Pneumonia due to respiratory syncytial virus

Advisers to the Centers for Disease Control and Prevention are weighing updates to their recommendation older adults get vaccinated for respiratory syncytial virus, discussing changes at a meeting Thursday that would more forcefully encourage some individuals receive a shot.At the meeting, the Advisory Committee on Immunization Practices reviewed safety and efficacy data on RSV vaccines sold by GSK and Pfizer, as well as clinical trial data for an experimental shot from Moderna thats nearing market.Currently, the CDC recommends adults 60 years or older discuss RSV vaccination with their physician a process known as shared clinical decisionmaking. Advisers debated whether, for some individuals at higher risk, a universal recommendation would be more appropriate. They wanted more data before making a decision, however, likely at a follow-up meeting scheduled for June 26 to June 28.The two approved vaccines from GSK and Pfizer, respectively sold as Arexvy and Abrysvo, hit the market last year for older adults. Both have sold well, but GSKs has claimed about two-thirds of the U.S market.Moderna aims to compete as well, and CDC advisers reviewed data from a Phase 3 trial of the companys RSV shot. The results showed the vaccine, dubbed mRNA-1345, was initially 84% effective in preventing RSV-related disease with two or more symptoms in adults 60 years or older. That efficacy appears to wane somewhat over time, as updated data show a 63% efficacy rate over a longer time period.Additionally, on Thursday, Pfizer released updated data on Abrysvos effectiveness, saying the shot was 78% effective through a second season in older adults. Pfizers disease definition was slightly different than Modernas however, measuring the vaccines prevention of disease with three or more symptoms.Moderna has submitted its vaccine for Food and Drug Administration approval, which is set to decide by mid-May. If approved, ACIP could recommend its use in June, Jefferies analyst Michael Yee wrote in a note to clients. But whether the ACIP recommends an annual or biennial vaccination routine might present risk for use of [Moderna], as GSK has suggested higher durability, Yee added.CDC advisers also discussed Thursday the risk of severe adverse events to the current vaccines from GSK and Pfizer.In particular, committee experts discussed Guillain-Barr syndrome, or GBS, an uncommon neurological condition that can cause muscle weakness and, in very rare instances, paralysis. In testing of their respective vaccines, GSK reported one case of GBS while Pfizer reported two.Out of the roughly 9.6 million RSV vaccine doses administered to date, there were 23 verified cases of GBS reported to a federal adverse event database, 15 with Abrysvo and 8 with Arexvy. In most of those cases, however, recipients also received another vaccine, such as for influenza, which can complicate analysis of the side effects cause.While CDC analysts found the data suggestive of a slight increase in GBS risk following RSV vaccination in older adults, they couldnt confirm a link. They also noted that any possible risk must be put in the context of the vaccines benefit.Amadea Bitton, a physician and ACIP panelist, said the benefits of vaccination against RSV still outweigh possible risks.Advisers also discussed the timing of vaccination and judged that shots in the late summer or early fall ahead of the typical RSV season would have the largest benefit. '

ABRYSVO, a bivalent vaccine, maintained consistently high protective efficacy for both RSV A and RSV B disease through two seasons after a single dose. ABRYSVO efficacy was 77.8% against RSV lower respiratory tract disease with three or more symptoms in a second full RSV season in adults 60 years of age or older. NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) today announced top-line ABRYSVO® vaccine efficacy and safety data for respiratory syncytial virus (RSV) in adults 60 years of age and older following a second season in the Northern and Southern Hemispheres from the ongoing pivotal Phase 3 clinical trial (NCT05035212) RENOIR (RSV vaccine Efficacy study iN Older adults Immunized against RSV disease). Vaccine efficacy against RSV-associated lower respiratory tract disease (LRTD), defined by three or more symptoms, after disease surveillance in season two was 77.8% (95.0% CI: 51.4, 91.1); vaccine efficacy following season one was 88.9% (95.0% CI: 53.6%, 98.7%)1, which demonstrates durable efficacy after two seasons. Consistent vaccine efficacy was demonstrated for both RSV A and RSV B after season two with vaccine efficacy against each subtype of ≥80% for LRTD with three or more symptoms. Vaccine efficacy was also sustained against less severe LRTD, defined by two or more symptoms, from 65.1% (95.0%% CI: 35.9%, 82.0%)1 after season one to 55.7% (95.0% CI: 34.7%, 70.4%) after the end of season two. Vaccine efficacy against RSV-associated LRTD, defined by three or more symptoms, across both seasons after approximately 16.4 months of disease surveillance was 81.5% (95.0% CI: 63.3, 91.6). No new adverse events were reported through the second RSV season beyond what was reported by subjects in the clinical trial during the first season. Pfizer is conducting post-marketing studies and surveillance programs to inform the safety pro ABRYSVO. “We are encouraged by the level of protection that we observed after two full RSV seasons for ABRYSVO,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. “This new data indicate that broad and durable protection against both types of RSV that cause disease, RSV A and RSV B, is the potential benefit to having a bivalent vaccine.” Pfizer intends to submit these data to regulatory authorities and vaccine technical committees. The company also intends to publish these findings in a peer-reviewed scientific journal and share them at an upcoming scientific congress. ABOUT RSV RSV is a contagious virus and a common cause of respiratory illness.2 The virus can affect the lungs and breathing passages of an infected individual and can potentially cause severe illness in young infants, older adults, and individuals with certain chronic medical conditions.3,4,5 In the United States alone, among older adults, RSV infections account for approximately 60,000-160,000 hospitalizations and 6,000-13,000 deaths each year.6,7,8,9,10,11,12,13,14 RSV disease is caused by the respiratory syncytial virus. There are two major subgroups of RSV: RSV A and RSV B. Both subgroups cause disease and can co-circulate or alternate predominance from season to season. ABOUT ABRYSVO Pfizer currently is the only company with an RSV vaccine to help protect older adults, as well as infants through maternal immunization. ABRYSVO is a bivalent vaccine that was designed to provide broad protection against all RSV-LRTD, regardless of the virus subgroup. The RSV fusion protein (F) in the prefusion conformation is a major target of virus infection blocking antibodies and is the basis of Pfizer’s RSV vaccine. Sequence variability in F between RSV subgroup A and B strains clusters in potent neutralizing antibody binding sites on prefusion F. In May 2023, the FDA approved ABRYSVO for the prevention of LRTD caused by RSV in individuals 60 years of age or older. ABRYSVO is a bivalent vaccine that was designed to provide broad protection regardless whether strain. This was followed by the ACIP’s recommendation of the vaccine for use in adults 60 years of age and older with shared clinical decision making, which occurred in June 2023. In August 2023, the FDA approved ABRYSVO for the prevention of LRTD and severe LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age. This was followed in September 2023 with ACIP’s recommendation for maternal immunization to help protect newborns from RSV seasonally where the vaccine should be administered from September through January in most of the continental United States. Also in August 2023, Pfizer announced that the European Medicines Agency (EMA) granted marketing authorization for ABRYSVO for both older adults and maternal immunization to help protect infants. The vaccine has also received approvals from la Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) of Argentina in September 2023; the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom in November 2023; Health Canada of Canada in January 2024; the Pharmaceutical Administration Bureau of Macau in February 2024; and for maternal immunization to help protect infants by the Ministry of Health, Labour, and Welfare of Japan in January 2024. Pfizer has also initiated two additional clinical trials evaluating ABRYSVO. One trial is being conducted in children ages two to less than 18 years who are at higher risk for RSV disease.15 A second trial is evaluating adults ages 18 to 59 years at higher risk for RSV due to underlying medical conditions such as asthma, diabetes and chronic obstructive pulmonary disease (COPD), and adults ages 18 and older who are immunocompromised and at high risk for RSV. INDICATIONS FOR ABRYSVO ABRYSVO™ is a vaccine indicated in the US for: the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in people 60 years of age and older pregnant individuals at 32 through 36 weeks gestational age for the prevention of LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age IMPORTANT SAFETY INFORMATION FOR ABRYSVO ABRYSVO should not be given to anyone with a history of severe allergic reaction (e.g., anaphylaxis) to any of its components For pregnant individuals: to avoid the potential risk of preterm birth, ABRYSVO should be given during 32 through 36 weeks gestational age Fainting can happen after getting injectable vaccines, including ABRYSVO. Precautions should be taken to avoid falling and injury during fainting Adults with weakened immune systems, including those receiving medicines that suppress the immune system, may have a reduced immune response to ABRYSVO Vaccination with ABRYSVO may not protect all people In adults 60 years of age and older, the most common side effects (≥10%) were fatigue, headache, pain at the injection site, and muscle pain In pregnant individuals, the most common side effects (≥10%) were pain at the injection site, headache, muscle pain, and nausea, In clinical trials where ABRYSVO was compared to placebo, infants born to pregnant individuals experienced low birth weight (5.1% ABRYSVO versus 4.4% placebo) and jaundice (7.2% ABRYSVO versus 6.7% placebo View the full ABRYSVO Prescribing Information. About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at . In addition, to learn more, please visit us on and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer. DISCLOSURE NOTICE: The information contained in this release is as of February 29, 2024. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about ABRYSVO, including its potential benefits, plans to submit season two data to regulatory authorities and vaccine technical committees, clinical trials initiated for ABRYSVO in other populations and post-marketing studies and surveillance programs for ABRYSVO, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of ABRYSVO; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when biologic license applications may be filed in particular jurisdictions for ABRYSVO for any potential indications; whether and when any applications that may be pending or filed for ABRYSVO may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether ABRYSVO for any such indications will be commercially successful; intellectual property and other litigation; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of ABRYSVO; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities regarding ABRYSVO and uncertainties regarding the commercial impact of any such recommendations; uncertainties regarding the impact of COVID-19 on our business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at and . 1 Walsh EE, Gonzalo PM, et al. “Efficacy and Safety of a Bivalent RSV Prefusion F Vaccine in Older Adults.” The New England Journal of Medicine. April 20, 2023. 2 Centers for Disease Control and Prevention. Respiratory Syncytial Virus Infection (RSV). . Updated December 18, 2020. 3 Centers for Disease Control and Prevention. RSV Transmission. . Updated December 18, 2020. 4 Centers for Disease Control and Prevention. Respiratory Syncytial Virus Infection (RSV) – Older Adults are at High Risk for Severe RSV Infection Fact Sheet. . 5 Centers for Disease Control and Prevention. RSV in Infants and Young Children. . 6 Centers for Disease Control and Prevention. RSV Surveillance & Research. . 7 Widmer K, Zhu Y, Williams JV, et al. Rates of Hospitalizations for Respiratory Syncytial Virus, Human Metapneumovirus, and Influenza Virus in Older Adults. J Infect Dis. 2012; 206(1):56-62. 8 Branche AR, Saiman L, Walsh EE, et al. Incidence of Respiratory Syncytial Virus Infection Among Hospitalized Adults, 2017–2020. CID. 2022;74(6):1004-1011. 9 McLaughlin JM, Khan F, Begier E, et al. Rates of Medically Attended RSV among US Adults: A Systematic Review and Meta-analysis. Open Forum Infect Dis. 2022; 9(7): ofac300. 10 Zheng Z, Warren JL, Shapiro ED, et al. Estimated Incidence of Respiratory Hospitalizations Attributable to RSV Infections across Age and Socioeconomic Groups. Pneumonia. 2022;14(1):6. 11 Centers for Disease Control and Prevention. October 2022 ACIP Meeting Slides. ACIP Adult RSV Work Group Considerations. Available at: . 12 Thompson WW, Shay DK, Weintraub E, et al. Mortality Associated with Influenza and Respiratory Syncytial Virus in the United States. JAMA. 2003; 289(2): 179.186. 13 Matias G, Taylor R, Haguinet F, et al. Estimates of Mortality Attributable to Influenza and RSV in the United States during 1997–2009 by Influenza Type or Subtype, Age, Cause of Death, and Risk Status. Influenza Other Respir Viruses. 2014; 8(5):507-15. 14 Hansen CL, Chaves SS, Demont C, Viboud C. Mortality Associated With Influenza and Respiratory Syncytial Virus in the US, 1999-2018.JAMA Network Open. 2022 Feb 1;5(2):e220527. 15 Pfizer Second-Quarter 2023 Earnings Teleconference Presentation, August 1, 2023, page, 24,

Preliminary results from phase III trial show primary endpoints met, with non-inferior immune responses observed in adults aged 50-59 compared to adults aged 60 and older Adults aged 50 and above with certain underlying medical conditions are at increased risk for RSV disease1 GSK is on track to be the first company to submit data in this population to regulators, with decisions on potential label expansion expected in 2024 PHILADELPHIA--(BUSINESS WIRE)-- GSK plc (LSE/NYSE: GSK) today announced positive preliminary results from its phase III trial [NCT05590403] evaluating the immune response and safety of AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) in adults aged 50 to 59, including those at increased risk of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) due to certain underlying medical conditions. These results will be presented at the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) meeting on October 25, 2023. This vaccine is currently approved in the US for active immunization for the prevention of RSV-LRTD in adults 60 years of age and older. It is also approved in Europe, Japan, and several other countries. The vaccine elicited an immune response in adults aged 50 to 59 at increased risk for RSV disease due to select underlying medical conditions that was non-inferior to that observed in adults aged 60 and above, meeting the trial’s primary co-endpoint. Vaccine efficacy has previously been demonstrated in adults aged 60 and above. The co-primary endpoint was also met for the broader group of adults aged 50 to 59 also enrolled in the trial. Safety and reactogenicity data were consistent with results from the initial phase III program. The most common local adverse event was pain, and most common systematic adverse events were fatigue and headache, most of which were transient and mild in intensity. Tony Wood, Chief Scientific Officer, GSK, said: “This trial reinforces our confidence in our RSV vaccine’s ability to help protect adults aged 50 to 59 at increased risk for RSV-LRTD. We will submit these data for regulatory review as quickly as possible with the goal of offering adults in this age group the option of a vaccine for the first time.” RSV is a common, contagious virus that can cause severe respiratory illness.2 Estimated rates of infection and hospitalization may be higher than reported in many high income countries, including the US.3 There is a substantial burden of RSV-associated illness for adults at increased risk for RSV disease due to advanced age, immunocompromised status, or underlying medical conditions, such as chronic obstructive pulmonary disease (COPD), asthma, and chronic heart failure. RSV can exacerbate these conditions and lead to pneumonia, hospitalization, or death.4 Final results from this trial will be presented at an upcoming medical conference and submitted for peer-reviewed publication. The data will also be submitted to the US Food and Drug Administration (FDA) and other regulators to support potential label expansions. Trial Design NCT05590403 is a phase III, placebo-controlled, observer-blind, randomized, multi-country immunogenicity trial to evaluate the non-inferiority of the immune response and evaluate safety in participants aged 50 to 59 at increased risk of RSV-LRTD compared to older adults aged 60 years and above after a single dose of GSK’s RSV vaccine. Immune response in participants aged 50 to 59 with pre-defined stable chronic diseases leading to an increased risk of RSV disease was assessed (n=570). These included participants with chronic pulmonary disease, chronic cardiovascular disease, diabetes, chronic kidney disease or chronic liver disease. Immune responses in a broader group of participants aged 50 to 59 without these pre-defined chronic diseases (n=570) was also evaluated compared to adults aged 60 and older. Approximately 1,520 participants were enrolled across eight countries. The trial’s primary endpoints were RSV-A and RSV-B neutralization titers of both groups of 50 to 59 year olds at one month after the vaccine administration compared to adults aged 60 and older. There were also safety and immunogenicity secondary and tertiary endpoints. The trial is ongoing to collect further immune data at six months and 12 months after vaccine administration. About AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) AREXVY contains recombinant respiratory syncytial virus glycoprotein F stabilized in the prefusion conformation (RSVPreF3). This antigen is combined with GSK’s proprietary AS01E adjuvant. The vaccine was approved by the US FDA on May 3, 2023, for the prevention of LRTD caused by RSV in individuals 60 years of age and older. In June 2023, the European Commission authorized the vaccine for active immunization for the prevention of LRTD caused by RSV in adults aged 60 years and older. In September 2023, Japan’s Ministry of Health, Labor and Welfare approved the vaccine for the prevention of RSV disease for adults aged 60 years and above. The vaccine has also been approved in the UK and Canada. Regulatory reviews in other countries are ongoing. The proposed trade name remains subject to regulatory approval in other markets. The GSK proprietary AS01 adjuvant system contains QS-21 STIMULON adjuvant licensed from Antigenics Inc., a wholly owned subsidiary of Agenus Inc. Please see the full US Prescribing Information: Indication for AREXVY AREXVY is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in individuals 60 years of age and older. Important Safety Information for AREXVY AREXVY is contraindicated in anyone with a history of a severe allergic reaction (eg, anaphylaxis) to any component of AREXVY Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of AREXVY Syncope (fainting) may occur in association with administration of injectable vaccines, including AREXVY. Procedures should be in place to avoid injury from fainting Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished immune response to AREXVY​ The most commonly reported adverse reactions (≥10%) were injection site pain (60.9%), fatigue (33.6%), myalgia (28.9%), headache (27.2%), and arthralgia (18.1%) Vaccination with AREXVY may not result in protection of all vaccine recipients Please see full Prescribing Information. About RSV in Adults RSV is a common contagious virus affecting the lungs and breathing passages.2 Adults can be at increased risk for RSV disease due to comorbidities, immune compromised status, or advanced age.4 RSV can exacerbate conditions, including COPD, asthma, and chronic heart failure and can lead to severe outcomes, such as pneumonia, hospitalization, and death.4 Each year, approximately 177,000 adults 65 years and older are hospitalized in the US due to RSV; an estimated 14,000 cases result in death.5 For adults 60 and older, data suggest an increased risk for severe RSV infection that can lead to hospitalization.6,7 About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Risk factors” in the company's Annual Report on Form 20-F for 2022, and Q2 Results for 2023 and any impacts of the COVID-19 pandemic. Registered in England & Wales: No. 3888792 Registered Office: 980 Great West Road Brentford, Middlesex TW8 9GS References 1. Branche et al. Incidence of Respiratory Syncytial Virus Infection Among Hospitalized Adults, 2017-2020. Clin Infect Dis 2022:74:1004–1011. 2. National Foundation for Infectious Diseases. Respiratory Syncytial Virus. Accessed October 2023. Available at: 3. Savic M, Penders Y, Shi T, Branche A, Pirçon J-Y. Respiratory syncytial virus disease burden in adults aged 60 years and older in high-income countries: a systematic literature review and meta-analysis. Influenza Other Respir Viruses 2022 2023; 17:e13031. 4. Centers for Disease Control and Prevention. RSV in Older Adults and Adults with Chronic Medical Conditions. Accessed October 2023. Available at: 5. Falsey AR, et al. N Engl J Med 2005; 352:1749-1759 DOI: 10.1056/NEJMoa043951. Accessed October 2023. 6. Tseng HF, Sy LS, Ackerson B, et al. Severe morbidity and short- and mid- to long-term mortality in older adults hospitalized with respiratory syncytial virus infection. J Infect Dis. 2020;222(8):1298-1310. doi:10.1093/infdis/jiaa361. 7. Belongia EA, King JP, Kieke BA, et al. Clinical features, severity, and incidence of RSV illness during 12 consecutive seasons in a community cohort of adults ≥60 years old. Open Forum Infect Dis. 2018;5(12):ofy316. doi:10.1093/ofid/ofy316.