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Biological E seeks approval from DCGI to conduct phase 3 trials for Corbevax as a booster dose for Covishield, Covaxin-Health News, Firstpost


Phase 2/3 trials of the RBD protein subunit vaccine are currently underway and results are likely to be announced this month.

A booster shot is an extra dose of the vaccine given periodically to “boost” the immune system. Image Credit: Tech2 / Abigail Banerji

Hyderabad-based pharmaceutical company Biological E has applied for permission from India’s drug regulator to conduct phase 3 clinical trial for its COVID-19 Corbevax vaccine as a single booster dose for those who have been fully vaccinated with Covishield or Covaxin.

Phase 2/3 clinical trials of the second indigenously developed Corbevax, an RBD protein subunit vaccine to be administered to adults 18 to 80 years, are currently underway, and the results are likely to be stated as follows. month.

Meanwhile, the company has submitted an application seeking the go-ahead from the Comptroller General of Medicines of India (DCGI) to conduct the phase 3 clinical study of Corbevax as a single booster dose on those fully inoculated with Covishield or Covaxin.

“Currently there are several publications that indicate the decrease of antibodies in vaccinated individuals, and that several countries have started or are in the process of administering booster doses to people who completed the primary vaccination,” he said.

“In light of this, we are here to submit the NOC grant application to conduct a phase 3 clinical study to evaluate the immunogenicity and safety of Corbevax when administered to COVID-19 -negative adult volunteers prepared with Covishield or Covaxin, ”stated the application submitted to DGCI last week.

The Subject Matter Expert Committee (SEC) on COVID-19 of the Central Drug Standards Control Organization (CDSCO) is likely to address the matter at its next meeting.

The DCGI in September also granted Biological E permission to conduct phase 2/3 clinical trials of the vaccine in children ages 5 to 18 with certain conditions.

The government said last week that science related to the use of booster doses of COVID-19 Vaccines is still evolving and advances are being closely followed.

At a press conference, NITI Aayog (Health) Fellow Dr. VK Paul said that there are several studies that are investigating the topic of booster doses.

“This is an evolving science and information paradigm … that information is still emerging. We are watching this science very carefully through our NTAGI system.

“We know that Covaxin has done a study on booster doses and those results may be available at any time … We also know that the WHO has not given a clear recommendation on this … we are watching the science as it emanates and in India too, there are studies that are analyzing this aspect, “he had said.

Biological E will supply 30 crore doses of Corbevax to the central government in December, as announced by the Union Ministry of Health in June. The Union Ministry of Health finalized arrangements with the Hyderabad-based vaccine maker to reserve Rs 30 million COVID-19 doses of vaccine, an official statement had said.

Biologics-E COVID-19 The candidate vaccine has been developed with the support of the Department of Biotechnology and its Biotechnology Industry Research Assistance Council of the PSU (BIRAC) from the preclinical stage to phase 3 studies.

Not only has the Biotechnology Department provided financial assistance in terms of grants of over Rs 100 million, but has also partnered with Biological-E to conduct all animal testing and testing studies through its Research Institute. Translational Health Sciences Institute of Technology (THSTI), Faridabad, had previously said a statement from the Ministry of Health.



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