HYDERABAD: City-based Bharat Biotech has begun Phase III trials of COVID-19 vaccine Covaxin, chairman and MD of the company Krishna Ella said while participating in Indian School of Business's Deccan Dialogue on Monday.
Another Hyderabad-based pharma company Biological E Ltd on Monday has begun its Phase I-II trials of its COVID-19 vaccine. "As we speak today, Covaxin has entered Phase III trials," Ella, who was accompanied by officials from Ministry of External Affairs in the panel titled 'India’s Critical Role in Healthcare Diplomacy'," said.
The Phase III trials will involve 26,000 volunteers across India, conducted in partnership with ICMR. It is the largest clinical trial conducted for a COVID-19 vaccine in India. Trial volunteers will receive two intramuscular injections approximately 28 days apart. Participants will be randomly assigned to receive Covaxin or placebo.
The trial is double blinded, such that the investigators, the participants and the company will not be aware of who is assigned to which group.This indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) bio containment facility.
However, Ella conceded that the prospect of distributing the vaccine to 1.3 billion people was "worrying". "I am not happy because this is a two-dose injectable vaccine," he said adding that there will be a need for 2.6 billion doses.
To avert the logistical nightmare of distributing a two-dose vaccine, Ella said that Bharat Biotech is also working on a single-dose vaccine which would work as a nasal drop. He said that nasal drop will need two drops but will work in a single dose.
Progress in BE vaccine
Meanwhile another Hyderabad-based vaccines and pharmaceutical company Biological E Limited (BE), US-based Dynavax Technologies Corporation and Baylor College of Medicine, a health sciences university in Houston on Monday announced that BE has initiated a Phase I/II clinical trial of its COVID-19 subunit vaccine candidate in India following approval from the Drugs Controller General of India (DGCI).
The results of this clinical trial are expected to be available by February 2021. BE’s Phase I/II clinical trial will evaluate the safety and immunogenicity of the vaccine candidate consisting of the Receptor Binding Domain of the Spike Protein of SARS-CoV-2 at three dose levels adjuvanted with CpG 1018 plus alum, in about 360 healthy subjects in the age range of 18 to 65 years.
The vaccination schedule consists of two doses for each study participant, administered via intramuscular injection 28 days apart.
"We are very happy indeed to transition our potential vaccine candidate to clinical trials and offer one more potential option for the prophylaxis of COVID-19," said Biological E. Limited MD Mahima Datla.
Vaccine or placebo assigned randomly
Trial volunteers will receive two intramuscular injections approximately 28 days apart. Participants will be randomly assigned to receive Covaxin or placebo. The trial is double blinded, such that the investigators, the participants and the company will not be aware of who is assigned to which group.
This vaccine is manufactured in Bharat Biotech’s BSL-3 bio containment facility