The shot was 90% effective in preventing symptomatic Covid and 100% effective in preventing moderate and severe symptoms, the US biotech company said said Monday in a statement. It was also 93% effective against the variants of concern, according to the results of a secondary analysis that mainly included cases of the predominant alpha variant in the United States.
The company plans to seek regulatory clearance globally, with most of the first available doses going to low- and middle-income countries, Stanley Erck, CEO of Novavax, said on a conference call. The study results, which were at least as good as many analysts expected, suggest that Novavax’s protein-based technology may be a rival to messenger RNA vaccines over time, especially if injected. reminders are needed.
The data “clearly positions Novavax as a viable alternative to mRNA vaccines,” Kelechi Chikere, analyst at Jefferies, wrote in a note to clients. Over time, Novavax’s vaccine could become a “universal booster” because of its high efficacy and low rate of side effects, Chikere said.
Novavax shares rose less than 1% to $ 210.56 at 10:36 a.m. in New York exchanges.
The vaccine uses recombinant protein technology, also used in the candidate developed by Sanofi and GlaxoSmithKline Plc. At over 90%, the overall vaccine efficacy is similar to the rates reported for messenger RNA injections developed by Pfizer Inc. with BioNTech SE and by Moderna Inc., as well as the Russian Sputnik V vaccine, using virus vector technology.
The Phase 3 trial of Novavax included nearly 30,000 participants in the United States and Mexico. Side effects of the injection, given in two doses 21 days apart, included headache, muscle pain and fatigue.
A single case of the highly contagious delta strain, which was first identified in India and remains rare in the United States, was detected among the trial participants, so the vaccine’s efficacy against it was not is inconclusive. And so far, there were only two cases for each of the beta and gamma variants detected in the trial.
The trick for Novavax will be to increase production. The company is on track to achieve a 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. Yet it remains behind the companies of MRNAs that have been in production for months.
While the United States has accumulated sufficient doses of Pfizer, Moderna and Johnson & Johnson is shooting to inoculate its people, other parts of the world have been slow to follow. Novavax and its partners have made arrangements to deliver 1.1 billion doses of vaccine to Covax, the World Health Organization-backed initiative to provide equitable access to vaccines for all countries.
“We see this as a large, ongoing market” similar to that for influenza vaccines, Erck said on the conference call, calling the side effect profile of Novavax’s vaccine “favorable”.
Use in the United States
In the United States, the vaccine can be used primarily as a booster, Novavax executives said on the call, citing the vaccine’s low rate of side effects and its ability to be shipped at refrigerator temperature as potential benefits. . However, Pfizer, Moderna and J&J also intends to produce boosters.
The new findings were similar to results from a 15,000-person trial of the vaccine in the UK that was published in March, where the shot has been shown to be 90% effective in preventing symptoms of Covid across variants and the original version of the virus.
(Updates with conference call details starting in third paragraph)