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The Union Health Ministry said on Tuesday that stakeholders at the Center and states were ready to roll out the mass vaccination program against Covid-19 within 10 days of vaccine approval.
The decision to launch India’s largest adult vaccination campaign, however, will be taken by the central government, he said.
Two vaccines – Covaxin developed by Bharat Biotech with the Indian Council for Medical Research (ICMR) and Covishield, a variant of AZD1222 from Oxford AstraZeneca manufactured under license by the Serum Institute of India – obtained regulatory approval on Sunday for a restricted use in emergency situations.
“The national dry run (Saturday) focused on four areas: testing the operational feasibility of Co-WIN (software platform) on a large scale; assess the links between planning, implementation and reporting mechanisms; identify challenges and address them prior to effective implementation; give confidence to program managers at different levels, ”Health Secretary Rajesh Bhushan said.
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“We performed the dry trial at 286 session sites and reviewed the operationalization of SOPs and protocols. On the basis of this exercise, we are ready for a deployment of the Covid-19 vaccine within 10 days of the date of the emergency use authorization granted by the regulator, ”he said.
Bharat Biotech, which has sent around 5 million doses of its candidate for quality checks and authorizations to the Kasauli Central Medicines Laboratory, hopes to be able to deploy the vaccine for use in the public as soon as possible.
“The fast-track approval came on January 3. We are ready to deploy it within 10 days of approval. The final decision will be made by the government, ”Bhushan said.
During the briefing, the first after approvals had been granted, the Center responded in detail to concerns about the elimination of Covaxin without phase 3 efficacy data.
ICMR CEO Dr Balram Bhargava said statutory rules developed prior to the pandemic allow the regulator to grant restricted use authorization based on phase 2 data in emergency situations.
“The New Drugs and Clinical Trials Rules of March 19, 2019 state that if remarkable efficacy is seen with a defined dose in the phase 2 clinical trial of a new drug for unmet medical needs of serious and life-threatening conditions , this can be considered. for the granting of marketing approval by the central licensing authority on the basis of phase 2 data, ”he said.
“In a pandemic situation,” restricted use approval is being considered based on safety and immunogenicity data while phase 3 trials are still ongoing, Dr Bhargava said. “The immunogenicity data generated by the Phase 2 clinical trial serves as a surrogate for efficacy. And the 2019 clinical trial rules provide for taking Phase 2 results into account to guide approval. “
During the dry trial of the vaccine at GTB Hospital in Delhi on Saturday.
Dr Bhargava said that “safety, efficacy and immunogenicity are necessary for the approval of a vaccine in a non-emergency situation”; however, “the existing pandemic situation with high mortality, available scientific data and lack of definitive treatment is being reviewed by the SEC (Subject Expert Committee) for expedited approvals … which is in our legal provision.”
Dr VK Paul, who heads the national high-level committee on vaccine administration, said Covaxin’s technology was the key scientific principle that led the SEC to recommend the granting of emergency authorizations without data to ‘efficiency.
“… It is a vaccine with an exciting antibody response, not just the S protein, but also the additional proteins… in the face of potential mutations, because this vaccine is a full virion vaccine and produces antibodies on multiple targets… This was noticed by the SEC; second, in their judgment, they stated that this vaccine should be used in clinical trial mode. Therefore, scientific principles and rigor were followed, ”said Dr Paul.
“I would like to stress and reiterate that by granting this authorization, all scientific and regulatory requirements have been met. These decisions are made in a context; it is not a regular authorization. The world is exercising this option by using scientific criteria, reflection and consensus to make decisions in the broader interest of public health, ”he said.
Dr Bhargava gave details of the granting of approval to Covaxin in “clinical trial mode”. “In phase 3, with 25,800 participants, there were no safety concerns after the first dose; and 5,000 received the second dose. Therefore, a restricted use [approval] was administered in clinical trial mode; which means that they must give their consent and that there must be regular follow-up, ”he said.
“The manufacturer has been asked by the drug controller to provide the SoPs and the protocol for the clinical trial mode. In a clinical trial mode, there will be no placebo, ”he said.
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Bhushan confirmed on Tuesday that the Indian government has not banned the export of any Covid-19 vaccine. During the meeting, the secretary of the biotechnology department, Renu Swarup, said the number of samples identified with the most contagious British strain of the virus had now reached 71 in the country.
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