FDA approves Moderna vaccine candidate for phase 2 study
The company said it will begin phase 2 trials with 600 participants shortly and is finalizing plans for a phase 3 trial as early as this summer.
"The imminent Phase 2 study start is a crucial step forward as we continue to advance the clinical development of mRNA-1273, our vaccine candidate against SARS-CoV-2," CEO Stephane Bancel said in a statement. "With the goal of starting the mRNA-1273 pivotal Phase 3 study early this summer, Moderna is now preparing to potentially have its first BLA approved as soon as 2021."This is breaking news. Please check back for updates.
Australia Latest News, Australia Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
FDA Approves Diabetes Drug for Type of Heart FailureThe FDA today approved a new use for the diabetes drug, dapagliflozin (Farxiga), to reduce the risk of a hospital stay or death in people who have a type of heart failure.
Read more »
FDA authorizes antibody test for emergency use to determine coronavirus ImmunityPerkinElmer's serological test is the first of its kind to receive emergency use authorization by the FDA in the fight against the coronavirus pandemic.
Read more »
Coronavirus vaccine in human trials relies on body's genetic materialIt's still unclear if the drug will work, and would be months away from potentially being available to the public, but the drug is now a contender to be the first vaccine of its kind ever approved to prevent an infectious disease.
Read more »
Pfizer, BioNTech set to begin U.S. coronavirus vaccine trialPfizer Inc and BioNTech SE said on Tuesday they have begun delivering doses of their experimental coronavirus vaccines for initial human testing in the United States.
Read more »
FDA authorizes antibody test for emergency use to determine coronavirus ImmunityPerkinElmer's serological test is the first of its kind to receive emergency use authorization by the FDA in the fight against the coronavirus pandemic.
Read more »
Jaboukie Young-White Examines Why Gay Men Still Struggle to Donate Blood During COVID-19While plasma from recovered coronavirus patients can help those with the disease, the FDA still has strict rules for gay men who want to donate
Read more »