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.

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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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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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Roche's SARS-CoV-2 Antibody Test Being Used As Part Of Moderna COVID-19 Vaccine Trials

By RTTNews Staff Writer | Published: 12/9/2020 1:22 AM ET

Swiss drug maker Roche Group (RHHBY) announced Wednesday a partnership with Moderna Inc. to utilise the Elecsys Anti-SARS-CoV-2 S antibody test in Moderna's ongoing mRNA-1273 vaccine research trials.

The company noted that its Elecsys Anti-SARS-CoV-2 S test can quantitatively measure the level of antibodies against SARS-CoV-2 in vaccine trial participants. It will help to establish a correlation between vaccine-induced protection and levels of anti-receptor binding domain or RBD antibodies.

Significantly, Moderna's vaccine triggers antibody response specifically to the RBD of the SARS-CoV-2 spike protein.

According to the company, measuring the quantitative levels of anti-RBD SARS-CoV-2 antibodies using Roche's test will help Moderna to gain valuable insights into the correlation between protection from vaccination and antibody levels. This could play a role in assessing if, or when, an individual needs revaccination, or in helping to answer other clinically relevant questions.

Roche recently received Emergency Use Authorization from the U.S. Food and Drug Administration for the Elecsys Anti-SARS-CoV-2 S antibody test.

Thomas Schinecker, CEO Roche Diagnostics, said, "Roche values the collaboration with Moderna, which has already included the successful use of our qualitative Elecsys Anti-SARS-CoV-2 test, targeting the nucleocapsid protein, in an earlier part of the studies. We are pleased to see that our quantitative Elecsys SARS-CoV-2 S test, which targets the spike protein, is now also being used as part of the Moderna vaccine trials, which could ultimately help to end this pandemic."

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FDA Authorizes Emergency Use Of Pfizer, BioNTech's COVID-19 Vaccine

By RTTNews Staff Writer | Published: 12/11/2020 11:05 PM ET

The U.S. Food and Drug Administration on Friday authorized a COVID-19 vaccine developed by Pfizer and BioNTech for emergency use, the first COVID-19 vaccine to be approved in the U.S.

The emergency use authorization allows BNT162b2, the Pfizer-BioNTech COVID-19 vaccine, to be distributed in the U.S for people over the age of 16. It was found to be 95 percent effective at preventing symptomatic COVID-19 in clinical trials.

"Today's emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine holds the promise to alter the course of this pandemic in the United States," Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a press release.

An emergency use authorization means that the FDA has given the drug a special authorization to be used during an emergency period. Pfizer would have to file a separate application for its vaccine to be fully approved by the FDA. Meanwhile, researchers will continue to monitor the vaccine's effectiveness in the real world.

FDA's decision to issue an emergency use authorization for the vaccine comes after it faced pressure from the White House to authorize the vaccine. Chief of Staff Mark Meadows told Stephen Hahn, the commissioner of the FDA, to resign if the vaccine was not cleared by Friday, according to the Washington Post. The agency had originally planned to complete the authorization by Saturday.

"The FDA's authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world," said Hahn said in a statement. "Today's action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency's career scientists to ensure this vaccine met FDA's rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization.

On Thursday, FDA's vaccine advisory committee had recommended the emergency use of the COVID-19 vaccine. The vaccine has already received a temporary authorization for emergency use in the U.K., Canada, and Bahrain.

Mexico's health agency Cofepris has also approved Pfizer's vaccine for emergency use, Deputy Health Minister Hugo Lopez-Gatell said at a press conference on Friday.

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US COVID Hospitalizations Cross 100K; New Deaths And Cases Break Record

By RTTNews Staff Writer | Published: 12/3/2020 6:41 AM ET

The number of people hospitalized with coronavirus infection has crossed 100000, and daily COVID deaths and new cases reached all time high on Wednesday.

As per the latest update published by COVID Tracking Project on Thursday, a total of 100,226 patients are currently admitted in U.S. hospitals with coronavirus infection —the first time hospitalizations have exceeded the 100000 mark.

With 3,194 new deaths reporting in the last 24 hours, the country's total number of COVID-19 casualties increased to 273836, as per latest data from the Johns Hopkins University Center for Systems Science and Engineering.

This is the highest daily casualty figure reported in the country, and an increase of about 20 percent from the previous record of 2,603 set on April 15.

It is for the first time that more than 3100 deaths due to the pandemic were reported in a single day in the United States.

In the same period, 2,03,653 new cases were reported nationwide, taking the national total to 13924957. Ten months after the first coronavirus case was reported in the country, daily infections crossed the 2,000,00 mark for the first time on Wednesday.

California reported more than 20000 COVID-19 cases, one tenth of the national total. It is set to overtake Texas as the worst affected state in the country.

As the number of hospitalizations steadily growing since last month, breaking records almost every day, the American Ambulance Association said in a letter to the Department of Health and Human Services that the 911 emergency call system is "at a breaking point".

CDC Director Robert Redfield warned that these next three months will be the most difficult time in U.S. history. "The reality is December and January and February are going to be rough times. I actually believe they're going to be the most difficult time in the public health history of this nation," he said during a U.S. Chamber of Commerce event Wednesday.

Meanwhile, the Centers for Disease Control and Prevention has shortened the recommended length of standard quarantine period for people without symptoms. According to revised guidance issued Wednesday, CDC recommends two additional options for how long quarantine should last. "Based on local availability of viral testing, for people without symptoms quarantine can end on day 10 without testing, and on day 7 after receiving a negative test result".

Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said in an interview that the United Kingdom's health regulators who authorized Pfizer's Covid-19 vaccine did not scrutinize the trial data as carefully as the US Food and Drug Administration is doing in its review.

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WHO Recommends Against Using Gilead Sciences' Remdesivir For Covid

By RTTNews Staff Writer | Published: 11/20/2020 1:47 AM ET

The World Health Organization or WHO has warned against using Gilead Sciences' Covid-19 drug remdesivir to treat hospitalized patients. According to the agency, there is currently no evidence that remdesivir improves survival and other outcomes in these patients.

Remdesivir is an FDA-approved intravenous antiviral drug, sold under the brand name Veklury. It has been approved or authorized for the treatment of Covid-19 in about 50 countries across the world. The drug is supposed to work by stopping the replication of SARS-CoV-2, the virus that causes COVID-19.

As per a WHO Guideline Development Group panel, the evidence suggested that the drug has "no important effect on mortality, need for mechanical ventilation, time to clinical improvement, and other patient-important outcomes."

The conditional recommendation by WHO against the use of remdesivir is part of a living guideline on clinical care for COVID-19, developed by the panel that consists of 28 clinical care experts, 4 patient-partners and one ethicist.

The group reviewed interim results of the WHO Solidarity Trial along with 3 other randomized controlled trials for the guidelines. In all, data from over 7000 patients across the 4 trials were considered.

The guidelines were developed in collaboration with the non-profit Magic Evidence Ecosystem Foundation that provided methodologic support.

The panel urged for more research, especially to provide higher certainty of evidence for specific groups of patients. They supported continued enrollment in trials evaluating remdesivir.

The WHO decision comes as the U.S. Food and Drug Administration issued an emergency use authorization for Eli Lilly and Co.'s rheumatoid arthritis drug baricitinib, in combination with remdesivir, to treat COVID-19 patients.

The authorization is to treat suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation or ECMO.

Remdesivir received FDA approval on October 22 to treat patients with COVID-19 requiring hospitalization. The drug is indicated for patients of age 12 years and older and weighing at least 40 kg.

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