Don’t doubt India’s drug regulator on COVID-19 vaccines: Government

The decisions being taken by the Drug Controller General of India (DCGI) regarding the novel coronavirus disease (COVID-19) vaccines should not be doubted ‘as it was renowned globally for its work’, Niti Aayog member VK Paul, told media December 8, 2020.

His statement came amid questions over transparency over key decisions being taken with respect to the COVID-19 vaccines.

“Whatever the science decides or whatever the regulator decides, please have faith. Doubts should not be created …we have a lot of expertise …Don’t succumb to fake news and contrary opinions,” Paul said at the weekly press conference given by the Union Ministry of Health and Family Welfare.

Doubting would not only destroy the reputation of the regulator but also went against the interests of common people, Paul said.

Union Health Secretary Rajesh Bhushan, in response to a query on emergency use authorisation (EUA), said the decisions regarding approval and timelines were domains of the regulator and the ministry would not like to intervene there.

On December 4, the DCGI, VG Somani, was asked by media about the sequence of events that led him to conclude there was no causality link between a serious adverse event and the Serum Institute of India (SII)’s vaccination in the case of a trial participant. At that time, Down To Earth (DTE) was told to pose such questions in the weekly press conferences to the ministry officials.

EUA in India

Bhushan explained that while India, like many other countries, might not have a phrase called EUA in any of its laws, there were provisions under the New Drugs and Clinical Trial Rules, 2019, to grant such permissions.

“This involves looking at voluminous data — animal, lab, biochemistry and immune response data — it is deep scrutiny. This process is watched by all countries and, therefore, we should leave it there,”  Paul said talking about granting EUA in India.

Three vaccine manufacturers — SII, Pfizer Inc and Bharat Biotech Intl Ltd — have already applied for emergency authorisations to the DCGI. While SII and Pfizer have presented a preliminary analysis of their phase-3 trial, Bharat Biotech is yet to start it.

Indian Council of Medical Research Director-General Balram Bhargava defended Bharat Biotech applying for EUA without any phase-3 data saying the DCGI would look at risk-benefit analysis from whichever phases of trials it came.

“The benefit has to be more than the risk, clearly and in this emergency situation, if the benefit is more, he may consider. Numbers are there, you can call phase I, phase II, phase III,” he said.

“From phase I, we get safety data and also from phase I and II we get safety and immunogenicity data. We have both for several days for many of these vaccines…for several months, they are available. That is a reassuring point,” he said.

Incidentally, all big vaccine manufacturers — Moderna Inc, Pfizer and AstraZeneca plc — have applied for emergency authorisation in various countries only on the basis of partial phase-3 trial results and not just on the basis of results of earlier phases.

Without naming these vaccine manufacturers, Bhargava also sought to downplay the fact that they had applied for the EUA only after partial phase-3 results. “The phase III data that show efficacy of 90-95 per cent is on a very small number of participants,” he said.

Eminent vaccine expert Gagandeep Kang also said no vaccine manufacture should apply for emergency use without any phase-3 data.

“No vaccine should be considered for any form of approval without clinical efficacy and reasonable safety data unless there is an accepted correlate of protection. There is no such correlate for SARS-CoV-2 vaccines at this time,” she told DTE.

Vaccine rollout plan

Bhushan also shared details about how vaccine rollout was planned in the country during the conference. Priority groups include about one crore healthcare workers, two crore frontline workers (people from central and state police departments, home guard and civil defense, disaster management volunteers and municipal workers) and about 27 crore people above 50 years or people less than 50 years with comorbidities.

“It should not be presumed that the immunisation would necessarily be sequential, that is, one group would be immunised after the other. Depending upon the availability of doses, there can be simultaneous immunisation too,” he said.

The health secretary also said the process to collect this data had begun across all states and Union territories and was being uploaded on a software called Co-Win.

Bhushan said about 1.54 lakh out of 2.39 lakh auxiliary nurses and midwives engaged in routine immunisation, would be deployed for COVID-19 vaccination. He, however, claimed this would have ‘minimal impact’ over routine health services, without going into the specifics.

About cold chain infrastructure, he said the existing infrastructure was capable of storing an additional quantity of COVID-19 vaccines (other than vaccines required to be stored for routine immunisation programmes for children) required for the first three crore people; that is, HCWs and frontline workers.

States had been asked to augment cold chain infrastructure further, he said. Additional supplies for this infrastructure would be sent to states beginning December 10, he added.

Meanwhile, The Lancet journal published the first interim results of any COVID-19 vaccine December 8. It published the results of the Oxford-AstraZeneca vaccine. The paper confirmed the efficacy — 90 per cent in one-and-a-half doses and 62 per cent in two full doses — and the safety that was claimed by AstraZeneca in its press release November 23.

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