COVID-19: Novavax begins Phase 3 trials for its vaccine in US, Mexico

Final phase trials to determine efficacy of a COVID-19 vaccine developed by Maryland based firm vavax Inc. has begun in US and Mexico, National Institute of Health (NIH) anunced on December 28. randomized, placebo-controlled trials will enrol approximately 30,000 people over of 18, with emphasis on people d 65 and above. tests to finally determine if NVX-CoV2373 jabs were fit for emergency use, would be conducted at approximately 115 sites across both rth American countries.

" launch of this study — fifth investigational COVID-19 vaccine candidate to be tested in a Phase 3 trial in United States — demonstrates our resolve to end pandemic through development of multiple safe and effective vaccines," Dr. Anthony Fauci NIAID director reckoned about trial. 

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Final Phase trials

According to NIH, all volunteers would be needed to give informed consent prior to ir participation. For trials, two-third of participants would randomly receive vaccine and one third would receive a saline placebo. Randomization will be in a 2:1 ratio with two volunteers receiving investigational vaccine for each one who receives a placebo. Throughout duration of trials, neir investigators participants would kw if y’ve received vaccine or placebo. All volunteers would receive second injection after duration of 21 days.

In aftermath, participants would be “followed closely” for potential side effects and asked to provide blood samples at specified time for a period of two years. Scientists will n analyse ir blood samples to detect and quantify immune responses to SARS-CoV-2, virus that causes Covid-19 to determine efficacy of vaccine.

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Meanwhile,  leer of firm behind AstraZeneca/Oxford vaccine has said that researchers found “winning formula” for efficacy. In an interview with Sunday Times, AstraZeneca chief Pascal Soriot said that vaccine, which is currently being evaluated by Britain’s independent medicines regulator, provides “100 per cent protection” against severe COVID infection requiring hospitalisation. He said that firm will publish results soon, amid reports that UK regulator could approve jab within days.