A quick debrief of the week’s top FDA approvals, FDA authorizations, or other infectious disease pipeline developments from the past week.
Operation Warp Speed Agencies Reveal Vaccine Rollout Strategy
Federal agencies, including the Department of Health and Human Services (HHS) and the Department of Defense (DoD), have detailed plans to carry out a key future step in Operation Warp Speed: the initial distribution of a SARS-CoV-2 vaccine.
As stated in the report, the “principal purpose and objective of Operation Warp Speed (the US accelerated vaccine program)” is “ensuring that every American who wants to receive a COVID-19 vaccine can receive one, by delivering safe and effective vaccine doses to the American people beginning January 2021.”
The plan suggests that the federal government intends for the vaccine to be provided at no cost to individuals who request it.
The report is addressed to congress, and authors state that federal funding enabled “strong progress” toward a “safe and effective COVID-19 vaccine with multiple candidates in phase 3 clinical trials.”
Notably, the Russian SARS-CoV-2 vaccine was approved before formal phase 3 trial results were gathered.
Vaccine development is currently being led by experts from HHS.
Phase 2 Data Shows Monoclonal Antibody Reduces COVID-19 Hospitalization Rates
Eli Lilly’s investigational IgG1 monoclonal antibody (mAb) therapy, LY-CoV555, showed a reduced rate of hospitalizations for COVID-19 patients in the outpatient setting.
This comes from interim analysis of its phase 2 BLAZE-1 clinical trial for LY-CoV555. Rate of hospitalizations and ER visits was 1.7 percent (5/302) for LY-CoV555 versus 6 percent (9/150) for placebo—a 72 percent risk reduction in this limited population. Most hospitalizations in the study occurred in patients with underlying risk factors (age or BMI), suggesting a more pronounced treatment effect for patients in these higher-risk groups.
"These interim data from the BLAZE-1 trial suggest that LY-CoV555, an antibody specifically directed against SARS-CoV-2, has a direct antiviral effect and may reduce COVID-related hospitalizations," Daniel Skovronsky, MD, PhD, Lilly's chief scientific officer and president of Lilly Research Laboratories, said. "The results reinforce our conviction that neutralizing antibodies can help in the fight against COVID-19."
MIT Scientists Propose CRISPR Testing for SARS-CoV-2
An editorial advocating a new method of CRISPR testing was published in NEJM by a team of scientists from MIT, University of Washington, and Brigham & Women’s Hospital.