Research and manufacturing delays have dogged the arrival of a Covid-19 vaccine from Novavax Inc., one of only six selected by the US government's Operation Warp Speed for a large order. At one point in May, the company’s shares were down 62% from a February high. On Monday, though, Novavax took a step toward a comeback, announcing that its vaccine was 90.4% effective in preventing mild and moderate Covid in a large trial in the US and Mexico and prevented all severe disease.
Late or not, the promising data suggests that Novavax's effort could be crucial in a pandemic fight that won't end soon. Even for those jaded by dozens of data releases, this is an impressive result that should help pave the way for rapid approval and rollout in the third quarter. The vaccine won’t see much initial use in the US, where the vaccination rate is already high, but it will be instrumental in inoculating the world, which is vital in the effort to tame the virus, keep variants at bay and minimize the human and economic damage.
While comparing clinical-trial data is fraught, especially during an evolving pandemic, the Novavax results appear to be among the best so far. Everyone pays attention to the headline number, and Novavax fell short of the 94% and 95% efficacy reported respectively by mRNA vaccines from Moderna Inc. and Pfizer Inc.'s collaboration with BioNTech SE, but context matters.
Here’s what makes the shot a standout: Novavax's trial took place when variants began to dominate; they were only a theoretical concern during mRNA vaccine tests. In the US trial, the vaccine was 93% effective against variants of concern and interest. The data isn't perfect; Novavax's results are a bit less conclusive than those from the mRNA vaccines because it recorded fewer infections as cases declined. And most variant infections came from the so-called alpha variant first identified in Britain, limiting information about others such as the concerning delta variant, which was first discovered in India. But the study is still highly promising, especially on top of similar results from an earlier trial in the UK. The vaccine did allow more infections in a trial in South Africa dominated by the beta strain first identified there, which partially evades vaccines. But notably, the shot still prevented all severe disease and death. The vaccine may be delayed, but the timing means more confidence that it works in the current environment.
The shot's combination of efficacy and availability is particularly exciting. Novavax has pledged 1.1 billion vaccines to COVAX, the organization leading the effort to vaccinate lower-income countries. Insufficient funding and manufacturing delays have left the group struggling to hit targets; Novavax’s doses are badly needed. The company hopes to make 100 million doses a month by the end of the third quarter and 150 million in the fourth quarter. The vaccine is also more stable and easily stored than mRNA vaccines, which will be helpful in broad distribution.
Novavax has also been especially willing to license its vaccine to manufacturers in other parts of the world, including South Korea's SK Biosciences Co., Japan’s Takeda Pharmaceutical Co. and the Serum Institute of India. Once those plants are up to speed, they should help more quickly vaccinate their home countries and further increase global availability.
On top of setting the vaccine up as a key tool this year, Monday's data suggests Novavax will have a long-term role in keeping the virus tamped down, which had been an unknown for investors. It's a validation of the underlying technology, which uses tiny virus protein fragments and an immune-boosting substance called an adjuvant to prompt a protective response. The company is testing a third dose as a six-month booster, and early data suggests it produces a strong immune response. Novavax is also part of a study in the UK examining mixing different vaccines, and good results could bode well for broad booster use. The company is also developing vaccines tailored to specific strains, and a combination flu and Covid shot, which could see use for years to come.
Novavax still has to deliver on its data by winning approval, delivering doses and speeding the next generation of shots to market. But at the very least, we know that when its vaccines arrive, they'll do a great deal of good.
Bloomberg
