The Moderna vaccine will initiate phase 3 clinical trials regeneron REGN-COV2 clinical trials.

Moderna announced today that it has identified the design of a Phase 3 clinical trial for its mRNA new crown vaccine based on feedback from the U.S. FDA.
select a dose level of 100 ?g as the dose used in Phase 3 clinical trials to minimize adverse reactions while maximizing the immune response, based on the results of Phase 1 clinical studies.
the randomized double-blind, placebo-controlled Phase 3 clinical trial, which is expected to include about 30,000 participants, will be conducted in collaboration with the National Institutes of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The main endpoint of the
trial will be the prevention of symptomatic COVID-19 disease; the main efficacy analysis method for
will be event-driven analysis based on the number of participants with symptomatic new coronary pneumonia.
Moderna has completed the production of the vaccines required for phase 3 research.
the company expects the administration of Phase 3 clinical studies to begin in July.
, the company announced that the first phase 2 clinical trial of its new crown vaccine has been completed to include a team of 300 healthy adults aged 18-54, as well as a "pilot" team of 50 people aged 55 and over.
Regenerative Element Launch Antiviral Cocktail Therapy REGN-COV2's first clinical trial for the treatment and prevention of COVID-19 Regenerative Yuan (Regeneron) today announced the launch of the first clinical trial of REGN-COV2, a research bi-cocktail antibody therapy developed by the company for the prevention and treatment of COVID-19.
REGN-COV2 clinical trial will consist of four different study populations: coVID-19 patients in hospital, patients with symptoms in non-hospitalized COVID-19, uninfected populations (e.g. health care providers) in high-risk exposure groups, and uninfected people (such as roommates) who are closely exposed to COVID-19 patients.
the safety and efficacy of REGN-COV2 (REGN109333-REGN10987) treatment of in-patient and non-inpatient COVID-19 patients are being evaluated in the first two adaptive phases 1/2/3 studies.
Phase 1 will focus on virology and safety endpoints, and Phase 2 will focus on virology and clinical endpoints. Data from the
Phases 1 and 2 studies will be used to refine the endpoint and determine the scale of the Phase 3 study.
REGN-COV2 consists of two monoclonal antibodies combined with the key receptor binding domain (RBD) of the neo-coronavirus sting protein.
the RBD binding sites of the two antibodies are different, so the combination can reduce the virus's ability to evade monoantibodies treatment by producing genetic mutations.
preclinical study of the two antibodies will be published in the journal Science. Dr. George D. Yancopoulos, co-founder, president and chief scientific officer of
Regeneration, said: "We have developed a unique antiviral antibody cocktail therapy with the potential to prevent and treat infections and to pre-empt the virus's 'escape'.
REGN-COV2 can have a significant impact on public health by slowing the spread of the virus and providing those who are already sick.
antibody cocktail therapy can also be used in elderly and immune-impaired patients with poor vaccine responses.
ultimately, the world needs coVID-19 solutions, and the innovative biopharmaceutical industry is working collectively to help as many people as possible in a variety of complementary ways.
" original title: COVID-19 Development Dynamics: Moderna's new crown vaccine is expected to launch phase 3 clinical trials in July, regenerative metaantibodies "cocktail therapy" to start human trials.