At review meet, PM asked about emergency authorisation process of vaccines: Officials

At a recent review meeting on procurement and delivery strategy of coronavirus disease (Covid-19) vaccines, Prime Minister Narendra Modi wanted to know the details about a vaccine’s emergency authorisation process.

According to some officials present in the meeting, the discussions underlined how the country’s top leadership is getting ready as possible vaccine candidates race towards the finishing line.

On Friday, the PM chaired a meeting of experts on procurement and delivery strategy of Covid-19 vaccines.

Later, he tweeted: “Held a meeting to review India’s vaccination strategy and the way forward. Important issues related to the progress of vaccine development, regulatory approvals, and procurement were discussed.”

Modi specifically asked about the process involved in the emergency authorisation of any new vaccine. His intent, the officials suggested, was to ensure that the government was not caught off guard or tangled in legal or bureaucratic processes during approval.

Two officials informed the PM that rules were in place for the emergency authorisation of vaccines. “We said our existing legal framework is sufficient for granting such an authorisation. The Epidemic Diseases Act, 2020, gives power to the states to take any measure to prevent an epidemic. It can be used for vaccines as well,” an official said.

The PM was also informed that the National Disaster Management Act, 2005, was widely used during the 68-day nationwide lockdown restrictions and in Covid-19-related containment zones. The Act can also come in handy to roll out vaccines.

“Notwithstanding anything contained in any other law for the time being in force, it shall be lawful for the Central Government to issue direction in writing to the Ministries or Departments of the Government of India, or the National Executive Committee or the State Government, State Authority, State Executive Committee, statutory bodies or any of its officers or employees, as the case may be, to facilitate or assist in the disaster management and such Ministry or Department of Government or Authority, Executive Committee, statutory body, officer or employee shall be bound to comply with such direction,” the Act states.

The Centre is also armed with the New Drugs and Clinical Trial Rules, 2019, which mentions “special situations for a new drug where relaxation, abbreviations, omission, or deferment of data may be considered”, said another official.

Union health secretary Rajesh Bhushan, principal scientific advisor Vijay Raghavan, and Dr. VK Paul, member (health), Niti Aayog, among others, had attended the meeting.

The officials, who spoke on condition of anonymity, said the PM was apprised of the progress on the research related to Covid-19 vaccine candidates both at home and abroad. The PM was informed that emergency authorisation for an anti-Covid-19 jab was yet to be issued by any country in the world.

Pfizer, which has developed a vaccine with its German counterpart, BioNTech, announced on Saturday that it would seek the US Food and Drug Administration’s (USFDA) approval for emergency authorisation.

The PM was told that emergency authorisation would require some more time and could not be granted immediately after a vaccine candidate’s appeal. The PM was also apprised of the status of the domestic vaccine makers.

In India, five Covid-19 vaccine candidates are in advanced stages of development. Four of the vaccine candidates are undergoing the phase II and III and another one phase I and II of trials.

The PM was informed about the trial results and what could be expected in the coming weeks and regulatory approvals, the official added. The progress of talks with other countries and foreign vaccine manufacturers were also discussed.

Initially, the country is looking at administering vaccines to up to 300 million Indians by next July and the PM was informed about the priority list in the first phase.

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