Ocugen’s vaccine candidate Covaxin met both co-primary endpoints in study

Biopharmaceutical company Ocugen announced its COVID-19 vaccine candidate Covaxin, developed by Bharat Biotech, showed positive results in the U.S. trial.

Ocugen, a Biotechnology Innovation Organization (BIO) member, discovers, develops, and commercializes novel gene and cell therapies and vaccines.

“Covaxin, an inactivated virus vaccine adjuvanted with TLR7/8 agonist, 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 U.S. target only S-protein antigen,” the company said.

Clinical trials also demonstrated that, in contrast to other inactivated vaccines, “TLR7/8 agonist adjuvant in COVAXIN™ generates a Th1-biased immune response that induces robust long-term memory B- and T-cell responses.”

Per Ocugen’s explanation, Covaxin is “a whole-virion inactivated COVID-19 investigational vaccine candidate that uses the same vero cell manufacturing platform that has been used in the production of polio vaccines for decades.”

The Phase 2/3 trial involved 491 U.S. adult participants – 24% of which were unvaccinated for COVID – who received two doses of Covaxin or placebo 28 days apart. The results were compared with the results of the Bharat-sponsored Phase 3 study in India, in which all participants were unvaccinated for COVID.

‘An important additional vaccine option’

Ocugen said Covaxin met its main goals, showing an immune response both in participants who had not received a COVID vaccine previously as well as those vaccinated with mRNA vaccines by Pfizer-BioNTech and Moderna.

“The successful completion of this study represents an important milestone to the ongoing management of COVID-19,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “This investigational COVID-19 vaccine candidate may provide an important additional vaccine option given that a portion of the public remains hesitant to receive mRNA vaccines.”

Per the press release, “Covaxin was found to be well-tolerated in vaccine-naïve individuals and in individuals previously vaccinated with mRNA vaccines in the United States (U.S.), with no vaccine-related serious adverse events, thrombotic events, or cases of myocarditis or pericarditis.”

According to the epidemiologist and health economist Dr. Eric Feigl-Ding, Chief of the COVID Task Force at the New England Complex Systems Institute, “these positive data represent an important step in the management of the ever-evolving COVID-19 pandemic.” He emphasized the importance of different vaccine approaches “with the continued emergence of variants to the SARS-CoV-2 virus.”

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