Malone, the Chief Medical and Regulatory Officer for
The Unity Project who invented messenger mRNA therapeutics in 1988, says the public is being misled about the vaccine’s efficacy and effects.
The
Gateway Pundit reports: A major Phase 3 clinical trial assessing the efficacy, safety, tolerability, and immunogenicity of Pfizer’s quadrivalent modified RNA (modRNA) influenza vaccine candidate in about 25,000 healthy U.S. adults has begun dosing participants, the pharmaceutical giant reported last month.
“For years, there has been a need to better address the burden of influenza, despite the use of existing seasonal flu vaccines. Our experience with RNA viruses and mRNA technology has given us an even deeper understanding of the opportunity to potentially provide more efficacious vaccines that could further reduce the yearly rates of the severe outcomes of viral disease like flu, including hospitalization and death,” claimed Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer.
“We are excited to start the first Phase 3 efficacy study of an mRNA-based influenza vaccine that could potentially deliver an improved flu vaccine to help address the significant burden of this disease,” she added.
Pfizer ensures that its clinical trial participants properly represent the racial and ethnic diversity of the countries in which they are conducted.
“The impact of flu on racial and ethnic minority groups in the U.S. is even larger. Black Americans are 1.8 times more likely than their white counterparts to be hospitalized for flu while Latino and Indigenous Americans are 1.2 and 1.3 times more likely, respectively,” according to the
news release.
This study is enrolling people who:
- Are at least 65 years old
- Are generally healthy or have stable chronic conditions
- Have not received an investigational or licensed flu vaccine in the last six months
This research study will last about six months. Participants will visit the research site at least three times, including a vaccination visit and two follow-up visits to monitor their health.
Last June, Moderna reported that the first trial participants had been dosed with the company’s seasonal influenza vaccine candidate in a Phase 3 trial (mRNA-1010). Roughly 6,000 adults from nations in the Southern Hemisphere participated in the trial.
“We are pleased to begin this Phase 3 study of our seasonal influenza vaccine candidate, mRNA-1010, our fourth mRNA vaccine candidate to begin a pivotal Phase 3 study. mRNA-1010 is the first of several influenza vaccine candidates we are developing with the aim of iteratively improving traditional vaccines by inducing broad and robust immune responses. We believe our mRNA platform, with the flexibility and speed of our manufacturing process, is well-positioned to address the significant unmet need in seasonal flu,”
said Stéphane Bancel, Chief Executive Officer of Moderna.
“Influenza vaccines are a key pillar in our respiratory vaccine strategy that includes the development of combination candidates targeting multiple viruses in a single vaccine, including influenza with SARS-CoV-2 and respiratory syncytial virus. With the start of dosing for its mRNA-1010 program, Moderna now has four programs in late stage Phase 3 studies, including its SARS-CoV-2 booster, RSV, seasonal flu and CMV vaccine candidates. Beginning in the fall of 2022, the Company’s Phase 3 pipeline could lead to three respiratory commercial launches over the next two to three years.”
