Every month through fall, the government-funded Covid-19 Prevention Network will roll out a new study of a leading candidate with 30,000 newly recruited volunteers.
The federal government is supporting Moderna's vaccine project with its Operation Warp Speed program. But exactly what type of immune response is needed to prevent the illness is not known, so Phase 3 studies are essential to determine whether a vaccine really works.
"We thank BARDA for this continued commitment to mRNA-1273, our vaccine candidate against COVID-19", said Stéphane Bancel, chief executive officer, Moderna.
According to a list maintained by the World Health Organization, there are four other vaccine candidates to reach Phase 3 testing: three made by Chinese entities and one by a collaboration between the University of Oxford and AstraZeneca.
There's still no guarantee that the experimental vaccine, developed by the National Institutes of Health and Moderna Inc., will offer protection. We are grateful to the efforts of so many inside and outside the company to get us to this important milestone. The study is blinded, so the investigators and the participants will not know who is assigned to which group. The registry also needs members of the community who are disproportionately affected by COVID-19 such as older persons, racial/ethnic groups like African Americans, Latinx and Native Americans and people with certain underlying health conditions.
The Phase 3 study protocol follows the U.S. FDA guidance on clinical trial design for COVID-19 vaccine studies.
In the expanded trial starting today, half the 30,000 participants will receive a 100-microgram dose of the vaccine, while the rest will be given a placebo.
If a participant is suspected to have COVID-19, the participant will be asked to provide a nasal swab for testing within 72 hours.
NIAID scientists developed the stabilized SARS-CoV-2 spike immunogen (S-2P).
"The safety data thus far looks good".
'For that a Phase 3 trial has been proposed.
In the third phase, the vaccine is administered to thousands of people. PPD has contributed an array of clinical development and laboratory services, including strategic expertise to the study design, patient-enrollment epidemiology modeling and biostatistics.
The trial will be conducted at more than 100 sites chosen to reflect a range of demographics and to ensure they include the most vulnerable populations.
While rival AstraZeneca said last week it was still on track to be producing doses by September, they and other drugmakers are now targeting delivery of a fully-tested vaccines by the end of the year at the earliest. In addition, Moderna recently announced a collaboration with Catalent, Inc. for large-scale, commercial fill-finish manufacturing of mRNA-1273 at Catalent's biologics facility for the USA, and with ROVI of Spain for fill-finish manufacturing outside the U.S.