Novavax Inc’s experimental COVID-19 vaccine is safe and 96 percent effective at preventing infection, but possibly not against all variants, trial data shows.
On Thursday, the Gaithersburg, Maryland-based company released results from two clinical trials, one held in the UK and the other in South Africa.
Both countries have seen highly infectious variants crop up in recent months that have spread around the world.
Across both trials, the vaccine candidate, called NVX-CoV2373, demonstrated 100 percent protection against severe disease, including all hospitalization and death.
In the Phase III UK trial, the vaccine was found to be 96.4 percent effective against mild, moderate and severe disease caused by the original coronavirus strain.
It was also 86.3 percent effective against the variant frist identified in the UK, known as B.1.1.7.
But in South Africa’s mid-stage study, the Novavax shot was not as protective and was found to be just 55.3 percent effective its variant, which is called B.1.351.
It remains unclear if the data will be enough for the U.S. Food and Drug Administration to grant Novavax’s shot emergency use authorization
In a late-stage UK study, Novavax’s coronavirus vaccine was shown to be 96% effective against the original COVID-19 strain and 100% effective at preventing severe disease. Pictured: Dr Stephaun Wallace (left) receives his second injection from Dr Tia Babu during the Novavax COVID-19 vaccine trial in Seattle, Washington, February 2021
Novavax’s vaccine uses synthesized pieces of the surface protein that the coronavirus uses to invade human cells and spurs antibody production (file image)
The Novavax shot was 86.3% effective against the UK variant but just 55.3% effective against the South African variant. There are more than 3,000 cases of all variants in the U.S.
‘We are very encouraged by the data showing that NVX-CoV2373 not only provided complete protection against the most severe forms of disease, but also dramatically reduced mild and moderate disease across both trials,’ said Stanley Erck, president and CEO of Novavax, in a press release.
‘Importantly, both studies confirmed efficacy against the variant strains.
‘Today marks one year since the WHO officially declared the COVID-19 pandemic, and with this data in hand, we are even more motivated to advance our vaccine as a potential weapon in the fight to end the suffering caused by COVID-19.’
Novavax, which has not produced a vaccine before, was one of six vaccine candidates to be given funding for research and development by the Trump’s administration’s Operation Warp Speed last summer.
However, no contracts were signed with the U.S. Department of Health and Human Services to supply doses of the vaccine.
Its shot contains synthesized pieces of the surface protein that the coronavirus uses to invade human cells.
The idea is that the protein will cause human cells to spur production of antibodies to fight the infection.
This technology is a more traditional method of administering vaccines compared to the newer technology in the Pfizer and Moderna vaccines that has never been used before.
The biotechnology company has been running trials in Britain, South Africa, the U.S. and Mexico.
The UK trial involved more than 15,000 participants between ages 18 and 84, including 27 percent who were over the age of 65.
Overall, there were 106 cases of COVID-19 in the trial, with 10 in the vaccine group and 96 in the placebo group.
In volunteers who were 65 year old or older, there were 10 cases of coronavirus, nine of which were among those who received the placebo.
UK Health Secretary Matt Hancock hailed the effectiveness of the variant, which is now linked to more than 90% of cases in Britain
Researchers determined the vaccine was 96.4 percent effective against the original strain and 86.3 percent against the variant circulating in the UK.
UK Health Secretary Matt Hancock hailed the effectiveness of the variant, which is now linked to more than 90 percent of cases in Britain.
‘Really encouraging results from @novavax tonight on its efficacy against variants,’ he tweeted.
‘We’ve ordered 60 million doses & if approved by the medicines regulator it will be another boost to the UK’s vaccination rollout as we work to overcome this virus.’
However, the U.S.-based, late-stage trial did not begin until December after Novavax had issues in scaling up the vaccine’s manufacturing.
The South Africa trial evaluated the safety and efficacy of the vaccine in 2,665 healthy adults.
In total, 51 cases of COVID-19 were identified the vaccine group and 96 in the placebo group – the vast majority of which were linked to the South African varaint.
Researchers determined this demonstrated 55.3 percent efficacy against strains in South Africa.
The news come less than two months after Novavax released data from an interim analysis shows.
That data showed, that the vaccine was 95.6 percent effective against the original virus and 85.6 percent effective against the B 1.1.7. variant.
At the time, the mid-stage study in South Africa found that the shot was just 49.3 percent effective against that country’s variant.