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Bharat Biotech’s Covid-19 vaccine gets nod for Phase 3 trial. Here’s how it came through

Hindustan Times logo Hindustan Times 23-10-2020 | Edited by Meenakshi Ray
a group of people standing in a room: :A healthcare worker is seen during swab test of the people in Chembur in Mumbai. (Pratik Chorge/HT Photo) © Provided by Hindustan Times :A healthcare worker is seen during swab test of the people in Chembur in Mumbai. (Pratik Chorge/HT Photo)

The Drugs Controller General of India (DCGI) has allowed Bharat Biotech International Limited to conduct the Phase 3 clinical trials of its vaccine candidate against the coronavirus disease (Covid-19) but added a few riders. A subject expert committee on Covid-19 at the Central Drugs Standard Control Organisation (CDSCO) had recommended granting permission to the Hyderabad-based pharma company for conducting latest phase of the clinical trial of its vaccine ‘Covaxin’ after assessing the safety and immunogenicity data of Phases 1 and 2 trials.

Covaxin is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). The vaccine maker had applied to the DCGI on October 2 seeking permission to conduct Phase 3 randomised double-blind placebo-controlled multicentre trial of its Covid-19 vaccine.

Also read | India’s first Covid-19 vaccine will be at least 60% effective: Bharat Biotech

The Phase 3 clinical trial of Covaxin will cover around 28,500 subjects, aged 18 years and above, and it will be conducted in 21 sites across 10 states, including Delhi, Mumbai, Patna and Lucknow. DGCI had granted permission to Bharat Biotech in July to conduct phase I and II clinical trials to develop the indigenous vaccine for Covid-19.

Here’s how the recommendation for Phase 3 trial of Bharat Biotech’s vaccine came through:

1. Bharat Biotech was asked to submit complete safety and immunogenicity data of the phase 2 trial as well as some clarifications before proceeding to the next stage.

2. The Phase 3 clinical trial application proposed a dose of 0.5 ml on day 0 and 28, news agency PTI cited sources as saying.

3. The Hyderabad-based firm presented its data from Phases 1 and 2 along with animal challenge data in two species, including non-human primates (NHP), on the inactivated coronavirus vaccine (BBV152) along with the proposal to conduct event-driven Phase 3 clinical trial to assess the efficacy of the vaccine, the recommendations stated.

Also read | Bharat Biotech in talks to take vaccine candidate global

4. “After detailed deliberation and based on the available evidence, the committee recommended for grant of permission to conduct Phase 3 clinical trial subject to the condition that the primary efficacy endpoint for symptomatic cases should be amended as below...," the recommendations said.

5. Once a suspect case is confirmed the principal investigator will evaluate the clinical information to classify it as a symptomatic case.

6. “Two criteria must be met for a participant to be a confirmed symptomatic case. Either criteria A or B with positive RT-PCR confirmation," the recommendations said.

7. The first criterion includes shortness of breath or difficulty in breathing, new-onset anosmia or ageusia, oxygen saturation of <94 per cent or escalation in supplemental O2, pneumonia diagnosed by chest X-ray or CT scan, evidence of shock, ICU admission/death (one or more).

8. The second includes fever, chills, new cough, myalgia or fatigue, headache, sore throat, nausea or vomiting, diarrhoea, congestion/runny nose (one or more symptoms).

(With agency inputs)

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