Sep 30, 2020 • 1:58 pm CDT
India's Vaccine Manufacture Intends to Produce 200 Million Doses
On September 29, 2020, an expanded collaboration was announced among the Serum Institute of India (SII), Gavi, and the Bill & Melinda Gates Foundation to accelerate the manufacture and delivery of up to an additional 100 million doses of safe and effective COVID-19 vaccines for low- and middle-income countries. This expansion brings the total number of vaccine doses to be covered by the partnership between SII, Gavi, and the Gates Foundation to an aggregate of up to 200 million doses.
SII stated it 'intends to manufacture COVID-19 preventive vaccines licensed from AstraZeneca and Novavax if they are successful in attaining full licensure and WHO Prequalification.'
Sep 30, 2020 • 1:46 pm CDT
The 4C Mortality Score Enhanced COVID-19 Hospitalization Decisions
The BMJ published a study on September 9, 2020, featuring an easy-to-use risk stratification score that was developed and validated based on commonly available parameters at hospital presentation. The 4C Mortality Score outperformed existing scores, showed utility to directly inform clinical decision making, and can be used to stratify patients admitted to hospital with COVID-19 into different management groups.
The 4C Mortality Score should be further validated with COVID-19 patients to determine its applicability in other populations, added these researchers.
Sep 30, 2020 • 8:54 am CDT
German Firm Launches Phase 2a Study for COVID-19 Vaccine Candidate
Germany based CureVac N.V. announced on September 29, 2020, that the first participant has been dosed in the CV-NCOV-002 Phase 2a clinical trial of its COVID-19 vaccine candidate, CVnCoV. The dose-confirmation study is being conducted in the countries of Peru and Panama and will enroll a total of 690 healthy participants.
The CVnCOV vaccine study participants will receive 2 vaccinations at intervals of 28-days. Different dose levels will be investigated, starting at 6 µg, with the aim to confirm safety and evaluate the reactogenicity of the vaccine in older adults.
Sep 30, 2020 • 8:27 am CDT
Inhaled Niclosamide as a Potential COVID-19 Antiviral Treatment
On September 29, 2020, researchers at The University of Texas at Austin College of Pharmacy released promising study results of a new method to treat the SARS-CoV-2 coronavirus that causes COVID-19. These Texas researchers found the antiviral niclosamide, when incorporated with human lysozyme as a carrier molecule, shows potential as an effective COVID-19 treatment when delivered directly to the airways.
Niclosamide, already U.S. FDA approved for other treatments, may serve as a promising alternative or additional therapy option to remdesivir (Veklury) for the treatment of COVID-19.
“We have demonstrated that administration of niclosamide-lysozyme particles to the airways of mice with established, lethal SARS-CoV-2 infection improves survival, greatly reduces lung tissue damage and significantly reduces viral loads in the lungs, brain, and kidneys,” says Dr. Ashlee Brunaugh, graduate research fellow.
Sep 30, 2020 • 6:40 am CDT
Egypt Secures 20 Million Doses of Russia's New Coronavirus Vaccine
On September 30, 2020, the Russian Direct Investment Fund and the Pharco pharmaceutical groups in Egypt (Biogeneric Pharma) announced an agreement to secure the supply of 25 million doses of the Sputnik V vaccine to Egypt.
This new agreement will enable 25% of Egypt’s population to have access to the Sputnik V vaccine. In the future, it is planned to distribute Sputnik V to neighboring countries, stated this press release.
Sep 30, 2020 • 5:49 am CDT
Europe Authorizes 15-Minute Coronavirus Test
New Jersey-based Becton, Dickinson, and Company (BD) announced on September 30, 2020, its 15-minute, point-of-care, SARS-CoV-2 antigen test for use on the BD Veritor™ Plus System has been CE marked to the IVD Directive (98/79/EC). BD stated it 'expects commercial availability of this new assay at the end of October 2020 for countries in Europe that recognize the CE mark.'
The BD Veritor Plus System is already in use across Europe to test for conditions such as Group A Strep, influenza A+B, and Respiratory Syncytial Virus.
Sep 30, 2020 • 5:05 am CDT
Protecting One Nation Requires Protecting All Nations
On Septemeber 30, 2020, the CEO of the Gates Foundation Mark Suzman stated: 'The only way to fully protect one nation is to protect every nation. And countries and companies are stepping up in unprecedented ways to make sure that the tools to fight this disease are available, affordable, and accessible to everyone who needs them.'
Furthermore, 'the Access to COVID-19 Tools Accelerator is the best shot we have for this. Created just 5-months ago, this collaboration is already delivering incredible results.'
As an example, a new agreement announced by the WHO on September 28, 2020, will provide 120 million rapid COVID-19 tests to low-and middle-income countries. With the Global Fund committing an initial US$50 million to enable countries to purchase the new tests.
Sep 30, 2020 • 4:44 am CDT
Mumbai's Slums Most Infected With SARS-CoV-2
The metro area of Mumbai was reported by FirstPost on September 30, 2020, to have the highest coronavirus seroprevalence of any city in India, with 57.8% of samples from slums found positive for SARS-CoV-2 antibodies. The virus infection rate decreased to 17.4% for samples collected from non-slum areas.
Additionally, the Indian Council of Medical Research's (ICMR) 2nd nationwide serosurvey for antibodies against SARS-CoV-2, found over 7% of India's adult population seems to have been exposed to the coronavirus before the end of August 2020.
According to data from the ICMR on September 29, 2020, a cumulative total of 7,41,96,729 samples have been tested during 2020.
Sep 29, 2020 • 5:33 am CDT
50 Countries Interested in Russia's Coronavirus Vaccine
On September 29, 2020, the Russian Direct Investment Fund (RDIF) announced more than 50 countries in Asia, the Middle East, Latin America, Europe, and the Commonwealth of Independent States have applied for access to the Sputnik V vaccine. The RDIF had announced earlier supply agreements with Mexico for 32 million doses, with Brazil for up to 50 million doses, India for 100 million doses, and Uzbekistan for up to 35 million doses.
Kirill Dmitriev, CEO of the RDIF stated: "... is ready to supply Sputnik V vaccine to countries of the region as novel coronavirus infection is our common enemy which can be defeated only by joining our efforts”.
Post-registration clinical trials of the Sputnik V vaccine involving 40,000 volunteers are currently ongoing with the first results expected to be published in October-November 2020, stated the RDIF press release.
Sep 29, 2020 • 4:10 am CDT
Herd Immunity Reached in Brazil's Amazon
According to a non-peer-reviewed study published on September 21, 2020, the transmission of the SARS-CoV-2 virus in Manaus, located in the Brazilian Amazon, increased quickly during March 2020, and then began to decline. The seroprevalence rate fell due to antibody waning. After correcting for this trend, these researchers estimate a final epidemic size of 66%.
Although non-pharmaceutical interventions and changes in population behavior may have helped to limit SARS-CoV-2 transmission in Manaus, the unusually high infection rate suggests that 'herd immunity' played a significant role in determining the size of the COVID-19 epidemic in Brazil.
As of September 28, 2020, Manaus (pop. of 1.8 million) had reported 4,031 fatalities related to COVID-19 during 2020.
Sep 29, 2020 • 3:47 am CDT
120 Million Coronavirus Rapid Tests for Low-and-Middle-Income Countries Funded
The World Health Organization (WHO) announced in Geneva on September 28, 2020, a new program to supply low- and middle-income countries (LMICs) with 120 million rapid antigen tests to detect the SARS-CoV-2 virus. WHO Director-General Tedros Adhanom Ghebreyesus, Ph.D., stated the program is vital to LMIC testing capacity.
"These (Abbott and SD Biosensor) tests provide reliable results in approximately 30 minutes, rather than hours or days, at a lower price with less sophisticated equipment."
WHO guidance published on September 11, 2020, highlights the value of these tests in areas where community transmission is widespread and where nucleic acid amplification-based diagnostic testing is either unavailable or where test results are significantly delayed.
Sep 29, 2020 • 3:19 am CDT
Over 111 Million Coronavirus Tests Completed in the USA
The US Centers for Disease Control and Prevention (CDC) COVID Data Tracker published data as of September 28, 2020, indicating there have been 111,348,492 diagnostic tests reported, excluding antibody and antigen tests, performed to confirm if a person has a SARS-CoV-2 coronavirus infection.
Overall, this new CDC data indicates the USA has a virus infection positivity rate of 8% during 2020.
Sep 29, 2020 • 3:07 am CDT
Potent Neutralizing Antibodies Against SARS-CoV-2 Identified in Preclinical Study
California based Sorrento Therapeutics, Inc. released preclinical data on September 28, 2020, reporting on COVI-GUARD™ (STI-1499) and COVI-AMG™ (STI-2020; Affinity Matured COVI-Guard) neutralizing antibodies (nAbs) against the SARS-CoV-2 virus, as well as a D614G virus variant infection.
Dr. Slobodan Paessler’s laboratory at the University of Texas Medical Branch at Galveston has generated promising preclinical animal data for STI-1499 and STI-2020 nAbs in a Syrian golden hamster model infected with SARS-CoV-2. Both nAbs demonstrated potent neutralizing activities against SARS-CoV-2 virus infection in preclinical models.
STI-1499 nAb has been cleared by the U.S. FDA for a Phase 1 clinical trial in hospitalized COVID-19 patients. STI-2020 is an affinity-matured version of the COVI-GUARD nAb and has demonstrated a greater than 50-fold increase in potency in vitro experiments.
The potency of both nAbs and their ability to mitigate SARS-CoV-2 infection from the lungs in a Syrian golden hamster model is very impressive, strongly supporting further development of these antibodies,” stated Dr. Henry Ji, CEO of Sorrento, in a press release.
Sep 28, 2020 • 8:01 pm CDT
Test Authorized for Asymptomatic COVID-19 Testing
The U.S. FDA granted Emergency Use Authorization on September 24, 2020, for Hologic’s Panther Fusion® SARS-CoV-2 test, which identifies the coronavirus causing COVID-19 by testing individuals without symptoms or other reasons to suspect COVID-19 infection. The assay is the first widely available, high-throughput molecular diagnostic test specifically authorized for screening asymptomatic people.
“Accurately identifying individuals early in the course of infection - so they can quarantine before passing on the virus - is critical to stemming the spread of this pandemic,” said Kevin Thornal, president at Hologic, in a September 28, 2020, press statement. “The high accuracy of molecular testing has made it the gold standard for infectious disease detection, and recent data demonstrate that Hologic’s molecular coronavirus tests are among the most sensitive available.”
Hospital, public health, and reference laboratories will run Hologic’s new test on the Panther Fusion systems that are already in wide use across the USA.
Sep 28, 2020 • 7:18 pm CDT
US Delivers 50 Ventilators To Enhance Guatemala's Coronavirus Treatments
The U.S. government confirmed on September 25, 2020, that it donated 50 new, state-of-the-art ventilators to Guatemala to assist its fight against COVID-19. The ventilators, produced by Vyaire Medical, reflect cutting-edge, in-demand medical technology. They are compact and deployable, providing Guatemala with flexibility in treating patients affected by the virus.
Sep 28, 2020 • 6:41 pm CDT
Convalescent Plasma Treatment For COVID-19 Debate Remains Inconclusive
The National Institutes of Health COVID-19 Treatment Guidelines Panel published an update in the Annals of Internal Medicine on September 25, 2020, which says 'Taking everything into account, the Panel has determined that currently, the data are insufficient to recommend for or against convalescent plasma for treating COVID-19.'
'Although providers have access to this therapy, the Panel cannot recommend it as a standard of care for treating COVID-19 at this time.'
Sep 28, 2020 • 1:32 pm CDT
Harvard Launches 'Risk Mitigation While Flying' Study
In order to provide evidence-based recommendations on strategies and practices to reduce the public health risks of flying during the COVID-19 pandemic, faculty at Harvard T.H. Chan School of Public Health announced on September 3, 2020, they are conducting industry-sponsored research to improve understanding of measures that reduce risks of SARS-CoV-2 transmission in the aviation system.
“As we study different aspects of the aviation system, we are identifying steps being taken by airlines, manufacturers, and airport operators that can reduce risks of SARS-CoV-2 transmission,” said Dr. Leonard Marcus, in a press statement.
“The effort to reduce risks requires a layered approach, including ventilation, mask-wearing, disinfection, and how people move through the aviation system. What is unique about this project is that we are engaging directly with major manufacturers, airlines, and airports across the aviation ecosystem to ensure that we develop a comprehensive, science-based approach.”
However, the U.S. CDC website stated on September 17, 2020: 'Travel increases your chance of getting and spreading COVID-19. Staying home is the best way to protect yourself and others from COVID-19.'
Sep 28, 2020 • 1:06 pm CDT
Older Cancer Patients At Great Risk From COVID-19
New research presented at the ESCMID Conference on Coronavirus Diseases on September 23, 2020, suggests that the poor outcomes and higher death rates in cancer patients with COVID-19 could be due to them generally being older and having more underlying conditions, rather than due to cancer itself. This study is by Dr. Maria Rüthrich, Jena University Hospital, Germany, and colleagues.
Sep 28, 2020 • 10:20 am CDT
Multisystem Inflammatory Syndrome in Children Is a Serious Coronavirus Risk
An inflammation syndrome in some children exposed to COVID-19 may serve as a warning to vaccine developers, a University of Virginia researcher and his colleagues said to the DailyProgress on September 27, 2020.
New research findings of the multisystem inflammatory syndrome in children, known as MIS-C, show that children with the condition have elevated levels of antibodies that their bodies created to fight the proteins the COVID-causing virus uses to infect a body. Furthermore, these researchers say it’s important that the findings be considered as labs everywhere race to bring a vaccine to market.
The exact cause of MIS-C and whether the increased antibodies are a cause or an effect of the condition is not known, says the U.S. CDC.
Separately, a study published by The Lancet on September 4, 2020, reviewed 39 observational studies and concluded saying 'MIS-C is a new pediatric disease associated with SARS-CoV-2 that is dangerous and potentially lethal. With prompt recognition and medical attention, most children will survive but the long-term outcomes from this condition are presently unknown.'
Sep 28, 2020 • 9:26 am CDT
UK Scientists Testing Airborne COVID-19 Transmission
UK scientists at the University of Bristol may be weeks away from finding out how long the SARS-Cov-2 coronavirus can survive in the aerosol particles people exhale, reported The Guardian on September 25, 2020.
Prof. Jonathan Reid, who is leading the Bristol team, told The Guardian: “We know that when bacteria or viruses become airborne in respiratory droplets they very quickly dry down and can lose viability, so that’s an important step to understand when assessing the role of airborne transmission in COVID-19.”
Prof Denis Doorly, at Imperial College London, who is not involved in the research, stated: “There is now huge interest in what it could take to mitigate the risk of infection in enclosed spaces, in terms of enhanced natural ventilation, or air-scrubbing systems, or UV-C lighting – but this all depends on knowing how much viable virus remains suspended in the air."
Sep 28, 2020 • 9:07 am CDT
Therapy Produced Positive Results For Outpatients With Mild and Uncomplicated COVID-19
California-based Eiger BioPharmaceuticals announced on September 28, 2020, results of an investigator-sponsored study of Peginterferon Lambda-1a (Lambda) in outpatients with mild and uncomplicated COVID-19. The study was co-led by Stanford University School of Medicine researchers Upinder Singh, M.D., and Prasanna Jagannathan, M.D., with the primary endpoint duration of viral shedding. The study's secondary endpoint was reducing the duration of symptoms and hospitalization in patients with mild COVID-19.
No difference was demonstrated in the duration of SARS-CoV-2 viral shedding and time to symptom resolution when compared with placebo. The median time to cessation of viral shedding in both study groups was 7-days. Lambda was found well-tolerated with few adverse events, which included elevated transaminases which self-resolved.
Sep 28, 2020 • 3:57 am CDT
Children May Have Reduced Susceptibilities to SARS-CoV-2 Infection Than Adults
In a meta-analysis published in the JAMA on September 25, 2020, there is preliminary evidence that children and adolescents have lower susceptibility to SARS-CoV-2, with an odds ratio of 0.56 for being an infected contact compared with adults.
However, this study provides no information on the infectivity of children, and the role that children play in the transmission of this coronavirus remains unclear.
Sep 27, 2020 • 11:27 am CDT
Over 109 Million Coronavirus Tests Completed
The U.S. CDC reported on September 26, 2020, that there have been 109,520,237 coronavirus diagnostic tests reported during the COVID-19 pandemic 2020. The types of tests most often discuss are RT-PCR, the nasal-swab test that detects viral RNA, and various antibody tests, that detect if you have an immune response due to past exposure to the SARS-CoV-2 virus.
Sep 27, 2020 • 11:12 am CDT
3,000 Muscovites Already Vaccinated Against COVID-19
According to TASS reporting on September 27, 2020, over 3,000 residents of the Russian Federation's capital city of Moscow have already been vaccinated against the coronavirus, the mayor of Moscow Sergey Sobyanin said on Rossiya 1 TV channel. 'I myself went through this vaccination procedure and you see - nothing happened to me, although several months have already passed.'
The Sputnik V vaccine was conditionally launched in Russia during August 2020.
Mayor Sobyanin's personal blog stated on September 25, 2020: 'I ask you to strictly observe the mask and glove regime in transport, in shops and other public places. And, by all means, show special attention to the elderly and chronically ill people who must stay at home again.'
Sep 27, 2020 • 10:53 am CDT
India Pledges COVID-19 Vaccine Production to 'Help All Humanity'
Indian Prime Minister Narendra Modi pledged at the United Nations on September 26, 2020, that India’s vaccine production capacity would be made available globally to fight the SARS-CoV-2 coronavirus pandemic.
“As the largest vaccine-producing country of the world, I want to give one more assurance to the global community today,” Modi said in a video posted on YouTube. “India’s vaccine production and delivery capacity will be used to help all humanity in fighting this crisis.”
Sep 27, 2020 • 4:53 am CDT
U.S. FDA Updates COVID-19 Response At-A-Glance Summary
The U.S. FDA issued an updated FDA COVID-19 Response At-A-Glance Summary on September 25, 2020, which provides a quick look at facts, figures, and highlights of the agency's response efforts during the coronavirus pandemic.
Sep 27, 2020 • 3:13 am CDT
Can Oral Polio Vaccination Help Prevent COVID-19?
California based Biomed Industries, Inc. announced on September 4, 2020, the initiation of a Phase 3 study with 3,600 participants to evaluate the efficacy and safety of oral polio vaccine and NA-831™ for prophylaxis and treatment of early onset of COVID-19.
Both poliovirus and coronavirus are positive-strand RNA viruses and they may induce and be affected by common innate immunity mechanisms. Recent reports indicate that COVID-19 may result in suppressed innate immune responses.
"We believe that a drug combination of NA-831™ with an oral polio vaccine could offer a safe, efficacious, and low-cost prevention and treatment for COVID-19," stated Lloyd L. Tran, CEO of Biomed.
Sep 26, 2020 • 5:00 pm CDT
Tokyo Approaches COVID-19 'Herd-Immunity'
A new, non-peer-reviewed study published on September 23, 2020, found COVID-19 infections may have spread widely across the city of Tokyo, despite the very low fatality rate. The seropositivity rate increased from 5.8% at the beginning of the study to an unexpectedly high 46.8 % by the end of the summer of 2020.
Given the temporal correlation between the rise in seropositivity and the decrease in reported COVID-19 cases that occurred without a shut-down, herd-immunity may be implicated in Japan's capital city.
Sep 26, 2020 • 3:44 pm CDT
Contact-Tracing Programs Fumble in the USA
Despite aggressive efforts by health departments, many COVID-19 patients do not report their close contacts, and many contacts cannot be reached, according to the U.S. CDC announcement on September 25, 2020. As an example, during periods of high COVID-19 incidence in North Carolina, 48% of COVID-19 patients reported no close-contacts, and 25% of contacts were not reached in Mecklenburg County.
The CDC stated 'improved timeliness of contact tracing, community engagement, and community-wide mitigation are needed to reduce SARS-CoV-2 transmission.'
Sep 26, 2020 • 3:20 pm CDT
New York Extends Enhanced Airline Screening to European Visitors
Anyone flying into New York from Europe will be required to complete COVID-19 contact tracing forms the state's governor's office announced on September 24, 2020. “We’re gonna mandate that you have to fill out the forms so that we’re able to keep track of the people who are coming in from Europe,” Cuomo’s top aide, Secretary Melissa DeRosa, said according to the NYPost.
New York has been screening air travelers arriving from certain US states for the past few months.
These actions are producing a positive trend in COVID-19 cases. Governor Andrew M. Cuomo announced on September 18, 2020, that New York State's COVID-19 infection rate reached a low of 0.88 of people tested.
Sep 26, 2020 • 1:17 pm CDT
Let's Talk Face Masks
There has been a lot of news about masks during the COVID-19 pandemic. Such as which masks to wear, when to wear a mask, why wear a mask, even about people who want to wear masks, people who don’t want to wear masks, and people who really, really don’t want to wear masks.
To confront these questions, the U.S. CDC published some important information about masks on June 28, 2020.
And recently, a study published on September 2, 2020, compared a variety of commonly available mask types and observed that some mask types approach the performance of standard surgical masks, while some mask alternatives, such as neck gaiters or bandanas ... offer very little coronavirus transmission protection.
Sep 26, 2020 • 12:33 pm CDT
Coronavirus Positive Tests Decreased 5.8% Last Week
The U.S. CDC reported on September 25, 2020, that since mid-July 2020, there has been an overall decreasing trend in the percentage of specimens testing positive for SARS-CoV-2, however, there has been some regional variation. Using combined data from the three laboratory types, the national percentage of respiratory specimens testing positive for the new coronavirus with a molecular assay decreased from 5.1% during week #37 to 4.8% during week #38.
Separately, the COVID-19 Tracker data indicates 109,520,237 tests have been reported as of September 26, 2020.
Sep 25, 2020 • 1:58 pm CDT
Respiratory Fatalities Decreased 5% in the USA Last Week
In the USA, the percentage of respiratory specimens testing positive for the SARS-CoV-2 virus decreased from 5.1% during week #37 .... to 4.8% during week #38, reported the U.S. CDC on September 25, 2020.
Sep 25, 2020 • 9:30 am CDT
The UK Finds COVID-19 and Flu Coinfections Produce Very Negative Outcomes
An analysis by Public Health England (PHE) of COVID-19 cases from January to April 2020 found that people with (2) viruses were more at risk of severe illness. Most cases of coinfection were in seniors, and more than half of them died, reported the BMJ on September 23, 2020.
And when combining intensive care admission or death into a composite variable, the odds of death were 6.33 times greater in people with coinfection (3.57 to 11.23) than in those with neither COVID-19 or influenza infections.
Jonathan Van-Tam, England’s deputy chief medical officer, told a PHE media briefing, “There is now some emerging evidence which clearly suggests that coinfection with influenza and COVID-19 produces bad outcomes. One of these diseases is currently vaccine-preventable, and that’s the really important point.”
The PHE updated data was published as a preprint on medRxiv on September 25, 2020.
Sep 25, 2020 • 8:35 am CDT
France Closes Marseille and Guadeloupe's Bars
In response to the ongoing COVID-19 outbreak in France, Health Minister Olivier Véran announced that bars and restaurants in the coastal city of Marseille and the island of Guadeloupe will shut their doors as of September 26, 2020. Additionally, in "super-red" areas which include the city of Paris, bars and cafes will soon be required to shut from 10 pm, reported France24.
As of September 25, 2020, France has confirmed 31,511 fatalities related to COVID-19.
Sep 25, 2020 • 7:59 am CDT
Cat Vaccine Study Against Coronavirus Launches in New York
Applied DNA Sciences, Inc. announced on September 16, 2020, that it and a spin-out of Takis Biotech are expected to initiate a veterinary clinical trial of one of the Company’s five LineaDNA™ vaccine candidates upon approval of the clinical plan by the U.S. Department of Agriculture. The goal of this vaccine is to prevent infections from the SARS-CoV-2 coronavirus in companion felines (cats).
Launched in Brewster, N.Y., this study will evaluate (30) feline immune responses of the LineaDNA vaccine candidate, which will be injection 1x per month at 1mg/month for the first 3-months of the trial, with dosing administered intramuscularly. The primary endpoint is to determine evidence of antibody and T-cell response in the companion felines.
In addition to curbing feline SARS-CoV-2 infections, the vaccine may have a secondary benefit of preventing the transfer of the SARS-CoV-2 virus from cats to their human owners.
Sep 25, 2020 • 7:40 am CDT
AstraZeneca's COVID-19 Vaccine Granted Partial Legal Immunity
According to Reuters reporting on September 25, 2020, European governments have agreed to pay legal claims above an agreed limit against AstraZeneca over potential side-effects from its AZD1222 SARS-CoV-2 vaccine candidate, which is conducting phase 3 studies in various countries. The AZD1222 vaccine was developed by Oxford University’s Jenner Institute.
This confidential agreement with AstraZeneca shifts some of the vaccine's legal risks to taxpayers in those countries, which were not disclosed.
Over 8,000 individuals have received vaccinations as part of clinical trials, as of September 12, 2020.
Sep 25, 2020 • 5:10 am CDT
10,000 UK Adults to Participate in Phase 3 Coronavirus Vaccine Study
Maryland-based Novavax, Inc. announced on September 24, 2020, that it has initiated a Phase 3 study to evaluate the efficacy, safety, and immunogenicity of the NVX-CoV2373 COVID-19 vaccine candidate in the United Kingdom and is expected to enroll and immunize up to 10,000 individuals over the next 6-weeks.
Sep 24, 2020 • 4:52 pm CDT
Men Have 62% Increased Risk of COVID-19 Associated Fatality
A new study published on September 23, 2020, found that being male proved to be an independent risk factor for a 62% increased risk of COVID-19 death, possibly related to them experiencing higher levels of inflammation. While most laboratory parameters were comparable between male and female patients with COVID-19, men had significantly higher inflammatory markers (IL-6, CRP, PCT, ferritin) across all phases of the disease.
"Men have higher death rates as well as more frequent ICU admissions and longer hospital stays, that are all associated with higher inflammatory parameters during all phases of COVID-19. "We need further studies on what exactly makes men more vulnerable to COVID-19", concluded Dr. Frank Hanses, University Hospital Regensburg, Germany.
"We do not yet know which biological or possibly social factors lead to these marked differences."
Sep 24, 2020 • 3:30 pm CDT
Eyeglasses Can Reduce COVID-19 Risk
In a study published by the JAMA on September 16, 2020, the proportion of inpatients with COVID-19 who wore glasses for extended daily periods (>8 h/d) was smaller than that in the general population, suggesting that daily wearers of eyeglasses may be less susceptible to COVID-19.
In this cohort of 276 patients hospitalized with COVID-19 in Suizhou, China, the proportion of daily wearers of eyeglasses was lower than that of the local population (5.8% vs 31.5%).
Sep 24, 2020 • 10:30 am CDT
Delivery Complications Uncommon in Coronavirus Infected Pregnant Women
According to a new JAMA study by researchers at Karolinska Institutet and Karolinska University Hospital published on September 23, 2020, an infection with the SARS-CoV-2 virus during pregnancy does not appear to increase the risk of complications during delivery or negatively impact the health of newborns.
This research also found that approximately two out of three women who tested positive for SARS-CoV-2 were asymptomatic, which means they were not aware of the virus infection.
However, preeclampsia was more common in infected women, stated these researchers in a press release.
Sep 24, 2020 • 9:38 am CDT
Second Coronavirus Wave's ‘Escapians’ Found in Texas
A new study published on September 23, 2020, found that 'virtually all SARS-CoV-2 strains in the second wave in Houston, Texas, have a Gly614 amino acid replacement in the coronavirus spike protein, a polymorphism that has been linked to increased transmission and infectivity. Furthermore, patients infected with the Gly614 variant strains had significantly higher virus loads in the nasopharynx on initial diagnosis.
This non-peer-reviewed study by Houston Methodist researchers 'helps to understand the origin, composition, and trajectory of future coronavirus infection waves, and the potential effect of the host immune response and therapeutic maneuvers on SARS-CoV-2 evolution.'
Furthermore, this finding reinforces other researchers’ concerns of the coronavirus is gaining momentum through naturally occurring mutations capable of producing mutant coronaviruses that can escape vaccines – dubbed ‘escapians’ – or mutants that can resist drugs and other therapies, reported Newswise.
Sep 24, 2020 • 9:10 am CDT
Fingerstick Coronavirus Test Now Authorized
The U.S. FDA issued an emergency use authorization (EUA) on September 23, 2020, for the first serology point-of-care (POC) test for COVID-19. The Assure COVID-19 IgG/IgM Rapid Test Device was authorized in July 2020 to help identify individuals with antibodies to SARS-CoV-2, indicating recent or prior COVID-19 infection.
Today, that EUA is being reissued to authorize the test for POC use using fingerstick blood samples.
This authorization means that fingerstick blood samples can now be tested for antibodies in POC settings like doctor’s offices, hospitals, urgent care centers, and pharmacies rather than having to be sent to a central lab for testing.
Sep 24, 2020 • 5:51 am CDT
Dental Clinics Can Defeat COVID-19
The DentaQuest Partnership has collaborated with the Organization for Safety Asepsis and Prevention to best practices and guidelines for dental clinics to reopen during the COVID-19 pandemic. In addition to the use of universal PPE and source control in dental settings, targeted SARS-CoV-2 testing of patients without signs or symptoms of COVID-19 might be used to identify those with asymptomatic or presymptomatic SARS-CoV-2 infection and further reduce the risk for exposures in dental settings.
A free 26-page guide was updated on September 10, 2020.
Sep 23, 2020 • 3:03 pm CDT
Convalescent Plasma Studies Launched by the U.S. NIH
Additional clinical trials funded by the US National Institutes of Health (NIH) are expanding enrollment to further evaluate convalescent plasma treatments for patients hospitalized with COVID-19. These studies are needed as observational studies indicate that convalescent plasma may improve outcomes among severely ill and hospitalized patients with COVID-19.
However, prospective, well-controlled randomized trials are needed to generate sufficient data on whether convalescent plasma is effective and safe for the treatment of COVID-19, stated the NIH’s press release published on September 22, 2020.
Sep 23, 2020 • 2:08 pm CDT
Coronavirus Infection Rates Vary by US State
A majority of the USA remains susceptible to a SARS-CoV-2 coronavirus infection, the director of the Centers for Disease Control and Prevention (CDC), told lawmakers on September 23, 2020. The infection rate ranges up to 20% of the population in some US states, and less than 1% in others, the director said, according to CNBC.
Dr. Robert Redfield stated on Twitter 'the CDC recommends that you wear masks in public settings around people who don’t live in your household and when you can’t stay 6 feet away from others. Masks help stop the spread of COVID-19 to others,' says Dr. Redfield.
Sep 23, 2020 • 8:53 am CDT
J&J Launches Large Phase 3 Coronavirus Vaccine Study
Johnson & Johnson announced on September 23, 2020, the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate, Ad26.COV2-S, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies. ENSEMBLE will enroll up to 60,000 volunteers across (3) continents and will study the safety and efficacy of a single vaccine dose of Ad26.COV2-S versus placebo in preventing COVID-19.
Sep 23, 2020 • 7:28 am CDT
Avigan Increased COVID-19 Recover Time
Japan-based Fujifilm Toyama Chemical Co. announced on September 23, 2020, its phase III trial evaluating Avigan was now complete, and it intends to apply for the antiviral medication to be approved for treating coronavirus patients after the trials showed the median recovery time was 11.9 days in those receiving Avigan, compared with 14.7 for patients given a placebo.
Avigan's generic name is favipiravir, was approved for use in Japan in 2014, but only for influenza outbreaks. Favipiravir, which can be taken orally as a pill, works by blocking the ability of a virus to replicate inside a cell.
Sep 23, 2020 • 5:44 am CDT
Most People Will Not Remain Asymptomatic While Infected
The findings of a new living systematic review published by PLOS on September 22, 2020, suggest that most people who become infected with the SARS-CoV-2 virus .... 'will not remain asymptomatic throughout the course of the infection.'
These researchers stated: 'the findings from systematic reviews, including this new one, do not support the claim that a large majority of SARS-CoV-2 infections are asymptomatic.'
These researchers estimated that, across all study settings, the proportion of SARS-CoV-2 infections that are asymptomatic throughout the course of infection is 20% (95% CI 17%–25%).
Sep 23, 2020 • 4:49 am CDT
'World Patient Safety Day' Focuses on Worker Protections
The COVID-19 pandemic during 2020 presents a stark reminder of the importance of health worker safety and offers 'too many examples of health workers becoming infected and dying from COVID-19. The harsh consequences of inequalities have also been laid bare by the pandemic,' states a new commentary published by The Lancet.
As everyone marks the WHO's World Patient Safety Day 2020 on September 17,2 020, it is crucial to highlight that there can be no patient safety ...' without health worker safety. One cannot exist without the other.'
As in previous outbreaks of Ebola virus disease, MERS, and SARS-1, only when health workers are safe can they keep patients safe. Furthermore, 'Governments and healthcare organizations must act now to support and protect the health workforce ... so that we can provide safe care for our patients,' concluded this editorial.