EPI-backed coronavirus vaccine from Novavax starts trials


American biotech company Novavax said on Monday (May 25) it's begun trials for a coronavirus vaccine in Australia.

NVX-CoV2373 includes Novavax' proprietary Matrix-M adjuvant to enhance immune responses and stimulate high levels of neutralising antibodies.

The results of the first phase of clinical trials in Melbourne and Brisbane are expected to be known in July, Novavax said.

A randomized, double-blinded, placebo-controlled phase 2 trial of the Ad5-nCoV vaccine has been initiated in Wuhan to determine whether the results can be replicated, and if there are any adverse events up to 6 months after vaccination, in 500 healthy adults-250 volunteers given a middle dose, 125 given a low dose, and 125 given a placebo as a control. The Phase I portion is a randomized, observer-blinded, placebo-controlled trial created to evaluate the immunogenicity and safety of NVX-CoV2373, both adjuvanted with Matrix-M and unadjuvanted.

The Phase 2 portion is expected to be conducted in multiple countries, including the United States, and would assess immunity, safety and COVID-19 disease reduction in a broader age range.

The company pointed out at "this Phase 1/2 approach allows for rapid advancement of NVX-CoV2373 during the pandemic and that the trial is being supported by the recently announced funding arrangement with the Coalition for Epidemic Preparedness Innovations (CEPI)".

"What we're bringing to the table is a very strong immunogenic vaccine". Still other candidate vaccines are more outdated, made from complete dead viruses. There are now several vaccines in clinical evaluation, and about 70 in pre-clinical evaluation. Pfizer, which develops its project together with the German laboratory Biontech, and another from the British pharmacist AstraZeneca, which investigates with the Jenner Institute, Oxford University.

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But it is still exceedingly rare, and the study estimated it will only affect 1 in 1,000 children exposed to the coronavirus. Most of the children with positive viruses have underlying medical conditions, making them more prone to the disease.

Before the emergence of COVID-19 CEPI's priority diseases included Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever and Chikungunya virus.

The vaccine, NVX-CoV2373, is a stable, prefusion protein mode using the company's proprietary nanoparticle technology.

The replicas of the spike protein are then injected into vaccine recipients to stimulate an immune response, including through the greater production of antibodies, which may provide longer-lasting protection against viral infection.

The vaccine, created by Maryland firm Novavax, has been formulated utilizing another technique from the others being developed all over the world.

CEPI kick-started the clinical trial with a $384 million investment in Novavax earlier this month, following an initial $4 million invested in March. The possible approval for NanoFlu and the possibility of success for the coronavirus vaccine in Phase 1 clinical trials are the main reasons behind any kind of optimism.

The Thai vaccine uses messenger RNA, which prompts body cells to produce antigens, molecules on the surface of viruses, that spur the immune system into action.