COVID Hospitalizations Fall Rapidly In US

By RTTNews Staff Writer | Published: 2/2/2021 6:08 AM ET

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The United States is witnessing significant improvement in all three metrics that measure the coronavirus pandemic's severity, with COVID-19 hospitalizations decreasing rapidly after falling below the 100,000 mark at the weekend.

Only 93,536 people are currently admitted in U.S. hospitals with coronavirus infection, which is the fewest since November 29, according to the latest data by COVID Tracking Project. Out of this, 18,572 patients are admitted in Intensive Care Units. The numbers reached a peak of 132,474 on January 6.

Compared to last week, the number of people currently hospitalized with COVID-19 is down by 10 percent or more in 38 states.

The test positivity rate continues to fall regularly. Out of nearly 1.60 million people who were tested for coronavirus on Monday, 9.78 percent were diagnosed with the disease.

With 130,759 additional cases reporting in the last 24 hours, the total U.S. cases rose to 26,317,623, according to the latest data by Johns Hopkins University. 1881 new deaths were reported across the country in the same period, taking the national total to 443,355.

January was the deadliest month in the United States so far with the pandemic, claiming the lives of 95,211 Americans, nearly 20000 more than in December.

On average, more people were hospitalized in the country than in any other month due to COVID-19.

A new projection from the University of Washington says nearly 200,000 more people are likely to die between now and May 1.

Nearly half a billion vaccine doses have been distributed across the country until Monday and at least 32,222,402 shots were administered, according to the US Centers for Disease Control and Prevention.

Anti-Covid vaccine distribution will "get better very quickly" as the Biden administration rolls out a series of measures aimed at ramping up inoculation, according to Dr. Anthony Fauci.

CDC's epidemiological expert Dr. Casey Barton Behravesh told reporters Monday that the risk of animals, including pets, spreading Covid-19 to human beings is considered to be low.

Meanwhile, Tokyo Olympic Games chief vowed that the global sports event will be held this year "no matter how the Covid situation will be."

"We will make sure the Games will be held no matter how the Covid situation will be. We go beyond the discussion of whether we hold (the Games) or not hold. We are to come up with 'new' Olympics," Games organizing committee president Yoshiro Mori said at a news conference Tuesday.

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Article written by an RTT News Staff Writer, and posted on the RTT News.com website.

Article reposted on Markethive by Jeffrey Sloe

Johnson & Johnson's Covid-19 Vaccine Safe, Well-tolerated

By RTTNews Staff Writer | Published: 1/14/2021 5:15 AM ET

Johnson & Johnson announced that its Covid-19 vaccine candidate, JNJ-78436735, being developed by its unit Janssen Pharmaceutical Companies and currently undergoing in a Phase 3 trial, has been found to be safe and well tolerated.

The interim Phase 1/2a data was published on Wednesday in the New England Journal of Medicine. A preview of part of these interim data was posted on medRxiv in September 2020.

As per the data, the single-dose investigational COVID-19 vaccine candidate provided an immune response that lasted for at least 71 days. This is the duration of time measured in this study in participants aged 18-55 years.

The ongoing Phase 1/2a multi-center, randomized, double-blind, placebo-controlled trial aims to evaluate the safety, reactogenicity, and immunogenicity of Janssen's COVID-19 vaccine candidate at two dose levels, administered intramuscularly as single-dose or two-dose schedules, eight weeks apart, in healthy adults, aged 18 to 55 years. The study is ongoing at multiple clinical sites in Belgium and the United States.

According to the company, the COVID-19 vaccine candidate induced an immune response and was generally well-tolerated across all study participants. After a single vaccination, neutralizing antibodies against COVID-19 were detected in over 90 percent of study participants at Day 29 and 100 percent of participants aged 18-55 years at Day 57.

These neutralizing antibodies remained stable through Day 71, currently the latest timepoint available in this ongoing study, in all participants aged 18-55 years.

The study also evaluated a two-dose regimen, in which the data showed that a second dose of the vaccine candidate, administered 56 days apart, was less reactogenic while it triggered more than a two-fold increase in antibodies against COVID-19.

Johnson & Johnson expects to announce topline Phase 3 data for its single-dose COVID-19 vaccine candidate in late January 2021.

If the single-dose vaccine is shown to be safe and effective, the company expects to submit an application for Emergency Use Authorization with the U.S. Food and Drug Administration shortly afterwards. Other regulatory applications around the world will be made subsequently.

Janssen is investigating multiple doses and dosing regimens of its COVID-19 vaccine candidate to evaluate long-term efficacy.

The single-dose regimen in the Phase 3 ENSEMBLE trial completed enrollment on December 17, 2020, while a two-dose regimen in the Phase 3 ENSEMBLE 2 study is ongoing.

Johnson & Johnson's phase III study of its COVID-19 vaccine candidate, JNJ-78436735, which was initiated in late September, was temporarily paused in early October due to an unexplained illness in a study participant. However, the trial resumed later after clearance from a regulatory board.

For comments and feedback contact: editorial@rttnews.com

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Article written by an RTT News Staff Writer, and posted on the RTT News.com website.

Article reposted on Markethive by Jeffrey Sloe

Parcare Health Network Faces Probe On COVID-19 Vaccine Distribution

By RTTNews Staff Writer | Published: 12/28/2020 10:14 AM ET

New York State Health officials are joining with State Police to investigate Parcare Community Health Network for allegedly violating state guidelines for distribution of COVID-19 vaccine by obtaining and distributing them illegally.

In a statement, NY State Health Commissioner Howard Zucker stated that the State Department of Health is aware of reports that "Parcare Community Health Network, an Orange County provider, may have fraudulently obtained COVID-19 vaccine, transferred it to facilities in other parts of the state in violation of state guidelines and diverted it to members of the public…"

He added that this is contrary to the state's plan to administer it first to frontline healthcare workers, as well as nursing home residents and staffers.

Meanwhile, Brooklyn-based health care company reportedly insisted that it followed all proper procedures to get the Moderna vaccines. The company said it was approved to administer the shots by both the state Department of Health as well as the Centers for Disease Control and Prevention.

Following the criminal probe, Parcare further said it proactively returned its remaining stash of COVID-19 vaccines, and also provided the documentation regarding the proper receipt of the vaccines to the State Health department.

ParCare reportedly had administered 869 of 2,300 doses it received through an order placed by the DOH.

ParCare's clinic in Orange County faces the investigation. It operates five other clinics located in Brooklyn and Manhattan.

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Article written by an RTT News Staff Writer, and posted on the RTT News.com website.

Article reposted on Markethive by Jeffrey Sloe

US Covid-19 Vaccination Begins As CDC Recommends Pfizer Vaccine

By RTTNews Staff Writer | Published: 12/14/2020 3:23 AM ET

The United States started Covid-19 vaccinations on Monday after Robert Redfield, the director of the Centers for Disease Control and Prevention or CDC, gave the approval for Pfizer- BioNTech's COVID-19 vaccine.

The CDC Director accepted the recommendation by CDC's Advisory Committee on Immunization Practices or ACIP for vaccination with Pfizer-BioNTech COVID-19 vaccine in people 16 years of age and older. The recommendation follows the Emergency Use Authorization or EUA issued by the U.S. Food and Drug Administration for the vaccine on last Friday.

Redfield said, "As COVID-19 cases continue to surge throughout the U.S., CDC's recommendation comes at a critical time."

The Pfizer Vaccine is authorized for use under EUA for active immunization to prevent covid-19 caused by severe acute respiratory syndrome coronavirus 2 or SARS-CoV-2 in individuals 16 years of age and older.

The ACIP recommendation is based on the scientific evidence supporting the COVID-19 vaccine, including data from a Phase 3 clinical study announced last month, as well as on interim guidance that ACIP made on December 1, 2020 regarding the allocation of initial vaccine doses.

The ACIP on December 1 had recommended for a Phase 1a rollout where first priority of COVID-19 vaccines is given to health care personnel treating patients, and residents in nursing homes and other long-term care facilities.

CNN reported that the first freight trucks carrying around 184,275 vials of the vaccine departed Pfizer's facility in Kalamazoo, Michigan, on Sunday.

The vaccines will be distributed by the U.S. Department of Defense in partnership with agencies within the Department of Health and Human Services, including the CDC, to government-designated facilities across the country.

Earlier, Gen. Gustave Perna, chief operating officer of Operation Warp Speed, noted that Pfizer would move vaccine from its manufacturing facility to the UPS and FedEx hubs, and then it would go out to already identified 636 locations nationwide.

According to Perna, the estimate is that 145 sites across all the states would have receive vaccine on Monday, another 425 sites on Tuesday, and the final 66 sites on Wednesday in the initial delivery of the Pfizer orders for vaccine.

Pfizer and Germany's BioNTech earlier said they now gather additional data and prepare to file a planned Biologics License Application or BLA with the FDA for a possible full regulatory approval in 2021.

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Article written by an RTT News Staff Writer, and posted on the RTT News.com website.

Article reposted on Markethive by Jeffrey Sloe