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

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

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

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Final Phase trials

According to NIH, all volunteers would be needed to give informed consent prior to their participation. For the trials, two-third of the participants would randomly receive the vaccine and one third would receive a saline placebo. Randomization will be in a 2:1 ratio with two volunteers receiving the investigational vaccine for each one who receives a placebo. Throughout the duration of trials, neither the investigators no the participants would know if they’ve received the vaccine or the placebo. All the volunteers would receive the second injection after the duration of 21 days.

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

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Meanwhile, the leader of the firm behind AstraZeneca/Oxford vaccine has said that the researchers found the “winning formula” for efficacy. In an interview with The Sunday Times, AstraZeneca chief Pascal Soriot said that the 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 the firm will publish the results soon, amid reports that the UK regulator could approve the jab within days.