Novavax Coronavirus Vaccine Induces Immune Response in Early Study, Shares Jump

Marco Green
August 5, 2020

Angela Rasmussen, another virologist concurred, calling the results "encouraging", but cautioned it was too early to say if the vaccine was safe before Phase 3 trials are concluded.

Novavax's COVID-19 vaccine study generated a promising immune response in an early-stage clinical trial in results unveiled Tuesday, reports The Wall Street Journal.

As far as taking the necessary regulatory approval for the large scale production of the vaccine, Novavax research chief Gregory Glenn told news agency Reuters that the company would have enough data by the end of December to be able to obtain regulatory approval. The addition of the company's Matrix-M adjuvant, a substance created to boost the body's immune response, did enhance the effect of the vaccine in the study, the company said. The vaccine candidate developed by the company is one of the very few candidates which are being funded by the Operation Warp Speed which is being led by the White House. Effective vaccines and treatments are considered essential to halting a pandemic that has claimed more than 695,000 lives worldwide. The company said it could start a large pivotal Phase III trial as soon as late September, and added that it could provide 1 billion to 2 billion doses of the vaccine in 2021.

The study tested four dose regimens of the vaccine, NVX-CoV2373, against placebo in 131 healthy adults up to 59 years old. Although it tested an unadjuvanted form of the vaccine and a single-dose regimen of the adjuvanted vaccine, all eyes were on two adjuvanted regimens: 5 micrograms and 25 micrograms given in two injections three weeks apart. The company said it would likely move forward with the lower dose.

The company said the number of antibodies found in volunteers who participated in the trials was twice the number of antibodies found in recovered patients from the disease.

Headache, fatigue, and muscle pain were among the more common side effects, and the vaccine was "well tolerated" overall, the company said.

Like the first human data for Moderna's COVID-19 vaccine reported in May, the data have not yet been peer-reviewed.

The Phase II portion of the study will be conducted in multiple countries, including the United States.

Other reports by Click Lancashire

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