“We’re thrilled that ABRYSVO is now authorised within the EU to assist stop RSV in adults aged 18 and older, which causes roughly 158,000 grownup hospital admissions yearly from RSV illness, a standard respiratory virus with signs that may be extreme and even life-threatening,” stated Alexandre de Germay, Chief Worldwide Industrial Officer, Government Vice President, Pfizer. “With a sign that additionally contains pregnant people between weeks 24 and 36 gestation to assist shield infants from delivery as much as 6 months of age, ABRYSVO’s expanded authorization for adults aged 18 to 59 within the EU signifies one other step for public well being by providing the potential to considerably cut back the burden of RSV in future seasons.”
The amended advertising authorization follows the latest optimistic opinion from the Committee for Medicinal Merchandise for Human Use (CHMP). The authorization is legitimate in all 27 EU member states plus Iceland, Liechtenstein, and Norway. The approval is predicated on outcomes from the pivotal section 3 medical trial ( NCT05842967 ) MONeT (RSV I M munizati ON Research for Adul T s at Larger Threat of Extreme Sickness), which investigated the security, tolerability, and immunogenicity of ABRYSVO in adults 18 by means of 59 years of age prone to RSV-associated LRTD resulting from sure persistent medical circumstances. It was additionally supported by the 1000’s of individuals vaccinated in medical trials involving ABRYSVO on this age group. 1,2,3,4 The outcomes of MONeT and different research have been revealed in peer-reviewed journals.
ABOUT RSV Respiratory Syncytial Virus (RSV) is a contagious virus and a standard reason behind respiratory sickness worldwide. 5 The virus can have an effect on the lungs and respiratory passages of an contaminated particular person, doubtlessly inflicting extreme sickness or loss of life. 6,7,8 There are two main subgroups of RSV: RSV-A and RSV-B. 9 Each subgroups trigger illness and may co-circulate or alternate predominance from season to season. In whole, RSV causes roughly 158,000 hospital admissions yearly amongst adults aged 18 and older throughout the EU, with an estimated 13,000 hospitalizations in these aged 18 to 64 years. 10
ABOUT ABRYSVO ABRYSVO is an unadjuvanted, bivalent vaccine that was designed to offer safety towards RSV-LRTD, whatever the virus subgroup. Within the prefusion state, the RSV fusion protein (F) is a significant goal of neutralizing antibodies, serving as the idea of Pfizer’s RSV vaccine. Variations within the F protein sequence amongst RSV-A and RSV-B subgroups are clustered in a key antigenic web site, a goal for potent neutralizing antibodies.
In August 2023, Pfizer introduced that the European Fee granted advertising authorization for ABRYSVO for each adults aged 60 years and older and maternal immunization to assist shield infants.
In the usin October 2024, the FDA authorised ABRYSVO for the prevention of decrease respiratory tract illness brought on by RSV in people 18 by means of 59 years of age who’re at elevated threat for LRTD brought on by RSV. Prior, in Might 2023, the FDA authorised ABRYSVO for the prevention of LRTD brought on by RSV in people 60 years of age and older. In August 2023, the FDA authorised ABRYSVO for the prevention of LRTD and extreme LRTD brought on by RSV in infants from delivery as much as 6 months of age by lively immunization of pregnant people at 32 by means of 36 weeks gestational age.
Along with the newest EU approval, ABRYSVO has obtained approvals for each indications in a number of nations worldwide.
U.S. INDICATIONS FOR ABRYSVO
ABRYSVO ® is a vaccine indicated within the U.S. for:
the prevention of decrease respiratory tract illness (LRTD) brought on by respiratory syncytial virus (RSV) in folks 60 years of age and older the prevention of LRTD brought on by RSV in folks 18 by means of 59 years of age who’re at elevated threat for LRTD brought on by RSV pregnant people at 32 by means of 36 weeks gestational age for the prevention of LRTD and extreme LRTD brought on by RSV in infants from delivery by means of 6 months of age
IMPORTANT U.S. SAFETY INFORMATION FOR ABRYSVO
ABRYSVO shouldn’t be given to anybody with a historical past of extreme allergic response (e.g., anaphylaxis) to any of its elements An elevated threat of Guillain-Barré syndrome (extreme muscle weak point) was noticed after vaccination with ABRYSVO For pregnant people: to keep away from the potential threat of preterm delivery, ABRYSVO must be given throughout 32 by means of 36 weeks gestational age Fainting can occur after getting injectable vaccines, together with ABRYSVO. Precautions must be taken to keep away from falling and harm throughout fainting Adults with weakened immune methods, together with these receiving medicines that suppress the immune system, could have a decreased immune response to ABRYSVO Vaccination with ABRYSVO could not shield all folks In adults 60 years of age and older, the commonest uncomfortable side effects (≥10%) have been fatigue, headache, ache on the injection web site, and muscle ache In adults 18 by means of 59 years of age, the commonest uncomfortable side effects (≥10%) have been ache on the injection web site, muscle ache, joint ache, and nausea In pregnant people, the commonest uncomfortable side effects (≥10%) have been ache on the injection web site, headache, muscle ache, and nausea In medical trials the place ABRYSVO was in comparison with placebo, infants born to pregnant people skilled low delivery weight (5.1% ABRYSVO versus 4.4% placebo) and jaundice (7.2% ABRYSVO versus 6.7% placebo)
View the complete ABRYSVO Prescribing Data .
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DISCLOSURE NOTICE: The data contained on this launch is as of April 1, 2025. Pfizer assumes no obligation to replace forward-looking statements contained on this launch as the results of new data or future occasions or developments.
This launch comprises forward-looking details about ABRYSVO, together with its potential advantages and an approval within the EU to increase the indication to incorporate prevention of LRTD brought on by RSV in people 18 by means of 59 years of age, that entails substantial dangers and uncertainties that might trigger precise outcomes to vary materially from these expressed or implied by such statements. Dangers and uncertainties embody, amongst different issues, uncertainties relating to the industrial success of ABRYSVO; the uncertainties inherent in analysis and improvement, together with the flexibility to satisfy anticipated medical endpoints, graduation and/or completion dates for our medical trials, regulatory submission dates, regulatory approval dates and/or launch dates, in addition to the potential of unfavorable new medical knowledge and additional analyses of present medical knowledge; dangers related to interim knowledge; the chance that medical trial knowledge are topic to differing interpretations and assessments by regulatory authorities; whether or not regulatory authorities will probably be glad with the design of and outcomes from our medical research; whether or not and when biologic license purposes could also be filed specifically jurisdictions for ABRYSVO for any potential indications; whether or not and when any purposes that could be pending or filed for ABRYSVO could also be authorised by regulatory authorities, which can rely on myriad components, together with making a willpower as as to whether the product’s advantages outweigh its identified dangers and willpower of the product’s efficacy and, if authorised, whether or not ABRYSVO for any such indications will probably be commercially profitable; mental property and different litigation; selections by regulatory authorities impacting labeling, manufacturing processes, security and/or different issues that might have an effect on the provision or industrial potential of ABRYSVO; uncertainties relating to the flexibility to acquire or preserve suggestions from vaccine advisory or technical committees and different public well being authorities relating to ABRYSVO and uncertainties relating to the industrial affect of any such suggestions; uncertainties relating to the affect of COVID-19 on our enterprise, operations and monetary outcomes; and aggressive developments.
An extra description of dangers and uncertainties may be present in Pfizer’s Annual Report on Kind 10-Okay for the fiscal yr ended December 31, 2024, and in its subsequent studies on Kind 10-Q, together with within the sections thereof captioned “Threat Components” and “Ahead-Trying Data and Components That Might Have an effect on Future Outcomes”, in addition to in its subsequent studies on Kind 8-Okay, all of that are filed with the U.S. Securities and Change Fee and obtainable at www.sec.gov and www.Pfizer.com .
1 Walsh EE, Falsey AR, Scott DA, et al. A Randomized Section 1/2 Research of a Respiratory Syncytial Virus Prefusion F Vaccine. J Infect Dis. 2022 Apr 19;225(8):1357-1366.
2 Schmoele-Thoma B, Zareba AM, Jiang Q, et al. Vaccine Efficacy in Adults in a Respiratory Syncytial Virus Problem Research. N Engl J Med. 2022 Jun 23;386(25):2377-2386. doi: 10.1056/NEJMoa2116154.
3 Baker J, Aliabadi N, Munjal I, et al. Equal immunogenicity throughout three RSVpreF vaccine tons in wholesome adults 18-49 years of age: Outcomes of a randomized section 3 research. Vaccine. 2024 Might 10;42(13):3172-3179. doi: 10.1016/j.vaccine.2024.03.070. Epub 2024 Apr 16.
4 Peterson JT, Zareba AM, Fitz-Patrick D, et al. Security and Immunogenicity of a Respiratory Syncytial Virus Prefusion F Vaccine When Coadministered With a Tetanus, Diphtheria, and Acellular Pertussis Vaccine. J Infect Dis. 2022 Jun 15;225(12):2077-2086. doi: 10.1093/infdis/jiab505.
5 World Well being Group. Respiratory Syncytial Virus (RSV) illness.
6 World Well being Group. Respiratory Syncytial Virus (RSV).
7 Facilities for Illness Management and Prevention. Respiratory Syncytial Virus An infection (RSV) – Older Adults are at Excessive Threat for Extreme RSV An infection Reality Sheet.
8 Facilities for Illness Management and Prevention. RSV in Infants and Younger Youngsters.
9 Nuttens C, Moyersoen J, Curcio D, et al. Variations Between RSV A and RSV B Subgroups and Implications for Pharmaceutical Preventive Measures. Infect Dis Ther . 2024;13(8):1725-1742. doi:10.1007/s40121-024-01012-2
10 Del Riccio M, Spreeuwenberg P, Osei-Yeboah R, et al. Estimation of the Variety of Respiratory Syncytial Virus–Related Hospitalizations in Adults within the European Union. J Infect Dis 2023 Might 29;228(11):1539–1548. doi: 10.1093/infdis/jiad189 .
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