Novavax reported ‘positive data’ on its experimental coronavirus vaccine on Wednesday.
Its phase one trial in more than 100 Australian adults showed that the vaccine triggered the production of coronavirus antibodies – infection-fighting immune cells – in everyone that got the shot after their second dose.
No one involved in the early safety testing reported any serious side effects, and most ‘adverse events’ were deemed unrelated to the vaccine, according to a report published in the New England Journal of Medicine (NEJM).
On the the heels of the results, Novavax announced that it it has launched the second half of the trial, in adults between ages 60 and 84 in the US and Australia.
Shares for Novavax rose four percent after the bell, and the results’ publication.
It comes after the Centers for Disease Control and Prevention (CDC) sent instructions to state health departments to prepare for COVID-19 vaccines to be shipped by the end of October – days before the November 3 Presidential election.
Novavax’s vaccine uses synthesized pieces of the surface protein that the coronavirus uses to invade human cells and spurs antibody production. Pictured: Three potential coronavirus vaccines are kept in a tray at Novavax labs in Gaithersburg, Maryland (file)
For the first half of its phase 1/2 trial of its coronavirus vaccine, called NVX-CoV2373, Novavax dosed 108 volunteers between ages 18 and 59 with its vaccine.
Eighty-three of those were given an adjuvanted form – a shot containing an immune response booster – while 25 got the vaccine sans adjuvant.
All participants were vaccinated in two doses.
All of the participants who got the shot 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 – those that may be most capable of blocking the virus from invading cells.
After a second dose of either form of the shot, everyone developed antibodies.
As has been the case with all vaccines that have reached clinical trials, antibody levels people’s bodies generated in response to the shots were higher than the levels seen in the immune cell-rich plasma of people who have recovered from COVID-19.
The next phase of testing will test the vaccine in about 1,500 older adults in the US and Australia and preliminary results are expected by year-end.
Novavax announced preliminary results of the phase 1 trial in August.
he company said it could start a large pivotal Phase 3 trial as soon as late September and, on a conference call, added that it could produce between one billion and two billion doses of the vaccine in 2021.
Novavax research chief Gregory Glenn told Reuters the late-stage clinical trial could potentially glean enough data to obtain regulatory approvals as early as December.
So far, the beginning of a phase 3 trial in the US has not been announced.
Novavax, which has not produced a vaccine before, created a shot that 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.
The Phase 2 will gauge the vaccine’s ability to prevent infections or reduce severity of COVID-19, in addition to safety and immune response, among a broader range of volunteers.
The Novavax vaccine was among the first of a handful of programs singled out for US funding 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 halting 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 help cover costs related to testing and manufacturing the vaccine, with the aim of procuring 100 million doses by January 2021.
Because COVID-19 vaccines are being developed at unprecedented speed, safety issues are being watched very closely.
‘When you are talking about vaccinating the entire world, safety is almost more important than efficacy,’ said Brad Loncar, chief executive of Loncar Investments, an investment fund specializing in biotechnology companies.
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