HHS Archives - Page 3 of 3 - Medical Design Sourcing

HHS puts $6.5M more toward COVID-19 testing

The U.S. Department of Health and Human Services (HHS) said today it will provide a total of $6.5 million to help two commercial diagnostic laboratories to expand capacity to conduct up to 4 million additional diagnostic tests for COVID-19 per month.

The investments in Aegis Sciences (Nashville, Tenn.) and in Sonic Healthcare USA (Austin, Texas) will provide laboratory equipment supplied by Beckman Coulter and Thermo Fisher Scientific (NYSE:TMO) and increase staffing and infrastructure to boost testing nationwide by an additional 1 million tests each week by early October, according to the agency.

Aegis will add laboratory staff and begin construction on new lab space at its Nashville testing facilities to meet its goal of processing more than 60,000 test samples per day beginning in September. Aegis has agreed to partner with the Office of the Assistant Secretary for Health to perform testing of samples from select locations with vulnerable populations, accor…

Moderna launches Phase 3 study of its COVID-19 vaccine candidate

Moderna Logo (PRNewsFoto/Moderna Therapeutics)

Moderna (NSDQ:MRNA) announced today that it began dosing participants in the Phase 3 clinical study of its mRNA-1273 COVID-19 vaccine candidate.

Cambridge, Mass.-based Moderna’s COVE (coronavirus efficacy) study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Dept. of Health and Human Services.

The company had previously announced on June 11 that it expected to begin the Phase 3 trial at some point this month. At that point, it had already fully enrolled the first cohort of healthy adults between ages 18-53 in the Phase 2 study, 13 days after the first participant was dosed, having prev…

HHS taps Pfizer to produce millions of COVID-19 vaccine doses

[Photo by Fusion Medical Animation on Unsplash]

Two U.S. government agencies today announced an agreement with Pfizer (NYSE:PFE) for production and delivery of 100 million doses of a COVID-19 vaccine.

The U.S. Dept. of Health and Human Services, along with the U.S. Defense Dept., agreed to the large-scale production and U.S. delivery deal once Pfizer’s vaccine is successfully manufactured and approved. In addition to the 100 million doses initially agreed upon. the U.S. government will be able to acquire an additional 500 million doses.

Pfizer will deliver the initial 100 million doses if the vaccine candidate receives FDA emergency use authorization (EUA) or licensure once a Phase 3 clinical trial is complete, demonstrating safety and efficacy in the fight against COVID-19. The timing of the agreement is designed to allow quick shipment once approval is garnered in an effort to meet the U.S. gov…