ABRYSVO RSVpreF RSV Vaccine

RSV and Flu Vaccine Coadministration Found Safe

Karen McClorey Hackett — Mon, 04 Dec 2023 15:56:35 +0000

Reviewer:

With the 2023-2024 influenza season accelerating in late 2023, a recent study reported good news for seniors also concerned about Respiratory syncytial virus (RSV) disease.

Published in the journal Clinical Infectious Diseases on November 22, 2023, researchers found that the ABRYSVO™ bivalent RSVpreF vaccine and seasonal inactivated influenza vaccine (SIIV) can be safely coadministered to individuals 65 years and older.

Furthermore, immune responses met the prespecified immunogenicity endpoint for noninferiority for both respiratory vaccines.

The study's results included geometric mean ratios of 0.86 for RSV-A and 0.85 for RSV-B neutralizing titers at one month after RSVpreF administration and 0.77 to 0.90 for strain-specific hemagglutination inhibition assay titers at one month after SIIV.

All comparisons achieved the prespecified 1.5-fold noninferiority margin.

These researchers wrote that by eliminating the need for an additional vaccination visit, coadministration of RSV and influenza vaccines for individuals recommended to receive both vaccines may offer convenience to patients and healthcare providers.

Coadministration of influenza vaccines with other respiratory vaccines, such as pneumococcal disease, has also been shown to be safe and immunogenic.

Although this Pfizer Inc.-funded study was conducted in older adults, these researchers expect that the favorable safety profile and robust immunogenicity observed with coadministration would support broader application.

The study was conducted in adults 65 years and older, a population well recognized for being substantially at risk for severe complications of both RSV illness and influenza infection.

Strengths of this study include the randomized, double-blind design, which enabled the comparison of RSVpreF and SIIV coadministration to sequential administration while providing all participants with both vaccines.

Sub Title:

Seniors benefit from coadministered RSVpreF and influenza vaccination

References:

Safety and Immunogenicity of Bivalent RSVpreF Vaccine Coadministered with Seasonal Inactivated Influenza Vaccine in Older Adults

Clinical Infectious Diseases MAJOR ARTICLE

ClinicalTrials.gov NCT05301322

Image:

Age Groups:

Seniors

Google News Keywords:

RSV, flu shot, vaccinations

Featured:

Fact checked:

Tuesday, December 5, 2023 - 22:00

Image Caption:

from Pixabay

RSV Vaccination May Protect Seniors from Hospitalization

Karen McClorey Hackett — Fri, 06 Oct 2023 08:09:23 +0000

Reviewer:

Holly Lutmer PharmD

Robert Carlson, MD

The U.S. Centers for Disease Control and Prevention (CDC) today reported that from February 2022–May 2023, hospitalizations for Respiratory Syncytial Virus (RSV) were less frequent but were associated with more severe disease than hospitalizations for influenza or SARS-CoV-2 virus infections.

And there were substantial variations in hospital admissions observed for RSV and influenza, but SARS-CoV-2 coronavirus infection admissions exhibited less seasonal variation.

After exclusions, 5,784 seniors were included in this CDC analysis, among whom 304 (5.3%) were hospitalized with RSV, 4,734 (81.8%) for SARS-CoV-2 infection and 746 (12.9%) with influenza.

Published on October 6, 2023, these findings are consistent with those from earlier studies that compared RSV disease severity among hospitalized adults with influenza disease. Patients hospitalized with RSV disease are more likely to be treated with supplemental oxygen, mechanical ventilation, or ICU admission than those hospitalized with influenza.

Although neither of the two clinical trials that led to U.S. Food and Drug Administration (FDA) approval of RSV vaccines for older adults was powered to assess the protection of RSV vaccination against hospitalization in seniors, both trials showed moderate to high efficacy of RSV vaccination against lower respiratory tract disease, which is in the causal pathway leading to severe disease.

Although additional studies are needed to assess the protection of these new RSV vaccines against severe respiratory disease in older adults, RSV vaccination can potentially prevent severe respiratory disease and is currently the only approved prevention product available for older adults, says the CDC.

Furthermore, the high RSV disease severity observed among older adults in this analysis is essential to guide decision-making for RSV vaccination in this population.

These discussions should occur in local communities before the 2023-2024 RSV season impacts seniors.

Sub Title:

RSV vaccines for older adults are US FDA approved

Reference:

Disease Severity of Respiratory Syncytial Virus Compared with COVID-19 and Influenza Among Hospitalized Adults Aged ≥60 Years —

Image:

Age Groups:

Seniors

Google News Keywords:

RSV, vaccinations

Featured:

Fact checked:

Sunday, October 8, 2023 - 06:15

Image Caption:

by Silvia P.

4th Vaccine Approved for Pregnant Women

Karen McClorey Hackett — Sat, 23 Sep 2023 16:30:49 +0000

Reviewer:

Robert Carlson, MD

For the first time, three respiratory vaccines and one Tdap combination vaccine are now approved for use by late-stage pregnant women.

On September 22, 2023, members of the U.S. CDC's Advisory Committee on Immunization Practices (ACIP) voted 11-1 to recommend a maternal respiratory syncytial virus (RSV) vaccine for pregnant women during 32 through 36 weeks gestation to protect their newborn from severe RSV illness.

The newly approved Pfizer Inc.'s ABRYSVO™ bivalent RSVpreF vaccine prevents infants' RSV lower respiratory tract infection.

This RSV vaccine has been shown to reduce the risk of RSV hospitalization for babies by 57% in the first six months after birth.

RSV is a common respiratory virus that usually causes mild, cold-like symptoms but can cause severe consequences for children and older adults. In fact, RSV may cause bronchiolitis and pneumonia and can lead to fatal respiratory distress.

"This is another new tool we can use this fall and winter to help protect lives," said CDC Director Dr. Mandy Cohen in a media release.

"I encourage parents to talk to their doctors about how to protect their little ones against serious RSV illness, using either a vaccine given during pregnancy or an RSV (Beyfortus™, monoclonal antibody) immunization given to your baby after birth."

The CDC says to talk to your healthcare provider, pharmacist, or local community health center about which vaccines women need to stay protected this fall and winter.

On September 22, 2023, Sarah Schillie, MD, MPH, MBA CAPT, U.S. Public Health Service, presented during the CDC meeting: Addition of an Addendum to the 2023 Immunization Schedules for Children/Adolescents and Adults.

Of note, yellow fever and smallpox (mpox) vaccines are not recommended for pregnant women.

Furthermore, all ACIP vaccine recommendations are not considered final until published in the Morbidity and Mortality Weekly Report.

In Europe, the European Commission recently authorized Abrysvo for EU-wide marketing authorization.

The article was updated on Sept 25, 2023, with a corrected link.

Sub Title:

RSV, Tdap, Influenza, COVID-19 vaccines approved for third trimester vaccinations

References:

New vaccine to help protect babies against severe RSV illness after birth

ACIP Presentation Slides: September 22, 2023

CDC - Tdap during pregnancy passes protection to baby

EMA - Abrysvo

CDC - Maternal RSV Vaccine Implementation Considerations

Image:

Age Groups:

Infant

Google News Keywords:

RSV, vaccinations

Featured:

Fact checked:

Sunday, September 24, 2023 - 06:00

Image Caption:

from Pixabay

About 2% Coinfected with RSV, SARS-2 and Flu

Karen McClorey Hackett — Tue, 25 Jul 2023 19:37:47 +0000

Reviewer:

Robert Carlson, MD

Scientists are expected to present new data today about rates of co-infections with SARS-CoV-2, influenza, and respiratory syncytial virus (RSV), offering one of the first snapshots of the interplay among these common but potentially deadly viruses.

Announced on July 25, 2023, the research included results from more than 26,000 respiratory tests of U.S. adults and children in late 2022 and found co-infections in more than 1% of positive samples.

Overall, the tests revealed that co-infections with two or more respiratory viruses occurred in 1.33% of positive results and .55% of the studied samples.

The positivity rates varied by the viruses involved, ranging from .38% in adults for both SARS-CoV-2 and RSV to 2.28% in adults with influenza A and SARS-CoV-2 infections.

SARS-CoV-2 is the betacoronavirus that causes COVID-19 in people.

However, co-infection rates in the pediatric group were higher than in the adult population for all three viruses.

These researchers noted the very high 6% co-infection rate of SARS-CoV-2 and influenza A in those under 21, which he said matched what was previously observed by the various studies.

"With changing behaviors as the COVID pandemic began to recede, we felt it was important to investigate the resurgence of other respiratory viruses and potential incidents of co-infection, especially with the additional circulation of SARS-CoV-2," said lead scientist George Pratt, Ph.D., at Quest Diagnostics in Marlborough, MA, in a press release on July 25, 2023.

"As we experience more flu seasons and future epidemics of respiratory viruses, we'll be able to acquire more co-infection rate data," Pratt said.

"Our current work would make a useful data point to help evaluate whether future co-infection rates are shrinking or growing," he added.

These findings, presented at the 2023 AACC Annual Scientific Meeting & Clinical Lab Expo, could have implications for how clinicians approach respiratory disease testing during future epidemics and seasonal outbreaks.

Unlike previous years, U.S. FDA-approved vaccines are available for all three respiratory viruses for the fall and winter of 2023.

Sub Title:

SARS-CoV-2, influenza, and RSV coinfections identified

References:

COVID, Flu, and RSV Co-infections

Respiratory Syncytial Virus, Influenza, and Coronavirus Disease 2019 Hospitalizations in Children in Colorado During the 2021-20

Influenza and Respiratory Syncytial Virus Infections in Pediatric Patients during the COVID-19 Pandemic

Image:

Google News Keywords:

coinfections, RSV, vaccinations

Featured:

Fact checked:

Wednesday, July 26, 2023 - 06:00

Image Caption:

by Pete Linforth

FDA Committee Debates RSV Vaccine(s) Risk/Benefit

Donald Hackett — Mon, 27 Feb 2023 11:34:59 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

New Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings have been scheduled this week to consider the safety of two Respiratory Syncytial Virus (RSV) vaccine candidates for seniors.

This U.S. Food and Drug Administration (FDA) vaccine committee includes industry leaders offering expert opinions in response to strategic questions.

The FDA's 179th meeting agenda and various digital presentations on February 28 and March 1, 2023, highlight these questions:

Are the available data adequate to support the safety of Pfizer's ABRYSVO (RSVPreF) when administered to individuals 60 years of age and older to prevent lower respiratory tract disease (LRTD) caused by RSV?
Are the available data adequate to support the safety of GSK's AREXVY (RSVPreF3+AS01E) when administered to individuals 60 years of age and older to prevent LRTD caused by RSV?

On February 28, 2023, under Topic #1, the VRBPAC will meet in an open session to discuss and make recommendations on the safety and effectiveness of ABRYSVO (RSV Vaccine), manufactured by Pfizer Inc., with a requested indication, in Biologics License Application (BLA) 125769, for active immunization for the prevention of acute respiratory disease and LRTD caused by RSV in adults 60 years of age and older.

On March 1, 2023, under Topic #2, the vaccine committee will discuss and make recommendations on the safety and effectiveness of AREXVY (RSV Vaccine, Recombinant, Adjuvanted), manufactured by GSK, with a requested indication, in BLA 125775, for active immunization for the prevention of LRTD caused by RSV-A and RSV-B subtypes in adults 60 years of age and older.

As of February 27, 2023, the FDA has not authorized any RSV vaccine candidate.

The FDA uses committees and panels to obtain independent expert advice on scientific, technical, and policy matters but is not bound to follow committee votes. VRBPAC meetings are open to the public, with selected consumer participation.

These VRBPAC meetings follow last week's U.S. Centers for Disease Control and Prevention (CDC) vaccine committee (ACIP) discussions focused on RSV vaccinations of infants and seniors and potential modifications to using RSV monoclonal antibody passive immunization.

Sub Title:

RSV vaccines lack US FDA authorization

Reference:

U.S. FDA RSV vaccine meeting February 28 - March 1, 2023

Image:

Age Groups:

Infant

Google News Keywords:

health, vaccines, vaccinations, rsv

Featured:

Fact checked:

Tuesday, February 28, 2023 - 07:30

Image Caption:

U.S. FDA 2023

RSV Vaccine Candidate Produced 10-20 Fold Increase in Virus-Killing Antibodies

Don Hackett — Tue, 08 Oct 2019 20:17:55 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

There is good news regarding the respiratory syncytial virus (RSV), a common virus with a high disease burden in young children.

Various health stakeholders believe maternal immunization can provide infants with protection from this respiratory virus during the crucial early weeks and months as their immune systems mature.

Maternal immunization, a strategy well-accepted to prevent infant influenza and pertussis, aims to provide passive immunity to infants by the transfer of maternal antibodies across the placenta.

A first-in-human study’s conclusion ‘strongly supports the development of the RSVpreF vaccine candidate to prevent RSV disease in infants, by immunizing pregnant women.’

The Phase 1/2 data are for the 18 to 49-year-old subgroup of a RSVpreF vaccine trial in non-pregnant adults in the US. The trial compared 3 dosages of the RSVpreF vaccine candidate, with and without aluminum hydroxide. The trial's results were presented at IDWeek, in Washington D.C., on October 5, 2019.

The candidate vaccine was reported to elicit RSV 50 percent neutralization titer geometric mean fold rises of 10.6 to 17.2 for subgroup A, and 10.4 to 19.8 for subgroup B, as measured 1 month postimmunization, with evidence of a dose-response.

This IDWeek presentation stated ‘the 10-20 fold increases in neutralizing antibody titers elicited by the RSVpreF vaccine with a stable prefusion F antigen represent a step-change relative to the historical performance of vaccine candidates, with F antigens that were not stabilized in the prefusion conformation.’

The RSVpreF vaccine candidate is currently in a phase 2b clinical trial in pregnant women in the USA

This is important news since there are about 33 million estimated cases of RSV annually in children less than 5 years of age.

The virus is spread from person to person via respiratory droplets and spreads into the respiratory tract, where it preferentially targets apical ciliated epithelial cells. The incubation period for RSV from the time of infection to onset of illness is between 3 and 5 days.

‘No vaccine is currently licensed for use specifically in pregnant women to protect infants, and Pfizer hopes to change that,’ said a Pfizer spokesperson.

‘These data strongly support the development of this vaccine candidate to prevent RSV disease in infants, by immunizing pregnant women, and to prevent RSV disease in older adults, by direct immunization,’ concluded these researchers.

Disclosure: This study was supported by Pfizer. Various researchers and presenters work for Pfizer.

RSV Vaccine information published by Precision Vaccinations

Sub Title:

RSVpreF vaccine candidate has the potential to prevent Respiratory Syncytial Virus disease in infants by immunizing pregnant women

References:

Phase 1/2, First-in-Human Study of the Safety, Tolerability, and Immunogenicity of a RSV Prefusion F-Based Subunit Vaccine Candi

Prevention of Pediatric Respiratory Syncytial Virus Lower Respiratory Tract Illness: Perspectives for the Next Decade

A PHASE 2B PLACEBO-CONTROLLED, RANDOMIZED STUDY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN PREGNANT WOMEN

The long road to protect infants against severe RSV lower respiratory tract illness

Image:

Age Groups:

Birth