Text size:
New Delhi: Narendra Modi’s government panel of experts has asked vaccine maker Bharat Biotech to make some changes to its proposal to conduct large trials using its indigenous Covid-19 vaccine, Covaxin.
The vaccine is being developed in collaboration with the country’s leading medical research body, the Indian Council for Medical Research (ICMR).
The Hyderabad-based firm had submitted the phase 3 clinical trial protocol along with interim data from the phase 1 and 2 clinical trials to the government’s Subject Matter Expert Committee (SEC).
The SEC advises the main drug regulator, India’s Comptroller General of Drugs, on applications seeking approval of new drugs, vaccines and clinical trials.
The SEC, in a meeting held on October 5, considered that the presented phase 3 study design was “in principle satisfactory”, but suggested some clarifications.
The minutes of the meeting were made available on the website of the Central Drug Standards Control Organization (CDSCO). The CDSCO is the arm of the health ministry that regulates the quality of medicines and vaccines in the country.
While the phase 1 trial generally involves fewer than 100 people, the phase 2 trial has 100 to 300 people enrolled. Phase 3 trials, for which the company had applied for permission, typically enroll more than 1,000 participants.
Read also: From Phase 0 to the long-term study, a look at how long it actually takes to develop a vaccine
Identify the appropriate dose: SEC to Bharat Biotech
According to the minutes, the panel, “after detailed deliberation”, opined that “the design of the Phase 3 study is in principle satisfactory”.
However, he noted that some definitions, such as asymptomatic patients, need further clarification.
In addition, the panel recommended to the company that the study “should start with the appropriate dose identified from the Phase 2 safety and immunogenicity data.”
Immunogenicity data show the immune response elicited in the body after administration of the vaccine.
The company has also been asked to submit safety and immunogenicity data from the phase 2 trial for consideration by the panel.
Read also: Bharat Biotech Partners with University of Washington for Intranasal Covid Vaccine
Biological E’s Covid vaccine candidate is asked to ‘review the proposal’
Another Hyderabad-based vaccine manufacturer, Biological E, had submitted a proposal for a phase 1 and 2 clinical trial protocol to the committee.
However, the panel recommended that the company complete and submit “non-clinical toxicity data in rabbits”.
He has also suggested to the company that it conduct an ascending dose safety study starting with “15 mcg doses, 25 mcg doses and 50 mcg doses before moving on to phase II study.”
In addition, it has instructed that “provocation studies with animals must be carried out in parallel and, consequently, the company must present the revised protocol together with the animal toxicity data.”
Read also: Covid proves only the latest, India’s place in vaccine history dates back to the 19th century
Subscribe to our channels on YouTube and Telegram
Why the media is in crisis and how you can fix it
India needs free, fair, unscripted and more questioning journalism as it faces multiple crises.
But the media is in its own crisis. There have been brutal layoffs and pay cuts. The best of journalism is shrinking, giving in to the raw spectacle of prime-time.
ThePrint has the best young journalists, columnists and editors working for it. To maintain journalism of this quality, it is necessary that intelligent and thoughtful people like you pay for it. Whether you live in India or abroad, you can do it here.
Support our journalism
