Expert panel’s condition: Must submit Ph 1 results before starting Ph II trial of Covaxin

Since wholesome individuals can be enrolled within the scientific trial, the SEC laid down that “RT-PCR test should be used as confirmatory test for Covid-19 during screening”.(Source: Getty/Thinkstock)
More than a fortnight earlier than the Indian Council of Medical Research (ICMR) wrote to scientific trial websites that it was “envisaged to launch” the Covid-19 vaccine “for public health use latest by 15th August 2020”, an professional committee of India’s medicine regulator had laid down 4 particular situations that the corporate creating the vaccine candidate must meet.

The Drugs Controller General of India (DCGI) permitted Phase I and II scientific trials of Covaxin, however a Subject Expert Committee (SEC), which evaluates purposes for scientific trials, stated that Hyderabad-based Bharat Biotech “should submit results of the Phase I clinical trial to the DCGI before initiating the Phase-II study”.

Also, the SEC advisable after its assembly held on June 15, “clinical trial sites should have facilities to handle emergency situations such as anaphylaxis (a severe allergic reaction)”, and that “the investigators should have appropriate qualification & experiences suitable for the conduct of the study”.

Since wholesome individuals can be enrolled within the scientific trial, the SEC laid down that “RT-PCR test should be used as confirmatory test for Covid-19 during screening”.

The SEC put these situations after the corporate introduced knowledge on “safety” and “immunogenicity” collected throughout pre-clinical trials performed on rats, mice, and rabbits.

Experts stated that these situations, that are important to the scientific trial, “will result” within the trial taking longer than ICMR’s unrealistic timeframe. The SEC set no deadlines.

An investigator who’s a part of the trial stated “immunogenicity” – the power to impress an immune response – would be the key side to be examined, and which is able to resolve if the trial can transfer from Phase I to II.

“Even with Covid-19, those with a mild infection don’t have that many antibodies. What immune response we will get, is the key question. This process may take a few months. You have to examine if the vaccine is able to produce enough neutralising antibodies to fight the virus,” the investigator stated.

“Even if the vaccine produces antibodies, we need to examine if they sustain for some time. The antibodies may last only for a few weeks. You can’t have a vaccine that has to be given every few weeks,” the investigator stated.

Referring to the primary essential situation – on submitting the outcomes of Phase I of the scientific trial – put by the professional committee, one other investigator stated the primary part was prone to take “at least three months”.

“Diverse populations have to be enrolled,” this investigator stated. “We have to check if the vaccine is equally effective in the young, elderly, and people with comorbidities. There is no way this can be done in a month. Besides the analysis of the data, the recruitment for the first phase will go on till October.” The course of “cannot be fast-tracked”, the investigator stated.

“Examining the vaccinating-related side effects will be the most crucial. There is vaccine-related enhanced respiratory syndrome, where you have vaccine-led infections of lungs and airways that cause an immune reaction. Then, you have a reaction because of the vaccine, which enhances the infection. This happened during the development of the vaccines for HIV and measles. The vaccine produces antibodies that are not sufficient – and they enhance the severity by allowing more of the virus to enter the cell,” he stated.

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