Bharat Biotech announces data from phase-III Covaxin clinical trials

Bharat Biotech has announced safety and efficacy analysis data from phase-III clinical trials of Covaxin, the company said in a statement.

“Analysis of 130 symptomatic COVID-19 cases, reported at least two weeks after the second dose, conducted at 25 sites across India. Covaxin is formulated with a novel Algel+IMDG adjuvant. IMDG is a TLR7/8 agonist known to induce memory T cell responses along with strong neutralising antibodies. The activation of cell-mediated immune responses is valuable in a multi-epitope vaccine such as Covaxin where immune protection can be achieved from S, RBD and N proteins alike. IMDG was developed under partnership between Virovax and NIAID, National Institutes of Health USA,” it notified.

It further said that Covaxin was well-tolerated and the Data Safety Monitoring Board has not reported any safety concerns related to the vaccine. The overall rate of adverse events observed in Covaxin was lower than that seen in other COVID-19 vaccines.

The statement also claimed that Covaxin is the first to report promising efficacy against asymptomatic infections based on qPCR testing that will help in reducing disease transmission.

Besides, it mentioned that the vaccine has been specifically designed to meet the needs of global distribution chains, the requirements for which are more critical in low- and middle-income countries. It has been formulated to enable shipping and long-term storage at two-to-eight degrees celsius. It is also formulated to adhere to a multi-dose vial policy, thereby reducing open vial wastage, saving money to procurement agencies and governments alike.

Expressing his thoughts, Professor (Dr) Balram Bhargava, Secretary, Department of Health Research, and Director General, Indian Council of Medical Research (ICMR), said, “I am delighted to note that Covaxin, developed by ICMR and BBIL under public-private partnership, has demonstrated an overall efficacy of 77.8 per cent in India’s largest COVID phase-III clinical trial thus far…….I am also pleased to see that Covaxin works well against all variant strains of SARS-CoV-2.”

The statement also highlighted that Bharat Biotech’s commitment to continued improvement of Covaxin is well under way with additional clinical trials to establish safety and efficacy in children between two to 18 years of age. A clinical trial to determine the safety and immunogenicity of a booster dose is also in process. Several research activities are being carried out to study variants of concern and to assess their suitability for follow-up booster doses.

According to the statement, Covaxin has been evaluated through neutralising antibody responses against several variants of concern, namely B.1.617.2 (Delta), B.1.617.1 (Kappa), B.1.1.7 (Alpha), B.1.351 (Beta), P2- B.1.1.28 (Gamma). The data from these studies have been extensively published in peer-reviewed journals and available for review in the public domain.

“Covaxin has now received emergency use authorisations in 16 countries including, Brazil, India, Philippines, Iran, Mexico, etc. with EUA’s in process in 50 countries worldwide. The company is in discussions with WHO to obtain emergency Use Listing for Covaxin. The product has been exported to several countries with additional requests for supplies being received,” said the statement.