Phase 3 testing begins for the Novavax vaccine in the US and Mexico

WASHINGTON – Clinical trials to learn a COVID-19 vaccine candidate’s safety and efficacy from American biotech company Novavax have started in the United States and Mexico, the US National Institutes of Health (NIH) announced Monday.

A similar Phase 3 trial for the same vaccine, designated NVX-CoV2373, is also initiated in the United Kingdom, where about 15,000 volunteers have been selected.

In the US and Mexico, the new tests will include around 30,000 volunteers over 18.

Two-thirds of the participants will receive the vaccine and one-third a placebo. None of them will know, for the trial’s duration, what was in the injection they accepted.

As stated by the leading US immunologist Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH:

“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,”

The goal is that at least 25 per cent of the participants in the US and Mexico trials should be aged 65 and over, the statement said.

Emphasis will also be placed on recruiting people who are more exposed to COVID-19 — African-Americans and Hispanics in particular — or who present with underlying health conditions that put them at higher risk, such as obesity or diabetes.

The vaccine is taken in 2 doses, three weeks apart. It can be stored between 2 and 8 degrees Celsius (35 and 46 degrees Fahrenheit) — much warmer temperatures than already approved vaccines from Pfizer/BioNTech and Moderna, meaning manufacturers could easier distribute it.

The Pfizer and Moderna vaccines are based on new technology, messenger RNA, while the Novavax vaccine is a recombinant protein vaccine.

The coronavirus has spikes (viral proteins) on its surface that contact cells it infects. These proteins can be reproduced and presented to the immune system to recognize them later and react if infected.

Two other vaccines that have managed Phase 3 trials, those from Johnson & Johnson and AstraZeneca/Oxford, are expected soon to seek emergency authorization for distribution in the US, the nation’s most affected by the pandemic in absolute numbers worldwide.

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