Experimental Novavax's

Novavax’s experimental coronavirus vaccine triggered antibodies in 100% of trial participants – Daily Mail

Novavax’s experimental coronavirus vaccine triggered antibodies in 100% of trial participants, study reveals

  • Novavax published ‘positive data’ from a phase 1 trial of its coronavirus vaccine in the New England Journal of Medicine on Friday 
  • All 108 volunteers dosed with the vaccine developed a antibodies to coronavirus after their second shot 
  • Novavax is launching its second phase of testing in older adults on the heels of the results
  • It comes as the CDC instructed states to prepare to distribute a vaccine by the end of October 

By Natalie Rahhal Us Health Editor

Published: | Updated:

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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Experimental Vaccine

Experimental J&J vaccine protects monkeys in a single dose-study – Yahoo Finance

By Julie Steenhuysen

CHICAGO, July 30 (Reuters) – Johnson & Johnson on Thursday kicked off U.S. human safety trials for its COVID-19 vaccine after releasing details of a study in monkeys that showed its best-performing vaccine candidate offered strong protection in a single dose.

When exposed to the virus, six out of six animals who got the candidate vaccine were completely protected from lung disease and five out of six were protected from infection as measured by the presence of virus in nasal swabs, according to the study published in the journal Nature.

“This gives us confidence that we can test a single-shot vaccine in this epidemic and learn whether it has a protective effect in humans,” Dr. Paul Stoffels, J&J’s chief scientific officer, told Reuters in a telephone interview.

The U.S. government is backing J&J’s vaccine effort with $456 million in funding as part of a spending spree aimed at speeding production of a vaccine to end the pandemic, which has infected millions and killed more than 660,000 people.

Stoffels said prior tests of this type of vaccine in other diseases found that a second shot significantly increases protection. But in a pandemic a single-shot vaccine has a significant advantage, sidestepping a lot of the logistical issues involved in getting people to come back for their second dose.

The company plans to take up the question of one or two doses in its phase 1 trial, which kicked off this week in the United States.

Depending on those results, J&J plans to start large-scale, phase 3 testing with a single-shot regimen in the second half of September. Around the same time, the company will start a parallel phase 3 study testing a two-shot regimen of the vaccine, Stoffels said.

J&J’s vaccine uses a common cold virus known as adnovirus type 26 or Ad26 to ferry coronavirus proteins into cells in the body, causing the body to mount an immune defense against the virus.

In the monkey study, scientists from J&J and Harvard’s Beth Israel Deaconess Medical Center studied seven different potential vaccines in 32 animals and compared the results to 20 control animals who got placebo shots.

Six weeks later, all of the animals were exposed to the SARS-CoV-2 virus. All 20 animals that received the placebo developed high levels of virus in their lungs and nasal swabs.

In the best-performing candidate, which J&J selected for human testing, none of the animals had virus in their lungs and only one showed low levels of virus in nasal swabs. Lab tests showed they all had developed antibodies capapable of neutralizing the virus after a single shot.

“This study shows that even just a single immunization with the Ad26 vaccine leads to neutralizing antibody responses and robust protection of monkeys against COVID-19,” said Dr. Dan Barouch, a vaccine researcher at Beth Isreal Deaconness who led the research in collaboration with J&J.

(Reporting by Julie Steenhuysen; editing by Richard Pullin)

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COVID Experimental

Experimental COVID-19 vaccine is put to its biggest test – MSN Money

The biggest test yet of an experimental COVID-19 vaccine got underway Monday with the first of some 30,000 Americans rolling up their sleeves to receive shots created by the U.S. government as part o…
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