Long-Term Care Facilities and Trials

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

The Pharma Data

DECEMBER 17, 2020

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

Vaccine Trials Long-Term Care Facilities FDA

Keys to Success in Vaccine Development for Special Populations

PPD

MAY 11, 2023

To effectively implement vaccine clinical trials for special populations, it is critical for vaccine developers to partner with a contract research organization (CRO) that has demonstrated experience recruiting and retaining pediatric and elderly study participants — and managing the nuances these patients and their caregivers require.

Vaccine

Vaccine Clinical Trials Long-Term Care Facilities Trials

Biden Will Ask Americans to Wear Masks for 100 Days

The Pharma Data

DECEMBER 4, 2020

The recommendation from the Advisory Committee on Immunization Practice (ACIP), if heeded, will steer the initial short supply of vaccines to about 21 million health care personnel and 3 million Americans working or living in long-term care facilities. An FDA advisory panel is set to meet on Dec. A global scourge.

Long-Term Care Facilities

Long-Term Care Facilities Vaccine Nurses Hospitals

CDC Director Warns of Dire Winter Ahead for COVID Hospitalizations, Deaths

The Pharma Data

DECEMBER 3, 2020

The recommendation from the Advisory Committee on Immunization Practice (ACIP), if heeded, will steer the initial short supply of vaccines to about 21 million health care personnel and 3 million Americans working or living in long-term care facilities. An FDA advisory panel is set to meet on Dec. A global scourge.

Hospitals

Hospitals Long-Term Care Facilities Vaccine Nurses

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

The Pharma Data

APRIL 14, 2021

Adverse events reported in at least 1% of BLAZE-1 clinical trial participants on bamlanivimab 700 mg alone or placebo were nausea (3% vs 4%), diarrhea (1% vs 5%), dizziness (3% vs 2%), headache (3% vs 2%), pruritus (2% vs 1%) and vomiting (1% vs 3%). Bamlanivimab alone. Source link:[link].

Government

Government Long-Term Care Facilities Hospitals Treatment

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

DECEMBER 19, 2020

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

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Britain Approves Emergency Use of Pfizer’s COVID Vaccine

The Pharma Data

DECEMBER 2, 2020

The recommendation from the Advisory Committee on Immunization Practice (ACIP), if heeded, will steer the initial short supply of vaccines to about 21 million health care personnel and 3 million Americans working or living in long-term care facilities. The global race to develop a vaccine has been stunningly fast.

Vaccine

Vaccine Long-Term Care Facilities Hospitals Nurses

bamlanivimab and etesevimab together for treatment of COVID-19 in the U.S.

The Pharma Data

APRIL 16, 2021

A Phase 3 study of bamlanivimab alone or bamlanivimab and etesevimab together in residents and staff at long-term care facilities (BLAZE-2, NCT04497987 ) is also ongoing. In addition, bamlanivimab is being tested in the National Institutes of Health-led ACTIV-2 study in ambulatory COVID-19 patients.

Treatment

Treatment Hospitals Long-Term Care Facilities Virus

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

The Pharma Data

FEBRUARY 1, 2021

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

Nurses Vaccine Long-Term Care Facilities Virus

Lilly plans donation of COVID-19 therapies to Direct Relief for use in low- and lower-middle-income countries | Eli Lilly and Company

The Pharma Data

MAY 4, 2021

A Phase 3 study of bamlanivimab alone or bamlanivimab and etesevimab together in residents and staff at long-term care facilities (BLAZE-2, NCT04497987 ) is also ongoing. Results from the Phase 2 cohorts of BLAZE-1 were published in the New England Journal of Medicine and The Journal of the American Medical Association.

Therapies

Therapies Hospitals FDA Approval Long-Term Care Facilities

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

The Pharma Data

JUNE 25, 2021

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

Trials Long-Term Care Facilities Virus Government

Clinical Catch-Up: January 18-22 | BioSpace

The Pharma Data

JANUARY 24, 2021

With a presidential inauguration and a federal holiday, it wasn’t an enormously busy week for clinical trial news, but there was a fair amount, nonetheless. It inked a deal with the National Institute of Allergy and Infectious Diseases (NIAID) to launch a Phase I trial. Read on to see. COVID-19-Related. Non-COVID-19-Related.

Long-Term Care Facilities

Long-Term Care Facilities Trials Virus Clinical Trials

New Data Show Treatment with Lilly’s Neutralizing Antibodies Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Together Reduced Risk of COVID-19 Hospitalizations and Death by 70 Percent

The Pharma Data

JANUARY 26, 2021

“Notably, the 70 percent decrease in risk of hospitalizations or death seen in this Phase 3 trial of bamlanivimab and etesevimab together is consistent with the reduction in risk of hospitalization or ER visits seen with bamlanivimab alone in the Phase 2 trial. INDIANAPOLIS, Jan. Across 1,035 patients, there were 11 events (2.1

Hospitals

Hospitals Treatment Long-Term Care Facilities Trials

Study Suggests Link Between Sleep Supplement and COVID-19

The Pharma Data

DECEMBER 21, 2020

At the moment, eight clinical trials are currently being carried out to determine if the link between melatonin and the novel coronavirus is legitimate. Healthcare workers and residents of long-term care facilities are expected to receive the vaccines first, followed by adults aged 75 and older, and frontline essential workers.

Long-Term Care Facilities

Long-Term Care Facilities Vaccine Virus Clinical Trials

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

OCTOBER 28, 2020

A Phase 3 study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities (BLAZE-2, NCT04497987) is also ongoing. A Phase 2 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing.

Government

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

The Pharma Data

NOVEMBER 9, 2020

We thank those who have contributed to this medical advancement, particularly the clinical trial investigators and participants around the country.” A Phase 3 study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities (BLAZE-2, NCT04497987) is also ongoing.

Treatment

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Lilly’s bamlanivimab and etesevimab together reduced hospitalizations and death in Phase 3 trial for early COVID-19

The Pharma Data

MARCH 11, 2021

In this data set, the safety profile of bamlanivimab and etesevimab together was consistent with observations from other Phase 1, Phase 2 and Phase 3 trials evaluating these antibodies. Junshi Biosciences has completed a similar Phase 1 study in healthy volunteers in China and has initiated Phase 1b/2 trials in COVID-19 patients globally.

Hospitals

Hospitals Trials Long-Term Care Facilities Treatment

EMA issues advice on Lilly’s bamlanivimab (LY-CoV555) alone and administered together with etesevimab (LY-CoV016) for the treatment of confirmed COVID-19 in the European Union

The Pharma Data

MARCH 5, 2021

” To support the opinion, the EMA reviewed Phase 2 and Phase 3 results from Lilly’s BLAZE-1 trial. A Phase 3 study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities (BLAZE-2, NCT04497987 ) is also ongoing. Bamlanivimab alone. About BLAZE-1.

Treatment

Treatment Hospitals Long-Term Care Facilities Therapies

Biden Says He Will Release All Vaccine Doses After Taking Office

The Pharma Data

JANUARY 8, 2021

” The CDC has decided that health care workers and people working or living in long-term care facilities will be the first folks to get the COVID-19 vaccine. “These are all reasonable questions to consider and evaluate in clinical trials. ” © 2021 HealthDay.

Vaccine

Vaccine Long-Term Care Facilities Hospitals FDA

‘Warp Speed’ Officials Say U.S. COVID Vaccine Distribution Too Slow

The Pharma Data

DECEMBER 31, 2020

According to the Times , he said that health care facilities are still learning how to store the vaccines at super-low temperatures, and many states are setting aside doses for use at long-term care facilities, an effort that’s expected to take several months. A global scourge. By Thursday, the U.S.

Vaccine

Vaccine Long-Term Care Facilities Virus Hospitals

Drug Discovery Digest

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

Keys to Success in Vaccine Development for Special Populations

Trending Sources

Biden Will Ask Americans to Wear Masks for 100 Days

CDC Director Warns of Dire Winter Ahead for COVID Hospitalizations, Deaths

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

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

Britain Approves Emergency Use of Pfizer’s COVID Vaccine

bamlanivimab and etesevimab together for treatment of COVID-19 in the U.S.

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

Lilly plans donation of COVID-19 therapies to Direct Relief for use in low- and lower-middle-income countries | Eli Lilly and Company

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

Clinical Catch-Up: January 18-22 | BioSpace

New Data Show Treatment with Lilly’s Neutralizing Antibodies Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Together Reduced Risk of COVID-19 Hospitalizations and Death by 70 Percent

Study Suggests Link Between Sleep Supplement and COVID-19

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

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

Lilly’s bamlanivimab and etesevimab together reduced hospitalizations and death in Phase 3 trial for early COVID-19

EMA issues advice on Lilly’s bamlanivimab (LY-CoV555) alone and administered together with etesevimab (LY-CoV016) for the treatment of confirmed COVID-19 in the European Union

Biden Says He Will Release All Vaccine Doses After Taking Office

‘Warp Speed’ Officials Say U.S. COVID Vaccine Distribution Too Slow

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