- First Phase 3 efficacy study to be conducted using an mRNA-based influenza vaccine; study will enroll 25,000 U.S. adults 18 years and older
- Influenza causes 140,000 to 710,000 hospitalizations and 12,000 to 52,000 deaths in the U.S. every year1
- mRNA-based vaccines require only the genetic sequences of the viruses, enabling more flexible, rapid manufacturing which may lead to improved strain match, and the potential opportunity to improve upon the efficacy of current flu vaccines
Pfizer Inc. (NYSE: PFE) announced today that the first participants have been dosed in a pivotal Phase 3 clinical trial to evaluate the efficacy, safety, tolerability and immunogenicity of the company’s quadrivalent modified RNA (modRNA) influenza vaccine candidate in approximately 25,000 healthy U.S. adults.
“ For times, there has been a need to more address the burden of influenza, despite the use of being seasonal flu vaccines. Our experience with RNA contagions and mRNA technology has given us an indeed deeper understanding of the occasion to potentially give further efficient vaccines that could further reduce the monthly rates of the severe issues of viral complaint like flu, including hospitalization and death, ” said Annaliesa Anderson,Ph.D., elderly Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. “ We’re agitated to start the first Phase 3 efficacity study of an mRNA- grounded influenza vaccine that could potentially deliver an advanced flu vaccine to help address the significant burden of this complaint. ”
Each time, indeed when presently available vaccine strains match circulating influenza contagion strains well, those vaccines generally confer only 40 to 60 protection, with indeed lower protection in times with poor matching of strains.2 With circulating influenza strains continually changing, prognosticating the stylish match for the coming season’s vaccine is delicate for global health experts as those strains are chosen further than six months before the launch of the influenza season that they target. The inflexibility of mRNA technology and its rapid-fire manufacturing could potentially allow better strain matches in unborn times, and in a epidemic influenza situation, mRNA technology could allow rapid-fire, large- scale manufacturing of vaccines. mRNA- grounded influenza vaccines bear only the inheritable sequence of the contagion.
Influenza annually causes,000 to,000 hospitalizations,,000 to,000 deaths3 and about$ 25 billion in profitable loss in theU.S. 4 The impact of flu on ethnical and ethnical nonage groups in theU.S. is indeed larger. Black Americans are1.8 times more likely than their white counterparts to be rehabilitated for flu while Latino and Indigenous Americans are1.2 and1.3 times more likely, independently.5 Although vaccination remains one of the stylish ways to help help infection and serious illness, ethnical and ethnical nonage communities in theU.S. continue to be vaccinated at lower rates, 6 and clinical trial registration for new or advanced vaccines tend to warrant diversity.7 Pfizer made a public commitment to help reduce health difference through its clinical trials and insure that Pfizer’s clinical study populations completely represent the ethnical and ethnical diversity of the countries where trials are conducted.
About Pfizer’s mRNA- grounded Flu Vaccine Program
The quadrivalent modRNA vaccine seeker will render World Health Organization recommended strains for the Northern Hemisphere 2022- 23 cell culture- or recombinant- grounded influenza vaccines.8 fresh information about the study can be set up atwww.clinicaltrials.gov.
This Phase 3 study is informed by preliminarily participated data from the ongoing Phase 2 trial which demonstrates a safety and immunogenicity profile probative of program advancement and is part of Pfizer’s broader influenza vaccine program, concentrated on using mRNA technology in a vaccine to help cover against the flu. Beyond the modRNA vaccine seeker, Pfizer has ongoing studies exploring more new mRNA technology like tone- amplifying RNA( saRNA), which has the implicit to give added benefit in the future.
In 2018, Pfizer entered into a worldwide collaboration and license agreement with BioNTech under which Pfizer has the exclusive right to carry out the clinical development and commercialization of mRNA ‐ grounded influenza vaccines. Upon implicit blessing and commercialization, BioNTech would admit a kingliness on Pfizer’s deals.
About Pfizer improvements That Change Cases ’ Lives
At Pfizer, we apply wisdom and our global coffers to bring curatives to people that extend and significantly ameliorate 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 drugs and vaccines. Every day, Pfizer associates work across developed and arising requests to advance heartiness, forestallment, treatments and cures that challenge the most stressed conditions of our time. harmonious with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we unite with health care providers, governments and original communities to support and expand access to dependable, affordable health care around the world. For further than 150 times, we’ve worked to make a difference for all who calculate on us.