President Joe Biden hinted Tuesday that Novavax’s COVID-19 vaccine candidate could be the next to receive emergency use authorization in the U.S. and would be shared with countries in need of aid. Novavax’s COVID-19 vaccine is cheaper and easier to store than the mRNA vaccines made by Moderna and Pfizer/BioNTech. It’s exactly what the world needs right now as the rollout of AstraZeneca’s and Johnson & Johnson’s affordable shots is paused due to safety concerns.
The president’s comment sent the Maryland-based company’s stock surging as much as 16 percent Tuesday before cooling off Wednesday morning.
Novavax’s promise doesn’t stop at the COVID-19 vaccine. Last week, the company reported positive results from a phase 2 trial for its malaria vaccine candidate R21 in a preprint with The Lancet. The vaccine showed an efficacy rate of 77 percent. If the phase 3 trial produces similar results, it will be a game-changer in preventing malaria, which killed over 400,000 people, mostly children, in 2019. The prominent malaria vaccine on the market, Mosquirix, made by GlaxoSmithKline, is only 35 percent to 55 percent protective against the life-threatening disease.
Novavax’s malaria vaccine contains a proprietary ingredient, called Matrix-M, that the company also injects in its COVID-19 vaccine candidate NVX-CoV2373 and flu vaccine candidate NanoFlu. Matrix-M is an adjuvant used to enhance a vaccine’s immune response. In the case of the COVID-19 vaccine, Novavax uses a lab-made version of the spike protein of the original coronavirus to train the immune system to produce antibodies. When exposed to the harmful virus, the adjuvant signals the immune system to spring into action.
In the R21 phase 2 trial, children who were given vaccines containing 50 mg of Matrix-M displayed 6 percent stronger immunity to malaria than those given vaccines containing half the Matrix-M dosage. Novavax has begun recruiting volunteers for R21’s phase 3 study in four countries.
R21 was developed by the University of Oxford, which also developed the COVID-19 vaccine manufactured by AstraZeneca. License to the experimental malaria vaccine is held by The Serum Institute of India (SII). Novavax will receive royalties on all sales of the vaccine if approved.
On the COVID-19 side of things, Novavax has an agreement with the U.S. government to supply 100 million doses of its vaccine once the FDA authorizes emergency use. The vaccine was found to be 96 percent effective against the original coronavirus in a global phase 2 study. Phase 3 trials in the U.S. are expected to report results this quarter, and an EUA application will follow in the second quarter.
