Novavax Says Early Data Shows Vaccine Protects Against Omicron

A third shot six months after the first two doses indicated an increase in antibodies to levels associated with protection seen in earlier large clinical trials, the Maryland-based company said Wednesday. In those trials, the vaccine demonstrated efficacy of around 90%.

The company said it could begin manufacturing its Omicron-specific vaccine in early January and start clinical trials in the first quarter of 2022.

“We are encouraged that boosted responses against all variants were comparable to those associated with high vaccine efficacy in our Phase 3 clinical trials,” said Gregory Glenn, Novavax’s president of research and development.

“Given the continued evolution of the coronavirus, the development of an Omicron vaccine could be necessary. Novavax has cloned, expressed and characterized the Omicron spike protein vaccine and will soon enter the GMP-phase of production,” he added.

Novavax shares rose 5.29% to $193 in after-hours trading.

Earlier this week, Novavax’s vaccine was recommended for use by the European Medicines Agency, marking the first endorsement by a major regulator of a shot that uses an established technology.

Novavax will begin shipping vaccines to the EU’s 27 member states next month. In August, the European Commission struck a deal with the drugmaker for 200 million doses of its shot.

Novavax, based in Gaithersburg, Md., and supported with $1.6 billion from the U.S. government, has yet to seek approval from the Food and Drug Administration because of manufacturing issues that have held up its application. It plans to file for FDA approval by the end of the year. It is already seeking approval in several other countries, including the U.K, Canada and Australia.