Published Jan 09, 2023 | 9:13 PM ⚊ Updated Jan 09, 2023 | 9:13 PM
Hyderabad-based Bharat Biotech’s manufactures the Covid19 vaccine—Covaxin which is marketed by Ocugen Inc in the USA. (Supplied)
Ocugen Inc, which markets Hyderabad-based Bharat Biotech’s Covid-19 vaccine Covaxin in the US, said on Monday, 9 January, that the vaccine showed an immune response in individuals who had not received a Covid-19 vaccine previously, as well as in those vaccinated with mRNA vaccines commonly used in the United States.
Ocugen announced positive results from the Phase 2/3, observer-blind, immuno-bridging and broadening study of Covaxin, which uses the same vero cell manufacturing platform that has been used in the production of polio vaccines for decades.
Covaxin, an inactivated virus vaccine, has been demonstrated in clinical trials to generate a broader immune response against the whole virus, covering important antigens such as S-protein, RBD, and N-protein; whereas currently approved vaccines in the US target only S-protein antigen, Ocugen said.
Additionally, in contrast to other inactivated vaccines, clinical trials have demonstrated that Covaxin generates an immune response that induces robust long-term memory B- and T-cell responses.
“The successful completion of this study represents an important milestone to the ongoing management of Covid-19,” Dr Shankar Musunuri, chairman, CEO, and co-founder of Ocugen, said in a statement.
He added that given that a section of the public was hesitant to receive mRNA vaccines, this investigational Covid-19 vaccine candidate, “which relies on a well-established approach to vaccine development and manufacturing, may provide an important additional vaccine option”.
This study enrolled 419 adult participants that were randomised 1:1 to receive two doses of Covaxin or placebo, 28 days apart. Blinded safety results and preliminary unblinded immunogenicity results are available through Day 56, one month following the second vaccination.
Immunogenicity results from Covaxin-vaccinated participants in the US were compared with results in Covaxin-vaccinated participants in the Bharat Biotech International (Bharat Biotech)-sponsored Phase 3 study in India.
Approximately 24 percent of tested participants in the US were vaccine-naïve while all participants in the Bharat Biotech Phase 3 study were vaccine-naïve. Immune responses were adjusted for differences between the US and Indian cohorts in baseline neutralising antibody, body mass index, gender, and age.
Blinded safety data are also available for one month following vaccination. There were no deaths, related potential immune mediated medical conditions (PIMMCs), or related adverse events of special interest (AESIs).
There were also no cases of myocarditis, pericarditis, thrombotic events, or Guillain-Barré syndrome.
Thirty medically attended adverse events in 18 subjects and two serious adverse events (SAE) in one subject were reported, and all were considered unrelated to vaccination.
“These positive data represent an important step in the management of the ever-evolving Covid-19 pandemic,” said Dr Eric Feigl-Ding, epidemiologist and health economist, and chief of the Covid Task Force at the New England Complex Systems Institute, in the statement.
“The need for different vaccine approaches to Covid-19 has become critically apparent with the continued emergence of variants to the SARS-CoV-2 virus.”
The topline data from the immuno-bridging and broadening study will be critical to support Ocugen’s future plans for the development of Covaxin in the US.
Hyderabad-based Bharat Biotech’s Covaxin, India’s indigenous Covid-19 vaccine, was developed in collaboration with the Indian Council of Medical Research and the National Institute of Virology.
