The announcement of Novavax's vaccine trial comes as drugmakers pause clinical trials on drugs for other ailments to focus on COVID-19, the illness caused by the novel coronavirus that has resulted in more than 346,000 deaths globally.
Human trials for a coronavirus vaccine have begun in Australia as USA biotechnology company Novavax hopes to release a proven jab this year.
NVX-CoV2373 consists of a stable, prefusion protein made using Novavax' proprietary nanoparticle technology, and incorporates that company's proprietary saponin-based Matrix-M™ adjuvant.
The results of the first phase of clinical trials in Australia are expected to be known in July, Novavax said, and thousands of candidates in several countries would then become involved in a second phase.
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If the Phase I data is promising, Novavax said it will quickly initiate the Phase II portion of the study. 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 Covid19 disease reduction in a broader age range.
Novavax received its largest ever investment of $388 million from the Coalition for Epidemic Preparedness and Innovations (CEPI), which was co-founded and set up in November 2017 with funding from the Bill and Melinda Gates Foundation.
"What we're bringing to the table is a very strong immunogenic vaccine".
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He added that should this or any other vaccine prove to be a success, it would most likely be delivered via a risk-based approach. The mRNA vaccines make the body produce coronaviruses spike proteins by stimulating it to activate the immune response. CEPI also invested in platform technologies that can be used for rapid vaccine and immunoprophylactic development against unknown pathogens (Disease X). The ideal vaccine might generate both antibody and T cell responses to defend against SARS-CoV-2. Phase 1 will be a randomized, placebo-controlled trial to test the immunogenicity and safety of NVX-CoV2373.
In a bid to boost its global vaccine manufacturing abilities, Gaithersburg biotechnology firm Novavax has paid roughly $167 million to buy a biologics manufacturing plant in the Czech Republic.
The new Ad5 vectored COVID-19 vaccine evaluated in this trial is the first to be tested in humans. The trial is a two-part randomized, observer-blinded, placebo-controlled study created to evaluate the immunogenicity and safety of the vaccine with or without Matrix-M adjuvant in healthy participants ≥ 18 to 59 years of age.
The prestigious medical journal The Lancet published last Friday an article in which he indicated that the latter, the first to reach the stage in question It was found to be safe, well tolerated and capable of generating an immune response against the disease.
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