FDA Approves New Anthrax Vaccine for Adults Despite Lack of Publicly Available Information on Testing, Ingredients

The vaccine, Cyfendus, is approved for use after suspected or confirmed exposure to anthrax, but must be administered together with other antibacterial drugs. Brenda Baletti, PhD

https://childrenshealthdefense.org/defender/fda-approves-cyfendus-anthrax-vaccine-adults/

The U.S. Food and Drug Administration (FDA) on Thursday approved an anthrax vaccine for adults ages 18-65, according to Emergent BioSolutions, the vaccine’s maker.

The vaccine, Cyfendus, is approved for use after suspected or confirmed exposure to Bacillus anthracis, also known as anthrax, but must be administered together with other antibacterial drugs, Reuters reported.

Emergent said it had been delivering Cyfendus to the U.S. Department of Health and Human Services (HHS) since 2019, under pre-emergency use authorization status.

The efficacy of Cyfendus for post-exposure prophylaxis was tested only on animals.

Dr. Meryl Nass, bioterrorism and anthrax expert, told The Defender she is skeptical about whether the vaccine offers any new substantive health benefit.

“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,” Nass added.

Emergent said the drug has been in development for 20 years in collaboration with 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), formerly headed by Dr. Anthony Fauci.

Paul Williams, senior vice president at Emergent, said anthrax “remains a high-priority national security threat.”

Cyfendus is comprised of Emergent’s anthrax vaccine adsorbed (AVA), marketed as Biothrax, plus an additional adjuvant, the name of which the company did not disclose.

Cyfendus is administered in two doses over 14 days to elicit an immune response that the company said: “can be especially important in response to a large-scale public health emergency involving anthrax.”

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.

History of the anthrax vaccine

The anthrax vaccine was developed and in limited use in the military since 1970.

Biothrax has been produced by Emergent since 2002. Prior to Thursday’s announcement, it was the only anthrax vaccine licensed for humans in the U.S.

Nass explained that in 1997, the U.S. Department of Defense (DOD) made the vaccine compulsory as part of the Anthrax Vaccine Immunization Program (AVIP) for all 2.5 million military service members — including active duty and reserve personnel and civilian contractors.

The DOD implemented the mass vaccination program in 1998.

Reports of adverse reactions and dissent on the part of service members led to congressional hearings and in early 2000, the U.S. House of Representatives Committee on Government Reform recommended halting the mandatory program, although it was not officially halted.

As of 2000, more than 500,000 service members had received at least one dose of the vaccine, which was designed to be administered in six doses.

The plant where the government produced the anthrax vaccine faced a series of regulatory issues and was closed in 1997, according to Nass.

BioPort acquired it from the state-owned Michigan Biologic Products Institute in 1998 and rebuilt it, but was not FDA-authorized to produce the vaccine. So for a period, the vaccines were unavailable.

Then, starting on Sept. 18, 2001 — a week after the 9/11 attacks — when Americans were in a state of fear or heightened concern, media outlets began reporting that a sophisticated, weaponized and fatal form of anthrax had been sent via mail to numerous news outlets and American politicians.

New letters continued to appear over the next six weeks and the media and the government implied they were somehow linked to the 9/11 attacks.

Later, the media and figures such as John McCain linked the anthrax to Saddam Hussein in Iraq. In 2008, the FBI accused U.S. Army scientist Bruce Ivins of being responsible for the attacks, although Ivins took his own life before he could be prosecuted and the FBI’s claims are widely doubted.

ProPublica, McClatchy and PBS Frontline, which did their own investigation, questioned the FBI’s evidence.

The Government Office of Accountability (GAO) and the National Academies of Science both also found that the FBI lacked data to back its claims.

But the hype created by the anthrax letters primed the American public to support draconian legislation such as the Patriot Act, Dr. Joseph Mercola argued.

It also became the primary justification for continuing to produce the vaccine and administer it to service people, Pam Long wrote in The Defender.

In 2002, shortly after the FDA approved BioPort’s new vaccine plant, the GAO issued a report to Congress on the AVIP.

The report enumerated a significant number of adverse reactions to the vaccine — more than double the rate reported by the manufacturer — along with the mass exodus of military pilots and other valuable military personnel who refused the mandate.

It also noted that anthrax adverse reactions were very similar to Gulf War syndrome symptoms and that many veterans reported the vaccine as the cause of this illness, which they also reported in congressional hearings, according to Nass.

From 2000 to 2018, the military anthrax mandate was challenged several times in court for lacking FDA approval and licensure, and for lacking proven potency against fatal inhalation of anthrax.

During this time, the DOD restricted the anthrax vaccine to a smaller group of “at-risk troops” and halted and resumed the program several times.

Prior to 2001, the DOD concluded that biological agents such as anthrax were not a threat for mass casualties due to the limited number of countries with the expertise and sophistication required to weaponize and disseminate anthrax.

According to an investigation by investigative journalist Whitney Webb, the 2001 anthrax attacks also rescued Emergent Biosolutions, then BioPort, from certain financial ruin.