The Indian regulatory framework has specific provisions for grant of emergency use authorisation for vaccines, and the risk-benefit ratio will be a key metric to grant the licence in a situation where vaccine manufacturers have submitted only Phase 2 clinical trials data, the Centre Tuesday said.
Union Health Secretary Rajesh Bhushan said the legal framework for grant of such licences is covered under the New Drugs and Clinical Trial Rules, 2019. “(It) clearly specifies that under specific, special situations, relaxation, abbreviation, omission or deferment of data, including local clinical trial data, may be considered for approval… This is our law,” Bhushan said.
With three manufacturers applying to the Drugs Controller General of India (DCGI) for emergency use authorisation of their Covid-19 vaccines for commercial use, the Centre also underlined that a decision would be taken based on scientific processes that are “aligned with global practices”. “This involves looking at voluminous data, animal data, laboratory data, biochemistry data, human response data, and the quality of information collected. Therefore, it is very deep scrutiny. The Indian regulator is not one individual, it is aided by scientists and experts. We hope the process is expeditious but it will not compromise on scientific rigour,” Dr V K Paul, the head of the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC), said.
While Bharat Biotech has submitted only Phase 2 data for its vaccine, and Pfizer & Serum Institute have submitted clinical trial data from outside India, ICMR Chief Dr Balram Bhargava said that the regulator, in case of “temporary licensure”, will look into the “risk-benefit ratio”. “The benefit has to be more than the risk; in an emergency situation, if the benefit is more, then the regulator may consider.”
On Tuesday, Congress leader Anand Sharma raised “fundamental questions and concerns” regarding the applications by Pfizer and Bharat Biotech, with Health Minister Harsh Vardhan. “We are all keen to have 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 got licence from the country of origin (the US). Bharat Biotech has not completed Phase 3 trials and not even released any interim data on efficacy of its vaccine,” Sharma said.
On vaccine manufacturer Bharat Biotech submitting Phase 2 data while seeking approval, instead of large Phase 3 clinical trial data, Bhargava said, “You can call it Phase 1, 2 or 3, but from Phase 1, we get clearly the safety data, from Phase 1-2, we get safety and immunogenicity data. We have the safety, immunogenicity of certain studies for several months available for many of these vaccines.”
Bhushan, the co-chair of NEGVAC, said it is not necessary that a country’s regulatory framework “make mention of the phrase ‘emergency use authorisation’” and that there were provisions enabling Indian regulators to grant temporary licences in emergency situations of a pandemic. “Simply the fact that this phrase is not used in the national regulatory framework of a country does not mean that the country does not have enabling provision to accord approval which is early, and is distinct from regular market approval,” he said. Bhargava went on to list the different terms used by different countries regarding temporary licences.
“The most important point is that our national regulatory authority is really respected the world over as being one of the most robust, following all scientific processes and timelines,” he said.
On efficacy of a vaccine, Bhargava said the WHO has “clearly said that if the efficacy is more than 50 per cent, we expect (it) to be used”. “… and that number is available for different vaccines on a very small number of participants. Whatever Phase 3 data is available, for whatever vaccines, is available for a very small number of participants. I would re-emphasise the point that risk-benefit is probably the more important thing to look at in the situation of a pandemic. And it’s ultimately for the regulator to decide.”
In his letter to Vardhan, Sharma said there cannot be “shortcuts” and “people’s lives cannot be compromised”. “It is unheard of that a company which has not even released elementary data of the first two trials and whose phase three trials are still on… their applications have been entertained,” he said.
Sharma said he had told the Health Minister to wait for the data to come out. “Let it be peer reviewed. Don’t play with people’s lives.”