Novavax’s Covid-19 vaccine candidate showed strong efficacy against the coronavirus, the company said on Monday, citing findings in a large trial that signal a new option is nearing for a global community still desperate for protection against the virus and its variants.
The shot was 90% effective at preventing symptomatic Covid and 100% effective at preventing moderate and severe symptoms, the US-based biotech firm said. The finding is particularly encouraging for India since Novavax has a deal with Pune’s Serum Institute of India (SII) to manufacture at least a billion doses for low- and middle-income countries, which includes India.
SII has begun stockpiling doses of the vaccine, which will be sold as Covovax once approved by regulators. The government expects to have access to at least 200 million doses of the vaccine between August and December, a top official said at a press briefing in May.
The latest clinical trial, which included 30,000 participants, showed it was also 93% effective against variants of concern, according to results from a secondary analysis that mostly included cases of the Alpha variant predominant in the US.
The company plans to apply for regulatory clearance globally, with much of the first available doses going to low- and middle-income countries, Stanley Erck, Novavax’s chief executive officer, said on a conference call, Bloomberg reported.
The study results, which were at least as good as many analysts expected, suggest Novavax’s protein-based technology can be a rival to messenger RNA vaccines over time, especially if booster shots are needed.
“If you are going to stop this pandemic, you can’t just stop it in the US,” Erck said in an interview on Monday with David Westin on Bloomberg Television, calling his company’s shot particularly well suited to help with lower-income countries. “We can ship it at just standard refrigerated temperatures, and it can go anywhere in the world.”
The data “clearly position Novavax as a viable alternative to mRNA vaccines,” Kelechi Chikere, an analyst at Jefferies, wrote in a note to clients, according to Bloomberg. Over time, Novavax’s vaccine could become a “universal booster” due to its high efficacy and low rate of side effects, Chikere said.
Novavax shares rose 1% to $211.74 at 12:50 p.m. in New York trading.
The vaccine is based on a recombinant protein technology, also used in the candidate developed by Sanofi and GlaxoSmithKline Plc, and the one being made by Biological E in India.
At over 90%, the overall efficacy of the vaccine is similar to reported rates for messenger RNA shots developed by Pfizer Inc. with BioNTech SE and by Moderna Inc., as well as the Sputnik V vaccine from Russia, using viral vector technology.
Side effects for the shot, given as a two-dose regimen taken 21 days apart, included headache, muscle pain and fatigue.
While the company didn’t provide exact numbers on the side effect rates, Erck said on Bloomberg Television that the shot will “have probably the most benign safety profile of any vaccine.”
Only one case of the highly contagious Delta strain, which was first identified in India and remains rare in the US, was detected among trial participants, so the vaccine’s efficacy against it isn’t conclusive. And there were only two cases each of the Beta and Gamma variants detected in the trial so far.
The trick for Novavax will be ramping up production. The company is on track to reach manufacturing capacity of 100 million doses per month by the end of the third quarter and 150 million per month by the end of 2021. Still, it remains behind mRNA companies that have been in production for months.
”We look at this as a large ongoing market” akin to that of influenza vaccines, Erck said on the conference call.