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Sep 10, 2023 • 12:34 pm CDT
by Patrick Sommer

A Moderna Inc. funded study published on September 7, 2023, offered positive news ahead of the U.S. Centers for Disease Control and Prevention meeting of the Advisory Committee on Immunization Practices on September 12, 2023, at 10 a.m. ET.

This non-peer-reviewed preprint study of the ongoing phase 2/3 study of Moderna's mRNA-1273.815 monovalent (50-µg omicron XBB.1.5 spike mRNA) or mRNA-1273.231 bivalent (25-µg omicron XBB.1.5 and 25-µg omicron BA.4/BA.5 spike mRNAs) vaccines, administered as 5th doses to adults.

In this interim analysis, XBB.1.5-containing monovalent and bivalent vaccines elicited potent neutralizing responses against variants of the omicron XBB-lineage (XBB.1.5, XBB.1.6, XBB.2.3.2, EG.5.1, and FL.1.5.1) as well as the recently emerged BA.2.86 variant, in about 50 study participants.

And the safety profile of the XBB.1.5-containing vaccine was consistent with those of prior vaccines.

According to these researchers, these results overall indicate that the XBB.1.5-containing mRNA-1273.815 vaccine has the potential to provide protection against these emerging variants and support the Covid-19 vaccine update in 2023-2024 to a monovalent XBB.1.5-containing vaccine.

This study was not powered for a statistical comparison of the immune responses between the vaccine groups or vaccine efficacy. The corresponding author is Spyros Chalkias, MD Moderna, [email protected].

Previously, Moderna announced that clinical trial data from a research assay confirmed its updated COVID-19 vaccine generated an 8.7-fold increase in neutralizing antibodies in humans against BA.2.86 (Pirola).

Previously known as SpikeVax, this COVID-19 Vaccine is a Messenger RNA (mRNA) vaccine targeted against the SARS-CoV-2 betacoronavirus to prevent severe COVID-19. On December 18, 2020, the U.S. Food and Drug Administration issued an emergency use authorization.

 

Sep 10, 2023 • 8:50 am CDT
South Africa measles outbreak September 2023

The Republic of South Africa's year-long battle against measles outbreaks continues in September 2023.

In the past weeks (week 34 up until week 35), 17 laboratory-confirmed measles cases were detected across the country from four of the eight provinces.

As of September 2, 2023, Gauteng province reported most of the cases (11), Limpopo reported three, Kwa-Zulu Natal reported two, and North West reported one case.

Measles is highly contagious. Around 90% of people who are not protected will become infected following exposure to the virus.

The National Institute for Communicable Diseases (NICD) criteria for declaring the measles outbreak was met in the Northern Cape province in week 15, the North West province in week 24, and the Free State province in week 25. 

Since late 2022, the NICD has tested 6,816 serum samples for measles, of which 1160 (17%) were confirmed positive.

The NICD has implemented numerous vaccination programs throughout the measles outbreaks and continue in September 2023.

According to the U.S. Centers for Disease Control and Prevention (CDC), India leads all other countries over the past year with about 57,000 cases.

In addition, the CDC published a global Travel Health Notice on June 29, 2023, highlighting various measles outbreaks.

Sep 9, 2023 • 9:00 am CDT
by Oleg Mityukhin

While most people have heard of norovirus outbreaks on cruise ships, this diarrhea-causing virus also impacts people on land.

The U.S. CDC's Morbidity and Mortality Weekly Report on September 8, 2023, highlighted about 27 cases of acute gastroenteritis among hikers on the Pacific Crest Trail in 2022, suggesting a possible norovirus outbreak.

The CDC wrote preventing future outbreaks will require fostering increased awareness of handwashing and the lack of effectiveness of alcohol-based hand sanitizers against norovirus and more frequent cleaning of public facilities.

These hikers and others are eagerly awaiting news of a norovirus vaccine.

On September 6, 2023, Vaxart, Inc. announced top-line data from the Phase 2b challenge study of its oral tablet monovalent norovirus vaccine candidate, VXA-G1.1-NN.

Vaccination with VXA-G1.1-NN led to a statistically significant reduction in infection rate, a non-statistically significant reduction in norovirus acute gastroenteritis, and a substantial reduction in viral shedding.

The oral vaccine candidate was also safe and well tolerated with no vaccine-related serious adverse events.

Dr. James F. Cummings, Vaxart's Chief Medical Officer, commented in a press release, "The magnitude of the reduction in shedding could have an impact on transmission and may have important public health benefits, as norovirus spreads rapidly among people gathering in large numbers, including settings such as daycare centers, nursing homes, and workplaces, and may reduce the potential spread of the infection to families at home."

"The results of this study highlight the potentially distinctive profile of mucosal vaccination and the potential that our oral pill vaccines may have in protecting against infection and blocking transmission – potential benefits that have also been seen with our influenza vaccine," added Dr. Cummings.

Norovirus is the leading cause of acute viral gastroenteritis in all age groups in the U.S. On average, norovirus causes 19 to 21 million cases, infects 15% of all children under age 5, and leads to 465,000 emergency department visits, 109,000 hospitalizations, and 900 deaths, says the U.S. CDC.

As of September 9, 2023, norovirus vaccine candidate news is posted by Precision Vaccinations.

Sep 8, 2023 • 2:39 pm CDT
WHO world flu zone map 2023

Most health experts say 'what happens in the Southern Hemisphere is a reliable indication of the next flu season in the United States.'

This opinion is based on the yearly circulating influenza viruses and flu shot composition.

Flu seasons in the Southern Hemisphere usually occur between April and September, compared with October through May in the north.

According to a new Morbidity and Mortality Weekly Report (MMWR) published today, the 2023-2024 influenza vaccines should protect people from severe hospitalizations.

On September 8, 2023, the U.S. Centers for Disease Control and Prevention (CDC) MMWR stated the adjusted vaccine effectiveness against severe acute respiratory infection hospitalization associated with any influenza virus during the 2023 Southern Hemisphere season was 51.9% (95% Confidence Interval 39.2%–62.0%).

Despite the encouraging data, fewer than 30% of persons identified in this CDC study were vaccinated against influenza in the five countries studied before their illness onset.

This news means the circulating influenza viruses were genetically similar to those targeted by the 2023–2024 Northern Hemisphere influenza vaccine available in the U.S.

Over 100 million flu shots have already been distributed this year.

In anticipation of the new flu season, the CDC recommends U.S. healthcare providers eagerly administer seasonal influenza vaccine to all eligible persons.

The findings in this CDC report are subject to at least five limitations, and no industry conflicts of interest were disclosed. Corresponding author: Ashley L. Fowlkes, [email protected].

Sep 8, 2023 • 12:47 pm CDT
US CDC - Malaria-endemic in the Americas & the Caribbean 2023

Malaria was eliminated as a public health threat in the United States in the mid-1950s, recent locally-acquired cases refreshed the awareness of this mosquito-transmitted disease.

The species of Anopheles mosquitoes biologically capable of transmitting malaria have been found throughout the U.S.

The U.S. CDC published a Morbidity and Mortality Weekly Report on September 8, 2023, confirming eight malaria cases were reported in Florida (seven) and Texas (one) from May 18–July 17, 2023.

As of August 2023, no additional autochthonous P. vivax cases have been detected in Florida or Texas, and there has been no evidence of infected Anopheles mosquitoes since early June. 

Although the risk for autochthonous malaria in the U.S. remains very low, U.S. clinicians need to consider a malaria diagnosis in patients with an unexplained fever, especially in areas where autochthonous malaria has been recently reported, wrote the CDC.

The recent cases underscore the potential for imported malaria cases from outbreak areas with competent vectors to produce local mosquito transmission of malaria parasites.

Before traveling internationally to areas where malaria is endemic, travelers should consult their healthcare provider regarding recommended malaria prevention measures, including potentially taking malaria prophylaxis.

Furthermore, malaria is preventable with vaccines available in Africa but not in the U.S.

Separately, the Pan American Health Organization (PAHO) called on Member States to maintain surveillance, early detection, and timely treatment of malaria cases in the Americas.

On September 7, 2023, the PAHO reported between 2022 and 2023, Argentina, Bahamas, and Jamaica reported sporadic cases of imported malaria and local transmission, including in areas where this disease had not previously been reported.

Sep 8, 2023 • 10:40 am CDT
US CDC FluView report Sept. 8, 2023

According to the U.S. Centers for Disease Control and Prevention (CDC) new report, very few influenza samples tested positive last week.

The CDC's FluView Week #35 report, published on September 8, 2023, data from clinical laboratories indicate 233 specimens tested positive for influenza, reflecting a 0.8% rate.

And public health laboratories reported only 41 positives out of 1,466 samples.

Nationwide, 1.8% of patient visits to healthcare providers last week were due to respiratory illness that included fever plus a cough or sore throat.

This data is increasing week over week, which can usually predict a flu outbreak is forecasted.

The unfortunate news is that influenza continues to cause related fatalities.

National Center for Health Statistics Mortality Surveillance data available on September 7, 2023, shows four death certificates listed influenza as an underlying or contributing cause of death.

Additionally, two influenza-associated pediatric deaths occurring during the 2022-2023 season were reported to the CDC during week #35.

A total of 174 influenza-associated pediatric deaths occurring during the 2022-2023 season have been reported to CDC. This is the most significant number of fatalities since the 2019-2020 flu season.

The CDC's new Director, Mandy K. Cohen, MD, MPH, recently recommended on X that people start getting their annual flu shot ahead of the 2023-2024 flu season.

'It's that time of year — I got my flu shot... Get yours to #FightFlu.'

Sep 8, 2023 • 9:55 am CDT
MIT News 2023

A team of researchers at MIT today announced they are working on making mRNA vaccines produce a more robust immune response at a lower dose.

Published in the journal Nature Biomedical Engineering on September 7, 2023, this study showed how MIT researchers delivered COVID-19 antigen and the antigen to boost the immune response without needing a separate adjuvant.

The researchers’ tests also showed that the vaccine induced a strong immune response when delivered intranasally compared to the response elicited by traditional intramuscular vaccination.

In mice, intramuscular or intranasal administration of nanoparticles with the lead ionizable lipid and with mRNA encoding for the fusion protein (either the spike protein or the receptor-binding domain of SARS-CoV-2 increased the titres of antibodies against SARS-CoV-2 tenfold with respect to the vaccine encoding for the unadjuvanted antigen.

“With intranasal vaccination, you might be able to kill Covid (SARS-CoV-2) at the mucus membrane before it gets into your body,” commented Daniel Anderson, a professor in MIT’s Department of Chemical Engineering and the senior author of the study in an MIT News article.

“Intranasal vaccines may also be easier to administer to many people since they don’t require an injection.”

The researchers believe the effectiveness of other types of mRNA vaccines now in development, including vaccines for cancer, could be improved by incorporating similar immune-stimulating properties.

If further developed for use in humans, this type of mRNA vaccine could help to reduce costs, reduce the dosage needed, and potentially lead to longer-lasting immunity, wrote these researchers.

The National Institutes of Health and Translate Bio funded the research.

Sep 7, 2023 • 5:55 pm CDT
by David Mark

A joint team of Yale, University of Georgia, and Emory University scientists have received a $25 million government grant to develop an mRNA cancer vaccine. 

On September 7, 2023, Carlos Salcerio with Yale News reported the research combines the team's expertise in mRNA and dendritic cells.

These researchers seek to develop synthetic mRNA that will carry instructions for cancer-specific antigens to dendritic cells. 

By programming dendritic cells with synthetic mRNA, researchers can precisely instruct the immune system to target cancer-specific antigens without attacking healthy cells.

Healthy cells modified to include unrecognized proteins using mRNA might have otherwise been treated as a foreign entity. 

The researchers recognized that vaccine breakthroughs often involve considerable complexities and difficulties.

"We're not naive.... we know how difficult this stuff is..... we have to pick our winners to move forward into the clinic.... but I would say that certainly there should be winners."

Sep 7, 2023 • 11:21 am CDT
US CDC cholera outbreak map 2023

Three new outbreaks of cholera and/or Acute Watery Diarrhoea were recently reported from Uganda, Sudan, and the Republic of the Congo.

According to the World Health Organization (WHO) Edition #6, 28 countries have reported cholera cases since the beginning of 2023.  

The WHO African Region remains the most affected region, with 16 countries reporting cholera outbreaks since the beginning of the year.  

As of September 5, 2023, the overall capacity to respond to multiple and simultaneous outbreaks continues to be strained due to the global lack of resources, including shortages of oral cholera vaccines (OCV).

The WHO has pre-qualified three OCVs for use in 2023.

Based on the large number of outbreaks, their geographic expansion, and a lack of vaccines and other resources, WHO continues to assess the risk at the global level as very high.

In the U.S., there are very few cholera cases reported.

Sep 7, 2023 • 8:19 am CDT
by Lori Heron

Since Ebola virus disease (EVD) impacts everyone in an outbreak area, another agency has approved a preventive vaccine for young children.

Merck today announced that the European Commission (EC) approved an expanded indication for the ERVEBO® vaccine for active immunization of individuals one year of age or older to protect against EVD caused by Zaire ebolavirus.

ERVENO was previously approved for use in the European Union for individuals 18 or older. 

The U.S. FDA recently issued similar approval for young children.

ERVEBO is approved in the European Union, United Kingdom, United States, Canada, Switzerland, and ten countries in Africa.

ERVEBO is a live recombinant viral vaccine with a vesicular stomatitis virus backbone that protects people from Zaire ebolavirus. This vaccine does not protect people from the Sudan ebolavirus or the Marburg virus.

Dr. Eliav Barr, senior vice president, head of global clinical development, and chief medical officer, Merck Research Laboratories, commented in a press release on September 7, 2023, “When outbreaks of Ebola virus disease occur, they can quickly become a public health crisis. We are proud to play a role, alongside the global public health community, in helping to prepare for potential outbreaks of Zaire ebolavirus.”

In January 2021, Merck confirmed an agreement with UNICEF to establish the world’s first global Ebola vaccine stockpile to support future Zaire ebolavirus (EBOV) outbreak preparedness and response efforts.

Over 500,000 doses of ERVEBO have been delivered to the stockpile, administered by the International Coordinating Group on Vaccine Provision.

The initial EBOV case was confirmed in 1976 in the African countries of South Sudan and the Democratic Republic of Congo. Recent data suggest EBOV outbreaks may originate from human-to-human transmission instead of spillover events.

The U.S. Centers for Disease Control and Prevention published a list of EBOV Cases and Outbreaks as of August 2023.

Sep 7, 2023 • 7:32 am CDT
by Joshua Choate

While there are no approved human vaccines for Lyme disease, results from a new study show a booster dose can produce a strong immune response in children, adolescents, and adults.

France-based Valneva SE and Pfizer Inc. today announced positive pediatric and adolescent immunogenicity and safety data for their Lyme disease vaccine candidate, VLA15, when given as a booster.

The VLA15-221 Phase 2 clinical trial showed a strong anamnestic antibody response for all serotypes in pediatric (5 to 11 years of age) and adolescent participants (12 to 17 years of age), as well as in adults (18 to 65 years of age), one month after administration of a booster dose (month 19).

Depending on the primary vaccination schedule (month 0-2-6 or month 0-6), participants seroconverted after the booster dose, yielding seroconversion rates of 95.3% and 94.6% for all outer surface protein A (OspA) serotypes in all age groups, respectively.

Additionally, OspA antibody titers were significantly higher one month after the booster dose compared to one month after the primary schedule, with 3.3- to 3.7-fold increases (Geometric Mean Fold Rises) in adults, 2.0- to 2.7-fold increases in adolescents and 2.3- to 2.5-fold increases in children for all serotypes.

“Protection against Lyme disease is important for anyone who lives or spends time outdoors in areas where Lyme disease is endemic. This data from the VLA15-221 study is vital to improve our understanding of how vaccination may help to protect both adults and children from this potentially devastating disease,” commented Annaliesa Anderson, Ph.D., Senior Vice President and Head of Vaccine Research and Development at Pfizer, in a press release on September 7, 2023.

These results follow six-month antibody persistence data in children and adults reported for the VLA15-221 study in December 20222 and positive immunogenicity and safety data reported in April 20223.

Pfizer aims to submit a Biologics License Application to the U.S. Food and Drug Administration and a Marketing Authorisation Application to the European Medicines Agency in 2026, subject to positive Phase 3 data.

Sep 6, 2023 • 10:44 am CDT
by Markus Winkler

Moderna, Inc. today announced that clinical trial data from its research assay confirm its updated COVID-19 vaccine, which is pending approval by the U.S. Food and Drug Administration, generates an 8.7-fold increase in neutralizing antibodies in humans against BA.2.86 (Pirola), a new variant under monitoring.

The U.S. Centers for Disease Control indicates that the highly mutated BA.2.86 variant may be more capable of causing infection in people who previously had COVID-19 or were vaccinated with previous vaccines.

"These results demonstrate that our updated COVID-19 vaccine generates a strong human immune response against the highly mutated BA.2.86 variant. Taken together with our previously communicated results showing a similarly effective response against EG.5 and FL.1.5.1 variants, these data confirm that our updated COVID-19 vaccine will continue to be an important tool for protection as we head into the fall vaccination season," said Stephen Hoge, M.D., President of Moderna, in a press release on September 6, 2023.

Public health authorities are vigilantly monitoring the BA.2.86 variant, a highly mutated strain of the SARS-CoV-2 betacoronavirus with over 30 mutations as compared to prior Omicron strains.

Moderna's clinical trial data around its updated COVID-19 vaccine's effectiveness against BA.2.86 have been shared with regulators and submitted for peer review publication.

Sep 6, 2023 • 5:29 am CDT
US CDC COCA Call Sept. 2023

The Centers for Disease Control and Prevention (CDC) today announced it is preparing for co-circulating influenza virus, SARS-CoV-2, and respiratory syncytial virus (RSV) during the 2023-2024 season.

The CDC stated on September 5, 2023, that vaccines can provide life-saving protection against all three viral respiratory diseases.

Furthermore, the CDC recommends these vaccines for older adults, who are at a higher risk of severe illness from these diseases.

For example, the CDC recently published a Health Advisory about increased RSV activity in the Southeastern United States, including Georgia and Florida.

During a Clinician Outreach and Communication Activity (COCA) Call on September 19, 2023, CDC presenters will provide updates about the latest recommendations and clinical considerations for administering influenza, COVID-19, and RSV vaccines to seniors this year.

This COCA Webinar link is https://www.zoomgov.com/j/1606020154, ID: 160 602 0154, and Passcode: 493303.

According to the CDC, clinicians play a vital role in ensuring that older adults protect themselves by encouraging them to stay up to date on vaccinations.

Sep 6, 2023 • 4:44 am CDT
GSK September 2023

GSK and the YMCA today announced they are hosting GSK's Sideline RSV "Community Conversations" event series to raise awareness about respiratory syncytial virus (RSV) infection in older adults.

This is an essential event since the U.S. CDC issued a Health Advisory on September 5, 2023, regarding the 2023-2024 RSV season. 

The events will occur at four YMCA locations in Chicago, Los Angeles, New York City, and Phoenix, joined by GSK's campaign spokesperson Earvin "Magic" Johnson Jr., to help spark important conversations about RSV.

Kicking off in September 2023 and running through RSV Awareness Month in October, the private events will include perspectives from medical professionals and patients and convene public health leaders, media, and 60+ YMCA members.

"As a dedicated public health advocate, I'm excited to be able to visit older adults in their communities to talk about their risk for RSV infection," said Johnson in a press release.

"Like many of us, and being over 60 myself, I used to be unaware of RSV's effect on older adults."

"Now, I'm passionate about educating others and encouraging them to understand their risks and be proactive about their health."

For older adults, data suggest an increased risk for severe RSV infection that can lead to hospitalization.

RSV can exacerbate certain underlying medical conditions, such as chronic obstructive pulmonary disease, asthma, and chronic heart failure, and can lead to severe outcomes, such as pneumonia, hospitalization, and death.

As of September 6, 2023, two RSV vaccines were approved by the U.S. FDA.

To learn more, visit www.SidelineRSV.com. 

Earvin Johnson played for Michigan State in college in 1979, then for the Los Angeles Lakers, winning numerous championships.

Sep 5, 2023 • 3:26 pm CDT
Florida Health Dept - RSV map, September 2, 2023

The Centers for Disease Control and Prevention (CDC) today announced a Health Alert Network Health Advisory CDCHAN-00498 to notify clinicians and caregivers about increased respiratory syncytial virus (RSV) activity in the Southeastern United States.

Historically, such regional increases have predicted the beginning of the RSV season in the U.S.

Across both prepandemic and pandemic years, RSV circulation began in Florida, said the CDC on September 5, 2023.

The Florida Department of Health segmented reports into five RSV regions, each with its own RSV season.

As of week #35, September 2, 2023, Florida's RSV activity had increased admission, positivity, and emergency room rates, but no current outbreaks. 

In anticipation of the onset of the 2023-2024 RSV season, the CDC encourages clinicians to prepare to implement new RSV prevention options.

A new monoclonal antibody product, Beyfortus™ (Nirsevimab-alip), protects infants and some young children at higher risk for severe RSV disease. Its availability in the U.S. is expected in October 2023.

Also, two new RSV vaccines are available to protect older adults from severe RSV disease: RSVPreF3 (Arexvy, GSK) or RSVpreF (Abrysvo, Pfizer), based on shared clinical decision-making between the healthcare provider and the patient.

Furthermore, the CDC recommends healthcare personnel, childcare providers, and staff at long-term care facilities should stay home and not go to work when they have a fever or symptoms of respiratory infection to reduce the spread of respiratory infections, including RSV.