Tag: Johns Hopkins Center for Health Security

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ELI LILLY monoclonal antibody treatment for COVID Shows Promise

Eli Lilly Corporate Center
the staff of the Ridgewood blog
Ridgewood NJ, according to Johns Hopkins Center for Health Security , ELI LILLY A recent study published in the New England Journal of Medicine last week reported that convalescent plasma derived monoclonal antibody treatment (LY-CoV555), developed by Eli Lilly, showed clinical benefit in patients. The study found that patients experienced decreased viral loads and severity, and had no serious adverse effects in outpatients. The phase II trial involved outpatients that had mild to moderate COVID-19. A total of 452 patients participated, receiving either low, medium or high concentration of the antibody, or placebo. Researchers measured the change in viral load after 11 days of treatment, and the study has reported on interim findings. Patients receiving the medium dose (2800 mg) had about a 3 fold reduction in viral load. Differences among placebo and treatment groups were non-significant and smaller for both the low and the high dosage categories. However, patients receiving any antibody dose had lower symptom severity as well as lower hospitalization rates than placebo. Additionally, the percentage of adverse events was similar across treatment and placebo groups.

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CDC Study found that mask use increased from 78% in April to 89% in June, but Other crucial mitigation measures, stagnated or declined

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the staff of the Ridgewood blog

Ridgewood NJ, according to Johns Hopkins Center for Health Security a recent CDC study published in the MMWR assessed self-reporting of recommended behaviors to mitigate SARS-CoV-2 transmission, including mask-wearing, hand washing, social distancing, and staying home when sick. The Data Foundation COVID Impact Survey collected national data on reported mitigation behaviors from April to June among adults.

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AstraZeneca and Johnson & Johnson, vaccine trials are positioned to restart after being paused over potential safety concerns

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the staff of the Ridgewood blog

New Brunswick NJ, according to Johns Hopkins Center for Health Security two major vaccine trials, those of AstraZeneca and Johnson & Johnson, are positioned to restart after being paused over potential safety concerns. The AstraZeneca trial was paused on September 6th, but after independent monitoring of the adverse event several trial sites in other countries resumed later in September. The US FDA held off on restarting AstraZeneca trial sites in the US through October in order to further investigate the event with their own team. The Johnson & Johnson vaccine trial was paused on October 11 after a participant suffered a stroke. This adverse event was also independently reviewed and a final report was sent to the US FDA that recommends the vaccine trial continue. The Johnson & Johnson trial can start re-enrolling participants as early as next week. This vaccine is of particular interest to many since it is a one-dose vaccine which would greatly simplify the process of quickly inoculating millions of people. The AstraZeneca vaccine has already shown promising preliminary results and seems to produce an immunogenic response in elderly participants as well as in younger ones. It is important that any eventual vaccine can produce immunogenic responses in the eldery, in children, and in those with underlying conditions. The Pfizer vaccine has begun to enroll a cohort of children between the ages of 12-18 to test its efficacy in this age group. 16- and 17-year-old volunteers are the first to be enrolled in this study, with researchers soon looking to enroll their younger peers.

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Obesity Leads to elevated risk of severe COVID-19 disease

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the staff of the Ridgewood blog

Ridgewood NJ, according to Johns Hopkins Center for Health Security ,the US CDC updated its guidance regarding individuals at elevated risk of severe COVID-19 disease and death due to underlying medical conditions, including more detailed information regarding the risk associated with obesity. The previous iteration of the guidance noted that individuals with a body mass index (BMI) of 30 or higher were at elevated risk of severe COVID-19 disease. The most recent update includes multiple categories: obesity (BMI of greater than 30 but less than 40) and severe obesity (BMI of 40 or greater). Additionally, the guidance notes that individuals “having overweight” (BMI of greater than 25 but less than 30) may also be at elevated risk of severe disease. The expanded risk group could potentially mean that 72% of all Americans are at elevated risk of severe disease based solely on their weight. Notably, BMI does not accurately characterize body fat percentage or overweight/obesity in all individuals, but it provides a simplified metric to help categorize risk associated with these conditions.

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Long-term health consequences for COVID-19 patients

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Ridgewood NJ, according to Johns Hopkins Center for Health Security ,nine months into the COVID-19 pandemic, clinicians are observing more well-defined patterns of long-term health consequences for COVID-19 patients. A commentary published in JAMA describes some of the frequently reported manifestations in recovered patients. Although long-term health effects are more likely to be exhibited by patients with more severe disease (e.g., admitted to an intensive care unit), these effects are also being observed in persons with milder illnesses. General fatigue and dyspnea were the most commonly reported long-term sequelae, in addition to general joint and chest pain.

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Phase 2 clinical trial indicated Eli Lilly’s monoclonal antibodies reduced viral load in COVID-19 patients mitigated symptoms and resulted in fewer hospitalizations

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the staff of the Ridgewood blog

Ridgewood NJ, according to Johns Hopkins Center for Health Security ,Pharmaceutical manufacturer Eli Lilly submitted an EUA request to the FDA for its monoclonal antibody cocktail as a COVID-19 treatment after clinical trials for the drugs met the target clinical endpoints. Results from a Phase 2 clinical trial indicate that a combination of two of Eli Lilly’s monoclonal antibodies reduced viral load in COVID-19 patients mitigated symptoms and resulted in fewer hospitalizations and emergency department visits. The study included 268 total participants with mild-to-moderate COVID-19 symptoms, 112 of whom received the treatment and 156 who received a placebo. Additionally, a press release issued by the company indicates that no serious adverse events were reported. The company stated that it aims to make 100,000 doses of a single antibody available by the end of October and 1 million by the end of 2020. For the combination therapy, the company hopes to produce 50,000 doses by the end of 2020, and it is collaborating with various external partners to ensure availability for lower-income countries.

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CDC Reconfirms COVID infections are principally spread through “close contact”

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the staff of the Ridgewood blog
Ridgewood NJ, according to Johns Hopkins Center for Health Security, the CDC published new guidance on the potential for airborne transmission of SARS-CoV-2 earlier this week. The updated guidance distinguishes between droplet and airborne transmission (as well as contact transmission); however, it emphasizes that respiratory droplets exist in a spectrum of sizes, ranging from large droplets “that fall out of the air rapidly” to smaller droplets or particles “that can remain suspended for many minutes to hours and travel far from the source.” The guidance also describes aerosols—referring both to smaller droplets and particles and the “clouds of these respiratory droplets in the air”—and clarifies the public health definition of “airborne transmission”—specifically, transmission via “infectious, pathogen-containing, small droplets and particles suspended in the air over long distances and that persist in the air for long times.”

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Johnson & Johnson (J&J) published preliminary findings for COVID19 Vaccine

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the staff of the Ridgewood blog
New Brunswick NJ,  according to Johns Hopkins Center for Health Security , Johnson & Johnson (J&J) published (preprint) preliminary findings from the Phase 1/2a clinical trials for its candidate SARS-CoV-2 vaccine (Ad26.COV.S). The studies included nearly 800 participants, who were split into 3 cohorts for the randomized, double-blinded, placebo-controlled study. The first 2 cohorts were made up of 402 healthy adults aged 18-55 years, and the third cohort included 394 healthy adults over the age of 65. The vaccine was given as a single dose or 2 doses administered 56 days apart. The vaccine was generally well tolerated, and the researchers reported 2 serious adverse events. One of the serious adverse events was determined to be unrelated to the vaccine, and the other was a fever that resolved within 12 hours.

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Mask Debate Rages On

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Ridgewood Nj, according to Johns Hopkins Center for Health Security the use and availability of face coverings, including for the general public and for healthcare workers, has been one of the major ongoing storylines over the course of the pandemic. Researchers continue to evaluate the role of masks and other face coverings in mitigating SARS-CoV-2 transmission, and hospitals and health systems in the US (and likely elsewhere) continue to struggle to maintain sufficient supply of respirators and surgical masks that are critical for protecting healthcare workers and patients.

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COVID19 : LATEST VACCINE CLINICAL TRIALS

AstraZeneca
the staff of the Ridgewood Blog
Oxford UK,  according to Johns Hopkins Center for Health Security, less than a week after suspending Phase 3 clinical trials for its candidate SARS-CoV-2 vaccine due to a serious adverse event, AstraZeneca announced that the trials have resumed in the UK. According to a press release issued by AstraZeneca, the trials resumed after the UK government’s Medicines Health Regulatory Authority (MHRA) evaluated the evidence and determined that it was safe to continue testing the vaccine. The press release states that AstraZeneca and the University of Oxford are not permitted to “disclose further medical information” regarding the adverse event, presumably including the associated safety data reviewed by MHRA or the results of their analysis. It appears that the Phase 3 trials in other countries remain on hold.

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CDC Walks Back the Mortality Rate Walk Back

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the staff of the Ridgewood blog
Ridgewood NJ, A number of social media posts, including this blog  including on Facebook and Twitter, are claiming that the CDC “quietly” corrected its COVID-19 mortality data to remove 94% of the reported deaths. Now according to Johns Hopkins Center for Health Security this is factually inaccurate, and we want to provide some quick clarification to correct this misinformation.

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Europe debates whether to reopen schools and how to best protect students and teachers

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the staff of the Ridgewood blog
Ridgewood NJ, according to Johns Hopkins Center for Health Security, like most of the rest of the world, European countries have been debating whether to reopen schools and how to best protect students and teachers. Public Health England conducted enhanced surveillance among schools that reopened between June 1-July 31 in order to provide better information regarding SARS-CoV-2 transmission risk in school settings. While approximately 80% of schools remained open in some capacity during the UK lockdown to support certain priority groups (eg, children of healthcare workers), the vast majority of children did not attend in-person classes. In June, the number of students attending schools increased from 475,000 to more than 1.6 million.

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US CHILDREN and SCHOOLS : Among COVID hospitalized children, 42% had an underlying medical condition

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Ridgewood NJ, according to Johns Hopkins Center for Health Security ,the beginning of the 2020-21 school year continues to be tumultuous with some schools conducting classes in-person, some only teaching remotely, and others utilizing hybrid approaches. Plans also continue to change rapidly in many school districts, particularly in those that have been forced to implement quarantine, to varying degrees, or even suspend in-person classes entirely following positive SARS-CoV-2 tests among students or staff. Schools in multiple states—including Georgia, Indiana, Mississippi, North Carolina, and Tennessee—have had to adapt existing plans in response to COVID-19 cases.

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COVID-19 Pandemic at Six Months

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from Johns Hopkins Center for Health Security

Ridgewood NJ, Six months ago, in late December 2019, reports emerged about 27 cases of unidentified pneumonia in Wuhan, China, potentially linked to a local market. At that time, very little was known about the disease, pathogen, or origin of the outbreak, and while we have learned much over the past 6 months, many mysteries remain.
The pandemic has grown to more than 10 million cases and 500,000 deaths across nearly every country around the world. As of July 1, the WHO reported 10.36 million cases and 508,055 deaths worldwide, covering more than 200 countries and territories. Among these countries and territories, 86 are reporting “Community Transmission”—the WHO’s highest tier—which indicates “larger outbreaks of local transmission,” “large numbers of cases not linkable to transmission chains,” and “multiple unrelated clusters in several areas of the country.”

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COVID 19 Response the Battle of the Healthcare Bureaucracies

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the staff of the Ridgewood blog

Ridgewood NJ, there have been various criticisms that the COVID 19 response on growing tensions between the federal government’s response to the growing US COVID-19 epidemic and state officials, including governors, but healthcare workers on the front lines are expressing concern as well.
We have also seen it with contradictory actions between our local, county and state bureaucracies.
In a series of interviews, STAT News elicited feedback from healthcare workers across the country regarding the COVID-19 response, and many reportedly expressed frustration with both state and federal responses. Their major concerns included delays in implementing response activities (eg, social distancing), spread of misinformation about the current state of the epidemic and response, supply shortages (eg, personal protective equipment [PPE]), and poor testing availability and strategy. Many healthcare workers feel that insufficient response by government agencies has put them at elevated risk. Additionally, reports continue about the US government “seizing” supplies ordered by states and hospitals. US President Donald Trump and other US government officials have previously called on states and hospitals to acquire their own supplies; however, some orders placed by states and hospitals have reportedly been diverted to the US government, and there appears to be little or no insight into how the government is using or distributing them.

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