Coronavirus | SII, Bharat Biotech emergency vaccine authorisation on hold

DCGI awaits more evidence before providing clearance

A medic fills a syringe with Covaxin, a COVID-19 vaccine, in Ahmedabad. File

India may have to wait longer for a locally produced vaccine as an expert committee of the Drug Controller General of India (DCGI) has kept on hold, pending more evidence, proposals by the Serum Institute of India (SII) and Bharat Biotech requesting emergency use authorisation (EUA) for their vaccine candidates Covishield and Covaxin, respectively.

Referring to the SII’s Covishield vaccine, the committee said: “...recommended that the firm should submit updated safety data of the Phase II/III clinical trial in the country, Immunogenicity data from the clinical trial in UK and India and, the outcome of the assessment of UK-MHRA [the U.K. regulator] for grant of EUA,” according to the minutes of the meeting uploaded on the regulator’s website late on Wednesday.

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It had a similar response to the data presented by Bharat Biotech on Covaxin, saying that data generated after the

completion of Phase 3 trials was needed to make an evaluation.

“Neither company presented complete data from their ongoing Phase 3 trials. We also wanted more information on the reported case of a volunteer in Chennai , who reportedly had a severe adverse reaction,” the person cited above told The Hindu  on condition of anonymity. The latter, however, does not find mention in the official minutes.

A volunteer in Chennai, as

The Hindu  reported last month, sued the SII for what he believed was an adverse neurological reaction from being administered the vaccine. SII has denied the link and counter-sued the applicant. While Indian Council of Medical Research officials have said that an “initial” investigation showed the reaction wasn’t due to the vaccine, a fuller explanation is not yet available from the government.

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The 10-member committee, called the Subject Expert Committee, consists of members from multiple disciplines, including microbiology, pharmacology, paediatrics and pulmonary medicine. The committee meets periodically to recommend approval, or rejection, of new drugs and vaccines.

India’s law allows a potential vaccine or drug to be commercially approved even without trials on Indians, provided the same has been approved in another country. However, such decisions usually rely on the discretion of the committee members who may ask for minimal, or several, lines of evidence before arriving at a decision.

Pfizer-BioNTech — whose vaccine has been approved for use in the United Kingdom and Bahrain — had applied to Indian regulators before SII and Bharat Biotech, and was scheduled to present its data to the committee but did not turn up, the source added.

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The committee also gave permission to Pune-based Gennova Biopharma, which is developing an m-Rna vaccine , to begin human trials.

The SII is testing a vaccine candidate developed by Oxford University and AstraZeneca on 1,600 volunteers in India , and Bharat Biotech has begun testing its vaccine in 28,500 volunteers across the country. SII’s vaccine is yet to be approved by regulators anywhere, including in the United States and the United Kingdom for public use.

“Were any of these countries’ regulators to approve, we would consider favourably for approving it [the vaccine] in India. But now, we have neither this nor convincing India-specific data,” the source said.

The Union Health Ministry termed as “fake news” a media report on Wednesday that said SII and Bharat Biotech’s applications had been “rejected”. However, a Ministry spokesperson did not offer additional clarification.

On Tuesday, scientists who have developed the Oxford vaccine, which is based on a chimpanzee adenovirus vector platform, reported in the medical journal Lancet  that while the vaccine had an efficacy of 70% and was largely well-tolerated, there was at least one volunteer who “possibly” experienced a severe reaction on being inoculated with the vaccine. Severe reactions are expected with most vaccines but regulators, in deciding whether a vaccine should be licensed, make an assessment based on whether the benefits outweigh the risks.

Covaxin, which is a vaccine based on an inactivated SARS-CoV-2 strain, has not yet made public its data on the vaccine’s efficacy. Pfizer-BioNTech and Moderna made public their efficacy data from their Phase 3 trials before approaching the regulators.

Both SII and Bharat Biotech are relatively ahead of other vaccine companies in India developing potential vaccines for COVID-19, having initiated large human trials, or Phase-3 trials. On Wednesday, a delegation led by the Ministry of External Affairs, comprising of the High Commissioners and government representatives of 70 countries across the world, from Asia, Africa, Europe, North America, South America and Oceania, visited Bharat Biotech’s Hyderabad facilities to be briefed about Covaxin. Prime Minister Modi visited these facilities, as well as that of SII, in November.

Officials have said that 30 crore Indians are expected to be inoculated in the first half of 2021.