Beyfortus (Nirsevimab) RSV Antibody

66% of Infants Protected Against RSV

Karen McClorey Hackett — Mon, 12 May 2025 16:27:42 +0000

Reviewer:

As the current respiratory syncytial virus (RSV) season ends, most infants are protected against this severe disease.

According to the U.S. CDC's MMWR ( 74(16);273–281) published on May 8, 2025, in the first RSV season with widespread availability of maternal vaccine and long-acting monoclonal antibody, RSV-associated hospitalization rates among infants were lower than in prepandemic seasons.

National immunization survey data indicate that the estimated proportion of U.S. infants aged 0–7 months protected by maternal vaccination or nirsevimab increased during the 2024–25 RSV season, from 30% in October 2024 to 66% in February 2025.

Maternal RSV vaccines and nirsevimab (Beyfortus) for infants became widely available for prevention of severe RSV disease among infants and young children during the 2024–25 RSV season.

To evaluate the association between the availability of these products and infant and child RSV-associated hospitalization rates, the rates among children aged <5 years were compared for the 2024–25 and 2018–20 RSV seasons.

Among infants aged 0–7 months (eligible for protection with maternal vaccination or nirsevimab), 2024–25 RSV-associated hospitalization rates were lower compared with 2018–20 pooled rates (estimated relative rate reductions of 43% [RSV-NET: 95% CI = 40%–46%] and 28% [NVSN: 95% CI = 18%–36%]).

The largest estimated rate reduction was observed among infants aged 0–2 months (RSV-NET: 52%, 95% CI = 49%–56%; NVSN: 45%, 95% CI = 32%–57%) and during peak hospitalization periods (December–February).

The CDC wrote that these findings highlight the importance of implementing the CDC's recommendations to protect infants as early in the RSV season as possible, before peak transmission, and for infants born during the RSV season, within the first week of life, ideally during the birth hospitalization.

Data: Monthly estimates of infant protection against RSV by maternal RSV vaccination or receipt of nirsevimab, as well as intent for nirsevimab receipt, reported by adult females aged 18-49 years, are from the National Immunization Survey─Adult COVID Module (NIS─ACM). Overall, 18,389 RSV-associated hospitalizations (15,405 in RSV-NET and 2,984 in NVSN) were identified among children aged <5 years; these included 11,681 during 2018–20 and 6,708 during 2024–25. Median patient age was 6.7 months and 14.7 months in RSV-NET (p<0.001) and 6.3 months and 12.7 months in NVSN (p<0.04),

Sub Title:

Infant RSV hospitalizations significantly reduced in 2025

References:

CDC - Maternal RSV Vaccination or Receipt of Nirsevimab

Interim Evaluation of Respiratory Syncytial Virus Hospitalization Rates Among Infants and Young Children

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US CDC May 2025

RSV Passive Immunization Options Increase in 2025

Karen McClorey Hackett — Sat, 21 Dec 2024 16:13:18 +0000

Since 1998, various respiratory syncytial virus (RSV) monoclonal antibody (mAb) therapies have been approved to prevent serious lower respiratory tract disease caused by RSV in young children.

Over the past two years, a single-dose, long-acting mAb designed to protect infants has been approved in Canada, Europe, and the USA.

As of March 2024, among females with an infant less than 8 months, 41.3% reported that their infant received an approved mAbs.

However, unmet needs remain for effective interventions to help protect more infants from the burden of RSV.

To meet this need, Merck is developing clesrovimab (MK-1654), the company's investigational prophylactic long-acting mAb designed to protect infants from RSV disease during their first RSV season.

Clesrovimab is designed to be administered as the same single dose, regardless of weight, and is being studied in healthy preterm, full-term, and at-risk infants.

On December 17, 2024, Merck announced the U.S. Food and Drug Administration had accepted the Biologics License Application (BLA) for clesrovimab and set a Prescription Drug User Fee Act date of June 10, 2025.

Dr. Paula Annunziato, senior vice president of infectious diseases and vaccines, Global Clinical Development, Merck Research Laboratories, informed Vax-Before-Travel, "RSV is the leading cause of infant hospitalization in the U.S., and there is a high unmet need for effective immunization to protect both healthy and high-risk infants from RSV."

"Given the significant burden of this disease, we believe it is important to have multiple options to protect against RSV."

"We are confident in the strength of clesrovimab's clinical data, product profile, and potential to help address the significant burden of RSV on infants and families. If approved, clesrovimab would be the first and only immunization designed to help protect infants with a single dose regardless of weight for the duration of their first RSV season," added Annunziato.

If the BLA is approved, Merck anticipates that clesrovimab shipments will be available to arrive in time for the 2025 RSV season.

Sub Title:

RSV mAbs offer infants extensive disease protection

Reference:

FDA Acceptance of Biologics License Application for Clesrovimab

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by Bill Kasman

RSV Protection Options Are Plentiful in 2024

Karen McClorey Hackett — Tue, 24 Sep 2024 17:44:01 +0000

Reviewer:

Robert Carlson, MD

For the first time, ample supplies of protective immunizations are available as the 2024-2025 Respiratory Syncytial Virus (RSV) season begins in the United States.

The Lancet Infectious Diseases recently published an overview of RSV immunizations, highlighting different target populations, antigens, and clinical trial results.

This overview, published on September 23, 2024, discussed the market approval of a protein-based maternal vaccine and monoclonal antibody (mAb) to protect infants. About 40% of infants were administered the mAb Beyfortus (nirsevimab) last RSV season.

First-year experience protecting infants with Beyfortus in high-income countries such as the U.S. shows a significant public health benefit.

On July 10, 2024, the New England Journal of Medicine reported that in a real-world setting, Beyfortus reduced the risk of infant hospitalization for RSV- associated bronchiolitis by 83%.

There are also mRNA and two protein-based RSV vaccines approved for older adults.

These researchers wrote, 'It is expected that the RSV vaccine landscape will continue to develop to protect all people globally in the coming years.'

'The vaccine and mAb landscape remain active with 30 candidates in clinical development using four approaches: protein-based, live-attenuated and chimeric vector, mRNA, and mAbs.'

'Candidates in late-phase trials aim to protect young infants using mAbs, older infants and toddlers with live-attenuated vaccines, and children and adults using protein-based and mRNA vaccines.'

'As RSV vaccines have not yet reached low-income and middle-income countries, we outline urgent steps to minimize the vaccine delay.'

These RSV immunization products are generally available at health clinics and pharmacies in the U.S.

Sub Title:

Passive immunization protects infants from RSV

Reference:

The respiratory syncytial virus vaccine and monoclonal antibody landscape: the road to global access

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RSV Detections Can be Deceiving

Karen McClorey Hackett — Mon, 19 Aug 2024 16:27:59 +0000

Reviewer:

Robert Carlson, MD

Globally, the timing of seasonal respiratory syncytial virus (RSV) outbreaks can vary by year and geography.

Based on various data sources, RSV cases are scarce everywhere as of August 19, 2024.

For example, the World Health Organization Influenza Update N° 488 reported that most countries had not reported RSV activity for the 2024-2025 season.

And in the U.S., the Centers for Disease Control and Prevention (CDC) reported RSV incidence levels remained low as of August 19, 2024.

According to the CDC, RSV circulation in the U.S. usually begins in Florida and then migrates to the southeast and later to the north and west regions.

When reviewing the Florida Department of Health's latest RSV data, there appears to be a mixed message this year.

As of August 10, 2024, Florida reported that RSV positivity rates were increasing while hospital admissions were decreasing.

While health officials await inevitable changes to these reports, people in the U.S. have ample RSV protection options.

Over the past year, three RSV vaccines and enhanced one monoclonal antibody have become readily available at health clinics and pharmacies in the U.S. Expanded health insurance initiatives support these RSV products financially.

As the fall respiratory season approaches, the CDC encourages at-risk people, including children, to discuss RSV prevention options with a healthcare provider sooner rather than later in 2024.

Sub Title:

Pharmacies offer RSV vaccines in 2024

Reference:

WHO Influenza Update N° 488

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US CDC RSV Detection Trends August 2024

RSV Season Has Arrived in Florida

Karen McClorey Hackett — Wed, 31 Jul 2024 16:47:41 +0000

Reviewer:

Robert Carlson, MD

While the World Health Organization (WHO) recently reported that respiratory syncytial virus (RSV) activity was not detectable in most countries, new data indicates that this respiratory virus has arrived in the United States.

According to the U.S. Centers for Disease Control and Prevention (CDC), RSV activity usually begins in Florida and then migrates to the southeast, later to the north and west regions.

As of July 20, 2024, the Florida Department of Health reported that RSV admissions were increasing, but there had been no outbreaks this early in the season.

Since Florida's week report #29 was published, the CDC has not issued any Travel Health Advisories regarding RSV's health risks for Florida visitors. This virus impacts the health of many seniors and children in the U.S.

Unlike previous years, the U.S. government has approved three RSV vaccines and cleared passive immunization for infants and young children.

For the 2024-2025 season, the CDC recommends that everyone 75 and older receive the RSV vaccine. Those 60–74 who are at increased risk of severe RSV, meaning they have certain chronic medical conditions or live in nursing homes, receive one of the approved vaccines.

Eligible adults can get an RSV vaccine at any time, but the best time is in late summer and early fall before RSV usually spreads in communities.

This CDC recommendation is for adults who did not get an RSV vaccine last year.

Furthermore, the RSV vaccine is not currently an annual vaccine, meaning people do not need to get a dose every RSV season.

The CDC's Director, Dr. Mandy Cohen, commented in a press release on June 26, 2024, “The CDC has updated its RSV vaccination recommendation for older adults to prioritize those at highest risk for serious illness from RSV."

As of July 31, 2024, these innovative RSV vaccines and monoclonal antibody therapy (Beyfortus) are offered in Florida clinics and pharmacies.

Sub Title:

RSV Vaccines and antibody therapy are available in August 2024

References:

Florida RSV Review Week #29

US CDC Updates RSV Vaccination Recommendation

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Florida Dept Health RSV Map Week 29: July 14, 2024–July 20, 2024

National RSV Vaccination Program Launches in the UK

Karen McClorey Hackett — Wed, 17 Jul 2024 12:53:28 +0000

Reviewer:

Robert Carlson, MD

The United Kingdom (UK) has announced that it will be the first country to implement a national program using the same vaccine to protect newborns following vaccinating pregnant women and older adults against Respiratory Syncytial Virus (RSV).

Each year in the UK, RSV infections are responsible for 20 to 30 infant deaths and around 9,000 hospital admissions in those aged over 75.

A press release issued by the Department of Health and Social Care and Andrew Gwynne MP on July 17, 2024, stated that the vaccination program will commence in Scotland in mid-August, followed by England, Wales, and Northern Ireland in September.

Minister for Public Health and Prevention Andrew Gwynne commented in the press release, "As someone who has seen the devastating effects of RSV firsthand, I am thrilled to see the UK leading the way in tackling this devastating disease."

The program follows the advice from the independent Joint Committee on Vaccination and Immunisation published in September 2023.

The UK selected Pfizer Inc.'s RSV vaccine for the program.

This new vaccination program is the second UK effort to protect infants from RSV.

In November 2022, following European Commission approval, the UK's Medicines and Healthcare products Regulatory Agency approved Beyfortus® (nirsevimab), a single-dose, long-acting antibody, to prevent RSV lower respiratory tract disease in newborns and infants during their first RSV season.

Beyfortus is the first and only single-dose RSV protective option for the broad infant population, including those born healthy, at term or preterm, or with specific health conditions.

In the United States, three RSV vaccines, including Beyfortus, have been FDA-approved and are available for the 2024-2025 RSV season.

Sub Title:

Beyfortus nirsevimab is approved to protect infants from RSV in the United Kingdom

References:

UK - National RSV vaccination programme announced

MHRA Grants Approval of Beyfortus for Prevention of RSV Disease in Infants

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by Artur Pawlak

Second-Gen Passive Immunization Significantly Protects Infants from RSV

Karen McClorey Hackett — Thu, 11 Jul 2024 21:32:10 +0000

Reviewer:

Robert Carlson, MD

The New England Journal of Medicine recently published the results of a randomized controlled clinical trial that reaffirms the estimated effectiveness of Beyfortus™ (nirsevimab), a second-generation monoclonal antibody that reduces the risk of hospitalization for respiratory syncytial virus (RSV)- associated bronchiolitis in infants by 83%.

This finding is significant since RSV is the leading cause of bronchiolitis, resulting in about three million hospitalizations each year worldwide.

This study, funded by the National Agency for AIDS Research–Emerging Infectious Disease and others, included 1035 infants, of whom 690 were case patients (median age, 3.1 months; interquartile range, 1.8 to 5.3) and 345 were matched control patients (median age, 3.4 months; interquartile range, 1.6 to 5.6).

The effectiveness of a single-dose nirsevimab therapy against RSV-associated bronchiolitis resulting in critical care was 69.6% (95% CI, 42.9 to 83.8) (27 of 193 case-patients [14.0%] vs. 47 of 146 matched control patients [32.2%]).

And against RSV-associated bronchiolitis resulting in ventilatory support was 67.2% (95% CI, 38.6 to 82.5) (27 of 189 case-patients [14.3%] vs. 46 of 151 matched control patients [30.5%]).

The European Commission granted Beyfortus worldwide approval on November 4, 2022, followed by approvals from the U.K., Canada, and the U.S. FDA.

In the United States, among females with an infant <8 months, 41.3% reported that their infant received nirsevimab as of May 2024. For the 2024-2025 RSV season, Beyfortus's supply is expected to meet demand.

Sub Title:

Beyfortus a recombinant human immunoglobulin G1 kappa long-acting mAbs that binds to the prefusion conformation of the RSV F protein

References:

Nirsevimab and Hospitalization for RSV Bronchiolitis

Effectiveness of Nirsevimab in Children Hospitalised With RSV Bronchiolitis (ENVIE)

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Infant

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U.S. CDC to Review Various Vaccines Next Week

Donald Hackett — Thu, 20 Jun 2024 16:02:40 +0000

Reviewer:

Holly Lutmer PharmD

Robert Carlson, MD

The U.S. Centers for Disease Control and Prevention (CDC) recently confirmed a meeting of the Advisory Committee on Immunization Practices (ACIP) will be conducted from June 26-28, 2024.

The agenda for this ACUP meeting includes discussions of new and existing vaccines, such as:

With three RSV vaccines and one monoclonal antibody approved by the U.S. FDA, people and healthcare providers are seeking CDC insights for the 2024-2025 RSV season.

Dengue - While the FDA and CDC recommend the Dengvaxia vaccine, it is not generally available in the U.S. Additionally, Takeda's Qdenga® vaccine is offered in many countries confronting severe dengue outbreaks in 2024, such as Brazil, but not the U.S.

On the second day, the ACIP will discuss updated COVID-19, influenza, and pneumococcal vaccine options.

The third day's agenda includes an additional RSV discussion regarding how best to protect infants, as well as pneumococcal and HPV vaccine updates.

This ACIP meeting, like most, is open to the public and can be viewed via a YouTube link.

Any interested person wishing to make an oral public comment during an ACIP meeting should submit a request before the meeting according to the instructions in the Federal Register Notice.

The ACIP develops recommendations for U.S. immunizations, including the ages at which vaccines should be given, the number of doses, the time between doses, and precautions and contraindications. The ACIP's recommendations are forwarded to the CDC's Director and, if adopted, become official CDC policy.

Previously approved ACIP recommendations have been published in the CDC's Morbidity and Mortality Weekly Reports, and related presentations have been posted at the CDC link.

Contact the ACIP Secretariat with questions at acip@cdc.gov.

Sub Title:

ACIP to discuss dengue RSV and other vaccines

References:

MEETING OF THE ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP)

US CDC ACIP

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Passive Immunization Reduced RSV Related Infant Hospitalizations by 82%

Karen McClorey Hackett — Thu, 02 May 2024 16:43:39 +0000

Reviewer:

Robert Carlson, MD

Today, the first population-based, real-world evidence (RWE) of the positive benefits infants receive when passively immunized to prevent respiratory syncytial virus (RSV) disease was published.

RWE demonstrates if immunization is effective in day-to-day practice, as opposed to "efficacy" determined in carefully controlled clinical trials.

According to the interim results of an ongoing clinical study published in The Lancet Infectious Diseases on April 30, 2024, Beyfortus™ (nirsevimab) reduced respiratory syncytial virus (RSV) hospitalizations by 82% (95% CI: 65.6 to 90.2) in infants under six months of age, compared to infants who received no RSV intervention,

These results are from the first RSV season after the U.S. FDA approved Beyfortus. They are part of the three-year NIRSE-GAL study conducted in Spain collaboratively with the Galician Directorate of Public Health of the Xunta de Galicia (Galician government) and Sanofi.

Positive results from recent RWE studies have been published from several broad infant immunization programs across the U.S., Spain, and France during the 2023-2024 RSV season.

"The NIRSE-GAL study (www.nirsegal.es/en) represents a monumental stride in pediatric public health, showcasing an over 80% effectiveness in preventing severe RSV infections in immunized infants," wrote Federico Martinon Torres, Head of Pediatrics, Hospital Clínico Universitario Santiago, Spain and principal investigator of NIRSE-GAL study, in an email to Precision Vaccination News on May 2, 2024.

"Our real-world findings in Galicia (Spain) on the nirsevimab's effectiveness and impact .... have drawn considerable attention worldwide, emphasizing the critical role of structured immunization programs in controlling infectious diseases."

"As the lead researcher of the NIRSE-GAL study, I am profoundly encouraged by our results: Immunizing just 25 infants with nirsevimab prevents one hospitalization, demonstrating the profound impact of preventive strategies on public health."

In addition to this new effectiveness study, an interim analysis of 2023-24 surveillance data published in the U.S. Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report (March 2024) shows a single dose of Beyfortus was 90% effective in preventing hospitalizations due to RSV in babies who were immunized below eight months of age.

As a long-acting antibody provided directly to newborns and infants in a single dose, Beyfortus offers rapid protection to help prevent lower respiratory tract disease caused by RSV without requiring immune system activation.

Beyfortus administration can be timed to coincide with the RSV season.

In infants, RSV is the most common cause of lower respiratory tract disease, including bronchiolitis and pneumonia.13 It is also a leading cause of hospitalization in infants worldwide, with most hospitalizations for RSV occurring in healthy infants born at term.

According to a press release from Sanofi and AstraZeneca on May 2, 2024, the companies are producing Beyfortus well before the next RSV season, with the vast majority of doses planned to be available by October 2024.

The ABRYSVO™ vaccine was approved by the U.S. FDA on August 21, 2023, as an alternative therapy for pregnant women between 32 and 36 weeks gestational age.

In a subgroup of pregnant individuals who were 32 through 36 weeks gestational age, Pfizer Inc.'s Abrysvo reduced the risk of LRTD by 34.7% and the risk of severe LRTD by 91.1% within 90 days after birth compared to placebo. Within 180 days after birth, Abrysvo reduced the risk of LRTD by 57.3% and 76.5% for severe LRTD compared to placebo.

Sub Title:

Beyfortus reduces RSV related infant hospitalizations

References:

Effectiveness and impact of universal prophylaxis with nirsevimab in infants against hospitalisation for respiratory syncytial v

Beyfortus real-world evidence published in The Lancet shows 82% reduction in infant RSV hospitalizations

Estimate of Nirsevimab Effectiveness for Prevention of Respiratory Syncytial Virus–Associated Hospitalization Among Infants

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Why Was the Maternal RSV Vaccine Study Stopped

Karen McClorey Hackett — Mon, 15 Apr 2024 14:47:15 +0000

Reviewer:

Robert Carlson, MD

Recently, a clinical trial enrollment was stopped ahead of schedule because of safety concerns. The trial's early findings indicated that the risk of severe lower respiratory tract disease in infants caused by the respiratory syncytial virus (RSV) was lower with the maternal vaccine candidate than with the placebo.

However, the risk of preterm birth was found to be higher with the candidate vaccine.

Published by The New England Journal of Medicine (NEJM) in March 2024, the RSV Prefusion F Protein–Based Maternal Vaccine — Preterm Birth and Other Outcomes phase 3 study (NCT04605159) focused on efficacy and safety data on GSK's RSVPreF3-Mat RSV prefusion F protein-based maternal vaccine candidate involving more than 5,000 pregnant people and their infants in 24 countries.

"We have discontinued our work on this RSV maternal candidate vaccine, and we are closing out all ongoing trials except the MAT-015 follow-on study to monitor subsequent pregnancies," a GSK spokesperson announced.

According to an editorial published by The NEJM on April 12, 2024, the vaccine candidate given during pregnancy was about 66% effective at protecting against RSV-associated respiratory illness and about 69% effective at protecting against severe disease.

However, Emily Harris explained that the researchers had stopped the trial early because of an increased risk of preterm births.

About 7% of infants whose birthing mothers had received the vaccine were born before 37 weeks, compared with roughly 5% of infants whose mothers had received a placebo.

The researchers noted that the higher rate of preterm births was "predominantly observed" among low- and middle-income countries and was not explained by SARS-CoV-2 coronavirus infection or COVID-19 vaccination.

The maternal vaccine evaluated in the study is similar to Pfizer Inc.'s ABRYSVO™, which the U.S. Food and Drug Administration (FDA) approved in 2023 to protect against RSV in infants. The FDA-approved vaccine is being monitored for vaccine-associated risks, including preterm births.

Despite the potential risks of maternal RSV vaccination, "it is essential to weigh this small risk against the proven benefits," the authors of a linked editorial wrote.

The U.S. CDC's RSVVaxView reported that, as of 2024, the overall RSV vaccination rate among pregnant women was about 18%.

Similar to a vaccine, a single-dose, extended half-life monoclonal antibody has been approved to offer passive immunization to prevent lower respiratory tract infections in children caused by RSV.

According to recent research, BEYFORTUS™ (Nirsevimab) is about 90% (95% CI = 75%–96%) protective against RSV-associated hospitalization in infants in their first RSV season.

As of February 2024, the CDC reported that about 43% of women with infants under eight months had received nirsevimab.

Sub Title:

RSVPreF3-Mat RSV prefusion F protein-based maternal vaccine development discontinued

References:

RSV Prefusion F Protein–Based Maternal Vaccine — Preterm Birth and Other Outcomes

Safety Concerns Put a Stop to Maternal RSV Vaccine Study

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Genomic Surveillance Lands at Chicago and Miami Airports

Donald Hackett — Thu, 14 Mar 2024 20:14:08 +0000

Reviewer:

Robert Carlson, MD

In 2021, health officials started testing airline passengers who passed through a New York airport to identify imported emerging infectious diseases, part of the U.S. national biosecurity initiative.

Over the past three years, more than 300,000 travelers from over 135 countries have participated each year in the U.S. Centers for Disease Control and Prevention (CDC) Traveler-based Genomic Surveillance (TGS) program.

The TGS has been offering testing services in Los Angeles, Newark, Seattle, Boston, San Francisco, NYC (JFK), and Washington, DC (IAD).

As of March 12, 2024, the TGS expansion includes Miami and Chicago airports.

International travelers arriving at these airports volunteer to self-collect nasal swab samples, which are shipped to a laboratory network for reverse transcriptase polymerase chain reaction testing.

Positive samples undergo whole genome sequencing to determine virus variants.

Selected TGS samples are then shared with the CDC's laboratory, where they undergo viral characterization, which can provide information about a new variant's transmissibility, virulence, and response to current treatments or vaccines.

However, program participants are not notified of their test results.

The key benefit of the $37 million budget airport testing program is expedited information sharing with public health authorities to help control disease outbreaks before they cause widespread impact.

During the U.S.'s 2023–2024 respiratory season, the TGS conducted an enhanced multipathogen nasal sampling pilot, which tested for Flu A/B, RSV, SARS-CoV-2, and other respiratory pathogens.

An example use-case is the respiratory syncytial virus (RSV) season.

Each year, RSV circulation in the U.S. begins in Florida in the fall, then transitions to the southeast and later to the north and west regions. With the enhanced TGS, health officials can learn when RSV is spreading via air travelers.

Furthermore, RSV vaccinations could be promoted in targeted cities.

Additionally, the CDC has conducted airplane wastewater sampling at San Francisco and Boston airports since August 2022. Positive samples undergo whole genome sequencing to determine variants.

This airplane wastewater program is expanding from a pilot phase to broader implementation in 2024.

The TGS, led by the CDC's Travelers' Health Branch, is a public-private partnership. It collaborates with XpresCheck (an airport-based testing company) and Concentric by Ginkgo (a network of over 60 laboratories with genetic sequencing capability). The companies may expand the program to check for more different disease-causing germs.

"We are thrilled to have the opportunity to take the TGS program to the next level. Multipathogen biomonitoring expands this critical biosecurity infrastructure for the United States," said Matt McKnight, General Manager for Biosecurity at Ginkgo Bioworks, in a press release on March 12, 2024.

The CDC's Advanced Molecular Detection Program supported the pilot program when it launched in September 2021.

Sub Title:

US CDC nasal sampling program provides information about a virus variant transmissibility

References:

CDC Traveler-based Genomic Surveillance for Early Detection

US CDC Notes from the Field 2013

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US CDC Traveler-based Genomic Surveillance map March 2024

RSV, COVID-19, Flu Hospitalizations Declining in February 2024

Karen McClorey Hackett — Thu, 08 Feb 2024 22:38:22 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

According to the U.S. government, the current respiratory season is ending with less impact on hospitalization than last year.

The combined weekly hospitalization rate for COVID-19 and influenza from the National Healthcare Safety Network during the week of December 30, 2023, was 87.5% of 2022's peak (16.8 vs 19.2 admissions per 100,000).

On February 8, 2024, the Centers for Disease Control and Prevention (CDC) published potentially its last Outlook regarding respiratory disease for the remainder of the 2023-2024 season.

The CDC anticipates that total hospitalizations for COVID-19, influenza, and RSV will decline but remain elevated into February 2024.

COVID-19 surveillance data, hospital admission forecasts, and growth estimates indicate that COVID-19 activity remains elevated but has decreased and is likely to continue decreasing into February.
Hospital admission forecasts and growth estimates indicate that influenza activity will remain elevated into February.
RSV activity remains elevated but is decreasing nationally. The national per capita hospitalization rate remains lower than the peak for the last RSV season.

The CDC wrote, 'We do not anticipate producing additional respiratory disease outlooks during the remainder of the 2023-2024 season. We continue to monitor respiratory diseases and will update this Outlook should we identify any unusual events, such as a significant resurgence of these diseases.'

The final CDC Outlook is based on expert judgment, historical data, and scenario modeling.

From a prevention perspective, the CDC confirmed ample supplies of respiratory vaccines and antibody therapies are available at most clinics and pharmacies in the U.S.

Sub Title:

COVID-19 and influenza hospitalization rate is 87.5% of 2022

Reference:

Respiratory Disease Season Outlook - Feb. 8, 2024

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Pregnant Women Prefer RSV Passive Immunization Protection for Infants

Karen McClorey Hackett — Thu, 25 Jan 2024 15:54:09 +0000

Reviewer:

Robert Carlson, MD

In 2023, the U.S. Food and Drug Administration (FDA) approved one respiratory syncytial virus (RSV) vaccine and an updated monoclonal antibody therapy to prevent respiratory disease in very young children.

Given these were new options, health officials did not know which product pregnant women would prefer during the 2023-2024 RSV season.

According to new data published by the U.S. Centers for Disease Control and Prevention (CDC) on January 23, 2024, the winner has been Beyfortus™ (Nirsevimab).

As of December 2023, among mothers with an infant younger than eight months, 28.7% reported that their infant received Beyfortus, and 33.9% reported that they plan to get Beyfortus for their infant.

Among women 18-49 years of age trying to get pregnant, 44.2% reported planning to get Beyfortus for their expected child.

Regarding vaccination, among women who were pregnant and ≥32 weeks gestation since September 22, 2023, the overall coverage with the RSV vaccine was 14.4% as of January 13, 2024.

Beyfortus is an extended half-life monoclonal antibody offering passive immunization to prevent lower respiratory tract infections.

Monoclonal antibodies do not activate the human immune system, as would occur with vaccination. Instead, the antibodies themselves protect against disease, which is called passive immunization.

The FDA recommends it for all infants younger than eight months of age who are born during—or entering—their first RSV season.

While the timing of each RSV season in the U.S. varies geographically, Beyfortus may be administered from October through the end of March in most of the continental, says the U.S. CDC.

Beyfortus is also recommended for some children aged 8 through 19 months who are at increased risk for severe RSV disease and entering their second RSV season.

Except in rare circumstances, the CDC says that most infants younger than eight months do not need Beyfortus if they were born 14 or more days after their mother got the RSV vaccine.

The U.S. FDA first approved Synagis® (Palivizumab), a multi-dose injectable RSV antibody that provides one month of protection, in 1998.

Sub Title:

28 percent of new infants got RSV protection from Beyfortus Nirsevimab in 2023

References:

CDC RSV prevention

CDC Nirsevimab Receipt and Intent for Infants 2024

RSVVaxView Dashboard 2024

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Google News Keywords:

RSV, vaccinations

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Fact checked:

Friday, January 26, 2024 - 06:00

Image Caption:

US CDC Nirsevimab Receipt and Intent for Infants Jan. 10, 2024

Texas Publishes 'Big Three' Respiratory Virus Trends and Insights

Karen McClorey Hackett — Mon, 22 Jan 2024 17:18:17 +0000

Reviewer:

Robert Carlson, MD

The Texas Department of State Health Services (DSHS) today announced it had launched new data tools to empower people to keep tabs on respiratory viruses in Texas.

In Texas, respiratory virus season runs from October to May and usually peaks in the winter. However, these viruses create health risks at any time of year.

Launched on January 22, 2024, the respiratory virus dashboard accessible through DSHS's Texas Health Data site shows trends in illnesses from influenza, COVID-19, and Respiratory syncytial virus (RSV), the respiratory viruses most likely to cause serious disease at this time of year.

Updated each Friday, this innovative dashboard's data includes emergency room visits, hospitalizations, and deaths.

"Those data points demonstrate the diseases' most severe effects on people, communities, and the health care system," said DSHS Commissioner Jennifer Shuford, MD, MPH, in a press release.

"The dashboard provides a near real-time look at conditions so that people can make informed decisions on precautions for themselves and their families, and health care professionals can make recommendations to their patients."

DSHS is also publishing a new weekly respiratory virus surveillance report, combining separate reports on influenza, COVID-19, and RSV.

The report contains more in-depth data on the three diseases, including, but not limited to, information on the burden of influenza-like illness (ILI), counties where different types of flu have been found, and the proportions of COVID-19 variants present in Texas.

As of January 19, 2024, compared to the previous week, the updated surveillance report confirmed the following:

The percentage of specimens testing positive for influenza reported by hospital laboratories has increased.

The percentage of patient visits due to ILI has decreased.

No influenza-associated pediatric deaths were reported.

Ten influenza-associated institutional outbreaks were reported in long-term care facilities.

Furthermore, the Walgreens Flu Index® only listed Tyler-Longview and El Paso, Texas, in its top ten cities reporting influenza medication dispensing.

Getting immunized against respiratory viruses is a good way for people to protect themselves against the severe disease, hospitalization, and death they can cause, wrote DSHS.

According to recent U.S. CDC data, the national percentage of the population reporting receipt of COVID-19, influenza, and RSV vaccines remains low for children and adults.

The percent of the population reporting receipt of the updated 2023-24 COVID-19 vaccine is 11% for children and 21.5% for adults 18+, including 40.9% among adults age 65+.

The percent of the population reporting receipt of a flu vaccine is 47.5%, and influenza vaccination coverage among pregnant women as of December 2023 is about 3% points lower compared to the end of December 2022 (36% Vs. 39%),

The percentage of adults aged 60+ who report receiving an RSV vaccine is 21.1%.

As of January 22, 2024, various respiratory vaccines remain available at most pharmacies in Texas.

Sub Title:

Texas Launches Respiratory Virus Data Dashboard and Weekly Surveillance Report

References:

Texas Launches New Respiratory Virus Dashboard and Report

Texas Respiratory Illness Interactive Dashboard

Texas Respiratory Virus Surveillance Report

2023-2024 Vaccination Trends - CDC

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Google News Keywords:

RSV, vaccinations

Featured:

Fact checked:

Tuesday, January 23, 2024 - 06:15

Image Caption:

Texas DSHS respiratory disease map Jan. 19, 2024

Houston's Flu and RSV Season Fizzles Out

Karen McClorey Hackett — Sun, 14 Jan 2024 12:45:22 +0000

Reviewer:

Robert Carlson, MD

As the world looks forward to a healthy 2024, various health agencies recently reported signs of changing influenza and respiratory syncytial virus (RSV) detections.

From a global perspective, the World Health Organization (WHO) Influenza Update N° 462 confirmed the influenza season increased in the temperate Northern Hemisphere,

In the United States, the Centers for Disease Control and Prevention (CDC) FluView reported on January 12, 2024, that influenza case decreases have been noted after several weeks of increases in key indicators.

The CDC also reported a significant decrease in RSV cases, especially in Texas.

Since a 35% infectious rate peak in November 2023, RSV detections in Texas have gradually decreased to about 10% as of January 6, 2024.

In Texas, the Department of State Health Services Influenza Surveillance Report 2023-2024 Season MMWR Week 01 stated that compared to the previous week, the percentage of patient visits due to influenza-like illness (ILI) has decreased in Texas.

From a city perspective, Texas is no longer a national hot spot for influenza medications.

The Walgreens Flu Index® provides unique insights into flu activity. Its analysis is coupled with retail prescription data for antiviral medications used to treat influenza.

According to the Walgreens Flu Index, Week Ending January 6, 2024, only El Paso and Beaumont-Port Arthur, Texas, are listed in the top ten cities confronting the flu.

Furthermore, in Harris County, which includes the city of Houston, the weekly ILI trend has been decreasing for the past three weeks.

And the Harris Health Department reported that the weekly RSV diagnosis trend has decreased for the past nine weeks.

The good news from the CDC is ... that regardless of your respiratory virus risk, ample flu shots and RSV vaccines are available at most pharmacies in the U.S.

Moreover, for new mothers, recent news indicates an increasing supply of the Beyfortus™ passive immunization monoclonal antibody therapy available for infants and children for this RSV season.

Sub Title:

Influenza and RSV vaccines available in Texas

References:

WHO Influenza Update N° 461

CDC - Key Updates for Week 1, ending January 6, 2024

2023-2024 Texas Influenza Surveillance Activity

RSV State Trends January 11, 2024

Walgreens Flu Index web application

Houston Health Department Influenza Data Jan. 6, 2024

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Google News Keywords:

RSV, influenza, vaccinations