Delving into the Latest Updates on RSVpreF with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine

Synonyms

recombinant respiratory syncytial virus pre-fusion F protein, water for injections(Pfizer), Respiratory Syncytial Virus Vaccine, PF 06928316

+ [4]

Target

RSV F protein

Mechanism

Respiratory syncytial virus F protein modulators(Respiratory syncytial virus F protein modulators)

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

Respiratory Syncytial Virus InfectionsLower Respiratory Tract InfectionsInfluenza, Human+ [1]

Inactive Indication-

Originator Organization

Pfizer Inc.

Active Organization

Pfizer Inc.Pfizer Europe MA EEIG

Pfizer Australia Pty Ltd.

+ [1]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

CA (04 Jan 2023),

Lower Respiratory Tract Infections

RegulationPriority Review (US), Breakthrough Therapy (US), Fast Track (US)

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The purpose of the study is to learn about the safety and immune activity of the RSVpreF vaccine. It will be studied in infants born to mothers living with HIV. These infants may have higher chances of getting sick or dying due to RSV infection. Respiratory Syncytial Virus (RSV) is a common type of virus (germ) that can cause severe illness (airway diseases), where medical help is needed. Vaccines help your body make antibodies which help fight against diseases. The antibodies are substances your body uses to fight off an infection. The antibodies can be passed to the infant through the placenta of the mother.
The study will look at the safety, tolerability, and immune activity in mothers and their infants.
This study is seeking pregnant women who are:
Less than or equal to 49 years old and have HIV (Human immunodeficiency virus -
Receiving standard medical care during the pregnancy
Do not have syphilis (bacterial sexually transmitted disease), Hepatitis B Virus ((HBV) liver infection), Tuberculosis ((TB) bacterial lung infection).
Have been on stable (anti-retroviral) HIV treatment for more than or equal to 90 days.
agree to be present for all study visits, procedures, and blood draws.
Participants will either receive:
RSVpreF vaccine
A placebo. A placebo does not have any medicine it but looks just like the study vaccine.
Pregnant participants will be involved in the study from:
consent during their current pregnancy, and
for 6 months after delivery of their baby (around 10 months in total). Pregnant participants will have at least 5 planned visits in this study. Infant participants: All eligible babies born to enrolled mothers will be followed up from birth for up to 6 months. Infant participants will have at least 3 study visits, with some site visits allowed to happen via home visits or over the telephone.

Start Date12 Mar 2024

Sponsor / Collaborator

Pfizer Inc.

NCT06077968 / RecruitingNot Applicable

Retrospective Study Evaluating ABRYSVO Vaccine Effectiveness Against Severe Lower Respiratory Tract Infection in Older Adults

The main purpose of this study is to learn about the effectiveness of Pfizer's ABRYSVO vaccine. This vaccine helps to prevent infections caused by Respiratory Syncytial Virus (RSV). RSV is a virus that can cause infections in the airways. These symptoms can be cold-like symptoms, but in some cases can lead to severe symptoms or hospitalization.
This study uses only healthcare data that are already collected from routine visits to healthcare providers. This means that participants will not be actively enrolled in the study and there are no study treatments. The study will look at data for about two years. This study will look at patient information from:
Adults ages 60 years and older
Are eligible to receive the ABRYSVO vaccination

Start Date01 Nov 2023

Sponsor / Collaborator

Pfizer Inc.

[+1]

NCT05900154 / CompletedPhase 1

A PHASE 1, OPEN-LABEL, AGE-DESCENDING, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE (RSVpreF) IN CHILDREN 2 TO <18 YEARS OF AGE

The purpose of this study is to learn about the safety and immune activity of the vaccine (called RSVpreF) in children 2 to <18 years of age.
This study will identify the dose level to be used in Phase 2/3 trials in this age cohort. All participants will receive one injection of RSVpreF. This study has four study visits, two in-clinic and two telehealth visits. Blood samples will be collected for testing. This study is about 6 months long for each participant and will be conducted in the United States.

Start Date22 Jun 2023

Sponsor / Collaborator

Pfizer Inc.

100 Clinical Results associated with RSVpreF

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100 Translational Medicine associated with RSVpreF

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100 Patents (Medical) associated with RSVpreF

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56

Literatures (Medical) associated with RSVpreF

01 Dec 2023·Lancet regional health. Americas

Cost-effectiveness analysis of nirsevimab and maternal RSVpreF vaccine strategies for prevention of Respiratory Syncytial Virus disease among infants in Canada: a simulation study

Article

Author: Moghadas, Seyed M ; Halperin, Scott A ; Shoukat, Affan ; Langley, Joanne M ; Galvani, Alison P ; Abdollahi, Elaheh

Background:

The cost-effectiveness of immunisation strategies with a long-acting monoclonal antibody (nirsevimab) and/or a protein-based maternal vaccine (RSVpreF) for protecting infants from Respiratory Syncytial Virus (RSV)-associated illness has not been previously determined for Canada. We estimated the health benefits and cost-effectiveness of nirsevimab for immunising the entire birth cohort, regardless of gestational age or other risk factors. Additionally, we evaluated the health benefits and cost-effectiveness of a combined strategy of year-round vaccination of pregnant women with RSVpreF and immunisation of infants at high risk, including those born preterm or with chronic conditions, with nirsevimab during the RSV season.

Methods:

We developed a discrete-event simulation model, parameterized with the data on medically-attended RSV infections among infants under one year of age from 2010 to 2019, including outpatient care, hospitalisations, and deaths. Intervention scenarios targeting twelve monthly birth cohorts and pregnant women, reflecting the 2021 census data for Ontario, Canada were evaluated over a follow-up time horizon of one year from birth. Taking into account the costs (in 2023 Canadian dollars) associated with RSV-related outcomes, we calculated the net monetary benefit using the quality-adjusted life-year (QALY) gained. Further, we determined the range of price-per-dose (PPD) for nirsevimab and RSVpreF within which the program was cost-effective. Cost-effectiveness analyses were conducted from both healthcare and societal perspectives.

Findings:

Using a willingness-to-pay of CAD$50,000 per QALY gained, we found that immunising the entire birth cohort with nirsevimab would be cost-effective from a societal perspective for a PPD of up to $290, with an annual budget impact of $83,978 for 1113 infants per 100,000 population. An alternative, combined strategy of vaccinating pregnant women and immunising only infants at high risk of severe disease would lead to a lower budget impact of $49,473 per 100,000 population with a PPD of $290 and $195 for nirsevimab and RSVpreF vaccine, respectively. This combined strategy would reduce infant mortality by 76%-85%, comparable to a 78% reduction achieved through a nirsevimab-only program of the entire birth cohort. The PPD for cost-effective programs with nirsevimab was sensitive to the target population among infants.

Interpretation:

Passive immunisation of infants under 6 months of age with nirsevimab and vaccination of pregnant women with RSVpreF could be a cost-effective strategy for protecting infants during their first RSV season.

Funding:

This study was supported by the Canadian Immunisation Research Network (CIRN) and the Canadian Institutes of Health Research (CIHR). Seyed M. Moghadas acknowledges support from the Natural Sciences and Engineering Research Council of Canada (MfPH and Discovery grants). Alison P. Galvani acknowledges support from the The Notsew Orm Sands Foundation.

01 Dec 2023·Indian journal of pediatrics

Respiratory Syncytial Virus Infection: An Update

Review

Author: Soni, Akshita ; Kabra, S K ; Lodha, Rakesh

Respiratory syncytial virus (RSV) is a highly contagious respiratory virus that can cause mild to severe illness in children. It is the leading cause of lower respiratory tract infections (LRTI) in children under the age of one year, and it can also affect older children and adults, especially those with underlying medical conditions. In the post-COVID period, there seems to be an increase in the incidence, possibly due to 'immunity debt'. Symptoms of RSV infection in children may include fever, runny nose, and cough. In severe cases, it can lead to bronchiolitis (inflammation of the small airways in the lungs) or pneumonia (infection of the lungs). Most children with RSV infection recover within a week or two, but some may require hospitalization, especially those who are premature or have underlying medical conditions. As there is no specific treatment for RSV infection, supportive care is the mainstay of management. In severe cases, oxygen therapy or mechanical ventilation may be necessary. High flow nasal cannula seems to be beneficial. There have been promising advances in development of RSV vaccines; few trials in adults and pregnant women have reported encouraging results. The US FDA has approved two RSV vaccines for use in older adults (GSK's Arexvy and Pfizer's ABRYSVO).

01 Nov 2023·Paediatric drugs

Respiratory Syncytial Virus Prefusion F Subunit Vaccine: First Approval of a Maternal Vaccine to Protect Infants.

Review

Author: Syed, Yahiya Y

Pfizer is developing a bivalent respiratory syncytial virus (RSV) prefusion F subunit vaccine (RSVpreF; ABRYSVO™) for preventing RSV illness in infants and individuals aged ≥ 60 years. RSVpreF received approval for vaccination of pregnant individuals to help protect infants against RSV illness on 21 August 2023 in the USA. RSVpreF is also approved in the USA (31 May 2023) for active immunization of individuals aged ≥ 60 years for the prevention of lower respiratory tract disease (LRTD) caused by RSV. In the EU, RSVpreF has received approval for both indications, and it has been submitted for regulatory approval in Canada (both indications) and in Japan (maternal immunization to protect infants). This article summarizes the milestones in the development of RSVpreF leading to the approval for use in pregnant individuals to prevent LRTD in infants.

150

News (Medical) associated with RSVpreF

26 Jun 2024

·firstwordpharma.com

Moderna reports waning efficacy for RSV jab as CDC committee backs shots for 75-and-up group

Moderna shares sank 11% on Wednesday after the biotech revealed 18-month efficacy data for its newly approved respiratory syncytial virus (RSV) vaccine mRESVIA (mRNA-1345). The results, presented before a panel of advisors to the US Centers for Disease Control and Prevention (CDC), showed that mRESVIA's effectiveness waned substantially compared to rival RSV vaccines from GSK and Pfizer.The CDC's Advisory Committee on Immunization Practices (ACIP) convened this week to vote on which patient groups should receive RSV, influenza, COVID-19 and other vaccines this fall.US regulators late last month approved mRESVIA – based on the same mRNA technology Moderna uses for its COVID-19 vaccine Spikevax – to protect adults 60 and older from lower respiratory tract disease (LRTD) caused by RSV infection. The shot is expected to be available in time for the start of this fall's RSV season.Efficacy dwindles to about 50%According to Moderna's ACIP presentation, mRESVIA demonstrated 50.3% efficacy at preventing RSV-related LRTD with two or more symptoms after 18 months, and 49.9% efficacy at preventing more serious infection involving at least three symptoms over the same time period. That stands in stark contrast to the vaccine's initial potency of 83.7% reported at 3.7 months in an earlier analysis.A spokesperson for Moderna offered some context, saying that "immunity from RSV is not lifelong, and as with all currently licensed RSV vaccines, mRESVIA demonstrates waning (effectiveness) over time." The biotech is banking on mRESVIA's convenience factor to differentiate it in the market, highlighting its availability in pre-filled syringes to make it easier to administer.Lagging behind rivalsStill, the longer-term data raise concerns about mRESVIA's ability to carve out its own niche in RSV while facing two competitors, both of which were approved by the FDA last year for people aged 60-plus.A single dose of GSK's Arexvy reduced symptomatic RSV LRTD by 82.6% during the first RSV season compared to placebo, and by 56.1% during the second RSV season. Meanwhile, Pfizer's Abrysvo was found to be 77.8% effective against RSV-associated LRTD with three or more symptoms through two seasons.Evercore ISI analysts suggested that "GSK's Arexvy still appears to have the most impressive VE (vaccine efficacy) of the group, which we believe will help it to maintain majority market share." Arexvy generated about $1.5 billion in sales last year, followed by Pfizer's Abrysvo at $890 million, although a recent tender win in the UK could see Pfizer's shot turn up the heat. For more, see – Spotlight On: Domestic setback for GSK's RSV vaccine could show Pfizer means business.Analysts have projected mRESVIA sales of $397 million this year, potentially reaching blockbuster status with $1.5 billion in sales by 2026.Pfizer's vaccine is also approved for maternal use to protect infants and the company is hoping to grow that to all at-risk adults aged 18 and older, while GSK's shot was recently greenlit for people ages 50 to 59 who are at high risk of severe RSV.ACIP votes to broaden RSV useMeanwhile, the CDC's ACIP panel unanimously recommended late Wednesday that RSV vaccines be given to all people ages 75 and older if they have not yet had one, as well as to those aged 60 to 74 at risk of severe disease because they have other health conditions. If the CDC director ultimately waves through the policy recommendation, that would be a step-up from previous guidance, which said that older adults may be offered a vaccine, but stopped short of saying they should be given a shot.

VaccineDrug ApprovalmRNAClinical ResultClinical Study

24 Jun 2024

·www.fiercepharma.com

Rallying in RSV vaccine race, Pfizer gains contract win over GSK in the UK

GSK got off to a head start in its RSV vaccine battle with Pfizer. But the U.S. company is gaining ground, evidenced by winning a supply contract on GSK's home turf. After losing round one of its respiratory syncytial virus (RSV) vaccine bout with GSK, Pfizer is rallying. And what better way to do it than to win a major contract in your rival’s home country? The U.K. government has selected Pfizer to supply 5 million doses of its RSV shot Abrysvo over the next two years. The notice was posted earlier this month on the U.K. government's "Find a Tender" website, with the contract value withheld “so as not to prejudice the legitimate commercial interest of the supplier,” it explained. On Monday morning, the U.K. introduced its RSV immunization program, with instructions on how patients can receive their shots of Abrysvo. The vaccine is expected to become available in early August, the U.K. said. It’s a big win for the U.S. company which has been playing catch-up against its rival since GSK became the first drugmaker to score an FDA approval in the indication in May of last year for its shot Arexvy. Four weeks later, Pfizer gained its nod. The head-start gave GSK a key edge in commercializing its shot last year as it reported revenue of Arexvy at 1.238 billion pounds ($1.5 billion), compared to $890 million for Abrysvo, with most of the sales for both companies coming in the U.S. In the fourth quarter of last year, however, Pfizer showed its was making progress as its sales of Abrysvo increased sequentially from $375 million to $515 million. The boost was aided by an FDA approval of Abrysvo in August to vaccinate pregnant mothers. Arexvy’s approval was limited to adults ages 60 and older before it was expanded earlier this month to at-risk adults ages 50 and older. In July of last year, Sanofi and AstraZeneca scored a green light for Beyfortus to protect babies up to 24 months of age. In the U.S., Pfizer lists Abrysvo’s wholesale acquisition (PDF) cost at $295 per shot compared to $280 for Arexvy (PDF). The performance of the vaccines is comparable. In year one, while Arexvy has shown 94% effectiveness at protecting against severe disease, Abrysvo's trial result came in at 89%.

Drug ApprovalVaccineClinical ResultmRNAClinical Study

24 Jun 2024

·firstwordpharma.com

GSK loses out to Pfizer in supplying domestic market with RSV vaccine

GSK lost out to a key rival in the battle to supply respiratory syncytial virus (RSV) vaccines for the UK’s upcoming immunisation programme, dealing a blow to the drugmaker on its home turf. In documents published Monday, the UK Health Security Agency said that Pfizer’s RSV shot Abrysvo has been chosen ahead of GSK’s Arexvy.The UK’s immunisation programme will kick off at the start of September, targeting adults aged between 75 years and 79 years, as well as pregnant women to protect their infants. The Health Security Agency noted that Abrysvo will be used in both groups.Pfizer’s shot is approved for use in the two groups, while GSK’s jab is only authorised for use in older adults. The two products carry list prices of $295 and $280, respectively, in the US, although discounts are typically offered to government tenders, such as for the UK’s programme.According to Bloomberg – citing the contents of a redacted contract published earlier this month – Pfizer will supply over 3.5 million doses of Abrysvo for older adults and more than 1.4 million doses to pregnant mothers in England and Northern Ireland over the next two years. While further details were not disclosed, a Pfizer spokesperson said that the contract followed a competitive tender process.GSK’s vaccine has so far been leading the sales battle of the RSV vaccines, bringing in revenue of £1.2 billion ($1.5 billion) last year, compared with $890 million for Pfizer’s shot.

VaccineDrug ApprovalClinical Study

100 Deals associated with RSVpreF

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Respiratory Syncytial Virus Infections	US	Pfizer Inc.	31 May 2023
Lower Respiratory Tract Infections	CA	Pfizer Canada ULC	04 Jan 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Influenza, Human	Phase 3	AU	Pfizer Inc.	13 Apr 2022
Respiratory Tract Infections	Phase 3	US	Pfizer Inc.	17 Jun 2020
Respiratory Tract Infections	Phase 3	JP	Pfizer Inc.	17 Jun 2020
Respiratory Tract Infections	Phase 3	AR	Pfizer Inc.	17 Jun 2020
Respiratory Tract Infections	Phase 3	AU	Pfizer Inc.	17 Jun 2020
Respiratory Tract Infections	Phase 3	BR	Pfizer Inc.	17 Jun 2020
Respiratory Tract Infections	Phase 3	CA	Pfizer Inc.	17 Jun 2020
Respiratory Tract Infections	Phase 3	CL	Pfizer Inc.	17 Jun 2020
Respiratory Tract Infections	Phase 3	DK	Pfizer Inc.	17 Jun 2020
Respiratory Tract Infections	Phase 3	FI	Pfizer Inc.	17 Jun 2020

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05842967 (MONeT, Corporate Publications) Manual	Phase 3	Asthma \| Diabetes Mellitus \| Pulmonary Disease, Chronic Obstructive ... View more	-	ABRYSVO	ztjuzfjvhu(qczmdagoaw) = Participants demonstrated RSV-A and RSV-B subgroup neutralizing responses non-inferior to the response seen in the Phase 3 (NCT05035212) RENOIR study of ABRYSVO in more than 34,000 adults aged 60 or older where vaccine efficacy was previously demonstrated. fpucwlezxv (shahcjweok ) Met View more	Positive	09 Apr 2024
NCT05035212 (RENOIR, Biospace) Manual	Phase 3	Respiratory Syncytial Virus Infections	-	ABRYSVO (three or more symptoms)	phhcbryxkm(ylnplsjavb) = rgrdyovlio okkojzwsop (giyfnypoun, 51.4 ~ 91.1) View more	Positive	29 Mar 2024
				ABRYSVO (two or more symptoms)	phhcbryxkm(ylnplsjavb) = xpifaxgzqj okkojzwsop (giyfnypoun, 34.7 ~ 70.4) View more
RENOIR (NEWS) Manual	Not Applicable	Respiratory Syncytial Virus Infections	-	Abrysvo (older adults with two or more symptoms of RSV)	nplvdvaexc(hzckpbqyul) = xqfovdepry uziajilhnf (gxaebcqzcz )	Positive	29 Nov 2023
				Abrysvo (older adults with two or more symptoms)	nplvdvaexc(hzckpbqyul) = uabigckhoh uziajilhnf (gxaebcqzcz )
MATISSE (NEWS) Manual	Not Applicable	Respiratory Syncytial Virus Infections	-	Abrysvo (first 90 days after birth)	mhijhgpbzi(edrcqszwdn) = lxfrfqbqjs dtvsasjlxq (aevbnivkoi )	Positive	29 Nov 2023
				Abrysvo (within 180 days)	mhijhgpbzi(edrcqszwdn) = swvliyfqlc dtvsasjlxq (aevbnivkoi )
NCT05301322 (CTgov)	Phase 3	Influenza, Human \| Respiratory Syncytial Virus Infections	1,471	SIIV+RSVpreF (RSVpreF + SIIV: Coadministration Group)	wgpwwqgigf(aqwfkrzcif) = gamilrppfy afvizrzduf (ucprblncwt, ceohmzpjlx - afnzajdxmc) View more	-	27 Oct 2023
				Placebo (Placebo: Coadministration Group)	wgpwwqgigf(aqwfkrzcif) = pvlrlwwoio afvizrzduf (ucprblncwt, tyrjwjmeng - ywfkmivzkp) View more
NCT04424316 (FDA) Manual	Phase 3	Respiratory Syncytial Virus Infections	7,392	Abrysvo	osahpbwxxa(kaekpdbosb) = nwpynforbn qopvbrwvzk (ilubkjexii, 31.2 - 73.5) View more	Positive	23 Aug 2023
				Placebo	-
NCT05035212 (FDA) Manual	Phase 3	Respiratory Syncytial Virus Infections	34,383	ABRYSVO	eunwdtpuyk(arohprrmks) = kgywyilkhs gmrozdzxwa (livqumwanj ) View more	Positive	31 May 2023
				Placebo	eunwdtpuyk(arohprrmks) = ubidylwyit gmrozdzxwa (livqumwanj ) View more
NCT04424316 (MATISSE, Corporate Publications) Manual	Phase 3	Respiratory Syncytial Virus Infections	-	RSVpreF	sxlzcmpqav(julixbpfzx) = yjtiyhsiyq klrbvtbldi (cqwdhofgau ) View more	Positive	01 Nov 2022
				Placebo	-
NCT03529773 (Pubmed \| Am J Trop Med Hyg) Manual	Phase 1/2	Respiratory Syncytial Virus Infections	618	RSVpreF	atkgqgydcl(jmbcnaylbj) = RSVpreF recipients more frequently reported local reactions and systemic events than placebo recipients; these were mostly mild or moderate. lotryiuzyn (snshmotxxn ) View more	Positive	21 Dec 2021
				Placebo