Read more about Biological E to start phase 3 clinical trials of its Covid-19 vaccine soon on Business Standard. The phase III clinical study, to be conducted in 15 sites across India, will evaluate the immunogenicity and safety of Biological E s vaccine candidate in 1,268 healthy subjects
April 24, 2021
The Phase III clinical study to be conducted in 15 sites across India Biological E. Ltd, has successfully completed the Phase I and II clinical trial of its Covid-19 subunit vaccine candidate in India and received the approval to start the Phase III clinical trial from the Central Drugs Standard Control Organization (CDSCO) - Subject Expert Committee (SEC).
Its candidate includes an antigen developed by Texas Children’s Hospital Center for Vaccine Development and in-licensed from BCM Ventures, Baylor College of Medicine’s integrated commercialization team, along with Dynavax Technologies Corporation’s advanced adjuvant CpG 1018.
The Phase III clinical study to be conducted in 15 sites across India will evaluate the Immunogenicity and Safety of Biological E’s SARS-CoV-2 Covid-19 vaccine for protection against Covid-19 disease in about 1,268 healthy subjects in the age range of 18 to 80 years. It is intended to be part of a larger global Phase III study.
Updated:
Approval from a Subject Expert Committee of CDSCO follows successful completion of Phase I/II
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The vaccines Biological E plans to produce with assistance of DFC’s financing complement existing efforts to immunise as many people as possible in a short span. Nagara Gopal
Approval from a Subject Expert Committee of CDSCO follows successful completion of Phase I/II Pharmaceuticals and biologics firm Biological E has received approval to start Phase III clinical trial of its COVID-19 subunit vaccine candidate from a Subject Expert Committee of the Central Drugs Standard Control Organization (CDSCO).
The Phase III clinical study to be conducted in 15 sites across the country will evaluate the immunogenicity and safety of Biological E’s SARS-CoV-2 vaccine for protection against COVID-19 in about 1,268 healthy subjects aged 18-80 years. It is intended to be part of a larger global Phase III study.
Biological E Covid vaccine candidate gets CDSCO nod for Phase III trials
By IANS |
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Only 4% beneficiaries turn up for 2nd dose of Covid vaccine. Image Source: IANS News
Hyderabad, April 24 : Hyderabad-based vaccine and pharmaceutical company Biological E. Limited (BE) announced on Saturday that its Covid-19 subunit vaccine candidate has received approval to begin Phase III clinical trials in India.
A statement issued by the company said that it has received clearance from the subject expert committee (SEC) of Central Drugs Standard Control Organisation (CDSCO) following the successful completion of the Phase I/II clinical trials.
The Phase III clinical study to be conducted in 15 sites across India will evaluate the immunogenicity and safety of BE s SARS-CoV-2 Covid-19 vaccine in about 1,268 healthy subjects in the age range of 18 to 80 years. It is intended to be part of a larger global Phase III study.
Biological E to initiate Ph III trial of COVID-19 vaccine candidate
Biological E to initiate Ph III trial of COVID-19 vaccine candidate
24 April 2021 | News
Image credit- shutterstock.com
Biological E. Limited (BE), a Hyderabad-based vaccine and pharmaceutical company, has announced that it has successfully completed the Phase I/II clinical trial of its COVID-19 subunit vaccine candidate in India and received the approval to start the Phase III clinical trial from the Central Drugs Standard Control Organization (CDSCO) - Subject Expert Committee (SEC).
BE started the Phase I/II Clinical Trial of its COVID-19 Vaccine Candidate in the second week of November 2020. Its candidate includes an antigen developed by Texas Children’s Hospital Center for Vaccine Development and in-licensed from BCM Ventures, Baylor College of Medicine’s integrated commercialization team, along with Dynavax Technologies Corporation’s (Nasdaq: DVAX) advanced adjuvant CpG 1018