An expert committee of the Central Drugs Standard Control Organisation (CDSCO) on Wednesday will review the application of three coronavirus vaccine manufacturers, namely Pune-based Serum Institute of India, Hyderabad-based Bharat Biotech International, and Pfizer-BioNTech. All three vaccine-making companies are seeking emergency use authorisation from the authorities.
Recently, Bharat Biotech, during its COVID-19 vaccine trial, changed the dosage from 3 micrograms antigen to 6 micrograms antigen. Therefore, Bharat Biotech has now two distinct arms of their early phase trials. It is obvious that altering a dosage can change the results of immunogenicity, a point that the subject expert committee will review on Wednesday, according to a report in Business Standard.
Additionally, the expert committee will also review the applications of Pfizer-BioNTech and Serum Institute so that their vaccines get an entry to the market.
Bharat Biotech, which has collaborated with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV), has submitted the data from Phase-1 and Phase-2 trials to the regulators for the evaluation of Covaxin's efficacy but data of Phase-3 trial is yet to be submitted, which are underway.
Several experts have raised questions about Bharat Biotech applying for emergency usage as Covaxin is still going through an efficacy trial. However, the ICMR, the apex health research institute, has backed Bharat Biotech's move.
According to ICMR director, Balram Bhargava, if a vaccine provides more benefits than harm then it might get approval from the regulator for emergency use. He added, "Numbers are there from phase-1, we get the safety data, and from phase 1 and 2, we get immunogenicity data".
Bhargava said that he has a record of all the vaccines covering a period of several months, and added, "the risk-benefit is the most important thing to look at in a pandemic situation, but ultimately the national regulatory authority has to take the decision".
As per the daily, two experts working closely with the regulators said in a risk-benefit analysis during a pandemic, one had to look at the safety parameters of the candidate and then evaluates its efficacy.
Pfizer-BioNTech's BNT162b2 COVID-19 vaccine candidate, which has received a nod for emergency use in the UK and Bahrain, had conducted the global trial on over 43,000 people globally. However, in terms of efficacy data, some experts said it would be important to look at the data from people of Indian origin. "It is important to have data on the Indian demographics. We will definitely evaluate this point". Pfizer-BioNTech has not yet applied for conducting clinical trials in India.
Meanwhile, Serum Institute has finished its phase-3 trial on 1,600 Indian volunteers to examine the safety and immunogenicity of its Covishield vaccine. SII is likely to discuss the matter with AstraZeneca--its counterpart in the UK-- to arrive at a decision. AstraZeneca will reportedly submit the data from the UK arm to the Indian regulator this month.