Novavax Kicks Off Phase 3 Trial of COVID-19 Vaccine in UK

Novavax yesterday launched a phase 3 clinical trial of its COVID-19 vaccine in the UK, becoming the latest drugmaker to bring a vaccine candidate to late-stage testing.

The study will evaluate the safety and efficacy of two doses of NVX-CoV2373 vs. a placebo in 10,000 participants ages 18 to 84 years old. Participants who get the vaccine will receive two injections consisting of 5mcg of the antigen and 50 mcg of the adjuvant component administered 21 days apart.

The Maryland-based drugmaker is conducting the trial in partnership with the UK government’s Vaccines Task Force. Gregory Glenn, president of research and development at Novavax, said data from the trial will “support regulatory submissions for licensure in the UK, EU and other countries.”

NVX-CoV2373 entered phase 2 testing in the U.S. and Australia last month following positive results from phase 1 testing. The vaccine is also in stage 2 testing in South Africa (DID, Aug. 25).

The company did not specify when it expects data from the trial. It plans to release the study protocol “in the coming days.”

Novavax is also gearing up for a separate phase 3 trial of the vaccine in the U.S. under its $1.6 billion agreement with Operation Warp Speed. That trial, which is expected to begin soon, plans to enroll 30,000 participants (DID, July 8).

The company is also scaling up its manufacturing capacity, aiming to produce 2 billion doses of the vaccine annually by mid-2021. — Jordan Williams