U.S. Phase 3 trial reveals Novavax COVID-19 vaccine to be 90 percent effective against COVID-19

A fourth strong contender appears to have emerged for COVID-19 vaccines in the United States, as this week’s results from the Phase 3 PREVENT-19 trial of the Novavax, Inc. COVID-19 demonstrated a 90 percent overall efficacy against the disease.

The NVX-CoV2373 vaccine fully protected against moderate and severe cases and demonstrated 93 percent efficacy against major COVID-19 variants. Although 29,960 participants were active in the trial, the only deaths experienced in the course over their duration occurred in patients given placebos.

“Today, Novavax is one step closer to addressing the critical and persistent global public health need for additional COVID-19 vaccines,” Stanley Erck, president and CEO of Novavax, said. “These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe COVID-19 infection.”

In response to the strong results, Novavax has signaled an intent to file for regulatory authorizations in the third quarter. This will be dependent on the completion of the process qualification and assay validation portions of the process to guarantee the company can meet chemistry, manufacturing, and controls requirements. Currently, the company is on schedule to provide a manufacturing capacity of 100 million doses per month by the end of the third quarter. This will advance to 150 million doses per month by the end of 2021.

PREVENT-19 was a placebo-controlled, observer-blinded, and randomized study that saw 77 cases of COVID-19 emerge in all. Of these, 63 cases struck the placebo group, while only 14 were observed among the vaccinated. Even among the vaccinated who got COVID-19, its effects were minor. Of note is that the test stressed recruiting a representative population from among those most impacted by the disease to assure its efficacy would reach where it was most needed. The vaccine was 91 percent effective among such high-risk populations — which is to say, those over age 65, those with certain comorbidities, or those frequently exposed to COVID-19.

Other data of interest included that the vaccine was fully effective against variants not deemed to be of concern or interest. It was generally well-tolerated, with few serious side effects, and most experienced mixes of injection site pain, tenderness, fatigue, headaches, and muscle pains.