Nov 27, 2020 • 5:03 pm CST
400,000 Russian Military Personnel to Receive the Sputnik V Vaccine
Russia's military has launched a coronavirus vaccination campaign among nearly 400,000 of its active-duty personnel, Defense Minister Sergei Shoigu announced on November 27, 2020, according to Interfax. 'More than 2,500 Russian soldiers have been vaccinated so far, projecting that number to go up to 80,000 by the end of 2020.'
Minister Shoigu himself received the Sputnik V vaccine in September 2020.
Nov 27, 2020 • 11:03 am CST
FDA Opens Up COVID-19 Vaccine Advisory Meeting
The Food and Drug Administration (FDA) announced a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee. The general function of this committee is to provide advice and recommendations to the FDA on regulatory issues related to COVID-19 vaccine candidates (docket number FDA-2020-N-1898). This meeting will be held on December 10, 2020, from 9 a.m. Eastern Time to 6 p.m. ET, and will be open to the public.
Dr. Stephen M. Hahn, director of the FDA, Tweeted on November 27, 2020: 'I’m committed to an open and transparent process as FDA looks at vaccine candidates.'
Nov 27, 2020 • 8:12 am CST
California Continues Leading Coronavirus Testing
Over 181 million diagnostic tests, excluding antibody and antigen tests, have been performed to confirm SARS-CoV-2 virus infections in the USA. As of November 25, 2020, the state of California leads the USA in coronavirus testing reported with 18,991,347, followed by New York (17,023,225), Florida (13,412,326), and Texas (11,066,403).
Overall, the U.S. CDC's new data indicates a national COVID-19 infection positivity rate of 7.79%.
Nov 27, 2020 • 7:48 am CST
Single-Dose, Intranasal Coronavirus Vaccine Candidate Launches Phase 1 Study
Altimmune, Inc. announced that it has submitted an Investigational New Drug application to the U.S. FDA to commence a Phase 1 clinical study of its single-dose intranasal COVID-19 vaccine candidate, AdCOVID, which is designed to stimulate a broad immune response including both systemic immunity and local immunity in the nasal cavity and respiratory tract.
“It’s not widely known or appreciated that nasal mucosal immunity may be essential in preventing the spread of the SARS-CoV-2 virus to other individuals by stopping replication and transmission of the virus at the site of infection – the nose and respiratory tract,” said Frances E. Lund, the Charles H. McCauley Professor and Chair for the University of Alabama at Birmingham, Department of Microbiology, in a press statement issued on November 25, 2020.
“Several recent studies have shown that in the absence of mucosal immunity, the nasal cavity may become a reservoir for the coronavirus, particularly in children, potentially allowing for disease transmission even after an intramuscular vaccination."
"A vaccine that prevents transmission by children would allow them to return to school."
Nov 27, 2020 • 5:49 am CST
COVID-19 Vaccine Allocations Are Based on Each State's Population
The US government announced on November 24, 2020, 'they've allocated 6.4 million doses of COVID-19 vaccines to states based on their total populations.' reported NPR.
"We wanted to keep this simple," Alex Azar, secretary of Health and Human Services, said at a media briefing. "We thought it would be the fairest approach, and the most consistent."
The new allocation-by-population policy is a departure from earlier distribution discussions, and it downplays the role of the CDC's Advisory Committee on Immunization Practices (ACIP) advisory group, which proposed vaccine allocations based on equity-based, high-risk groups, as of 5 pm on November 23, 2020. The ACIP’s Phase 1a proposed vaccine allocation plan included healthcare workers, those seniors living in Long-Term Care Facilities, and those working for these facilities.
Nov 26, 2020 • 8:45 am CST
Few Influenza A or B Viruses Detected
The World Health Organization reported 'despite continued or even increased testing for influenza in some countries, influenza activity remained at lower levels than expected for this time of the year around the globe.'
Furthermore, as of November 23, 2020, in the temperate zone of the Northern Hemisphere (USA, Canada), influenza activity remained below inter-seasonal levels, though sporadic detections of influenza A and B viruses were reported in some countries. And in the temperate zones of the Southern Hemisphere, influenza activity was reported at the inter-seasonal level.
Of the flu cases tested, 63% were influenza A. Of the sub-typed influenza A viruses, 11.3% were influenza A(H1N1)pdm09 and 88.7% were influenza A(H3N2).
Nov 26, 2020 • 8:05 am CST
Postexposure Hydroxychloroquine Use Did Not Prevent SARS-CoV-2 Infection
An open-label, cluster-randomized trial involving asymptomatic coronavirus contacts of patients with polymerase-chain-reaction (PCR)–confirmed COVID-19 in Catalonia, Spain, published by The NEJM on November 24, 2020, were administered postexposure therapy with hydroxychloroquine. This study's researchers concluded: 'it did not prevent SARS-CoV-2 infection, or symptomatic COVID-19, in healthy persons exposed to a PCR-positive case-patient.'
"Despite the promising in vitro results that placed hydroxychloroquine (Plaquenil) among the leading candidates for COVID-19 treatment and prophylaxis, there are no compelling data to suggest that hydroxychloroquine is effective," the authors wrote.
Nov 25, 2020 • 5:28 am CST
Most Americans Do Not Have Serologic Evidence of the SARS-CoV-2 Virus
A cross-sectional, original study published by the JAMA on November 24, 2020, found that as of September 2020, most persons in the USA did not have serologic evidence of previous SARS-CoV-2 infection.
In JAMA's latest update, which looked at more than 177,000 people from July to September, researchers found that the prevalence of antibodies ranged from just 1% to 23% depending on the time frame and geographic jurisdiction. These researchers expanded a previous CDC-led seroprevalence survey from 10 to 52 represented jurisdictions, broadening the geographic scope, and representativeness of SARS-CoV-2 serosurveillance in the USA.
The COVID-19 tests most people 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, the betacoronavirus that causes COVID-19.
Nov 25, 2020 • 4:11 am CST
California Leads in Coronavirus Testing
The U.S. CDC reported on November 24, 2020, there have been over 179 million coronavirus testes confirmed in 2020. The state of California leads the USA with 18,991,347 coronavirus tests performed, followed by New York (16,849,004), Florida (13,308,686), and Texas (10,947,092).
The COVID-19 tests most people 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, the betacoronavirus that causes COVID-19.
Nov 24, 2020 • 5:23 pm CST
COVID-19 Vaccine Delivery Dry Runs Taking Place Across USA
Army Gen. Gustave F. Perna held a press briefing on Operation Warp Speed in Washington, D.C. on November 24, 2020, when he stated: 'Once the FDA authorizes the vaccines from pharmaceutical companies Pfizer and Moderna, they will be distributed to any location in America that the state approves as the provider. Officials are now working with each jurisdiction to plan and then figure out allocation within the states.'
'It's important to ensure everyone understands the cold storage, distribution, use, and administration process for the vaccines,' Perna said.
For each location, however, there's a minimum delivery requirement of the vaccine, which is 975 doses by Pfizer, and 100 doses by Moderna," he said.
After issuing the initial batch, called the "safety stock," officials will monitor providers to ensure they're following the guidelines, he said. Once there is confidence that the process is being followed correctly, more vaccines will be made available to them.
Nov 24, 2020 • 4:20 pm CST
No Association Found Between Vaccination During Pregnancy and Stillbirth
The Obstetrics & Gynecology's December 2020 - Volume 136, published a study that evaluated whether the CDC's Advisory Committee on Immunization Practices recommended influenza and tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccinations during pregnancy were associated with increased risk of stillbirth.
This analysis of 795 confirmed stillbirths in the case group and 3,180 live births in the control group, found no significant association between vaccinations during pregnancy and stillbirth.
Overall, from 2007 to 2015, the stillbirth rate in the Vaccine Safety Datalink was 5.2 per 1,000 live births and stillbirths.
Nov 24, 2020 • 3:58 pm CST
Phase 2 Study Attempts to Modulate Cardiac Complications of COVID-19
Capricor Therapeutics, Inc. announced that the initial patients have been dosed in its Phase 2 study evaluating intravenous infusion of CAP-1002, using its allogeneic cardiosphere-derived cells technology as a treatment option for patients with COVID-19.
The limited study is now enrolling patients who have been diagnosed with SARS-CoV-2 and require supplemental oxygen.
Linda Marbán, Ph.D., CEO of Capricor, stated in a press release: “It is important to remember that many patients are suffering from long-term cardiac consequences from COVID-19. As CAP-1002 directly targets cardiac dysfunction, CAP-1002 potentially may also be an important tool in the treatment of the cardiac complications of COVID-19.”
Nov 24, 2020 • 3:43 pm CST
H5N8 Avian Flu Found in the United Kingdom
According to recent reports from the World Organization for Animal Health, the United Kingdom reported H5N8 avian influenza outbreaks in waterfowl in Devonshire, Northern Ireland, Lancashire, and Lincolnshire during early November 2020.
Nov 24, 2020 • 3:04 pm CST
CDC Publishes COVID-19 Vaccine Allocation Presentations
To ensure the decision process is fully transparent, the U.S. CDC's Advisory Committee on Immunization Practices published the presentations delivered during the emergency meeting that discussed various issues related to experimental COVID-19 vaccine candidates allocations. This digital meeting was conducted on November 23, 2020.
Nov 24, 2020 • 2:05 pm CST
City of Hope Launches Coronavirus Prevention Vaccine Candidate
The City of Hope announced it has initiated a phase 1 clinical trial for the investigational vaccine, known as COH04S1, which aims to stimulate the immune system to produce antibodies, that can block the SARS-CoV-2 coronavirus from entering cells, and also spur abundant T cells that are thought to provide the elusive long-term protection that could protect against future outbreaks.
“Based on preclinical research, we are hopeful that the vaccine will protect against SARS-CoV-2 infection that can lead to COVID-19 disease, helping to halt the spread of the current COVID-19 pandemic,” said Don J. Diamond, Ph.D., a professor with City of Hope’s Department of Hematology & Hematopoietic Cell Transplantation, in a related press statement.
Nov 24, 2020 • 11:55 am CST
Sputnik V Vaccine Reports 95% Efficacy
Based on an analysis of a very large phase 3 clinical trial, the Sputnik V vaccine efficiency was found to be 95%. Announced on November 24, 2020, the evaluation of vaccine efficacy was carried out among 18,794 volunteers on the 28th day after receiving the first injection (7th day after receiving the second injection) of the Sputnik V vaccine or placebo, upon reaching the second checkpoint in accordance with the Clinical Study Protocol.
Alexander Gintsburg, Director of the N.N. N.F. Gamaliel, stated in a press release: “We believe that the calculated efficacy rate will be even higher when analyzing the data after 3-weeks after the second immunization when the strongest and most stable response of the organism is achieved. We are planning to carry out a third interim analysis of the data and we have every reason to believe that the result will exceed our initial expectations."
Nov 24, 2020 • 8:12 am CST
US Navy Awards $5.3 Million For Treatment of Hypovolemia of Septic Shock Due to COVID or other Pathogens
Vivacelle Bio, Inc. announced on November 24, 2020, the Department of Defense awarded $5.3 million dollars for the clinical trial of VBI-S, an intravenously injected fluid for the treatment of septic shock due to various pathogens including COVID-19, other viruses, and/or bacteria. Approximately 270,000 people in the USA and 10 million people worldwide die of septic shock annually. And, about 70% of COVID deaths are due to septic shock.
The key component of VBI-S (VIVACELLE) is a colloid made of soybean oil encapsulated by phospholipids. This thermodynamically stabilized spherical arrangement of molecules is called a nano-micelle. It is comprised entirely of biocompatible and metabolizable components. The use of nano-micelles as a colloid to raise the blood pressure in hypovolemic subjects is unprecedented, says the company.
Harven DeShield, J.D., Ph.D., and CEO of Vivacelle Bio commented, "We are well poised to leverage our nanotechnology to rapidly address unmet clinical needs and save lives."
Nov 24, 2020 • 4:35 am CST
3-Antigen Prophylactic Hepatitis B Vaccine Seeks European Approval
VBI Vaccines Inc. announced the submission of a Marketing Authorization Application to the European Medicines Agency for the Company’s 3-antigen prophylactic hepatitis B vaccine candidate, Sci-B-Vac, seeking approval for the prevention of infection caused by all known subtypes of the hepatitis B virus in adults.
“We believe our 3-antigen prophylactic hepatitis B vaccine has the potential to be an important intervention in the fight to eliminate Hepatitis B infections and this submission is a significant milestone for the product,” said Jeff Baxter, President & CEO, in the company's press release issued on November 23, 2020.
Nov 23, 2020 • 8:41 pm CST
Over 178 Million Coronavirus Tests Completed in the USA
Updated data from the U.S. CDC indicates about 178 million diagnostic tests, excluding antibody, and antigen tests, were performed to confirm if a person has a SARS-CoV-2 infection. During 2020, the state of California leads with 18,991,347 coronavirus tests performed, followed by the states of New York (16,694,212), Florida (13,197,053), and Texas (10,847,872).
Overall, the reported CDC data indicates a coronavirus infection positivity rate of 7.74%, as of November 23, 2020.
Nov 23, 2020 • 4:36 pm CST
Single-Dose Flu Medicine Approved for Post-Exposure Prophylaxis
Genentech announced that the U.S. FDA approved on November 23, 2020, a supplemental New Drug Application for Xofluza® (baloxavir marboxil) as a treatment to prevent influenza in people 12 years of age and older, following contact with someone with influenza (known as post-exposure prophylaxis).
Xofluza is the first single-dose influenza medicine approved for post-exposure prophylaxis.
“With today’s approval, Xofluza is now available as the first single-dose, post-exposure preventive treatment for influenza,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development, stated in a related press release.
Nov 23, 2020 • 2:44 pm CST
Merck Accelerates Severe COVID-19 Treatment Development Through Acquisition
Merck and OncoImmune announced on November 23, 2020, that the companies have entered into a definitive agreement pursuant to which Merck will acquire all outstanding shares of OncoImmune, which recently announced positive top-line findings from an interim efficacy analysis of a Phase 3 study evaluating its lead therapeutic candidate CD24Fc for the treatment of patients with severe and critical COVID-19.
CD24Fc is a first-in-class recombinant fusion protein that targets the innate immune system.
Dr. Roger M. Perlmutter, President Merck Research Laboratories, stated in a press release: “Recent clinical investigations support the view that CD24Fc may provide benefit beyond the standard of care therapy for COVID-19 patients requiring oxygen support."
The interim analysis of data from 203 participants (75% of the planned enrollment) reported by OncoImmune indicated that patients with severe or critical COVID-19 treated with a single dose of CD24Fc showed a 60% higher probability of improvement in clinical status, as defined by the protocol, compared to placebo. The risk of death or respiratory failure was reduced by more than 50%, added Merck.
Nov 23, 2020 • 2:32 pm CST
15-Valent Pneumococcal Conjugate Vaccine Seeks Europe's Approval
Merck announced it has submitted applications to the U.S. FDA and European Medicines Agency for licensure of V114, Merck’s investigational 15-valent pneumococcal conjugate vaccine, for use in adults 18 years of age and older.
“For more than a century, Merck inventors have developed vaccines that help tackle some of society’s biggest public health challenges, and that heritage is reflected today in our pneumococcal vaccine portfolio,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, in a press statement issued on November 23, 2020.
“These submissions for V114 help bring us closer to offering more options to help protect against pneumococcal disease.”
Nov 23, 2020 • 7:24 am CST
FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19
The U.S. Food and Drug Administration (FDA) issued an emergency use authorization for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing about 88 pounds with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19.
This FDA authorization announced on November 21, 2020, includes those who are 65 years of age or older or who have certain chronic medical conditions.
This is the first treatment of any kind to have prospectively confirmed and statistically significant anti-viral activity against SARS-CoV-2, said Regeneron's released press stated. The recommended dose is 1,200 mg of casirivimab and 1,200 mg of imdevimab (2,400 mg total) administered as a single intravenous infusion.
Nov 22, 2020 • 3:18 am CST
Oral, Once-Daily COVID-19 Treatment Launches Phase 2 Study
Clear Creek Bio, Inc. announced that the company has dosed the first patient in the CRISIS2 study, a Phase 2 clinical study evaluating brequinar for the treatment of COVID-19. Brequinar is an orally available, potent, and selective small-molecule DHODH inhibitor that has been shown in vitro to inhibit viral replication of SARS-CoV-2 as well as a broad spectrum of RNA viruses.
Vikram Sheel Kumar, M.D., Chief Executive Officer of Clear Creek Bio, stated in a press release: “We believe brequinar’s unique drug profile, with oral bioavailability and high potency, supports its development as an oral, once-daily treatment for COVID-19.”
Nov 21, 2020 • 8:31 pm CST
BCG Vaccination Associated with Decreased SARS-CoV-2 Seroprevalence
A retrospective observational study published by Cedars-Sinai researchers on November 19, 2020, raised the possibility that the U.S. FDA approved vaccine known as Bacillus Calmette-Guérin (BCG) may help prevent the new coronavirus infections or reduce the severity of the COVID-19 disease.
Of the 6,201 Health Care Workers (HCW) in the study, a history of BCG vaccination was associated with decreased seroprevalence of anti-SARS-CoV-2 IgG and reduced reported COVID-19-related clinical symptoms in this cohort.
Therefore, 'large randomized prospective clinical trials of BCG vaccination are urgently needed to confirm if BCG vaccination can induce a protective effect against SARS-CoV2 infection,' stated these researchers in a press release.
As an example, the BRACE phase 3 clinical trial, last updated on October 22, 2020, intends to recruit about 10,000 HCW in the UK, Australia, the Netherlands, Spain, and Brazil.
Nov 20, 2020 • 8:48 pm CST
COVID-19 Vaccine Review Meeting Scheduled For December 10th
The U.S. Food and Drug Administration (FDA) has announced a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on December 10, 2020, to discuss the request for emergency use authorization (EUA) of a COVID-19 vaccine (BNT162) from Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH.
“I want to assure the American people that the FDA’s process and evaluation of the data for a potential COVID-19 vaccine will be as open and transparent as possible,” said FDA Commissioner Stephen M. Hahn, M.D., in a press release issued on November 20, 2020.
“While we cannot predict how long the FDA’s review will take, the FDA will review the request as expeditiously as possible, while still doing so in a thorough and science-based manner, so that we can help make available a vaccine that the American people deserve as soon as possible."
Nov 20, 2020 • 10:28 am CST
Flu Season Fails To Start in the USA
Nationwide during Week #46, the U.S. CDC confirmed 1.5% of patient visits reported through the U.S. Outpatient Influenza-like Illness Surveillance Network (ILINet) were due to Influenza-Like Illness (ILI). This ILI percentage is below the national baseline of 2.6%.
The CDC said on November 20, 2020, 'please note, the ILINet monitors' outpatient visits for ILI, not laboratory-confirmed influenza, and as such, will capture visits due to other respiratory pathogens, such as SARS-CoV-2, that present with similar symptoms.'
The percent of samples found positive for influenza at clinical labs was (0.2%) during Week #46.
Furthermore, no influenza-associated pediatric deaths occurring during the 2020-2021 season have been reported to the CDC. Last flu season, the CDC confirmed 195 pediatric fatalities related to influenza in the USA.
Nov 20, 2020 • 9:57 am CST
Prioritized Communities Receive Bamlanivimab Allocation
Texas Governor Greg Abbott provided an update on the distribution of bamlanivimab, the monoclonal antibody therapy for COVID-19. The Texas Department of State Health Services (DSHS) has allocated this initial shipment of bamlanivimab to acute care hospitals across Texas, including hospitals in Lubbock, with additional doses expected to be shipped each week.
According to a press statement on November 19, 2020, DSHS has prioritized communities with high COVID-19 disease burden for this initial allotment of bamlanivimab through a formula that included total new case counts in the area, new COVID-19 hospital admissions, and total COVID-19 hospital patients.
Bamlanivimab is for outpatients with mild to moderate COVID-19 who are aged 12 years or older and are at higher risk of severe disease.
Governor Abbott stated: "This therapy drug will help prevent hospitalizations and reduce the strain on our healthcare system and workers."
Nov 20, 2020 • 9:20 am CST
Novartis Secures Rights for Acute Respiratory Distress Syndrome Cell Therapy
Novartis announced that it entered into an extensive license and collaboration agreement with Australia-based Mesoblast to develop, commercialize, and manufacture remestemcel-L for the treatment of acute respiratory distress syndrome (ARDS), including that associated with COVID-19.
Remestemcel-L, is an investigational therapy comprising of culture-expanded mesenchymal stromal cells derived from the bone marrow of an unrelated donor. Remestemcel-L is thought to have immunomodulatory properties to counteract the cytokine storms that are implicated in various inflammatory conditions by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.
The Novartis press statement issued on November 19, 2020, said 'ARDS is an area of significant unmet need, with an approximate 40% mortality rate with the current standard of care, which includes prolonged ICU treatment and mechanical ventilation.'
Nov 20, 2020 • 5:57 am CST
The WHO Recommends Against Administering Remdesivir (Veklury)
A WHO panel made a conditional recommendation against the use of remdesivir (Veklury) in hospitalized patients with COVID-19, regardless of disease severity on November 20, 2020.
This new guidance published in the WHO's Therapeutic and COVID-19 living document adds to recommendations published in the previous version: a strong recommendation for systemic corticosteroids in patients with severe and critical COVID19, and a conditional recommendation against systemic corticosteroids in patients with non-severe COVID-19.
Work on this recommendation began on October 15, 2020, by an international guideline development group, which includes 28 clinical care experts, 4 patient-partners, and one ethicist, when the WHO Solidarity Trial published its interim results. Data reviewed by this panel included results from this trial, as well as 3 other randomized controlled trials. In all, data from over 7000 patients across the 4 trials were considered.
The WHO stated 'the evidence suggested no important effect on mortality, need for mechanical ventilation, time to clinical improvement, and other patient-important outcomes.'
Nov 19, 2020 • 9:05 pm CST
Anti-COVID-19 Nasal Spray Shows Promise
A nasal spray that can provide effective protection against the SARS-CoV-2 virus has been developed by researchers at the University of Birmingham (UB), using materials already cleared for use in humans. The spray is composed of two polysaccharide polymers.
The first, an antiviral agent called carrageenan, is commonly used in foods as a thickening agent, while the second a solution called gellan, was selected for its ability to stick to cells inside the nose, said these UB researchers in a press release issued on November 19, 2020.
A non-peer-reviewed study describes cell culture experiments designed to test the ability of the solution to inhibit infection. These UB researchers found cell-virus cultures inhibited the infection up to 48-hours after being treated with the solution and when diluted many times.
Nov 19, 2020 • 4:02 pm CST
Drug Combination Authorized for Treatment of COVID-19
The U.S. Food and Drug Administration (FDA) issued an emergency use authorization on November 19, 2020, for the drug baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized adults and pediatric patients 2-years of age or older, requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation.
Baricitinib is a janus kinase inhibitor, which blocks the activity of one or more of a specific family of enzymes, interfering with the pathway that leads to inflammation. Baricitinib is a prescription oral tablet medication that is FDA-approved (and sold under the brand name Olumiant) for the treatment of moderately to severely active rheumatoid arthritis.
FDA Commissioner Stephen M. Hahn, M.D., stated in a press release: “As part of our Coronavirus Treatment Acceleration Program, the FDA continues to use every possible avenue to facilitate new treatments for patients as quickly as possible to combat COVID-19.”
Nov 19, 2020 • 11:45 am CST
Chapare Virus Outbreak Confirmed by the CDC
The U.S. CDC confirmed an outbreak of Chapare hemorrhagic fever (CHHF) occurred in Caranavi Province, Bolivia, during 2019, which resulted in (5) confirmed cases, with (3) related fatalities.
The CDC states CHHF is a viral hemorrhagic fever caused by infection with the Chapare virus, which is in the arenavirus family. Arenaviruses are usually spread to people through direct contact with infected rodents or indirectly through the urine or feces (droppings) of an infected rodent.
As of November 19, 2020, the CDC says there are no preventive vaccines targeted for the Chapare virus.
Nov 19, 2020 • 8:03 am CST
$590 Million Loan Pending for Disposable Vaccine Injection Device
The U.S. International Development Finance Corp (DFC) is expected to announce that it has extended a $590 million loan to ApiJect Systems America, a Connecticut based company that produces a disposable injection device that delivers vaccines and medications. The single-use, self-contained devices are designed to be an alternative to traditional vials and syringes.
The ApiJect Prefilled Injector brings together an aseptically-filled Blow-Fill-Seal container and a Needle Hub* to reliably deliver injectable vaccines.
"This is going to be, we believe, the next generation of safe injections worldwide," ApiJect Systems Corp. Executive Chairman Jay Walker told NPR o November 19. 2020.
Nov 19, 2020 • 7:17 am CST
COVID-19 Vaccine Candidate Produces Strong Immune Response in Seniors
The Lancet published a study review on November 18, 2020, that describes the safety and immunogenicity of this vaccine in a wider range of participants, including adults aged 70 years and older. The vaccine candidate, (AZD1222) ChAdOx1 nCoV-19 appears to be better tolerated in older adults than in younger adults and has similar immunogenicity across all age groups after a boost dose.
According to the University of Oxford researchers, 'this study shows the vaccine causes few side effects and provokes a response in T-cells that target the virus within 14 days of the first dose and a protective antibody response within 28 days of the booster dose. Neutralizing levels were achieved by 14-days after a boost vaccination in 208 of 209 patients.'
Dr. Angela Minassian, Investigator at the University of Oxford and Honorary Consultant in Infectious Diseases said in a press statement: ‘Inducing robust immune responses in older adults has been a long-standing challenge in human vaccine research. To show this vaccine technology is able to induce these responses, in the age group most at risk from severe COVID-19 disease, offers hope that vaccine efficacy will be similar in younger and older adults’.
Nov 18, 2020 • 4:13 pm CST
26% Decrease in Childhood Vaccination Doses
Millions of children have missed routine vaccinations during 2020, causing a precipitous drop in immunizations that threatens to leave communities throughout the USA at risk of losing protection against highly contagious diseases, including measles, whooping cough, and polio, according to new data from the Blue Cross Blue Shield Association (BCBSA).
Children are on track to miss an estimated 9 million vaccination doses in 2020, a decrease of up to 26% in childhood vaccination doses compared to 2019.
“The U.S. is on the precipice of a severe immunization crisis among children,” stated Dr. Vincent Nelson, chief medical officer at BCBSA, in a press release issued on November 18, 2020.
Nov 18, 2020 • 1:25 pm CST
FDA Grants Breakthrough Therapy Designation for HIV PrEP
London based ViiV Healthcare announced that the U.S. FDA has granted Breakthrough Therapy Designation for long-acting, injectable cabotegravir for HIV pre-exposure prophylaxis (PrEP).
The Breakthrough Therapy Designation was based on efficacy and safety results from HPTN 083, a phase IIb/III randomized, multicentre, double-blind, clinical trial that compared long-acting, injectable cabotegravir to daily oral emtricitabine/tenofovir disoproxil fumarate 200 mg and 300 mg (FTC/TDF) for HIV prevention.
Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare, said in a press release “New PrEP medicines that decrease the risk of HIV acquisition in at-risk populations are an essential tool to help us end the global HIV epidemic."
Nov 18, 2020 • 9:59 am CST
Southern Hemisphere's Flu Season is Predictive of Influenza Cases in the USA
The correlation between seasonal influenza patterns in the USA, Australia, and Chile could be used to forecast the next seasonal influenza pattern, which can help to determine influenza vaccine strategy approximately 6-months ahead in the USA, reported a previous study published by PLOS One on November 25, 2019.
On November 9, 2020, the WHO's Report #380 indicated in the temperate zones of the Southern Hemisphere, no influenza detections were reported across most countries.
Nov 18, 2020 • 6:26 am CST
Pfizer's COVID-19 Vaccine Candidate Crosses Efficacy Finish Line
Pfizer and BionTech announced their phase 3 study's primary efficacy analysis demonstrates the BNT162b2 vaccine candidate to be 95% effective against COVID-19 beginning 28-days after the first dose. And the experimental vaccine's efficacy was consistent across age, gender, race and ethnicity demographics; observed.
Pfizer stated in a press release issued on November 18, 2020, that the 'safety data milestone required by the U.S. FDA for Emergency Use Authorization has been achieved.'
Dr. Albert Bourla, Pfizer Chairman and CEO, added: “With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world.”
Nov 18, 2020 • 5:47 am CST
Human Case of H5N1 Influenza Confirmed in Southeast Asia
The Ministry of Health in Lao People's Democratic Republic (PDR) reported a human case of infection with an avian influenza A(H5N1) virus. The case is a one-year-old female who was hospitalized then later discharged on October 19, 2020.
As of November 17, 2020, there have been 862 human cases of influenza A(H5N1) reported to the WHO since 2003, including (3) from Lao PDR.
Nearly all cases of avian influenza A(H5N1) infection in humans have been associated with close contact with infected live or dead birds, or influenza A(H5N1) virus-contaminated environments. Human infection can cause severe disease and has a reportedly high mortality rate.
Since the virus continues to be detected in poultry populations, further human cases can be expected, says the WHO. Furthermore, the 'WHO does not advise special screening at points of entry into Laos regarding this event, nor does it recommend that any travel or trade restrictions be applied.'
And, the annual flu shot is not effective against this type of influenza.
Nov 17, 2020 • 4:16 pm CST
Second Israel Based COVID-19 Vaccine Candidate Launches Phase 2 Study
Israel based RedHill Biopharma Ltd. announced on November 17, 2020, that the U.S. FDA has cleared the Company's Investigational New Drug Application for a Phase 2/3 study evaluating the orally-administered RHB-107 (upamostat) in patients with symptomatic COVID-19 who do not require hospitalization.
RHB-107 is a proprietary, first-in-class, orally-administered potent inhibitor of several serine proteases, with demonstrated antiviral and potential tissue-protective effects. This combined antiviral and potential tissue-protective action makes it a promising candidate for evaluation as a treatment for COVID-19 disease, says the company.
Nov 17, 2020 • 3:02 pm CST
Hoosiers Share COVID-19 Vaccine Trial Insights
Dr. Cynthia Brown with the Indiana University (IU) School of Medicine provided an update on November 17, 2020, stating several Hoosier volunteers are now enrolled in the late-stage clinical study of an investigational COVID-19 vaccine known as AZD1222. And more than 3,000 Hoosiers applied within days of the local study site being announced, reported Fox59.
The IU School of Medicine says 'early results from the trials of the AZD1222 vaccine candidate show a strong immune response producing both T cells and antibodies, which can find and attack virus cells.'
Nov 17, 2020 • 1:59 pm CST
COVID-19 Long-Haul Therapeutic Launches Phase 2 Study
Washington based CytoDyn Inc. announced it has filed a protocol with the U.S. FDA for a Phase 2 clinical trial for leronlimab as a treatment for COVID-19 patients suffering from long-hauler symptoms.
Leronlimab (PRO 140) inhibits the migration of Tregs into areas of inflammation, which can inhibit the innate immune response against pathogens and, most importantly, the migration of macrophages and release of pro-inflammatory cytokines in the lungs. Leronlimab can potentially mitigate the cytokine storm, says the company.
According to an article published by The JAMA on September 23, 2020, and a study done by British scientists, researchers estimate about 10% of COVID-19 patients become 'long-haulers.'
Nov 17, 2020 • 10:53 am CST
COVID-19 Vaccine Delivery Pilot Program Launches in USA
New York-based Pfizer announced a pilot delivery program for its experimental COVID-19 vaccine in four US states; Rhode Island, Texas, New Mexico, and Tennessee. “We are hopeful that results from this vaccine delivery pilot will serve as the model for other U.S. states and international governments, as they prepare to implement effective COVID-19 vaccine programs,” reported Reuters on November 16, 2020.
Pfizer and BioNTech's BNT162b2 vaccine candidate encodes an optimized SARS-CoV-2 full-length spike glycoprotein, at a 30µg dose level in a 2-dose regimen.
Nov 17, 2020 • 7:24 am CST
Avian Flu Confirmed by Three Countries
According to the World Organization for Animal Health (OIE) reports, additional highly pathogenic avian flu cases have been confirmed in South Korea, which reported H5N8 outbreaks in wild birds, Kazakhstan reported an H5 event in poultry, and Laos reported H5N1 in poultry.
Unlike the seasonal flu, highly pathogenic avian influenza refers to the disease caused by infection with avian (bird) influenza (flu) Type A viruses, says the U.S. CDC.
However, sporadic human infections with avian flu viruses have occurred. The CDC considers the risk to the risk to the public’s health from virus outbreaks in wild birds or poultry in the USA to be 'low.'
Nov 17, 2020 • 2:51 am CST
Looking Closer at COVID-19 Diagnostic Testing
The US Food and Drug Administration (FDA) published a new webpage, A Closer Look at COVID-19 Diagnostic Testing, on November 16, 2020, to enhance the information healthcare providers and other public health professionals more technical information regarding both diagnostic and antibody testing for COVID-19.
'No test is 100% accurate, and test performance and the related results can vary based on the prevalence of disease in the population being tested' states the FDA.
Nov 17, 2020 • 1:11 am CST
Cervical Cancer Can Be Prevented
The WHO‘s Global Strategy to Accelerate the Elimination of Cervical Cancer launched on November 17, 2020, outlining (3) key steps: vaccination, screening, and treatment. The WHO says the 'successful implementation of these actions could reduce more than 40% of new cervical cancer cases of the disease and 5 million related fatalities by 2050.
Vaccination against human papillomavirus (HPV) is recommended to prevent new HPV infections and HPV-associated diseases, including some cancers, says the US Centers for Disease Control and Prevention (CDC). There are safe and effective HPV vaccines authorized by the CDC that can protect males and females against cancers caused by HPV.
Nov 16, 2020 • 4:19 pm CST
CDC Scheduled Vaccine Committee Review Meeting For November 23rd
The U.S. CDC's Advisory Committee on Immunization Practices (ACIP) has announced a digital meeting for November 23, 2020. No agenda for this ACIP meeting has been released on the CDC website.
The last ACIP meeting was held on October 28, 2020, and reviewed various topics related to COVID-19 vaccine candidates. Those presentations can be found at this CDC link.
Nov 16, 2020 • 4:01 pm CST
FDA Clears COVID-19 Vaccine Candidate For Phase 2 Study
Pennsylvania based INOVIO announced that it has received clearance from the U.S. Food & Drug Administration on November 16, 2020, to proceed with the Phase 2 segment of its planned Phase 2/3 clinical trial for INO-4800, its COVID-19 vaccine candidate.
Nov 16, 2020 • 8:25 am CST
$800 Million Influenza Vaccine Manufacturing Facility to be Built in Australia
Australia-based Seqirus announced it will build in Tullamarine the only cell-based influenza vaccine manufacturing facility in the Southern Hemisphere to produce seasonal and pandemic flu vaccines, including Seqirus’s proprietary adjuvant MF59®, Australian antivenoms, and Q-Fever vaccine. The facility is expected to be operational in 2026.
The announcement on November 16, 2020, follows an agreement with the Australian Government for the supply of over 10-years of influenza pandemic vaccines, antivenoms, and Q-Fever vaccine.