timeline was not followed. The two experts believe that it was unfortunate that the ICMR took a threatening tone in this letter.
Following an outcry from medical researchers and doctors, the apex body issued a press release on July 4 stating that it is not 'bypassing any necessary process' and is following 'globally accepted norms to fast-track the vaccine development'. The statement, however, did not address the reason for choosing the deadline as August 15. It also did not clarify which stages of vaccine trial would be expected to be completed till then.
While the ICMR suggests it is following international norms for the fast track, only six of the 12 clinical trial sites have received ethical approval so far. The ICMR expects the trials to begin from July 7, but the sites have not received the vaccines yet.
BOOM checked ICMR's claims of following international norms for fast tracking by comparing the vaccine's timeline with other vaccine candidates.
Fast Tracking Of International Vaccines
The World Health Organization recognises Oxford and Moderna's vaccines as the frontrunners in the vaccine development process while COVAXIN is not even in the list of vaccine candidates released by the WHO on June 29. Oxford vaccine had stated that in a best case scenario, they would have phase III efficacy results by the autumn of 2020 (between September to December). The researchers have called this timeline ambitious even though the University had started screening candidates for the Phase I trial as early as March 27, 2020.
Even though, the US Food and Drug Administration fast tracked Moderna on May12,2020, the company is yet to begin Phase III trials. It announced its intention to develop a COVID-19 vaccine on January 23, 2020 followed by shipping its vaccines for phase I on February 24. It launched phase I trials on March 16 and phase II trials on May 29.
"Even in pandemic fast tracking, phase III trials should not be bypassed as they are important to check whether the virus is efficacious," said Bhan.
Bharat Biotech registered for a 15 month period for completing the trial. The ICMR claimed an August 15 launch. Bal also added that if the letter mentioned August 15, 2021 as a launch for the vaccine, it would have been a reasonable demand.
What Does The Trial Registration State?
Bharat Biotech registered a 15-month trial on July 1 with 12 clinical sites. A total of 1125 participants- 375 in Phase I and 750 in Phase II are supposed to be administered the BBV152 (A,B,C) vaccine. The Japanese Encephalitis vaccine is going to be used as a control. Phase II will begin only after Phase I is found to be safe.
Each participant is supposed to receive two doses on Day 0 and Day 14. After seven days of the first dose and checking the immunogenicity of 50 participants from the first group of 125, enrolment of group 2 and 3 will be initiated. Seven days after the second dose and day 28 in the cycle, the data of all three doses, its immunogenicity and safety will be reviewed by the Data Safety Monitoring Board from the Central Drugs Standard Control Organisation. The vaccine will only then be pushed to the phase 2 trials.
As only six of the 12 sites have received approval for the studies to begin them from July 7, most investigators feel that they will be able to complete only Phase I of the trial by August 15.
Bhan emphasised that the trial registration has no mention of the ICMR as a sponsor, so the tone that they used in the letter for expediting the process could have been avoided.
Preparedness Of The Clinical Trial Sites
BOOM spoke to doctors from 8 of the 12 clinical trial sites, 4 of whom are still to receive approval for conducting the clinical trials. From the four that have received approval, they are yet to receive standard operating procedures as well as the actual vaccines to begin trials. Only five of these twelve are public hospitals and medical colleges.
Dr. Chandrashkehar Gillurkar from Gillurkar Specialty Hospital, Nagpur stated that they will be screening patients who fit the inclusion criteria from July 7. "We have received many requests and have to enroll 30 patients for phase I. The screening process will take about 2-3 days and the patient has no co-morbidities, we will recruit and administer the trial."
Dr. Gillurkar also stated that they will definitely complete Phase I trials but will only wait for Phase II after receiving the approval from the centre.
Two doctors who wished to stay anonymous and have yet to receive approval for the study stated that they would finish the trials if the system is followed.
"Our ethical committee board will be meeting in the upcoming week and we should then start enrollment," one of the doctors said.
Two others who have received approval and are awaiting vaccines said that they are in the process of enrollment. One of the doctors stated that they would be starting the Stage 1 of Phase 1 that includes checking for the first dose of the vaccine. "We can surely finish Stage 1 but I cannot confirm about the rest till August 15," said the doctor.
Dr. Venkat Rao from ISM SUMS hospital, Bhubaneshwar and Dr. R. Vasudev from King George Hospital, Vishakhapatnam affirmed that they would only be able to comment on completion after their ethical committees approved the process.
"I will only be able to enroll my 100-125 volunteers after my Ethical Committee approves the process," said Dr. Vasudev.
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