The SII, which has partnered with AstraZeneca, for manufacturing the Oxford vaccine candidate for COVID-19 had submitted its first application to the DCGI on July 25 seeking permission for conducting the phase 2 and 3 trials of the potential vaccine. Barouch's group, in collaboration with Johnson & Johnson, developed a series of vaccine candidates created to express different variants of the SARS-CoV-2 spike protein, which is the major target for neutralizing antibodies. "We know that, if successful, this vaccine can be rapidly developed, produced on a large scale and delivered around the world".
"The World Health Organization, the US Food and Drug Administration or the European Union must approve the development of the vaccine by Russian Federation, something which has not happened yet", she noted.
Earlier, Director of Gamaleya Institute, Alexander Ginsburg, gives a controversial statement, "Prior the human trials, the vaccine is first tested on the researchers". Quinn said it's imperative that the vaccine trials include enough diverse participants of all races and genders to know whether a vaccine will be safe for populations with different health issues. The company plans to take the challenge of 1 or 2 doses in the first phase of the trial.
Moreover, neutralizing antibody responses correlated with protection, suggesting that this biomarker will be useful in the clinical development of COVID-19 vaccines for use in humans. The Mayo Clinic reports that pneumonia and flu vaccines will not protect against the virus.
Fauci predicts the US will have a "safe and effective" vaccine by the end of this year.
"After a thorough evaluation, the DCGI has given approval to SII to perform phase-II, III clinical trial based on the recommendations of the Subject Expert Committee (SEC)", the official source was quoted by news agency ANI as saying. Only about half of Americans said in May that they were willing to get a coronavirus vaccine. China has mobilized its army and fast-tracked tests in the global race to find a coronavirus vaccine, and is involved in several of the dozen or so worldwide clinical trials now under way.
Six months after the World Health Organization declared a global emergency, the novel coronavirus has killed more than 680,000 people and infected more than 17.5 million, according to an AFP tally.