At a recent review meeting on the coronavirus disease (Covid-19) vaccine procurement and delivery strategy, Prime Minister Narendra Modi wanted to know the details about the emergency authorization process for a vaccine.
According to some officials present at the meeting, the discussions underscored how the country’s top leaders are preparing for potential vaccine candidates to race to the finish line.
On Friday, the prime minister chaired an expert meeting on strategy for the procurement and delivery of Covid-19 vaccines.
Later, he tweeted: “A meeting was held to review India’s vaccination strategy and the way forward. Important topics related to the progress of vaccine development, regulatory approvals and acquisitions were discussed ”.
Modi asked specifically about the process involved in the emergency authorization of any new vaccine. His intention, officials suggested, was to ensure the government was not caught off guard or entangled in legal or bureaucratic processes during approval.
Two officials informed the prime minister that there were rules for the emergency authorization of vaccines. “We said that our existing legal framework is sufficient to grant such authorization. The Epidemic Disease Act of 2020 empowers states to take any action to prevent an epidemic. It can also be used for vaccines, ”said an official.
The prime minister was also informed that the 2005 National Disaster Management Act was widely used during the 68-day nationwide lockdown restrictions and in containment zones related to Covid-19. The law can also be helpful in implementing vaccines.
“Without prejudice to any other law that is in force for the time being, it shall be lawful for the Central Government to issue written instructions to the Ministries or Departments of the Government of India, or to the National Executive Committee or the State Government, State Authority, Committee State Executive, statutory bodies or any of their officials or employees, as the case may be, to facilitate or assist in the management of the disaster and said Ministry or Department of Government or Authority, Executive Committee, statutory body, official or employee must be obliged to comply with such direction ”, establishes the law.
The Center is also armed with the 2019 New Drugs and Clinical Trials Rules, which mentions “special situations for a new drug where relaxation, abbreviations, omissions or deferrals of data may be considered,” said another official.
The union’s health secretary, Rajesh Bhushan, senior scientific advisor Vijay Raghavan, and Dr. VK Paul, member (health), Niti Aayog, among others, attended the meeting.
The officials, who spoke on condition of anonymity, said the prime minister was informed about the progress of the investigation related to the Covid-19 vaccine candidates both at home and abroad. The prime minister was informed that the emergency authorization for an anti-Covid-19 jab had not yet been 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 approval from the United States Food and Drug Administration (USFDA) for an emergency authorization.
The prime minister was told that the emergency authorization would require more time and could not be granted immediately after the appeal of a vaccine candidate. The prime minister was also briefed on the status of domestic vaccine manufacturers.
In India, five Covid-19 vaccine candidates are in advanced stages of development. Four of the candidate vaccines are in phase II and III and another phase I and II trials.
The prime minister was briefed on the trial results and what to expect in the coming weeks and regulatory approvals, the official added. The progress of talks with other countries and foreign vaccine manufacturers was also discussed.
Initially, the country is considering giving vaccines to up to 300 million Indians by next July and the prime minister was informed about the list of priorities in the first phase.
.
