Novavax’s vaccine showed high efficacy; the company has a contract to distribute a billion doses of ... [+]
Novavax reported Monday that the phase 3 study of its Covid-19 vaccine, NVX-CoV2373, is highly effective against the disease. The study found that the vaccine prevented Covid over 90% of the time and was 100% effective at preventing moderate and severe versions of the disease. The company’s study prioritized finding patients that are typically underrepresented in clinical trials and are considered to be at high risk for severe Covid disease. Among the high-risk patients, the vaccine showed 91% efficacy.
“These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe Covid-19 infection,” CEO Stanley Erck said in a statement.
The company’s vaccine is different than those currently in circulation. For its vaccine, the company created protein nanoparticles that mimic part of the coronavirus called the “spike protein.” The nanoparticles are injected into patients along with an adjuvant, a substance that helps stimulate the immune system. Like many of the others, it also requires two doses, taken 21 days apart.
Novavax launched its clinical trial in December 2020 in the United States, just as the country was in the worst phase of its pandemic. The randomized, controlled trial included a placebo group, and the data the company is presented was observed between January 25 and April 30, 2021. Nearly 30,000 patients participated in the trial, and its recruitment made a point to ensure that high-risk individuals were studied, and found the vaccine to be 91% efficacious among this population.
The results the company presented, which have not yet been peer-reviewed (though earlier studies of the vaccine have been) found the vaccine had a good safety profile. It also found that Novavax’s vaccine was effective against variants of concern, particularly the Alpha variant, which was first seen in the United Kingdom and now comprises over 70% of cases in the United States. The findings of this study are consistent with an earlier phase 3 trial the company conducted in the United Kingdom.
With the results of this trial in hand, the company’s next step will be to obtain emergency use authorizations from the FDA and other public health bodies around the world so it can begin administration of its vaccine. The company says that it’s on track to be producing 100 million doses per month by the end of next quarter and will be at 150 million doses per month by the end of the year. This is later than the company had previously stated several months ago, due to supply-chain issues causing a delay in its ability to scale manufacturing.
There’s still plenty of demand for more vaccines around the world, particularly as countries like India and Brazil are seeing high case rates, while the U.K. and Europe are bracing themselves for another potential wave of cases. Novavax has an agreement with Covax to deliver up to 1.1 billion doses of its vaccine to emerging economies, along with agreements to produce doses in Korea, Japan, Canada and many other nations.
“Novavax continues to work with a sense of urgency to compete our regulatory submissions and deliver this vaccine, built on a well-understood and proven platform, to a world that is still in great need of vaccines,” Erck said in a statement.
