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Bio E s Covid-19 vaccine candidate gets SEC nod for phase-III trials

Bio E s Covid-19 vaccine candidate gets SEC nod for phase-III trials Top Searches Bio E s Covid-19 vaccine candidate gets SEC nod for phase-III trials Swati Bharadwaj / TNN / Apr 24, 2021, 15:39 IST FacebookTwitterLinkedinEMail Two shots of the intramuscular vaccine were administered 28 days apart as part of the study that evaluated the safety and immunogenicity of the vaccine candidate. (Representative image) HYDERABAD: Vaccine maker Biological E Ltd on Saturday said it has received approval of the subject expert committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) to start Phase III clinical trials of its Covid-19 subunit vaccine candidate, that it is developing with the Texas-based Baylor Medical College.

Biological E to begin phase 3 trials for COVID-19 vaccine

Biological E to begin phase 3 trials for COVID-19 vaccine By Yunus Y Lasania|   Published: 24th April 2021 5:24 pm IST Hyderabad: Hyderabad-based vaccine and pharmaceutical company Biological E. Limited (BE) today announced that it has successfully completed the phase I/II clinical trials of its COVID-19 subunit vaccine candidate in India. The company has also received approval to start phase III clinical trials from the Central Drugs Standard Control Organization (CDSCO) – Subject Expert Committee (SEC). The phase III clinical study to be conducted in 15 sites across India, and will evaluate the Immunogenicity and Safety of Biological E’s SARS-CoV-2 COVID-19 vaccine for protection against COVID-19 disease in about 1268 healthy subjects in the age range of 18 to 80 years. It is intended to be part of a larger global Phase III study, the company stated.

Johnson & Johnson COVID-19: CDC and FDA are leaning toward resuming use, sources say

The Centers for Disease Control and Prevention and the Food and Drug Administration are leaning toward resuming use of the Johnson & Johnson vaccine with a warning about blood clots, sources told CBS News. A decision is expected Friday, more than a week after the vaccine s distribution was paused following reports of rare but dangerous blood clots in eight people under the age of 50.  I think too many people may be scared off by taking the vaccine. They shouldn t be, but perception is everything when it comes to vaccines, said Dr. Peter Hotez, who works at the Texas Children s Hospital Center for Vaccine Development. 

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