NEW DELHI: In a pandemic situation, emergency use of vaccinations is considered based on safety and immunogenicity data while phase three clinical trial It is underway, the head of the Indian Council for Medical Research (ICMR), Balram Bhargava, said on Tuesday.
Explaining the process followed to grant approval to the Oxford Covid-19 vaccine and the indigenously developed Covaxin, he said: “The committee of subject matter experts (SEC) considered the existing pandemic situation, the high mortality, the science available and the lack of definitive treatments (SEC) on Covaxin.19 from CDSCO for granting expedited approval to these vaccines, and that is in our legal disposition. ”
The Comptroller General of Drugs of India (DCGI) had approved on Sunday the Covishield Oxford Covid-19 vaccine, manufactured by the Serum Institute, and the Covaxin from Bharat Biotech for restricted emergency use in the country, paving the way for a massive inoculation campaign.
Industry experts and some opposition leaders have raised concerns about the absence of phase 3 trial data on Covaxin. Critics have warned that “circumventing” the process and giving “premature” authorization could risk lives and fuel vaccinations in India.
“In a pandemic situation, restricted use is considered based on safety and immunogenicity data, while the phase three clinical trial is still ongoing. The immunogenicity data generated through the phase two clinical trial they serve as a surrogate for efficacy. The 2019 Clinical Trials Rule establishes considering the results of phase two to guide approval.
“Now the SEC guides the DCGI in the decision-making process for restricted use in emergency situations. We now have two vaccines,” Bhargava said.
By providing details of the Covishield studies in the UK, the Head of ICMR He said that animal studies showed that the vaccine prevented SARS-CoV-2 pneumonia in monkeys and caused good immunogenicity in mice.
Phase one and two clinical trials in 1,077 participants showed an acceptable safety profile and a homologous increase in antibody responses. Phases two and three of the first booster regimen in 560 participants showed that it is better tolerated in older adults than younger adults and has similar immunogenicity in all age groups after a booster dose. The result was published in The Lancet, said the head of ICMR.
The phase 3 trial in 11,636 participants from the UK and Brazil, with two standard doses, showed that the efficacy of the vaccine was 62.1 percent, in the case of a low dose followed by a standard dose, the efficacy was 90 percent. Overall, the efficacy of Covishield was 70.4 percent. This was posted online last month, he said.
Looking at the Covishield phase two and phase three clinical trials in India, there were 1,600 participants over the age of 18. Your immunogenicity data is being generated, more than half is available. Covishield is safe and immunogenic and the data showed that it is “not inferior to the UK product,” Bhargava said.
“It was an important point that led to approval,” he added.
As for Covaxin, Indian studies in animals such as rats, mice, rabbits, hamsters, and monkeys showed excellent safety and immunogenicity. It showed strong viral clearance from both the upper and lower respiratory tracts in large animals.
Phase one and two clinical trials in 375 and 380 participants respectively revealed very low adverse events, Bhargava said, adding: “It showed neutralizing antibody responses equivalent to human convalescent serum, strong antibody responses to all structural proteins … three months after vaccination. ”
The phase three clinical trial will include 25,800 participants, of which 24,000 have been enrolled so far. There are no safety concerns. They (participants) have had their first dose and more than 5,000 given the second jab.
“Permission for restricted use has been allowed in clinical trial mode, which means consent must be taken from participants and there must be regular follow-up of participants,” Bhargava said.
Explaining further, he said that the drug controller has requested the manufacturer of Covaxin to provide the protocol for the clinical trial mode.
The clinical mode means that everyone will consent to the vaccine, there will be no placebo and there will be a closer follow-up.
“As for the Covaxin (trace) publications, the animal studies have been published in Nature Communications and High science, which is a cellular journal. The phase one trial was being published in the Lancet Infectious Diseases … and the paper phase two is under review there. They also have the phase three protocol which is also being reviewed by the British Medical Journal. ”
“There is another important publication in the Indian Medical Journal research that has compared large animal data on all vaccine products and has shown the efficacy of this as well, “said Bhargava.
Referring to the New Drugs and Clinical Trials Rules issued on March 19, 2019, he said it clearly states that if remarkable efficacy is observed with a defined dose in the Phase 2 clinical trial of an investigational new drug for medical needs Not covered for serious life and potentially dangerous diseases in the country, the granting of marketing approval by the Central Licensing Authority may be considered based on data from Phase 2 clinical trials.
On video: Drug Controller asks manufacturers to provide standard operating procedures and protocol for a clinical trial mode: DG ICMR
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