The Phase-1 clinical trial of India’s first Covid-19 vaccine has begun in only two of the 12 designated centres, raising doubts on the availability of even the first phase data by August 15 – the original rollout target date for public use as envisaged by the Indian Council of Medical Research.
The delay is due to reasons ranging from non-receipt of the ethics committee approval at some hospitals to logistical challenges in shipping the vaccines to the testing centres after their evaluation at Central Drugs Laboratory, Kasauli.
On 29 June, Bharat Biotech International Limited presented COVAXIN as “India’s first vaccine candidate for Covid-19”, developed in collaboration with ICMR and the National Institute of Virology, Pune.
In a sharp advisory to the clinical trial sites, sent on 2 July, ICMR’s director-general Dr. Balram Bhargava has asked for “fast track (of) all approvals related to the initiation of the (vaccine’s) clinical trial and ensure that the subject enrollment is initiated no later than 7 July.”
On 17 July, Bharat Biotech announced the initiation of Covaxin’s phase-1 clinical trials “across the country on 15 July.”
However, a DH probe revealed that the trials have not begun at most of the 12 medical institutions.
Bharat Biotech sources too confirmed only two test sites – AIIMS Patna and PGIMS Rohtak as have started the trials on 15 and 17 July, respectively.
The state-run King George Hospital in Visakhapatnam is awaiting an approval letter from the government of Andhra Pradesh, while a private hospital Jeevan Rekha in Belagavi is waiting for the vaccines.
“Since it is Phase-1, our ethics committee of Andhra Medical College and KGH asked for the government’s permission. So, I wrote to the state medical authorities, seeking guidelines and official permission. Once the letter comes, probably by Monday, we can start the trial process,” Dr G Arjuna, superintendent of KGH told DH, adding that they are “planning to recruit at-least 50 volunteers for Phase-1.”
There is an in-principle accord for the trails, but a formal letter would set everything in order, Dr. Arjuna says.
ICMR officials stated the DG-ICMR letter to the trial site investigators as “meant to cut unnecessary red tape, without bypassing any necessary process, and speed up recruitment of participants.”
Dr. K Manohar, director, Nizam's Institute of Medical Sciences, Hyderabad had earlier told reporters that the phase-1 process began on 7 July. Dr Manohar did not explicitly answer when DH questioned if the trials have actually started at NIMS.
Dr. Amit Bhate, director, Jeevan Rekha said that their trials are expected to begin “next week.” “We are ready; we can proceed once we get the vaccines and instructions. I cannot reveal a date now,” Dr. Bhate told DH on Sunday.
Dr. Bhate said they are looking at a sample size of 150-200 for the trials.
AIIMS New Delhi’s ethics committee reportedly gave its nod for trials on Saturday.
ICMR officials said that in all, Covaxin tests would be conducted on 1125 volunteers - 375 in Phase-1 and 750 in Phase-2.
Dr. Bhargava’s letter had created a massive controversy since he stated COVAXIN (BBV152 Covid Vaccine) as envisaged to be launched for public health use by 15 August, “after completion of all clinical trials.”
Following criticism from experts and opposition parties that the government was “rushing through an elaborate and time taking vaccine testing process,” the premier research body apparently eased on the Independence Day deadline.
“The indigenous vaccine development process has been sought to be insulated from slow file movement. The aim is to complete these phases at the earliest, so that population-based trials for efficacy could be initiated without delay,” ICMR said in a later explanation. “Our trials will be done following the best practices and rigor, and will be reviewed, as required, by a Data Safety Monitoring Board.”
The Drug Controller General of India had permitted Phase 1 and 2 human clinical trials after Bharat Biotech submitted results from the preclinical studies, demonstrating safety and immune response, the Hyderabad based firm said.
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