Experts criticize Covaxin’s ‘abrupt’ endorsement in India; vaccine is bet of Brazilian clinics

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 Experts criticize Covaxin's 'abrupt' endorsement in India; vaccine is bet of Brazilian clinics


The criticisms surrounding the approval of Covaxin, Indian vaccine against covid-19 produced by Bharat Biotech, gained strength on Wednesday, 6. Scientists and political authorities demonstrated after the announcement that the guarantee was granted just one day after the drug regulator asked the manufacturer for more evidence of the vaccine’s effectiveness. The Brazilian Association of Vaccine Clinics (ABCVAC) negotiates the purchase of five million doses of Covaxin. The immunizer is also mentioned in the federal government’s vaccination plan.

“After detailed analysis, the expert committee recommended that the company should carry out preliminary studies of effectiveness in order for emergency use to be approved,” says the record of a meeting held by the regulator on January 1. The following day, Covaxin was approved for “restricted use as a precaution in a public emergency”.



Indian vaccine received authorization for emergency use on Sunday, 3, the day after the regulatory agency requested more data from clinical studies


© Disclosure / Bharat Biotech
Indian vaccine received authorization for emergency use on Sunday, 3, the day after the regulatory agency requested more data from clinical studies


The green light for the Bharat Biotech immunizer was already the target of questioning by health experts and opposition politicians due to the lack of data on the vaccine’s effectiveness, usually obtained in phase 3 of clinical trials, still in progress. News of the committee’s recommendation on the eve of approval increased criticism.

“We are perplexed by the abrupt change in thinking from the SEC (regulatory committee of experts) of the meetings held in the first two days of the analysis to the third day, when approval was recommended without considering the presentation of efficacy data as a condition for the endorsement, ”said The All India Drug Action Network (AIDAN), an independent public health enforcement network.

The All India People’s Science Network, an Indian network of activism groups for science, raised doubts behind the scenes of the approval: “The SEC … seems to have been pressured overnight to reconsider the decision and grant the endorsement the next day ”.

Bharat Biotech and Indian government officials have pointed out regulatory clauses that allow emergency approval of drugs for serious illnesses even without data from the final phase of clinical studies. The company and the regulatory agency did not respond to questions raised by the Reuters on the recommendation made the day before the approval.

Regulators endorsed it only in “clinical trial mode”, an unusual expression that frustrated experts. “They have introduced terminologies that are confusing,” said Giridhar Babu, professor of epidemiology at the Public Health Foundation of India. “The phrase ‘in clinical trial mode’ is not usually a term seen in approvals.” According to Babu, any confusion over vaccines can damage the immunization program by generating mistrust among the population: “It takes decades of work to establish confidence in vaccines.” /REUTERS

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