Govt: will balance risk, vaccine benefit nod


The Indian regulatory framework contains specific provisions for granting emergency use authorization for vaccines, and the risk-benefit ratio will be a key measure for granting the license in a situation where vaccine manufacturers do not submitted only data from Phase 2 clinical trials, the center said Tuesday. .

Union Health Secretary Rajesh Bhushan said the legal framework for granting such licenses is covered by New Medicines and Clinical Trials Rules, 2019. including clinical trial data premises, can be considered for approval… It’s our law, ”Bhushan said.

With three manufacturers asking the Drugs Controller General of India (DCGI) to allow the emergency use of their Covid-19 vaccines for commercial purposes, the Center also stressed that a decision would be made based on scientific processes. “Aligned with global practices”. . “It involves looking at big data, animal data, laboratory data, biochemical data, human response data and the quality of the information collected. Therefore, this is a very thorough review. The Indian regulator is not an individual, he is helped by scientists and experts. We hope the process will be swift but not jeopardize scientific rigor, ”said Dr VK Paul, head of the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC).

While Bharat Biotech has only submitted Phase 2 data for its vaccine and the Pfizer & Serum Institute has submitted data from clinical trials outside of India, ICMR Chief Dr Balram Bhargava , said the regulator, in case of a “temporary license”, will consider the “risk-benefit ratio.” “The benefit must be greater than the risk; in an emergency situation, if the benefit is greater, then the regulator can consider.

On Tuesday, Congress Leader Anand Sharma raised “fundamental questions and concerns” about Pfizer and Bharat Biotech’s demands, with Health Minister Harsh Vardhan. “We all want the vaccines but not at the cost of human lives and public health… Pfizer has not conducted any trials in India and the company has not obtained a license from the country of origin (the United States). Bharat Biotech has not completed phase 3 trials and has not even published interim data on the effectiveness of its vaccine, ”said Sharma.

On vaccine maker Bharat Biotech submitting phase 2 data while seeking approval, instead of big data from phase 3 clinical trials, Bhargava said, “You can call it phase 1, 2 or 3, but from phase 1 we clearly get the safety data, from Phase 1-2 we get safety and immunogenicity data. We have the safety, the immunogenicity of some studies for several months to number of these vaccines. “

Bhushan, the co-chair of NEGVAC, said that there is no need for a country’s regulatory framework “to mention the term ’emergency use authorization'” and that there are provisions allowing Indian regulators to grant temporary licenses in emergency situations of a pandemic. “Just because this phrase is not used in a country’s national regulatory framework does not mean that the country does not have an enabling provision to grant early and separate approval from regular market approval,” said he declared. Bhargava then listed the different terms used by different countries regarding temporary licenses.

“The most important point is that our national regulator is truly respected around the world as one of the most robust, adhering to all scientific processes and timetables,” he said.

Regarding the efficacy of a vaccine, Bhargava said the WHO has “made it clear that if the efficacy is above 50%, we expect it to be used.” “… And this number is available for different vaccines on a very small number of participants. Whatever Phase 3 data is available, for all vaccines it is available for a very small number of participants. I would like to stress again that the risk-benefit ratio is probably the most important thing to consider in a pandemic situation. And it is ultimately up to the regulator to decide.

In her letter to Vardhan, Sharma said that there cannot be “shortcuts” and “people’s lives cannot be compromised”. “It is unheard of for a company that has not even released data evidence from the first two trials and whose phase three trials are still ongoing… their claims have been reviewed,” he said. .

Sharma said he told the health minister to wait for the data to be released. “Let it be peer reviewed. Don’t play with people’s lives.


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