Government planning emergency use authorisation of Covid-19 vaccine, says Health Minister

The statement by the minister indicates that the government is planning to allow vaccination of a section of people even before phase 3 trials of Covid-19 vaccines are completed.

NEW DELHI: The government is considering “emergency use authorisation” of the Covid-19 vaccine especially for senior citizens and people working in high-risk settings, Union Health Minister Harsh Vardhan said in a major disclosure on Sunday.

“This shall be done after a consensus has been reached, ” said Vardhan, while interacting with his social media followers through “Sunday Samvaad”.

The statement by the minister indicates that the government is planning to allow vaccination of a section of people even before phase 3 trials of Covid-19 vaccines are completed and their results are analysed for safety and efficacy in a large number of volunteers.

The announcement by a senior functionary in the Narendra Modi government comes after the Trump administration in the US has already declared a similar intent.

Last week, the US Food and Drug Administration’s office had however said that drugmakers seeking an emergency authorization for a Covid-19 vaccine will have to meet a higher standard of efficacy than normally would be required for such a clearance.

Back home, senior officials in the Health Ministry, when reached for clarification on the issue said that while the Drug and Cosmetic Acts does provide for such an emergency use authorisation—it can be done only by the drug regulator CDSCO after analysing the limited data from early-stage trials.

“Also, as of now no vaccine maker or importer has approached the regulator for such an emergency use authorisation in India which was granted in case of some drugs for Covid-19,” said a top official.

There are three vaccine candidates—two of them homegrown—under human trials as of now in the country, which is now seeing over 95,000 Covid-19 cases every day.

The minister’s statement on Sunday is especially remarkable as various senior officials including ICMR director Cr Balram Bhargava, who had drawn flak in July for pushing hospitals to fast-track trials of Bharat Biotech vaccine, had later clarified that due scientific and ethical processes will be followed in vaccine development.

The same stand has been repeated by Dr V K Paul, member (health), Niti Aayog who also heads the expert group on Covid-19 vaccine, on several occasions.

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During the interaction, the minister meanwhile maintained that while no date has been fixed for the vaccine launch, it may be ready by the first quarter of 2021.

He added that the government is taking full precautions in conducting the human trials of the vaccine, while a detailed strategy on how to immunize the majority of the population is being drawn - that includes vaccine security, cost, equity, cold-chain requirements, and production timelines.

Vardhan also said that the vaccine will be first made available to those who need it the most, irrespective of their paying capacity.

A safe and effective vaccine will help in establishing immunity to Covid-19 at a much faster pace as compared to the natural infection, said the minister, adding that it is hoped that a consensus will emerge in the next few months over the desired level of protective herd immunity in any community.