Pfizer Announces Positive Data from Phase 3 Trial in Older Adults for Bivalent Respiratory Syncytial Virus (RSV) Vaccine Candidate

  • Vaccine efficacy was noticed in 85.7% of the extra extreme contributors a illness The main endpoint of decrease respiratory tract infections detected by three or extra RSV assays (LRTI-RSV)related signs
  • The investigational vaccine was effectively tolerated with none security considerations
  • Based on the outcomes of this pre-planned, interim efficacy evaluation, Pfizer intends to supplyFor regulatory approval in fall 2022

NEW YORK–( BUSINESS WIRE )– Pfizer Inc . (NYSE: PFE ) at present introduced constructive knowledge from a Phase 3 scientific trial (NCT05035212). RENOIR (RSV vaccine THE ANDPerformance research iDo notOmain adults Iimmunized towards RSV illness) in a examine utilizing its bivalent RSV prefusion F vaccine candidate, RSVpreF, in adults over 60 years of age. A bivalent vaccine candidate consists of two preF proteins chosen to optimize safety towards RSV A and B strains.

RSV illness is characterised by a number of respiratory signs, ranging from gentle to extreme illness, with extra extreme illness signs. A pre-planned, interim evaluation of Pfizer’s RSVpreF efficacy performed by an impartial, exterior Data Monitoring Committee (DMC) to evaluate safety towards RSV-related decrease respiratory tract illness (LRTI-RSV) confirmed vaccine efficacy: 66.7% (96.66% CI: 28.8%, 85.8%). This constructive end result allowed Pfizer to take a look at the baseline of probably the most extreme illness of LRTI-RSV, outlined by three or extra signs, the place a vaccine efficacy of 85.7% (96.66% CI: 32.0%, 98.7%) was noticed. The DMC additionally famous that the investigational vaccine doesn’t pose any security considerations. Based on these outcomes, Pfizer plans to submit a Biologics License Application (BLA) for RSVpreF to the US Food and Drug Administration (FDA) and put together proposals for different regulatory businesses in the approaching months.

“We are happy that this primary bivalent RSV vaccine candidate, RSVpreF, was proven to be efficient in our scientific trial towards this illness, which is related to excessive morbidity and mortality in older adults,” stated Annaliesa Anderson, Ph.D. , Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. “Scientists and researchers have labored to develop RSV vaccines for greater than half a century. These findings are an vital step in our efforts to assist shield towards RSV illness, and we look ahead to working with the FDA and different regulatory businesses to develop this vaccine candidate to assist deal with the numerous burden of RSV illness in the aged.

Pfizer plans to current the outcomes of this interim evaluation at a future medical congress and submit the outcomes to a scientific journal for peer overview.

The part 3 RENOIR trial is a world, randomized, double-blind, placebo-controlled examine designed to guage the efficacy, immunogenicity, and security of a single dose of RSVpreF in adults >60 years of age. To date, RENOIR has enrolled roughly 37,000 contributors, who have been randomized in a 1:1 ratio to obtain 120μg RSVpreF or placebo. Enrollment continues for roughly 40,000 contributors to build up circumstances in the primary season in the Southern Hemisphere.

Burden of RSV in older adults

RSV is an infectious virus that causes critical respiratory sickness in wholesome folks.1 The virus can have an effect on the lungs and airways of an contaminated particular person and may be life-threatening in the aged and adults with sure medical situations.2,3,4 Each yr, 336,000 aged folks worldwide are hospitalized for RSV.5 In the United States alone, RSV an infection in the aged causes roughly 177,000 hospitalizations and 14,000 deaths annually.4

RSV is a illness for which there are at present no preventive or therapeutic choices for the aged, and the medical neighborhood is restricted to offering assist to sick adults.

About RSVpreF

Pfizer’s investigational RSV vaccine candidate builds on basic science discoveries, together with one on the National Institutes of Health (NIH) that detailed the crystal construction of prefusion F, the primary type of the viral fusion protein (F) utilized by RSV to enter people. cells. An NIH examine confirmed that prefused form-specific antibodies have been extremely efficient in blocking viral an infection, suggesting {that a} prefused F-based vaccine could present optimum safety towards RSV. Following this landmark discovery, Pfizer examined many variations of the stabilized prefusion F protein and recognized a candidate that elicited a robust immune response towards the virus in preclinical analysis. A bivalent vaccine candidate consists of pre-infused recombinant RSV in equal quantities from subgroups A and B.

In addition to an investigational grownup vaccination program, in March 2022 Pfizer introduced that RSVpreF obtained Breakthrough Therapy Designation from the FDA for the prevention of decrease respiratory tract infections attributable to RSV in infants from beginning to 6 months of age. vaccination of pregnant girls. The FDA’s determination was primarily knowledgeable by the outcomes of the part 2b proof-of-concept examine of RSVpreF (NCT04032093), a world, double-blind, placebo-controlled examine that evaluated the security and immunogenicity of RSVpreF in wholesome pregnant girls aged 18 years and older. Those beneath the age of 49, these vaccinated between 28 and 36 weeks of being pregnant and their infants.

In June 2020, Pfizer introduced the initiation of a multicenter, worldwide part 3 scientific trial (NCT04424316). MATISSE (MATinside Ivaccination slearn for slove and THE ANDefficacy), to guage the efficacy and security of a single dose of RSVpreF in the offspring of pregnant girls to assist shield towards RSV after beginning. This analysis is ongoing.

About Pfizer: Discoveries that change sufferers’ lives

At Pfizer, we use science and our international assets to carry therapies that reach and considerably enhance folks’s lives. We are dedicated to setting the requirements for high quality, security and worth in the invention, growth and manufacture of healthcare merchandise, together with revolutionary medicines and vaccines. Pfizer colleagues work each day in developed and rising markets to enhance well being, forestall, deal with and fight among the most harmful illnesses of our time. In holding with our duty as one of many world’s main revolutionary biopharmaceutical corporations, we accomplice with healthcare suppliers, governments and native communities to assist and increase entry to dependable, inexpensive healthcare around the globe. For greater than 170 years, we have labored to make a distinction for everybody who depends on us. We repeatedly put up info vital to traders on our web site at www.Pfizer.com. Additionally, to study extra, go to us at www.Pfizer.com and comply with us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

DISCLAIMER:

The info contained in this launch is as of August 25, 2022. Pfizer undertakes no obligation to replace any forward-looking statements in this launch because of new info or future occasions or developments.

This launch consists of promising details about Pfizer’s respiratory syncytial virus vaccine candidate (RSVpreF) and its potential advantages. and the proposed rules to stop RSV-related decrease respiratory tract illness in individuals age 60 and older, which contain vital materials dangers and uncertainties that might trigger outcomes to vary materially from these expressed or implied by such statements. Risks and Uncertainties embrace, amongst different issues, uncertainties inherent in analysis and growth, together with the power to satisfy and develop scientific trial/growth deadlines, our scientific regulatory approval initiation dates, regulatory submissions, regulatory approvals and/or or embrace launch dates. , in addition to the opportunity of additional evaluation of adversarial new scientific knowledge and present scientific knowledge; dangers related to interim knowledge, together with dangers that the ultimate outcomes of a Phase 3 trial could differ from the interim knowledge mentioned in this launch; threat of scientific trial knowledge being topic to totally different interpretations and evaluations by regulatory businesses; whether or not regulatory authorities are happy with the design and outcomes of our scientific trials; Whether and when biologics license purposes could also be submitted for RSVpreF in varied jurisdictions for any potential indications (together with deliberate US BLA submissions); Whether and when any such purposes are prone to be accepted by regulatory authorities will depend upon quite a few elements, together with figuring out whether or not the product’s advantages outweigh its identified dangers and figuring out the product’s effectiveness and, if accepted, whether or not RSVpreF will likely be used commercially. profitable; choices by regulatory authorities affecting labeling, manufacturing processes, security and/or different issues that will have an effect on the provision or industrial potential of RSVpreF; uncertainties relating to the power to acquire suggestions for RSVpreF from vaccine advisory or technical committees and different public well being authorities and uncertainties relating to the industrial impression of such suggestions; uncertainties associated to the impression of COVID-19 on our enterprise, operations and monetary outcomes; and aggressive developments.

Additional descriptions of dangers and uncertainties are included in Pfizer’s annual report on Form 10-Ok for the yr ended December 31, 2021 and its subsequent experiences on Form 10-Q, together with the sections entitled “Risk Factors” and “Forward-Looking Information and Factors That Could Affect Future Results” “, and in addition All of their subsequent experiences on Form 8-Ok have been filed with the US Securities and Exchange Commission and can be found at: www.sec.gov and www.pfizer.com.

_________________________________

1 Centers for Disease Control and Prevention. Respiratory syncytial virus an infection (RSV). https://www.cdc.gov/rsv/index.html. Updated December 18, 2020. Available: February 22, 2022.

two Centers for Disease Control and Prevention. RSV in older adults and adults with continual medical situations. https://www.cdc.gov/rsv/high-risk/older-adults.html. Updated on December 18, 2020. Available July 22, 2022.

3 Centers for Disease Control and Prevention. Giving RSV. https://www.cdc.gov/rsv/about/transmission.html. Updated December 18, 2020. Available: February 22, 2022.

4 Centers for Disease Control and Prevention. Respiratory syncytial virus (RSV) an infection – Older individuals are at greater threat for extreme RSV an infection. https://www.cdc.gov/rsv/factsheet-older-adults.pdf. February 10, 2022

5 Shi T, Denuel A, Tietjen AK, et al. Estimating the worldwide illness burden of respiratory syncytial virus-associated acute respiratory infections in the aged in 2015: A scientific overview and meta-analysis. J Infect Dis. 2020;222(suppl 7):S577-S583. doi:10.1093/infdis/jiz059.

Category: Vaccines

In common:

[email protected]

+1 (212) 733-1226

Investors:

(*3*)[email protected]

+1 (212) 733-4848

Source: Pfizer Inc.

Leave a Comment

Your email address will not be published.