Bharat Biotech, Union Health Ministry deny claims that Covaxin was ‘rushed under political pressure’

Bharat Biotech said US-based media outlet STAT's report was fake news; the ministry said it was misleading, fallacious, and ill-informed.

BySumit Jha

Published Nov 17, 2022 | 9:27 PMUpdatedNov 17, 2022 | 9:27 PM

Covaxin

Hyderabad-based Bharat Biotech, the manufacturer of the Covid-19 vaccine Covaxin, has said that there was no external pressure to accelerate its development.

Its assertion came after US-based media outlet STAT, in an investigative report, said that the manufacturer rushed the development of the vaccine under political pressure.

The report also claimed that as a result of this, the firm skipped a mandatory process before launching the vaccine.

The Union Ministry of Health and Family Welfares also denied the allegations, and called them misleading and fallacious.

What were STAT’s finding?

STAT, which specialises in reporting on healthcare, claimed in its report that the Central Drugs Standard Control Organisation (CDSCO) endorsed Covaxin despite discrepancies in the number of clinical-trial participants.

The report stated: “In reporting the Phase 1/2 data, the protocol stated that 402 participants were given the first dose and 394 got the second one. But results published in Lancet Infectious Diseases in January 2021 stated that 375 people were given the first dose and 368 received a second one.”

It also claimed that several changes were made to the trial protocol to rush the approval of the vaccine, including the dropping of the placebo arm.

Quoting Bharat Biotech Director Krishna Mohan, the report said the trial process was vetted due to certain political pressure.

The report also claimed that the CDSCO subject expert committee (SEC) gave Bharat Biotech permission to initiate phase-II trials even before the results of the phase I trial were available.

Similarly, the phase-III trial was without the report of Phase-I and Phase-II. The permission had been granted based on preclinical studies conducted on animals.

The report also said that the CDSCO permitted Emergency Use without phase-III data.

Bharat Biotech denies all allegations

The manufacturer said the report was a targeted narrative against Covaxin put forth by a select few individuals and groups who have no expertise in vaccines or vaccinology.

It was well known that they helped perpetuate misinformation and fake news throughout the pandemic, said the company.

They fail to understand product development and licensure pathways worldwide, it added.

The company also said that the pressure was all internal to develop a safe, and effective vaccine for Covid-19, to save lives and livelihoods in India and globally.

Company admits to some parts of report 

STAT in its report claimed that the phase-III trial happened without the immunogenicity data of phase-I and phase-II trials. The company, however, admitted that the decision was taken without data from the phase-II trial.

“The decision to proceed to phase-III trials was taken based on data from phase-I studies and results from successful animal challenge trials,” said Bharat Biotech in the statement, which confirmed that the choice of a vaccine candidate for phase-3 trial was not based on immunogenicity data from the phase-II trial.

It added that vaccines against ebola and monkeypox were approved by stringent regulatory agencies in developed countries based on phase-I and II clinical data only, and without phase-III data.

If such approval was given by regulators in India, there would be uproar, but the same people and organisations remain silent on them, demonstrating their hypocrisy, said Bharat Biotech.

Some allegation unanswered

Bharat Biotech in its statement did not refute the allegation of discrepancies in the number of participants in the phase-I trial, which Bharat Biotech Director Krishna Mohan has as conceded “errors” in participant numbers. The company also did not refute the claim that Krishna Mohan spoke to STAT.

Krishna Mohan has only claimed in the story that the company faced “political pressure”.

The company also did not explain the reason behind the dropping of the placebo arm or changing the dosing interval to expedite the phase-II trial. It also did not deny that the phase-II trial began even before the immunogenicity data were evaluated.

Malini Aisola and Siddhartha Das — both members of the All India Drug Action Network, which has been quoted in the STAT story — told South First that Bharat Biotech has indeed not denied facts put forward in the STAT story,

“On the other hand, Bharat Biotech has confirmed that the data from the phase-II trial was not considered before proceeding with phase-III. In the statement, the company is deflecting and has not provided any response to other questions and discrepancies,” Aisola told South First.

‘Misleading, fallacious, and ill-informed’

Meanwhile, the Union Ministry of Health and Family Welfare (MoHFW) said the STAT report was completely misleading, fallacious, and ill-informed.

The ministry said that the SEC reviewed the data on the safety and immunogenicity of the vaccine and recommended the granting of permission for restricted use in an emergency situation in the 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 SEC’s approval for the commencement of the phase-III clinical trial of the proposed dose of Covaxin was based on scientific data presented by Bharat Biotech and established practices.

However, the ministry did not deny that the emergency-use authorisation was given without the availability of phase-III data.

“The authorisation to Covid-19 vaccines, including Covaxin, for restricted use in an emergency with various conditions and restrictions were granted by the national regulator only on the recommendations of the Subject Expert Committee of the CDSCO,” said the MoHFW in its statement.

“The government has not denied or provided an explanation for any of the specific corrected inconsistencies in the clinical trials highlighted by STAT. While it has pointedly refuted that any ‘political pressure’ was exerted to speed up the vaccine development and approval process, this was a claim made by Bharat Biotech’s director,” Das told South First.