Oxford's Covid-19 vaccine India trial: Serum Institute asked to modify protocol

Corona Vaccine Update: Paving the best way for the second and third part of human trials of Oxford’s vaccine in India

Drug regulator gets committee approval for nod to clinical trials by Serum Institute for Oxford COVID-19 vaccine

"We know that, if successful, this vaccine can be rapidly developed, produced on a large scale and delivered around the world".

Pharmaceutical giant AstraZeneca has promised not to profit from its COVID-19 vaccine, developed in partnership with Oxford University, during the pandemic as the company reported it was on track with late-stage trials for the treatment.

The company is also planning to begin the third phase of testing with a single shot vaccine in the second half of September as it will be utterly dependent on the outcome.

The vaccine used by J&J includes a common cold virus adenovirus type 26 or Ad26 for taking coronavirus proteins in the body cells, causing an enhancement in immune defense by the body against the virus. Barouch has been working on the development of a COVID-19 vaccine since January, when Chinese scientists released the SARS-CoV-2 genome.

Barouch and colleagues conducted a study in 52 NHPs, immunizing 32 adult rhesus macaques with a single dose of one of seven different versions of the Ad26-based vaccine, and giving 20 animals sham vaccines as placebo controls. The high levels of infection were developed in the nasal swabs and lungs of all those animals who have taken placebo shots.

The results were strong enough to prompt a phase 1/2a clinical trial in the US and Belgium, with a phase 3 clinical trial expected to follow in September.

It added that only one of the six showed very low levels of the virus in a nasal swab at two time points. The data, which was published in Nature, show the vaccine created an immune response as demonstrated by "neutralising antibodies". A single-shot immunization has practical and logistical advantages over a two-shot regimen for global deployment and pandemic control.

Investigators at Beth Israel Deaconess Medical Center (BIDMC) and other institutions have initiated a first-in-human Phase 1/2 clinical trial of the Ad26.COV2.S vaccine in healthy volunteers.

It says the vaccine prevented infection by providing complete or near-complete protection in the lungs from the virus in non-human primates in the pre-clinical study.

"After a thorough evaluation, the Subject Expert Committee (SEC) has sent its recommendation to DCGI asking it to give approval to Serum Institute's phase two and three human clinical trials of Oxford Vaccine candidate for COVID-19", the official told ANI. Kathryn E. Stephenson, assistant professor of medicine at HMS and associate member of the Ragon Institute, is the principal investigator for the trial at BIDMC, which is funded by Janssen Vaccines & Prevention.

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