Use of "Will" and "Validated" now subject to risks and uncertainties that could cause actual results to differ materially - RSV Vaccine
Classified as "forward-looking statements" in which investors are cautioned not to place considerable reliance on
Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding QS-21 STIMULON adjuvant, alone and formulated in vaccines and vaccine candidates such as GSK’s RSV vaccine candidate, Shingrix and Mosquirix, for instance, statements regarding vaccine efficacy, safety, mechanism of action and durability; clinical development and regulatory plans and timelines; current and future manufacturing capabilities, including our ability to scale-up manufacturing and to manufacture in a consistent, sustainable, eco-friendly, and cost effective manner; the ability of QS-21 STIMULON adjuvant to be used in effective and safe vaccines for the prevention and/or treatment of Covid-19 and other infectious disease; anticipated corporate milestones, including our ability to partner, license and/or otherwise monetize the QS-21 STIMULON adjuvant; and any other statements containing the words "may," "believes," "expects," "is designed to,” "estimates," "will," “establish,” “validated,” “best in class,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Quarterly Report on Form 10-Q or Annual Report on Form 10-K filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine
Arexvy Approved for Individuals 60 Years of Age and Older
May 03, 2023
Among a subset of these clinical trial participants, the most commonly reported side effects by individuals who received Arexvy were injection site pain, fatigue, muscle pain, headache and joint stiffness/pain. Among all clinical trial participants, atrial fibrillation within 30 days of vaccination was reported in 10 participants who received Arexvy and 4 participants who received placebo.
In two other studies, approximately 2,500 participants 60 years of age and older received Arexvy. In one of these studies, in which some participants received Arexvy concomitantly with an FDA-approved influenza vaccine, two participants developed acute disseminated encephalomyelitis (ADEM), a rare type of inflammation that affects the brain and spinal cord, seven and 22 days, respectively, after receiving Arexvy and the influenza vaccine. One of the participants who developed ADEM died. In the other study, one participant developed Guillain-Barré syndrome (a rare disorder in which the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis) nine days after receiving Arexvy.
The FDA is requiring the company to conduct a postmarketing study to assess the signals of serious risks for Guillain-Barré syndrome and ADEM. In addition, although not an FDA requirement, the company has committed to assess atrial fibrillation in the postmarketing study.
AREXVY™ RSVPreF3 OA RSV Vaccine May 2023
Taken from: https://www.precisionvaccinations.com/vaccines/arexvy-rsvpref3-oa-vaccine
AREXVY contains Agenus' proprietary QS-21 STIMULON™ within its AS01 adjuvant, which has already demonstrated positive immune responses and a favorable safety profile. QS-21 Stimulon improves a vaccine's effectiveness by inducing strong antibody and cell-mediated immune responses. It also plays a crucial role in boosting immune response in older adults who often experience age-related decline in immunity.
These are questions I will ask for any shot, drug, or medical procedure I am considering or being considered for me.
More obfuscation of what words actually mean.
They're telling their investors that the words may not mean what they historically have meant.
But are they telling their sales reps, uh, I mean drug reps to tell the doctors this? And telling the doctors to tell the patients?
"Mrs. So-and-so, I recommend you take this new RSV vaccine. The drug company says it believes that the vaccine will protect you from severe RSV and that the extra artificial chemicals they included to aggravate your immune system will be safe. And they also want me to let you know that "believes" and "will" are just what they think and hope the vaccine actually does do, because they haven't actually studied it long enough to know for certain. They are just projecting into the future what they HOPE might be true. So, it may not actually do anything and it may not actually be safe. Now, if you will just roll up your sleeve."