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On 2 June 2021, the DCGI removed the requirement that India-specific clinical trials (bridging trials) be held for vaccine candidates developed outside of India, provided that they are already approved by a recognised international public health agency such as the World Health Organization (WHO), European Medicines Agency (EMA), US Food and ...
In May 2020, Indian Council of Medical Research's (ICMR's) National Institute of Virology approved and provided the virus strains for developing an Indian COVID-19 vaccine. [ 25 ] [ 26 ] In June 2020, the company received permission to conduct Phase I and Phase II human trials of a developmental COVID-19 vaccine codenamed BBV152 , from the ...
National regulatory authorities have granted full or emergency use authorizations for 40 COVID-19 vaccines.. Ten vaccines have been approved for emergency or full use by at least one stringent regulatory authority recognized by the World Health Organization (WHO): Pfizer–BioNTech, Oxford–AstraZeneca, Sinopharm BIBP, Moderna, Janssen, CoronaVac, Covaxin, Novavax, Convidecia, and Sanofi ...
In February 2020, Cadila Healthcare decided to develop a DNA plasmid based COVID-19 vaccine at their Vaccine Technology Centre (VTC) in Ahmedabad. [6] The vaccine candidate was able to pass the pre-clinical trials on animal models successfully. A report of the study was made available via bioRxiv and later published in the journal Vaccine.
COVID-19 vaccine clinical research uses clinical research to establish the characteristics of COVID-19 vaccines. These characteristics include efficacy , effectiveness , and safety. As of November 2022 [update] , 40 vaccines are authorized by at least one national regulatory authority for public use: [ 1 ] [ 2 ]
HGC019 is a mRNA and Self-amplifying mRNA (saRNA) based COVID-19 vaccine candidate being developed by Gennova Biopharmaceuticals and HDT Bio Corp. with active support from NIH under The Indo-US Vaccine Action Program (VAP) and Department of Biotechnology, India. [1]
Koçak-19 Inaktif Adjuvanlı COVID-19 vaccine Kocak Farma Turkey Inactivated SARS‑CoV‑2: Phase I (38) [213] Phase 1 Study for the Determination of Safety and Immunogenicity of Different Strengths of Koçak-19 Inaktif Adjuvanlı COVID-19 Vaccine, Given Twice Intramuscularly to Healthy Volunteers, in a Placebo Controlled Study Design.
A phase I clinical trial was carried out to evaluate the safety and immunogenicity of the vaccine candidate in about 360 participants. [4] The phase II concluded in April 2021. [12] [13] [14] In April 2021, the Drugs Controller General of India permitted the vaccine candidate to start phase III clinical trials. A total of 1,268 healthy ...