Coronavirus Breaking News

The peer-review JAMA Network published an Original Investigation focused on the most appropriate monoclonal antibody (mAb) for preventing respiratory syncytial virus (RSV) in children.

This analysis was essential since RSV is a leading cause of respiratory disease in children and the primary cause of hospitalization for viral respiratory infections.

Published on February 17, 2023, this systematic review and network meta-analysis comparing the efficacy and safety of 4 mAbs for preventing RSV infection in children found associations with the improvement of clinically meaningful outcomes and no significant associations with RSV-related adverse effects and mortality.

These findings suggest that motavizumab, nirsevimab, and palivizumab are associated with reduced rates of RSV infections and hospitalizations.

Similar results were observed in the rate of supplemental oxygen use.

While RSV vaccine candidates are completing late-stage clinical studies, mAbs targeting RSV prevention have been U.S. Food and Drug Administration (FDA) for years.

For example, the U.S. CDC CDCHAN-00479 stated on November 4, 2022, that eligible high-risk children should receive the mAbs palivizumab (Synagis) treatment according to AAP guidelines to prevent RSV-associated hospitalizations. 

Recently, the Biologics License Application for nirsevimab (Beyfortus®) was accepted for review by the FDA on January 5, 2023. The FDA's Prescription Drug User Fee Act date for its decision is in the third quarter of 2023.

If approved, nirsevimab would become available in the U.S. for the 2023/2024 RSV season. 

Nirsevimab (MEDI8897) was developed in partnership between AstraZeneca and Sanofi.

The U.S. Centers for Disease Control and Prevention (CDC) today announced Equatorial Guinea declared an outbreak of Marburg virus disease (MVD) after confirming cases in the Kie Ntem Province.

In response, Equatorial Guinea declared an outbreak of MVD on February 13, 2023.

The CDC stated on February 16, 2023, that MVD is a rare and deadly disease that has sometimes caused outbreaks in several African countries.

Travelers to MVD endemic areas should separate themselves from others and seek medical care immediately if they develop fever, chills, muscle pain, rash, sore throat, diarrhea, weakness, vomiting, stomach pain, or unexplained bleeding or bruising during or after travel (up to 21 days).

And, call ahead before going to a healthcare facility and tell your doctor that you've been to an area reporting MVD cases, says the CDC.

Initially detected in 1967 in Germany, MVD is spread by contact with the blood or body fluids of a person infected with the Marburg virus. 

As of February 17, 2023, Angola, DR Congo, Equatorial Guinea, Cameroon, Germany, Ghana,  Guinea,  Kenya,  Serbia, South Africa, and Uganda have previously confirmed MVD cases.

While there are no U.S. FDA-approved Marburg preventive vaccines, several candidates are conducting clinical studies.

NPR reported today Dr. Leana Wen, an emergency physician and professor at the Milken School of Public Health at George Washington University, says there's one more urgent reason a vaccine must be prioritized.

"Healthcare workers are at particular risk, and in Equatorial Guinea and surrounding countries, illness and death of the relatively few doctors and nurses they have would have a tremendous lasting impact on health in their region."

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.

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.

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. 

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.