Remove Long-Term Care Facilities Remove Treatment Remove Trials
article thumbnail

COVID-19 Vaccine Developers Adjust Phase 3 Trial Protocols to Allow Authorized Vaccines | 2020-12-17

The Pharma Data

COVID-19 vaccine developers are faced with an ethical quandary — whether to let phase 3 trial participants become “unblinded” and to receive authorized vaccines as they become available, which could hinder the collection of meaningful trial data. Pfizer, which has received emergency approvals in the U.S.

Vaccine 52
article thumbnail

U.S. CDC Advisory Committee on Immunization Practices Recommends Vaccination with Moderna’s COVID-19 Vaccine for Persons 18 Years and Older

The Pharma Data

Today’s ACIP recommendation follows the December 1, 2020 ACIP recommendation for a Phase 1a rollout in which the first priority for COVID-19 vaccines is given to healthcare personnel treating patients and residents in long-term care facilities. Department of Health and Human Services (HHS) for review and adoption.

Vaccine 52
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Bamlanivimab alone with the U.S. government and is focusing on supply of bamlanivimab and etesevimab together

The Pharma Data

government for its neutralizing antibody therapies authorized for emergency use as a treatment for COVID-19. Lilly subsequently developed bamlanivimab and etesevimab for administration together, in order to meet the potential challenge of SARS-CoV-2 variants likely to resist treatment with either monoclonal antibody used alone.

article thumbnail

Drop in COVID Cases Seen in Nursing Homes as U.S. Vaccine Effort Makes Headway

The Pharma Data

million shots have now been administered in long-term care facilities, according to the U.S. Two widely anticipated new COVID-19 vaccines — from Johnson & Johnson and Novavax — appear to halt infections in places where more contagious variants are circulating, new trials show.

Nurses 52
article thumbnail

Update on AZD7442 STORM CHASER trial in post-exposure prevention of symptomatic COVID-19

The Pharma Data

AstraZeneca today announced results from the STORM CHASER trial assessing the safety and efficacy of AZD7442, a long-acting antibody (LAAB) combination, for the prevention of symptomatic COVID-19 in participants recently exposed to the SARS-CoV-2 virus. The PROVENT trial will give us more clarity in this patient population.

Trials 52
article thumbnail

Lilly Announces Agreement with U.S. government to Supply 300,000 vials of Investigational Neutralizing Antibody Bamlanivimab (LY-CoV555) in an Effort to Fight COVID-19

The Pharma Data

Lilly submitted a request for an EUA for bamlanivimab for the treatment of mild to moderate COVID-19 in high-risk patients to the FDA in early October. Bamlanivimab emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Food and Drug Administration (FDA).

article thumbnail

Lilly’s Neutralizing Antibody Bamlanivimab (LY-CoV555) Receives FDA Emergency Use Authorization for the Treatment of Recently Diagnosed COVID-19

The Pharma Data

Bamlanivimab is authorized for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization. Sites of care will then confirm their need and AmerisourceBergen will distribute bamlanivimab overnight.