Friday, 27 December 2024

FDA Approves Clinical Trial For ‘Self-Amplifying’ mRNA Bird Flu Vaccine

100 Percent Fed Up
Hits: 22

The U.S. Food and Drug Administration (FDA) approved a clinical trial to test a ‘self-amplifying’ mRNA vaccine candidate for H5N1 virus (bird flu).

“Arcturus Therapeutics Holdings Inc., a commercial messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has issued a ‘Study Can Proceed’ notification for the Company’s Investigational New Drug (IND) application, ARCT-2304, a self-amplifying mRNA (sa-mRNA) vaccine candidate for active immunization to prevent pandemic influenza disease caused by H5N1 virus,” Business Wire wrote.

“The clinical study is funded by Biomedical Advanced Research and Development Authority (BARDA) and designed to enroll approximately 200 healthy adults in the United States,” it added.

A closer look:

Image

“Arcturus is actively engaged with the U.S. government to prepare for the next pandemic, and clearance to proceed into the clinic with our STARR® self-amplifying mRNA technology is a key step in this important process,” said Arcturus Therapeutics President & CEO Joseph Payne.

“The Phase 1 clinical trial is designed to evaluate the safety, reactogenicity, and immunogenicity of ARCT-2304 as a potential vaccine to protect against the highly pathogenic H5N1 avian influenza,” Payne added.

Per Business Wire:

ARCT-2304 is a sa-mRNA vaccine candidate formulated within a lipid nanoparticle (LNP). The sa-mRNA vaccine candidate is designed to make many copies of mRNA within the host cell after intramuscular injection to achieve enhanced expression of haemagglutinin (HA) and neuraminidase (NA) antigens, thereby enabling lower doses than conventional mRNA vaccines. Utilizing a mRNA-based platform for pandemic influenza vaccine development offers further options for meeting domestic vaccine manufacturing surge capacity goals. The technology may make vaccines available much sooner than egg- and cell-based technologies. The lyophilized vaccine formulation is stable in refrigerators, thereby simplifying cold-chain storage and reducing distribution risks.

“Arcturus is actively engaged with the U.S. government to prepare for the next pandemic. Their STARR technology integrates self-amplifying RNA with Arcturus’ special LUNAR lipid delivery system. It’s out of this world and FDA is out of their minds!” Big Pharma whistleblower Brook Jackson commented.

Dr. Robert Malone previously warned about ‘self-replicating RNA vaccines’ after a trip to Japan.

Dr. Robert Malone: Japan Had “30,000 Person Rally” To Protest Self-Replicating RNA Vaccines, “The Third Atomic Bomb”

“I just came back from Tokyo where they had a 30,000 person rally because they’re about to deploy self-replicating RNA vaccines. Japan is being used as the guinea pigs for the world for this new technology. The Japanese people are calling this the third atomic bomb,” Malone said.

“This is being deployed in a cooperative agreement between a US company, Arcturus, a Canadian company, I’m sorry, an Australian company called CSL and a Japanese company,” he continued.

“Now the CEO of the Japanese company recently gave a press conference. What did he say? He said anybody that is spreading misinformation, we’re going to go after him legally, we’re going to try to have them jailed. If you say anything against their self-replicating RNA vaccine technology that’s never been rigorously tested, we don’t know if it’s going to infect other people. We don’t know if it’s going to spread. We know it’s going to replicate. We don’t know if it’s going to get into the brain of the elders in Japan,” Malone explained.

“But we do know that if we say anything about these concerns, the CEO is going to come after us and try to put us in jail. That’s the new world order. That’s what we’re coming into. That’s what they want to implement on us,” he continued.

“They want to shut us down. They want to prevent us from speaking. They want to completely control the narrative and they want to be able to deploy psychological warfare on all of you to control you, to train you, to respond to the fear narratives about avian influenza and monkeypox and whatever it is they want to deploy next in order to control you, in order to teach you to shut up, sit down, stay in your homes, and do what you’re told. Now I’m not okay with that, I don’t think you’re okay with that, and I hope that you join all of us in fighting this new tyranny,” he added.

WATCH:

 


Source link

Search