FDA Approves New Vaccine

The U.S. Food and Drug Administration (FDA) on Thursday approved an anthrax vaccine for adults aged 18-65.

“FDA has approved two vaccines, BioThrax and Cyfendus, to prevent disease in persons 18 through 65 years of age following suspected or confirmed Bacillus anthracis exposure, when administered in conjunction with recommended antibacterial drugs,” the FDA writes.

“For post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial drugs,” the FDA said regarding Cyfendus.

The FDA sent an approval letter for Cyfendus to Emergent on July 20, 2023.

“The efficacy is based solely on studies in animal models of inhalational anthrax,” Big Pharma whistleblower Brook Jackson said.

A 20-year journey: Emergent BioSolutions Inc. announces FDA approval of Cyfendus—an Anthrax vaccine.

NOTE: The efficacy is based solely on studies in animal models of inhalational anthrax.

"The journey from early development to approval is a major milestone that attests to… pic.twitter.com/XkXYSwsgDK

— Brook Jackson 💜 (@IamBrookJackson) July 21, 2023

Reuters reports:

Emergent BioSolutions (EBS.N) said on Thursday the U.S. Food and Drug Administration has approved its anthrax vaccine for use in adults aged 18 through 65.

The vaccine, Cyfendus, has been approved for use following suspected or confirmed exposure to a type of bacteria and has to be administered together with antibacterial drugs.

Anthrax is a potentially deadly infectious disease caused by exposure to the bacterium Bacillus anthracis. The bacteria most commonly affect hoofed animals such as goats, but people who come in contact with the spores can also become infected.

Emergent has been delivering Cyfendus to the U.S. Department of Health and Human Services since 2019, under pre-emergency use authorization status, and will continue to work with the U.S. government to transition to post-approval procurement, the company said.

“The approval of CYFENDUS™ vaccine is symbolic of Emergent’s longstanding partnership with the U.S. government and our shared commitment to helping protect public health,” said Dr. Kelly Warfield, Emergent’s senior vice president, science and development.

“The 20-year journey from early development to approval is a major milestone that attests to Emergent’s scientific and technical prowess and partnering capabilities. We are grateful for the yearslong collaboration with the Biomedical Advanced Research and Development Authority (BARDA) and early support from the Defense Advanced Research Projects Agency (DARPA) and the National Institute of Allergy and Infectious Diseases (NIAID),” Warfield added.

BARDA?

DARPA?

NIAID?

Those are three glaring red flags to stay far away from this monstrosity.

From Emergent BioSolutions:

“CYFENDUS™ vaccine is a component of the U.S. government’s preparedness efforts against anthrax, which remains a high-priority national security threat due to its ability to be easily disseminated, lethality, and potential for major public health impact,” said Paul Williams, Emergent’s senior vice president, products business. “The approval of the CYFENDUS™ vaccine demonstrates what effective public-private partnerships can achieve for national security. Emergent will continue to work closely with the U.S. government to transition this product to post-approval procurement while ensuring an uninterrupted supply of this important vaccine.”

CYFENDUS™ vaccine is comprised of Anthrax Vaccine Adsorbed (AVA) and an additional adjuvant. It has been demonstrated that by using an additional adjuvant, two doses administered over 14 days elicit protective levels of immune response, which can be especially important in response to a large-scale public health emergency involving anthrax. In December 2018, CYFENDUS™ vaccine was the subject of a pre-emergency use authorization package submitted to the FDA. The following year, the U.S. government began procuring this product for national preparedness efforts.

In addition to the CYFENDUS™ vaccine, Emergent’s anthrax franchise includes the BioThrax® vaccine, which will continue to serve a critical purpose, as well as two treatments, Anthrasil® [Anthrax Immune Globulin Intravenous (human)], a polyclonal antibody therapeutic, and raxibacumab, a monoclonal antibody therapeutic.

Dr. Meryl Nass, bioterrorism and anthrax expert, told The Defender she’s skeptical the shot has any health benefit.

“The fact that there is no label available, there is no information on how it was tested, what placebo was used, etc. — that all adds to the consternation and concern people should have about the value of this product.” @NassMeryl #TheDefenderhttps://t.co/swhwjUP0CN

— Children’s Health Defense (@ChildrensHD) July 22, 2023

“Given the history of the company’s many failures, and the lack of proper safety or efficacy testing of prior anthrax vaccines, one can only expect problems,” Nass said.

“The fact that there is no label available, there is no information on how it was tested, what placebo was used, et cetera — that all adds to the consternation and concern people should have about the value of this product,” she added.

The Defender reports:

Nass said that during the 2001 anthrax scare, where politicians and media organizations across the country received anthrax in the mail, five people died — but “everyone who got antibiotics early did not come down with anthrax and none of them died.”

“So,” Nass said, “antibiotics worked.” Nass emphasized that after exposure to anthrax, one needs treatment immediately — not over the longer period of time it takes for a vaccine to work.

“The fact that it’s required to be given with antibiotics,” Nass said, “which is what you should have when exposed to anthrax, raises the question: What additional benefit are you gonna get from this vaccine? I don’t know.”

Emergent’s stock shares gained 16.2% in pre-market trading after it announced the FDA approval.

Benchmark analyst Robert Wasserman said the approval provides “greater assurance” the company will reach its projected 2023 earnings of $260-$280 million, Bloomberg Law reported.

The price spike comes on the heels of “a difficult few years,” financially for the company, FiercePharma reported.

The company, founded in 1998 as government contractor BioPort to distribute and produce the anthrax vaccine for the U.S. military, reached its financial zenith early in the pandemic after earning lucrative contracts to produce Johnson & Johnson and AstraZeneca COVID-19 vaccines.

But a congressional report in 2021 revealed the company hid likely contamination problems at the plant from FDA inspectors and eventually had to destroy 400 million vaccine doses — which led its share price to fall from $133 to $7.