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The continual spreading of the Highly Pathogenic Avian Influenza (HAPI) H5N1 influenza A virus across the globe has prompted many questions without clear answers.
These questions accelerated recently when seven people, including various mammals, became infected over the past year.
Amesh Adalja, M.D. with MedPageToday, published an opinion article on February 16, 2023, focused on whether an influenza pandemic caused by this version of HAP is imminent.
'This is an important question that must be asked of all novel influenza viruses. However, the answers regarding influenza are not that simple and require placing this strain into a larger context of avian influenza more generally,' wrote Dr. Adalja. The full unedited article is posted at this link.
Avian influenza A (bird flu) viruses are common and widespread in birds.
Should a human-to-human HAPI outbreak occur, the U.S. Food and Drug Administration has already approved one type of 'bird flu vaccine' that could be effective.
While most people have already received their annual flu shot, this type of vaccine would not be very effective against HAPI viruses.
The World Health Organization (WHO) Influenza Update N° 438 recently reported influenza activity decreased globally.
In the countries of North America, most indicators of influenza activity fell to levels similar to or below levels typically observed this time of year.
As of February 9, 2023, Influenza A(H3N2) was the predominant virus detected in the U.S., whereas A(H1N1)pdm09 and A(H3N2) were co-circulated in Canada in the most recent reporting week.
In Europe, overall influenza activity continued to decrease, but influenza positivity from sentinel sites remained above the epidemic threshold at the regional level.
Separately, a leading mRNA-based flu shot candidate for adults announced encouraging interim results from its pivotal Phase 3 safety and immunogenicity trial of mRNA-1010 (P301).
As of February 4, 2023, the U.S. CDC confirmed about 172.76 million influenza vaccines had been distributed for the 2022-2023 flu season in the U.S.
Moderna Inc. today announced one of five influenza vaccine candidates in its portfolio published interim results from its pivotal Phase 3 safety and immunogenicity trial.
mRNA-1010 (P301) is an mRNA-based seasonal influenza (flu) vaccine candidate for adults.
mRNA-1010 encodes for hemagglutinin (HA) glycoproteins of the four influenza strains recommended by the World Health Organization (WHO) to prevent influenza.
Interim results indicate that mRNA-1010 achieved superiority on seroconversion rates for A/H3N2 and A/H1N1 and superiority on geometric mean titer ratios for A/H3N2 and non-inferiority on geometric mean titer ratios for A/H1N1.
Non-inferiority was not met for either endpoint for the influenza B/Victoria- and B/Yamagata-lineage strains.
"Today's results represent an important step forward in developing mRNA-based influenza vaccines to address the substantial burden of disease caused by influenza."
"We are encouraged by the safety and tolerability profile and the strong immunogenicity results against Influenza A viruses which cause the overwhelming majority of flu-related disease in older adults."
"We now look forward to the efficacy results from the ongoing pivotal Phase 3 efficacy study being conducted in parallel," said Stephen Hoge, M.D., Moderna's President, in a press release on February 16, 2023.
"While we did not achieve non-inferiority for the Influenza B strains, which are more frequent in younger populations, we have already updated the vaccine that we believe could improve immune responses against Influenza B and will seek to quickly confirm those improvements in an upcoming clinical study thanks to the agility of our mRNA platform."
The first per-protocol interim analysis of efficacy is now expected to be reviewed by an independent Data and Safety Monitoring Board (DSMB) before the end of the first quarter of 2023.
Based on these results, the DSMB will notify the Company whether the primary efficacy endpoint has been met or whether the study should continue accruing further cases toward the final analysis.
Moderna is advancing a portfolio of five influenza vaccine candidates that include additional HA antigens for broader coverage of circulating influenza A strains (mRNA-1011 and mRNA-1012) and candidates that incorporate both HA and neuraminidase (NA) antigens to target multiple proteins involved in the influenza virus lifecycle to reduce the potential of viral antigenic escape (mRNA-1020 and mRNA-1030).
Moderna is also developing combination vaccine candidates, including vaccine candidates against influenza and SARS-CoV-2, influenza and RSV, and influenza, SARS-CoV-2, and RSV.
The goal of Moderna's combination vaccine candidates is to protect against multiple respiratory pathogens in a single vaccine.
Moderna's unedited press release is available at this link.
Other flu shot news is posted at PrecisionVaccinations.
ImmunityBio, Inc. today announced Dr. Karim Chamie, Associate Professor of Urology at UCLA, will be presenting “Quality of life in QUILT 3.032 study: Patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) receiving IL-15R⍺Fc superagonist N-803 plus BCG” at the ASCO Genitourinary Cancers Symposium conference on February 16-18, 2023.
N-803 (Anktiva™), ImmunityBio’s lead cytokine fusion protein, is a novel IL-15 superagonist complex and has received Breakthrough Therapy and Fast Track Designations from the U.S. Food and Drug Administration (FDA) for BCG-unresponsive CIS NMIBC.
N-803 is currently under review by the FDA for this indication with a Prescription Drug User Fee Act target date of May 23, 2023.
Previously, on November 10, 2022, the peer-review journal NEJM Evidence published results from the QUILT 3.032 trial studying N-803 plus BCG in adults with NMIBC CIS with or without Ta/T1 papillary disease.
The published results demonstrate that in patients with BCG-unresponsive NMIBC CIS and papillary disease, BCG plus N-803 (referred to as NAI) CRs were achieved with the persistence of effect with a 90% probability of avoiding cystectomies in responders, a life-changing procedure of removing the bladder, and 100% bladder cancer-specific survival at 24 months.
“The peer review and publication of data in NEJM Evidence highlights the significance of the positive results of the QUILT 3.032 trial in patients with BCG-unresponsive NMIBC,” commented Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio, in a press release on November 10, 222.
“These data further our understanding of N-803’s unique role in potentially boosting the proliferation of natural killer and T cells while synergistically enhancing BCG efficacy.”
ImmunityBio is a vertically-integrated, clinical-stage biotechnology company developing next-generation therapies and vaccines that bolster the natural immune system to defeat cancers and infectious diseases.
Recent American Cancer Society (ACS) statistics show a concerning increase in prostate cancer cases, particularly among Black men, wrote Abe Rosenberg with the City of Hope.
On February 15, 2023, the new data indicated cancer mortality rates have decreased by 33% in the last three decades.
After decades of decline, prostate cancer rates increased by 3% annually from 2014 to 2019.
And there is a significant increase among men presenting with later-stage prostate cancer.
Furthermore, according to the ACS report, Black men have a 70% higher prostate cancer incidence rate than white men, and they are two to four times more likely to die of prostate cancer than any other ethnic group.
“People got confused,” commented urologic surgeon Diana Londoño, M.D., assistant clinical professor in the Division of Urology and Urologic Oncology, Department of Surgery, who sees patients at City of Hope’s Glendora clinical network location.
Dr. Londono emphasized the importance of regular screenings, especially postpandemic, as people resume seeing their doctors regularly.
To reach out to underserved communities where cancer rates are high, ACS unveiled a new initiative called IMPACT (Improve Mortality From Prostate Cancer Together), aimed at reducing prostate cancer disparities in Black men and deaths from prostate cancer for all men by 2035.
The Center for Community Outreach and Engagement runs several programs aimed at the same result.
The City of Hope is dedicated to making a difference in the lives of people with cancer, diabetes, and other life-threatening illnesses.
The Public Health Agency of Canada (PHAC) today issued a statement offering an update on the ongoing response to the Mpox outbreak.
On February 9, 2023, the World Health Organization (WHO) Director-General declared that Mpox remained a Public Health Emergency of International Concern.
This initial declaration was issued on July 23, 2022.
On February 14, 2023, the WHO noted a sustained decline in Mpox cases globally, with the majority of cases being reported from the Regions of the Americas, with 200-250 cases per week,
And about 4% of Mpox cases occurred in women.
Since the beginning of the Mpox outbreak, the Government of Canada has taken action to protect the health and safety of Canadians.
The ongoing management of Mpox relies on continued vigilance, re-emergence of cases, various public health measures, and vaccination.
Mpox vaccines will continue to be available in Canadian provinces and territories for those at higher risk, including second doses of Imvamune®.
Bavarian Nordic's MVA-BN vaccine is approved by the U.S. Food and Drug Administration for smallpox and Mpox under the JYNNEOS® brand.
Since May 2022, the Government of Canada has deployed over 145,000 doses of vaccine.
Mpox information can be found on the Government of Canada's Mpox: For health professionals website. Other outbreak news is posted at Mpox Today.
OSE Immunotherapeutics SA today provided a regulatory update on the clinical development plan of Tedopi®, a immunotherapy activating tumor-specific T-cells, in phase 3 in monotherapy in advanced or metastatic non-small cell lung cancer (NSCLC) after checkpoint inhibitor failure (ICI).
Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, commented in a press release on February 15, 2023, “We are pleased with the positive outcomes from the US Food & Drug Administration Type C Meeting following the supportive European Medicines Agency advice, as we are actively preparing a confirmatory phase 3 trial to support the regulatory registration of Tedopi®."
Both Agencies supported the continuation of the clinical development for Tedopi® through a new confirmatory phase 3 clinical trial versus standard of care in second-line treatment for HLA-A2+ patients in advanced in NSCLC.
Tedopi® is the first cancer vaccine to show positive and clinically meaningful efficacy results associated with a better safety and quality of life profile in monotherapy versus active comparator (chemotherapy-based standard of care) in the third line with secondary resistance to ICI in advanced or metastatic NSCLC.
The Nigeria Center for Disease Control and Prevention (NCDC) confirmed 216 diphtheria cases with 40 related fatalities deaths since December 2022.
About 184 diphtheria cases were reported as children, confirmed a news report on February 14, 2023.
The NCDC confirmed a previous diphtheria outbreak in Borno, north-eastern Nigeria, in 2011, with 98 cases and 21 deaths (the case-fatality ratio was 21.4%).
Diphtheria spreads quickly between people by direct contact or through the air through respiratory droplets from coughing or sneezing. It may also be spread by contaminated clothing and objects.
In Nigeria, Diphtheria infection is treated by administering a diphtheria antitoxin intravenously or through an intramuscular injection.
Antibiotics can also be given to eliminating the bacteria to prevent transmission and toxin production to others.
Children are fully vaccinated against diphtheria after three doses of the pentavalent vaccine, as the Nigerian immunization schedule recommends.
The latest U.K. travel advisory says serious tropical illnesses like malaria, typhoid, Lassa fever, and yellow fever occur in Nigeria.
And as of February 16, 2023, the U.S. CDC has issued various health alerts for Nigeria.
