Health ministry trashes reports of hasty approval to Covaxin under political pressure

File image of a vial of Covaxin vaccine

The Centre on Thursday rubbished media reports claiming lapses in the regulatory approval of Covaxin, the indigenous Covid-19 vaccine manufactured by Bharat Biotech, as misleading and fallacious.

The Union health ministry said that the regulators followed a scientific approach with prescribed norms for approving Covid-19 vaccines for Emergency Use Authorisation.

There have been media reports claiming that Bharat Biotech, the manufacturer of Covaxin, “had to skip certain processes” and “speed” up clinical trials due to political pressure. The reports further claim that there were several irregularities in the three phases of the clinical trials conducted for the vaccine. These media reports are completely misleading, fallacious and ill-informed,” the health ministry said.

The clarification from the government came two days after a report published on November 15 claimed to have accessed the ‘internal documents’ related to Covaxin’s approval.

According to the report, the Indian regulators endorsed Covaxin, despite discrepancies in the number of clinical trial participants.

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“Moreover, questionable changes were made to the trial protocols — which are established procedures for testing a vaccine or medicine — to expedite the approval process,” the report said.

Bharat Biotech has said that no external pressure to accelerate development of Covaxin.

"We condemn the targeted narrative against Covaxin put forth by a select few individuals and groups who have no expertise in vaccines or vaccinology. It is well known that they helped perpetuate misinformation and fake news throughout the pandemic. They are unable to comprehend global product development and licensure processes," the company said in a statement.

The Hyderabad-based company said it had internal pressure to develop a safe, and effective vaccine for the Covid-19 pandemic to save lives and livelihoods in India and globally.

The health ministry in a statement, Myth Vs Facts, said the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) met on January 1 and 2 last year and after due deliberations made recommendations in respect of proposal for Restricted Emergency Approval of Covid-19 vaccine of Bharat Biotech.

“Before Covaxin was approved for restricted emergency use in January 2021, the Subject Expert Committee reviewed the data on safety and immunogenicity of the vaccine and recommended for grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains,” the ministry said.

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The Union ministry said that the purported ‘unscientific changes’ in clinical trials of Covaxin, as claimed in the news reports, were made after submission made by Bharat Biotech in CDSCO, compliance of due process in CDSCO and with approval from the Drug Controller General of India.

“Additionally, later on, based on further submission made by Bharat Biotech and assessment of interim efficacy and safety data by SEC of CDSCO, the condition of administration of Covid-19 vaccine in ‘clinical trial mode’ was removed on March 11, 2021,” the ministry said.

Moneycontrol reached out to former director-general of the Indian Council of Medical Research, Dr Balram Bhargava, for a comment on the story but he didn’t respond.

Bhargava on July 2, 2020, wrote a letter to 12 institutions selected for conducting the clinical trials for fast-tracking the clinical trials of the indigenous Covid vaccine by Bharat Biotech.

“It is envisaged to launch the vaccine for public health use latest by 15 August 2020 after completion of all clinical trials,” read the letter.