Bharat Biotech has been granted permission to start the Phase III trials of Covaxin – India’s indigenous Covid-19 vaccine candidate.
[REPRESENTATIVE IMAGE] File photo of Covaxin (Picture Courtesy: Twitter @airnewsalerts)
The Drug Controller General of India (DGCI) on Thursday allowed Bharat Biotech International Limited to conduct the Phase III trials of its Covid-19 vaccine candidate Covaxin. The permission for the Phase III trials is subject to minor changes in the primary efficacy endpoint for the symptomatic cases.
The primary efficacy endpoint is the outcome by which the effectiveness of treatments in a clinical trial is evaluated. A carefully chosen endpoint can ensure no bias. A primary efficacy endpoint needs to be specified before the start of the clinical trial.
“The firm has presented their data from Phase I and II along with animal challenge data in two species including NHP on the Inactivated Corona Virus Vaccine (BBV152) along with the proposal to conduct event-driven Phase III clinical trial to assess the efficacy of the vaccine,” the expert panel of Subject Expert Committee (SEC) said.
The panel granted permission for the Phase III trials granted the researchers make the recommended amendments to the primary efficacy endpoint for the symptomatic cases. The panel has recommended that once a suspect case is confirmed, the principal investigator must evaluate the clinical information to classify it as a symptomatic case.
The classification of a confirmed symptomatic case, as per the panel recommendations, must include either of the two criteria along with a positive RT-PCR test:
1) Criteria A: One or more – Shortness of breath/difficulty in breathing, new onset anosmia/aguesia, oxygen saturation of less than 94 per cent or escalation in supplemental oxygen, pneumonia diagnosed by chest X-ray or CT scan, evidence of shock, ICU admission/death
OR
2) Criteria B: Two or more – Fever, chills, new cough, myalgia/fatigue, headache, sore throat, nausea/vomiting, diarrhea, congestion/runny nose.
Developed by Bharat Biotech along with the Indian Council of Medical Research and National Institute of Virology, Covaxin was India’s first indigenous vaccine candidate against the Covid-19.