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The U.S. CDC announced today, 'While influenza activity is low nationally, the number of influenza viruses detected by clinical and public health labs has increased in recent weeks.'
There were 38,685 specimens tested during week #45. Of which, 257 (0.7%) were influenza positive.
The majority of viruses detected are A(H3N2).
Among pneumonia, influenza, and/or COVID-19 (PIC) patients, 3,046 deaths were reported last week.
Of these fatalities, 2,175 listed COVID-19 as an underlying or contributing cause of death on the death certificate, and just four listed influenza.
This data indicates that current PIC mortality is due primarily to COVID-19 and pneumonia, but not influenza.
Furthermore, no influenza-associated pediatric deaths occurring during the 2021-2022 flu season have been reported to CDC.
An annual flu vaccine is the best way to protect against flu and its potentially serious complications. The CDC recommends most everyone six months and older should get a flu vaccine.
As of November 5, 2021, 162.5M doses of flu vaccine have been distributed in the U.S.
Flu vaccines are available at many different locations, including pharmacies and health departments. Visit www.vaccines.gov to find a flu vaccine near you.
Various influenza vaccines available for the 2021-2022 flu season are listed on this PrecisionVaccinations webpage.
The U.S. Centers for Disease Control and Prevention (CDC) vaccine advisory meeting agenda was posted on November 19, 2021.
Dr. Grace Lee will chair this digital meeting focused on Pfizer-BioNTech (Comirnaty) and Moderna (SpikeVax) COVID19 vaccine booster dose authorizations issued by the U.S. FDA earlier today.
Various Presentation Slides have been uploaded.
During the afternoon session, Dr. Sara Oliver is scheduled to lead the advisory member's vote.
This CDC vaccine meeting is virtual. No registration is required to watch the webcasts.
Germany-based BioNTech SE today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for BNT111, a cancer immunotherapy candidate for the potential treatment of advanced melanoma.
BNT111 is the lead product candidate from BioNTech’s fully owned FixVac platform that utilizes a fixed combination of mRNA-encoded, tumor-associated antigens aiming to trigger a strong and precise immune response against cancer.
The candidate is currently being investigated in a Phase 2 study in patients with anti-PD-1-refractory/relapsed unresectable Stage III or IV melanoma.
“The Fast Track Designation underlines the potential of our FixVac platform to address current treatment challenges of pre-treated and immune checkpoint blocker experienced melanoma with a limited standard of care therapy options left. This is an important step to pave the way for this versatile new treatment approach in a high medical need setting,” commented Özlem Türeci, M.D., Co-founder and Chief Medical Officer of BioNTech, in a related press statement.
The ongoing randomized Phase 2 trial (BNT111-01) in patients with anti-PD1-refractory/relapsed unresectable Stage III or IV melanoma investigates BNT111 in combination with Libtayo® (cemiplimab), an anti-PD-1 monoclonal antibody being co-developed by Regeneron and Sanofi.
The BNT111-01 trial is conducted in the U.S., the U.K., Australia, Spain, Germany, Italy, and Poland.
This new trial seeks to support initial data reported from the ongoing Phase 1 Lipo-MERIT monotherapy dose-escalation trial that demonstrated a favorable safety profile and anti-tumor responses of BNT111 alone and in combination with immune checkpoint inhibitor therapy in patients with advanced melanoma.
BNT111 is an intravenous therapeutic cancer immunotherapy candidate encoding a fixed set of four cancer-specific antigens optimized for immunogenicity and delivered as RNA-lipoplex formulation.
BNT111 is not yet authorized by any regulatory authority, and the safety and efficacy have not yet been established.
Biopharmaceutical New Technologies is a next-generation immunotherapy company located in Mainz, Germany, pioneering novel therapies for cancer and other serious diseases.
Washington-based CytoDyn Inc. today announced that the journal Frontiers in Immunology published an Original Research paper that found 'Leronlimab stabilized cell surface CCR5, leading to an increase in the levels of circulating and tissue-resident CCR5+CD4+ T cells in vivo in Leronlimab-treated macaques.'
Notably, the results of the study outlined in the research paper published on November 19, 2021, are as follows:
- Establish two CCR5 receptor occupancy calculation methods for longitudinal monitoring of anti-CCR5 therapeutic antibody blockade efficacy in both macaques and humans;
- Demonstrate that CCR5+CD4+ T cell levels temporarily increase with leronlimab treatment; and
- Facilitate future detailed investigations into the immunological impacts of CCR5 inhibition in multiple pathophysiological processes.
CytoDyn's Chief Medical Officer, Scott A. Kelly M.D., commented in a press release, "We will relentlessly pursue the various indications for leronlimab to realize its full therapeutic potential."
"Our continued work on the mechanism of action of leronlimab continues to lay the foundation for more exciting opportunities of leronlimab for patients and our shareholders."
CCR5 plays a critical role in the ability of HIV to enter and infect healthy T-cells.
In addition, it appears to be implicated in tumor metastasis and immune-mediated illnesses, such as NASH.
For example, the U.S. FDA designated Leronlimab for Fast Track Approval to treat HIV and metastatic cancer in February 2021.
CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications using leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor.
Germany-based CureVac N.V. announced the publication of the extended preclinical study of the second-generation vaccine candidate, CV2CoV, jointly developed with GSK.
CV2CoV is CureVac’s first candidate based on the advanced second-generation mRNA backbone.
Published in the journal Nature on November 18, 2021, the data features a direct comparison of CV2CoV with the licensed mRNA vaccine, Comirnaty® (Pfizer/BioNTech).
The data confirm how targeted optimizations of a non-chemically modified mRNA can significantly improve immune responses in a preclinical model, providing substantiated support for the unmodified mRNA technology approach.
Neutralizing antibody levels measured following complete vaccination of animals with either 12µg of CV2CoV or a 30µg standard dose of Comirnaty were shown to be highly comparable.
This applies not only to the development of advanced COVID-19 vaccines but to the mRNA technology field as a whole, said the company.
The study, conducted in collaboration with Dan Barouch, MD, Ph.D., of Beth Israel Deaconess Medical Center, investigated immune responses and the protective efficacy of CV2CoV and first-generation candidate, CVnCoV, against SARS-CoV-2 challenge in cynomolgus macaques.
Within the study, CV2CoV and CVnCoV were tested in cynomolgus macaques immunized with a 12µg dose of the respective candidate on days 0 and 28.
For comparison with Comirnaty®, animals were vaccinated twice, on days 0 and 21, with 30µg of the licensed vaccine, and antibody titers were measured at peak immunity at week 5.
In comparing CV2CoV with CVnCoV, CV2CoV consistently showed better activation of innate and adaptive immune responses, resulting in earlier response onset, higher antibody titers, and stronger memory B and T cell activation.
Higher antibody neutralizing capacity was observed with CV2CoV across a range of relevant virus variants, including Delta.
Presently at a preclinical development stage, the vaccine candidate is a non-chemically modified mRNA encoding the prefusion stabilized full-length spike protein of the SARS-CoV-2 virus and formulated within Lipid Nanoparticles.
CV2CoV was engineered with specifically optimized non-coding regions to exhibit improved mRNA translation for increased and extended protein expression compared to the first-generation mRNA backbone.
CureVac is a global biopharmaceutical company with offices in Tubingen and Boston, MA, in the field of messenger RNA technology, with more than 20 years of expertise in developing and optimizing the versatile biological molecule for medical purposes.
New York-based Regeneron Pharmaceuticals, Inc. announced that the European Commission (EC) had Approved the REGEN-COV® antibody cocktail.
Known in Europe as Ronapreve™, the EC granted authorization for the antibody cocktail for people aged 12 years and older to treat non-hospitalized patients with confirmed COVID-19, who do not require oxygen supplementation, and who are at increased risk of progressing to severe COVID-19 and to prevent COVID-19.
The antibody cocktail is fully Approved in Japan and conditionally approved in the United Kingdom and Australia.
Emergency authorizations are currently in place in more than 40 countries.
George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron, stated in a press release issued on November 12, 2021,
"With today's approval, we hope countries in the European Union will accelerate their adoption of this formidable tool to reduce the burden of COVID-19."
"For non-hospitalized infected individuals, our antibody cocktail was shown to reduce the risk of hospitalization or death by 70%; and in the prevention setting, it reduced the risk of symptomatic infections by 82%."
"Further, recently released data ... suggests a single dose provided long-term protection against COVID-19, beyond the currently authorized once-monthly dosing."
Regeneron invented the antibody cocktail and collaborates with Roche, who is primarily responsible for development and distribution outside the U.S.
In October 2021, the U.S. FDA accepted for priority review the first of two Biologics License Applications for REGEN-COV to treat COVID-19 in non-hospitalized patients and as prophylaxis in specific individuals.
The development and manufacturing of REGEN-COV have been funded in part with federal funds from the Biomedical Advanced Research and Development Authority, part of the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response.
The REGEN-COV cocktail of two monoclonal antibodies (casirivimab and imdevimab) was explicitly designed to block the infectivity of SARS-CoV-2, the coronavirus that causes COVID-19.
This antibody cocktail diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, says the U.S. NIH.
In the U.S., the FDA has not approved REGEN-COV but is currently authorized under an Emergency Use Authorization.
AN updated listing of antibody treatments is published on this PrecisionVaccinations.com webpage.
Massachusetts - based Moderna, Inc. announced the first participant had been dosed in the ConquerRSV multi-country Phase 2/3 study of mRNA-1345, the Company's Respiratory Syncytial Virus (RSV) vaccine candidate.
mRNA-1345 is a vaccine against RSV encoding for a prefusion F glycoprotein, which elicits a superior neutralizing antibody response compared to the postfusion state.
The vaccine candidate uses the same lipid nanoparticle (LNP) as Moderna's COVID-19 vaccine and contains optimized protein and codon sequences.
The U.S. FDA has granted Fast Track designation for mRNA-1345 in adults older than 60 years of age.
Unfortunately, there is no U.S. FDA-approved vaccine available today for RSV.
The Company recently shared interim data Phase 1 study of mRNA-1345 in older adults ages 65-79 years.
Neutralizing antibodies were confirmed to be present at baseline in all participants, as expected.
The data showed that a single mRNA-1345 vaccination of 50 µg, 100 µg, or 200 µg boosted neutralizing antibody titers against RSV-A by approximately 14-fold and against RSV-B by about 10-fold. Data were pooled across dose levels because there was not a significant difference between doses.
A single vaccination of 50 µg, 100 µg, or 200 µg was well-tolerated in older adults through month one.
Moderna is choosing study locations based on the ongoing epidemiology of RSV and expects to enroll approximately 34,000 participants.
To learn more about eligibility, please click here.
"RSV illness in older adults is often under-recognized, and there is no vaccine against it," said Stéphane Bancel, Moderna's CEO, in a press statement issued on November 17, 2021.
"We believe that vaccine candidates against RSV can have a positive impact on public health as RSV represents a significant unmet global need."
In the U.S. and areas with similar climates, RSV infections occur primarily during fall, winter, and spring.
Most people recover in approximately one to two weeks, but RSV can be serious, especially for young children under five years of age and older adults over 65 years of age.
In the U.S., RSV causes approximately 177,000 hospitalizations and 14,000 deaths in adults 65 years and older.
In addition to its RSV vaccine candidate, Moderna is advancing COVID-19 booster vaccine candidates and a seasonal flu vaccine candidate. And during Moderna's annual R&D Day in September, the Company announced that it is developing a single-dose vaccine that combines a booster against COVID-19 and a booster against flu.
Moderna intends to explore vaccine combinations including RSV, Flu, and COVID-19.
An updated list of RSV vaccine candidates is published on this PrecisionVaccinations webpage.
The Imperial College of London reported today results from swab tests taken at home by over 100,000 people in England between 19 October and 5 November showed that 1.57% of people were infected with the SARS-CoV-2 coronavirus.
This data is almost twice as high as reported in September 2021.
Furthermore, school-aged children had the highest infection prevalence at 5.21% for 13-17-year-olds and 4.95% for those aged 5-12.
However, the study also found that vaccination was helping to reduce virus spread among children.
Those aged 12-17 who had received a single Comirnaty vaccine dose had around a 56% lower infection risk than unvaccinated children.
"It is possible that the prevalence rate could rise once again now that children have returned to school following half-term," stated Prof Paul Elliott, School of Public Health, Imperial, in a press release.
The study also looked at the effectiveness of booster doses in preventing infection.
The risk of infection was around three times lower in those who had received the third 'booster' dose than those who received two.
For those aged 50 and above, having a third dose reduced the infection risk by around half compared to two doses.
These findings are from the ongoing REal-time Assessment of Community Transmission program, commissioned by the Department of Health and Social Care. Data are continually reported to the Government to inform decision-making.
Two additional EU members, The Czech Republic and Slovakia, announced tightened travel restrictions on people who have not had COVID-19 vaccinations in an attempt to prompt more people to get vaccinated amid surging infections.
The Czech government approved plans to allow only people who are vaccinated or have recovered from COVID-19 in the past six months to use various other services.
And Slovakia Prime Minister Eduard Heger called for a "lockdown for the unvaccinated."
Al Jazeera reported on November 18, 2021, these measures are similar to those in Austria and parts of Germany as Europe faces a rise in SARS-CoV-2 virus infections which lead to COVID-19.
The European Medicines Agency posted on Twitter today 'There are excessive cases of COVID-19 particularly in unvaccinated people. Many EU countries have large unvaccinated populations.'
'They are the most likely to go to hospitals and suffer from severe disease. We should close the gap between vaccinated & unvaccinated.'
And as of November 17, 2021, the European Centre for Disease Prevention and Control (ECDC) reported 65.4% of Europe had been fully vaccinated.
The ECDC published maps and details today in support of the Council Recommendation on a coordinated approach to travel measures in the EU.
The U.S. Embassy in Bogota advised U.S. citizens on November 17, 2021, there has been increased criminal activity throughout Cartagena as Covid-19 restrictions have been reduced, and extra precaution is merited in areas with less police presence.
Specifically, there have been several notable criminal events in the Chambacu neighborhood, the East of Centro Comercial Caribe Plaza, and Southern Cartagena.
Local media reported on November 18 the port city of Cartagena is preparing to receive more than 20 cruise ships in December 2021 and an estimated 25,000 tourists.
Cartagena’s police chief Nicolás Zapata reiterated that Cartagena is “safe to visit” and proven by the fact that five international flights arrive every day, representing a daily influx of 780 travelers.
The U.S. Embassy recommends U.S. citizens remain aware of their surroundings and that drivers stay on main roads while driving through these areas. Side streets can be narrow or often blocked by parked vehicles, even though a GPS may show the road passable.
And the Embassy suggests visitors enroll in Smart Traveler Program to receive security updates.
Additionally, the U.S. Embassy confirmed beginning November 16, 2021, anyone 18 years or older would be required to show proof of having received at least one dose of COVID-19 vaccine to enter large-scale events and certain business establishments throughout Colombia.
And beginning November 30, 2021, children 12 years and older will be subject to the exact requirements.
The U.S. CDC has issued various travel vaccine recommendations such as dengue, in addition to COVID-19 when visiting Columbia.
