The Cyfendus Anthrax Vaccine was tested on animals and approved for adults aged 18-65 by the all-knowing FDA. Who needs thorough safety and efficacy testing when you’ve got a vaccine that’s been in development for two whole decades? And let’s not forget the secretive adjuvant; they must have named it “Top Secret” for extra dramatic effect. Just remember, in the event of an anthrax scare, when politicians and media are diving for cover, you’ll have your two doses of Cyfendus to the rescue! But hey, who needs antibiotics when you can pin all your hopes on this groundbreaking vaccine, right? Happy vaccinating, folks! Stay safe and always trust the mysterious forces behind those impressive drug approvals! OK, enough of my sarcastic rant, let us get to the story, shall we?
In a significant move, President Biden’s Food and Drug Administration (FDA) has granted approval for the use of an experimental anthrax vaccine known as Cyfendus for all adults aged 18-65. The vaccine, produced by Emergent BioSolutions, has been met with controversy as it has only been tested on animals, according to Reuters. In this article, we delve into the implications of this approval, the concerns raised by experts, and the history of anthrax vaccines in the United States.
The Skeptical Experts
Dr. Meryl Nass, an expert in bioterrorism and anthrax, has expressed skepticism about the actual health benefits of the Cyfendus vaccine. Given the history of Emergent BioSolutions’ past failures and the lack of proper safety and efficacy testing of previous anthrax vaccines, Dr. Nass raises valid concerns about potential problems. The absence of crucial information, such as testing details and the placebo used, only adds to the uncertainty surrounding the vaccine’s value.
The Development and Collaboration
Emergent BioSolutions has been working on Cyfendus for two decades in collaboration with prominent organizations like the Defense Advanced Research Projects Agency (DARPA), the Biomedical Advanced Research and Development Authority (BARDA), and the National Institute of Allergy and Infectious Diseases (NIAID), previously led by Dr. Anthony Fauci. The vaccine, consisting of Emergent’s anthrax vaccine adsorbed (AVA), marketed as BioThrax, along with an undisclosed adjuvant, is administered in two doses over 14 days to elicit an immune response during large-scale public health emergencies involving anthrax.
The Effectiveness of Antibiotics
During the 2001 anthrax scare, where several politicians and media organizations received anthrax through the mail, prompt administration of antibiotics proved effective in preventing anthrax-related fatalities. Dr. Nass emphasizes the need for immediate treatment after exposure to anthrax, raising questions about the additional benefits the vaccine may offer.
Financial Gains and Company’s History
The FDA’s approval of Cyfendus has led to a 16.2% increase in Emergent BioSolutions’ stock shares, instilling confidence in reaching projected earnings for 2023. However, the company has faced financial challenges in recent years, including the destruction of 400 million vaccine doses due to likely contamination problems at one of its plants. The congressional report in 2021 exposed these issues, causing a significant drop in the company’s share price.
A Look Back: History of Anthrax Vaccine
The anthrax vaccine has a long history, dating back to its limited use in the military since 1970. Emergent BioSolutions’ Biothrax has been the only licensed anthrax vaccine for human use in the U.S. since 2002. The U.S. Department of Defense (DOD) made the vaccine mandatory as part of the Anthrax Vaccine Immunization Program (AVIP) for all military service members in 1997. However, due to adverse reactions and dissent among service members, congressional hearings were held in 2000, recommending the program’s halt.
The Anthrax Scare and Vaccine Continuation
Following the 9/11 attacks, media outlets reported anthrax letters sent through the mail to various news outlets and politicians. The fear created by these attacks primed public support for draconian legislation, including the Patriot Act. The anthrax scare became the primary justification for continuing the vaccine administration to service members. Despite numerous challenges in court regarding FDA approval and licensure, the DOD restricted the anthrax vaccine to a smaller group of “at-risk troops” and halted and resumed the program several times.
Conclusion
The approval of the Cyfendus anthrax vaccine for adults aged 18-65 has raised valid concerns and controversies surrounding its efficacy and safety. Experts question the necessity of the vaccine when prompt administration of antibiotics has proven effective in preventing anthrax-related fatalities. Additionally, Emergent BioSolutions’ past financial challenges and controversies add to the skepticism surrounding this approval. As the vaccine’s implementation moves forward, it is crucial to address these concerns and ensure the well-being of those who may receive it.
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