FDA Clears Investigational New Drug Application for Two Covid Biologics, Inhaled or Intranasal at High or Low Doses
Using Chimpanzee Adenovirus-vectored ChAd36) technology. NIH/NIAND's NexGen $5 BILLION Project will test 80 Subjects in Preparation for Possible Inhaled Biologics for Influenza, RSV, and Bird Flu
The Press Release
Source: https://finance.yahoo.com/news/ocugen-inc-announces-investigational-drug-113000195.html?guccounter=1&guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAAKxd_zALdkQnrK74YAx83pp4vZBGVBjMnIB10e7dFy42ZfAJkWiYIWKDBSTUpA2GYtH-XKSmVbVQYxDwLGY_7No68UHTvbb3p9ek8XKy1zrlsTNxoUstKJRQ2AWNCbA_x7aCrF3LHhjmiY9_srym6-LDMbSDrpIRmSUn9RR96dad
“We are grateful for our ongoing collaboration with NIAID and pleased to bring our novel vaccine technology into the clinic through Project NextGen,” said Mike Shine, Senior Vice President, Commercial at Ocugen. “COVID-19 remains a real public health concern, and an increasing number of studies are showing the benefit of mucosal vaccines that attack the virus where it enters the body—through the nose and mouth—to give better and longer protection. We look forward to this important next step in potentially providing a more durable and safer option to help prevent infection and transmission of COVID-19 regarding various variants of concern.”
Even though the pandemic has ended, COVID-19 still presents a significant burden in the U.S. The Centers for Disease Control (CDC) estimates that from October 1, 2024 to January 11, 2025, there were 4.4 to 7.9 million COVID infections, resulting in 120,000 to 210,000 hospitalizations and 14,000 to 25,000 deaths.
The Phase 1 trial would enroll 80 adult subjects aged 18 to 64 years. Forty (40) subjects would be assigned to the low-dose group, and 40 subjects would be assigned to the high-dose group. Within each group, 20 subjects would receive the inhalation form of the vaccine, and the other 20 subjects would receive the intranasal form. The primary aim of the study would be to determine safety, while secondary and exploratory endpoints include antibody production and the number of breakthrough COVID-19 infections.
OCU500 is based on a novel chimpanzee adenovirus-vectored (ChAd36) technology. Earlier clinical studies to prevent COVID-19 that employed a similar technology administered via inhalation demonstrated increased mucosal and systemic antibodies and a durable immune response up to one year using one-fifth the dose compared to the same vaccine administered intramuscularly. Ocugen intends to expand this mucosal platform to address other serious respiratory threats including seasonal influenza, bird flu, and respiratory syncytial virus (RSV).
The original ChAd36 vector that makes the Ocugen vaccine unique was licensed from Washington University in St. Louis.
"We are delighted to see the progress of the ChAd36 vector encoding a SARS-CoV-2 spike antigen that was originally designed and tested at Washington University in St. Louis,” said Dr. Michael Diamond, Professor of Medicine and Co-Director of the Center for Vaccines and Immunity to Microbial Pathogens at Washington University School of Medicine. "We believe this vector is ideal for mucosal administration and can be designed to carry COVID-19 strains as well as influenza and antigens from other respiratory viruses," added Dr. David Curiel, Professor of Radiation Oncology, Washington University School of Medicine, co-collaborator on the vector design.
Project NextGen is a $5 billion multi-government agency initiative to develop the next generation of vaccines and therapeutics to combat the spread of COVID-19. NIAID, with funding from Project NextGen, will cover the full cost of the Phase 1 clinical trial, including operations and related analysis. Ocugen is providing clinical trial materials and, upon completion, will have full right of reference to the findings, which Ocugen believes will provide clinical evidence to support the further development of the Company’s lead mucosal vaccine candidate.
"Ocugen further advanced the vector technology, enabling the incorporation of single/multiple antigens into a single vector. This innovation offers significant manufacturing flexibility in responding to emerging variants within one hundred days of identifying a circulating variant of concern," said Dr. Arun Upadhyay, Chief Scientific Officer at Ocugen. "This vector technology, combined with mucosal delivery, has the potential to enable rapid development of respiratory vaccines in response to future outbreaks including bird flu."
About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on X and LinkedIn.Press Release: https://finance.yahoo.com/news/ocugen-inc-announces-investigational-drug-113000195.html?guccounter=1&guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAAKxd_zALdkQnrK74YAx83pp4vZBGVBjMnIB10e7dFy42ZfAJkWiYIWKDBSTUpA2GYtH-XKSmVbVQYxDwLGY_7No68UHTvbb3p9ek8XKy1zrlsTNxoUstKJRQ2AWNCbA_x7aCrF3LHhjmiY9_srym6-LDMbSDrpIRmSUn9RR96dad
The Vaccine Reaction
The Vaccine Reaction has published this article on a new research project approved for an inhaled Covid drug.
Key Points:
Phase 1 of this study is fully paid by taxpayers.
It uses a new chimpanzee adenovirus-vectored (ChAd36) technology, and the inhaled vaccine is called OCU500.
80 subjects get EITHER inhalation or intranasal routes.
Of 80 subjects: 40 get a low-dose, and 40 get a high-doses.
Half of each group get it via inhalation, and the other 20 subjects will receive the intranasal form.
This is part of the NIH’s NexGen Project, and plans are to spend $8 billion of taxpayer money.
Primary outcome: safety. Secondary outcomes: antibody production and the number of breakthrough COVID-19 infections.
NexGen is planning to study 3 areas: strengthen, treat, and enable.
EMPHASES ARE MINE.
Biotech company Ocugen, Inc. has announced that the U.S. Food and Drug Administration (FDA) has cleared their Investigational New Drug (IND) application for a novel inhaled vaccine against SARS-CoV-2. The biologic uses novel chimpanzee adenovirus-vectored (ChAd36) technology. The approval will allow the company to initiate Phase I clinical trials for the inhaled vaccine, OCU500. The Phase I trial is expected to begin in the second quarter of this year and will be sponsored and conducted by the National Institute of Allergy and Infectious Diseases (NIAID).1
The Phase I trial will involve 80 adults ages 18-64 and will test a dual delivery approach via inhalation and intranasal routes, targeting the natural infection route of respiratory viruses. Of the 80 participants, 40 will be assigned to a low-dose group and the remaining 40 will be assigned to a high-dose group. Within each group, 20 subjects will receive the vaccine via inhalation, and the other 20 subjects will receive the intranasal form. According to the company’s press release, the primary aim of the study is to determine safety, while the secondary and exploratory endpoints include antibody production and the number of breakthrough COVID-19 infections.1
The Ocugen press release states that the ChAd36 vector demonstrates superior dose efficiency that will require one-fifth of the dose compared to traditional intramuscular delivery. The company hopes for a potential to expand to other respiratory diseases such as influenza, RSV, and bird flu.1
Inhalation COVID Vaccine Trials Funded With $5 Billion from NIH
The collaboration between the biotech company Ocugen and the NIAID, which falls under the U.S. National Institutes of Health (NIH), is part of the agency’s NextGen project. This $5 billion initiative, which was announced in April 2023, is a collaboration between the government and biotech companies aiming to help “address gaps in the nation’s COVID biologic and therapeutic capabilities.”1 Project NextGen includes three strategic areas: strengthen, treat, and enable.2
The strategy to “strengthen” includes advancing next generation COVID biologics with more breadth, protection, and capabilities. “Treat” involves having better durability against new variants and treatments for those who do not respond to vaccination. Falling under the strategy goal to “enable” includes advancing better and innovative vaccine approaches and faster vaccine manufacturing.2
Taxpayer Funded NextGen to “Revitalize” COVID-19 Prevention Program
An article published in the journal Clinical Infection Diseases outlining the NextGen initiative states:
The bedrock of this program is the U.S. government’s goal to revitalize the pipeline of solutions to address the most pressing gaps in COVID prevention and treatment capabilities for the nation”2
NextGen funding for Ocugen will use tax-payer dollars to cover the full cost of the Phase 1 inhalation COVID vaccine clinical trial, including operations and related analysis.1
The Ocugen press release maintains that COVID disease remains a public health threat and a significant burden to the United States. The Ocugen press release for the new inhaled vaccine states that the U.S. Centers for Disease Control and Prevention (CDC) estimated that there were 14,000 to 25,000 COVID infections deaths from October 2024 to Jan. 11, 2025. For comparison, there were 28,000 influenza related deaths during the roughly six-month flu season in 2024,3 and in 2024, there were 931,578 cardiovascular-related deaths.4
Mike Shine, senior Commercial Vice President at Ocugen, stated:
COVID-19 remains a real public health concern, and an increasing number of studies are showing the benefit of mucosal vaccines that attack the virus where it enters the body—through the nose and mouth—to give better and longer protection. We look forward to this important next step in potentially providing a more durable and safer option to help prevent infection and transmission of COVID-19 regarding various variants of concern.1
Shine has held leadership positions with Novapharm Therapeutics, Colgate Oral Pharmaceutical, and Pfizer with over 35 years of experience. He led the “successful commercial launch of the global $6 billion Prevnar vaccine franchise while with Pfizer Vaccines,” and has “driving sales in excess of $2 billion” according to an Ocugen press document released via GlobeNewswire when Shine was hired by the company.5
References
Click here to view References:
1 Hamilton T. Ocugen, Inc. announces investigational new drug application in effect after review by FDA to initiate phase 1 clinical trial evaluating first-in-class OC500 inhaled vaccine candidate for COVID-19. Yahoo Finance Jan.27, 2025.
2 Hofmeyer K. Project NextGen: Developing the next generation of COVID-19 vaccines and therapeutics to respond to the present and prepare for the future. Clinical Infection Diseases Feb. 13, 2024.
3 Correia S. Ocugen, Inc. announces Michael Shine as senior vice president, commercial. Global Newswire June 10, 2021.
4 Press Release. Ocugen, Inc. Announces Investigational New Drug Application in Effect After Review by FDA to Initiate Phase 1 Clinical Trial Evaluating First-in-Class OCU500 Inhaled Vaccine Candidate for COVID-19. Ocugen Jan. 27, 2025.
5 GlobeNewswire. Ocugen Inc. Announces Michael Shine as Senior Vice President, Commercial. Ocugen June 10, 2021.Source: https://thevaccinereaction.org/2025/02/fda-clears-investigational-new-drug-application-for-inhaled-covid-biologic/
WHAT I REALLY THINK
As RFK Jr successfully reached his initial confirmation vote today with the Senate Confirmation Hearing, I can only hope that he can reverse these kind of studies.
Get back to SAFETY and EFFICACY first, or try OMITTING ALL VACCINES FOR EVERYONE - or at least 1/2 of the population. Do a real research study, or even an antidotal one!
I think the public should have a voice on whether or not their tax dollars go for any of these studies. BAN THEM! MAKE THEM PAY FOR THESE STUDIES WITH THEIR OWN MONEY!
My vote would be to cancel all inhaled vaccine therapies - and cancel all the Covid vaccines, too. See how many babies don’t develop autism, shall we? Can we be like the Amish and STOP giving our babies vaccines? After all, they have ZERO Autism!
Anyway, I think they’ve already been spraying Covid vax into the clouds, hence the seeding that turns into toxic, abnormal fog and resulting sickness.
They study things and pass laws for things that they’re already doing.
God bless us all!
LET US PRAY
Thank You Father,
For loving us and being with us in all things. Bless our efforts, guide our politicians where possible, and lead us where You want us to go, DEAR LORD!
Protect us from all badness whether it is in the water, air, or our food. Heal our bodies and our land, HOLY GOD!
We ask all these things in the Mighty Name of Jesus.
Amen.
So true. Get rid of all this manufactured junk they attempt to put in our bodies. Our bodies are God's Temple, and we are to care for it, not some actor. Nowhere does God say Rockefeller medicine or other weapons are to be used to heal us.
1 Corinthians 3:16
Know ye not that ye are the Temple of God, and that the Spirit of God dwelleth in you?
1 Corinthians 3:17
If any man destroy the Temple of God, him shall God destroy: for the Temple of God is holy, which ye are.
s
1 Corinthians 6:19
Know ye not, that your body is the temple of the holy Ghost, which is in you, whom ye have of God? and ye are not your own.
How about we shove it up all the FDA's employees @$$'$ and see how that goes! Probably already getting doused with it via chemtrails! 👹