Novavax reported “ positive data ” on its experimental coronavirus vaccine on Wednesday.
The phase one study in more than 100 Australian adults showed that the vaccine caused the production of antibodies to the coronavirus – infection-fighting immune cells – in everyone who received the injection after their second dose.
No one involved in the early safety testing reported serious side effects, and according to a report published in the New England Journal of Medicine (NEJM), most of the ‘side effects’ were considered unrelated to the vaccine.
Following the results, Novavax announced that it has launched the second half of the study, in adults between the ages of 60 and 84 in the US and Australia.
Shares of Novavax were up four percent after the bell and the publication of the results.
It comes after the Centers for Disease Control and Prevention (CDC) sent instructions to state health departments to prepare for the shipment of COVID-19 vaccines by the end of October – days before the November 3 presidential election.
The Novavax vaccine uses synthesized pieces of the surface protein that the coronavirus uses to enter human cells and stimulate the production of antibodies. Pictured: Three potential coronavirus vaccines are stored in a tray at Novavax laboratories in Gaithersburg, Maryland (file)
For the first half of the phase 1/2 study of the coronavirus vaccine, called NVX-CoV2373, Novavax dosed 108 volunteers between the ages of 18 and 59 with its vaccine.
83 of them received an adjuvanted form – an injection with an immune response enhancer – while 25 received the vaccine without adjuvant.
All participants were vaccinated in two doses.
All participants who received the injection with the extra immune response booster developed antibodies in response to the ‘spike’ protein on the surface of the coronavirus.
Some of them also developed ‘neutralizing’ antibodies – the ones that can best block the virus from entering cells.
After a second dose of both forms of the injection, everyone developed antibodies.
As is the case with all vaccines that have reached clinical trials, the levels of antibody the human body generated in response to the injections were higher than the levels seen in the immune-cell-rich plasma of people recovered from COVID-19.
The next phase of testing will test the vaccine in approximately 1,500 older adults in the US and Australia, and preliminary results are expected by the end of the year.
Novavax announced preliminary results of the phase 1 trial in August.
The company said it could initiate a major pivotal phase 3 study in late September, adding during a conference call that it could produce between one billion and two billion doses of the vaccine by 2021.
Gregory Glenn, head of Novavax, told Reuters that the late-stage clinical trial could potentially collect enough data to obtain regulatory approvals as early as December.
So far, the start of a Phase 3 study in the US has not been announced.
Novavax, which has never produced a vaccine before, has made an injection with synthesized pieces of the surface protein that the coronavirus uses to invade human cells.
The idea is that the protein causes human cells to stimulate the production of antibodies to fight infection.
Phase 2 will investigate to what extent the vaccine can prevent infections or reduce the severity of COVID-19, in addition to its safety and immune response, in a wider group of volunteers.
The Novavax vaccine was one of the first of a handful of US-funded programs under Operation Warp Speed, the White House program to accelerate access to vaccines and treatments that can fight the virus.
Effective vaccines and treatments are considered essential to stop a pandemic that has claimed more than 180 lives in the US.
In July, the Trump administration agreed to pay Novavax $ 1.6 billion to cover the costs associated with testing and manufacturing the vaccine, with the goal of obtaining 100 million doses by January 2021.
As COVID-19 vaccines are being developed at an unprecedented speed, safety concerns are being closely monitored.
“When you talk about vaccinating around the world, safety is almost more important than effectiveness,” said Brad Loncar, CEO of Loncar Investments, an investment fund specializing in biotechnology companies.