Vaccine maker Novavax has said its shot was highly effective against Covid-19 and also protected against variants in a large, late-stage study in the US and Mexico.
The vaccine was about 90% effective overall and preliminary data showed it was safe, the company said.
The need for more vaccines around the world is critical and the Novavax jab, which is easy to store and transport, is expected to play an important role in boosting supplies in the developing world.
NEW DATA RELEASE: Novavax #COVID19 Vaccine Demonstrates 90% Overall Efficacy and 100% Protection Against Moderate and Severe Disease in PREVENT-19 Phase 3 Trial https://t.co/lIOiQXxDtD pic.twitter.com/4ePHxDpziZ— Novavax (@Novavax) June 14, 2021
That help is still months away, however. The company says it plans to seek authorisation for the shots in the US, Europe and elsewhere by the end of September and be able to produce up to 100 million doses a month by then.
“Many of our first doses will go to … low and middle-income countries, and that was the goal to begin with,” Novavax chief executive Stanley Erck told The Associated Press.
Less than 1% of people in the developing world have had one Covid-19 vaccine dose, according to Our World In Data.
Today, Novavax is excited to announce results of our PREVENT-19 Phase 3 #clinicaltrial in the US & Mexico, evaulating the safety and efficacy of NVX-CoV2373, our investigational #COVI19 #vaccine candidate. Thread: pic.twitter.com/ZuTEBO18wB— Novavax (@Novavax) June 14, 2021
Novavax’s study involved nearly 30,000 people aged 18 and above in the US and Mexico. Two-thirds received two doses of the vaccine, three weeks apart, and the rest got dummy shots.
There were 77 cases of Covid-19 – 14 in the group that got the vaccine and the rest were in volunteers who received dummy shots. None in the vaccine group had moderate or severe disease, compared to 14 in the placebo group.
The vaccine was similarly effective against several variants and in high-risk populations including the elderly and people with other health problems.
NVX-CoV2373 demonstrated overall efficacy of 90.4% (95% CI: 82.9, 94.6), achieving its primary endpoint. 77 cases were observed: 63 in the placebo group & 14 in the vaccine group. All cases in the vaccine group were mild. pic.twitter.com/B8mNsoOJ9Y— Novavax (@Novavax) June 14, 2021
Side effects were mostly mild – tenderness and pain at the injection site. There were no reports of unusual blood clots or heart problems, Mr Erck said.
Novavax reported the results in a press release and plans to publish in a medical journal, where it will be vetted by independent experts. The company previously released findings from smaller studies in the UK and South Africa.
Covid-19 vaccines train the body to recognise the coronavirus, especially the spike protein that coats it, and get ready to fight the virus off. The Novavax vaccine is made with lab-grown copies of that protein. That is different from some of the other vaccines now widely used, which include genetic instructions for the body to make its own spike protein.
Serious & severe adverse events were low in number & balanced between vaccine & placebo groups. pic.twitter.com/A8uS9l16tx— Novavax (@Novavax) June 14, 2021
The Novavax vaccine can be stored in standard refrigerators, making it easier to distribute.
Novavax previously announced manufacturing delays due to supply shortages. The company now expects to reach production of 100 million doses a month by the end of September and 150 million doses a month by December.
The company has committed to supplying 110 million doses to the US over the next year and a total of 1.1 billion doses to developing countries.
In May, vaccines alliance Gavi announced it had signed an agreement to buy 350 million doses of Novavax’s vaccine, with deliveries estimated to begin in the third quarter. Covax, the global initiative to provide vaccines to countries, is facing a critical shortage of vaccines after its biggest supplier in India suspended exports until the end of the year.