Government withholds EUA for SII, Bharat Biotech’s COVID-19 vaccines Covaxin and Covishield

The applications of SII and Bharat Biotech for EUA for their COVID-19 vaccines is on hold for now pending full disclosure of safety and efficacy evidence.

By: Jahnavi Sarma | | Published: December 11, 2020 9:36 am

Changes in the new variants are not sufficient to make the current vaccines ineffective, says Prof Krishnaswamy Vijay Raghavan.

With COVID-19 cases surging in India and elsewhere in the country, the Serum Institute of India (SII) and Bharat Biotech had applied for Emergency Use Authorisation for their vaccines Covishield and Covaxin respectively. However, their application has now been put on hold for the time being by the Drug Controller General of India (DCGI). The SII is testing a vaccine candidate developed by Oxford University and AstraZeneca on 1,600 volunteers in India. Bharat Biotech is testing its vaccine in 28,500 volunteers across the country. 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. The DCGI needs more evidence before providing the necessary clearance. This means that India may now have to wait a bit longer for an indigenous vaccine. Also Read - Obesity, alcohol consumption can lower effectiveness of Covid-19 vaccines

Need updated safety data to grant EUA

Referring to the SII’s Covishield vaccine, the committee at DCGI said the firm must submit the 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 for grant of EUA. This vaccine is yet to be approved by regulators anywhere, including in the United States and the United Kingdom for public use. The DCGI also responded in a similar manner to the data presented by Bharat Biotech on Covaxin. According to the DCGI, data generated after the completion of Phase 3 trials was essential to make a proper evaluation. And, neither company presented the complete data from their ongoing Phase 3 trials. Also Read - Almost 30% of recovered COVID-19 patients develop complications within 5 months, over 12% die

Tell us more about severe adverse reaction, says DCGI

The DCGI also wanted more information on the severe adverse reactions reportedly experienced by a volunteer in Chennai. Last month, a Chennai-based participant of the Covishield vaccine trials sued SII after he apparently experience an adverse neurological reaction after getting the shot. Though officials were quick to say that the reaction was not because of the vaccine, a more detailed explanation is still not available. This is another reason why clearance is being withheld. Also Read - COVID-19 vaccine side effects: Loss of sensation in arms and more reported by Pune health workers

Other developments in the vaccine scene in India

Both SII and Bharat Biotech are leading the vaccine race in India. They have started large phase 3 human clinical trials for their respective vaccine candidates. Last week, a delegation led by the Ministry of External Affairs, which included the High Commissioners and government representatives of 70 countries across the world, visited Bharat Biotech’s Hyderabad facilities where they were briefed about Covaxin. Earlier, Prime Minister Narendra too visited these and SII’s facilities. Meanwhile, Pfizer-BioNTech, whose vaccine has already been approved for use in the United Kingdom and Bahrain, had applied to Indian regulators much before SII and Bharat Biotech. They were supposed to present the available data to the DCGI committee. However, they did not turn up for the meeting. Pune-based Gennova Biopharma, which is developing an m-Rna vaccine, has got clearance for human trials from DCGI.

(With inputs from Agencies)

Published : December 11, 2020 9:36 am

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