Bharat Biotech International Ltd. has successfully developed India’s first indigenous vaccine candidate for COVID-19 to enter human trials. Named Covaxin, the vaccine has been cleared by the Drug Controller General of India (DCGI) and Ministry of Health & Family Welfare for phase I and II trials after the company submitted positive preclinical study results regarding safety and immune response.

“We are proud to announce Covaxin,” said Krishna Ella, chairman and managing director of Bharat. “The collaboration with the Indian Council of Medical Research [ICMR] and NIV was instrumental in the development of this vaccine. The proactive support and guidance from the Central Drugs Standard Control Organization [CDSCO] have enabled approvals to this project, and our R&D and manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform.”

Human clinical trials are scheduled to start across India in July, and the ICMR is aiming to launch the vaccine by Aug. 15.

If the trials are successful, Covaxin will be one of the most unprecedentedly quick launches in the vaccine world, as most clinical trials take no less than three to six months. But there remain concerns over safety and efficacy from such speedy trials.

However, the ICMR defends the decision as part of the current global norm in fast-tracking COVID-19 prevention measures. “Faced with the unprecedented nature of the COVID-19 pandemic and the consequent dislocation of normal life, all other vaccine candidates across the globe have been similarly fast-tracked,” said the ICMR. “In the larger public health interest, it is important for us to expedite the clinical trials for a promising indigenous vaccine.”

The Indian Drugs Manufacturers Association (IDMA) also stresses the importance of vaccines to control the highly contagious COVID-19 virus that has to date taken more than 500,000 lives globally.

“Vaccination is a crucial and necessary part of COVID-19 management,” Mahesh H. Doshi, the national president of IDMA, told BioWorld. “Once vaccination is widely available, it will give citizens herd immunity so they can resume their regular work without worrying about getting infected.

“Until a repurposed drug is found to treat COVID-19 effectively, vaccines are our only ray of hope,” he added. “I am sure that the ICMR will take all precautions and follow safety procedures before they allow a product to be released to the Indian market. I believe that the Indian regulators are proceeding with best practices that are in line with national and global standards.”

Bharat faced some controversy when a picture of what was allegedly a dose of Covaxin being administered to Bharat’s vice president, VK Srinivas, by a female health care professional was circulated on social media. It was accompanied by a caption that claimed that he was the first person it was administered to in a clinical trial.

The company took to Twitter to debunk those rumors.

“Certain images and messages being circulated on WhatsApp and other social media platforms have not been disseminated by Bharat Biotech,” the company stated. “The image being circulated is a routine procedural blood draw for testing all production staff.”

Several other Indian pharmaceutical companies have been pushing for vaccine launches to curb the COVID-19 pandemic, which has raged for longer than six months unabated and only shows signs of becoming worse. Zydus Cadila Ltd.’s ZyCov-D vaccine, for example, has already been granted permission by the CDSCO to move to human trials. The company expects to complete the first two phases in around three months.

Prior to Covaxin, Bharat made headlines in 2015 when it launched the first India-made rotavirus vaccine. Priced at roughly $1 a dose, it is among the cheapest available globally and has been subsequently inducted into the World Health Organization’s (WHO) immunization program.

However, even if the COVID-19 vaccines are ready to be launched in the coming months, there remains the question of whether the production and manufacturing process will be an issue due to a shortage of medical supplies caused by the deteriorating Sino-Indian relationship.

The border clashes between the countries have led to India tightening the scrutiny of Chinese consignments since May, disrupting COVID-19 medical supplies. The Pharmaceutical Export Promotion Council of India (Pharmexcil) has warned that if medical imports are not cleared on a priority basis, it will be a challenge to maintain the production efficiency of the medical supply chain, hindering efforts to bring the pandemic to a halt.

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