FDA approves freeze-dried version of Jynneos mpox vaccine

News brief

Yesterday the US Food and Drug Administration (FDA) approved a freeze-dried formulation of Bavarian Nordic's mpox vaccine, Jynneos, which can also be used to prevent smallpox. As with the frozen liquid version that is already FDA-approved, the freeze-dried version can be used in adults.

The FDA approval follows a standard FDA review of a supplemental Biologics License Application (sBLA) that Bavarian Nordic submitted in May 2024. The sBLA was primarily based on clinical data that showed comparable immune responses and safety between the freeze-dried and frozen liquid formulations, as well as additional nonclinical and manufacturing data.

"This approval will provide additional flexibility for stockpiling against a smallpox event or mpox outbreak," the company said in a news release.

Ease of storage, transport

The freeze-dried Jynneos version will be easier to store and transport, and will have a longer shelf life than the frozen liquid version that has been used extensively since 2022, when an outbreak caused by the clade 2 strain of the virus traversed the globe, hitting men who have sex with men especially hard. The original Jynneos vaccine requires specific cold-chain storage and transportation. It was approved in September 2019.

"Today's FDA approval represents a significant milestone in our development of this next generation of Jynneos and in our collaborative efforts with the U.S. government to strengthen public health security." said Paul Chaplin, PhD, president and CEO of Bavarian Nordic.

This approval will provide additional flexibility for stockpiling against a smallpox event or mpox outbreak.

Jynneos was the first smallpox vaccine developed under Project BioShield, a program created by Congress in 2004 to accelerate the research, development, procurement, and availability of medical countermeasures against biological, chemical, radiological, and nuclear agents through public-private partnerships.

Bavarian Nordic received a contract from the Biomedical Advanced Research and Development Authority (BARDA) to develop and supply a freeze-dried version of Jynneos for stockpiling. It started making the freeze-dried vaccine last year and will deliver the first vaccines later in 2025.

HHS begins layoffs, reassignments, including NIAID director

News brief

Stephanie Soucheray, MA

Today hundreds of employees at the US Department of Health and Human Services Health (HHS) received emails firing them from their jobs and thanking them for their service as part of HHS planned restructuring that was announced last week by Secretary Robert F. Kennedy Jr.

The restructuring seeks to eliminate at least 10,000 positions, and the Washington Post reported today that top leaders at both the National Institutes of Health (NIH) and the Indian Health Services (HIS) were out on leave or offered reassignment. Among those offered reassignment is Jeanne Marrazzo, MD, MPH, who was serving as the replacement to Anthony Fauci, MD, as the director of the National Institute of Allergy and Infectious Diseases (NIAID), which is the NIH's second largest institute.

According to an email to Marrazzo obtained by the Post, the letter stated, "The Department of Health and Human Services proposes to reassign you as part of a broader effort to strengthen the Department and more effectively promote the health of the American people."

It's chaos—absolute chaos.

According to Science, at least five directors of NIH's 27 institutes and centers have been told they are being reassigned. "It's chaos—absolute chaos," said one NIH senior scientist about the 1,200 NIH firings. Some staff learned of their firings only when their employee cards would not allow them building access.

Some FDA workers not allowed in Maryland office

The head of the Food and Drug Administration's (FDA's) tobacco center, Brian King, PhD, MPH, also said he was placed on leave and offered work at a remote IHS field office.

The FDA is expected to lose 3,500 workers in the coming weeks, with some staffers reporting that they arrived at FDA offices today in White Oak, Maryland, and found their badges did not work.

Former FDA Commissioner Robert Califf, MD, said on LinkedIn, "The FDA as we've known it is finished, with most of the leaders with institutional knowledge and a deep understanding of product development and safety no longer employed. I believe that history will see this a huge mistake."

In videotaped remarks last week, Kennedy said the HHS cuts would save US taxpayers $1.8 billion annually, and reducing staff from 82,000 to 62,000 would streamline the agency and eliminate government bloat. Kennedy said most of the jobs cut would be administrative.

Sanders, Cassidy ask Kennedy to testify

Senator Bill Cassidy, (R-LA) chair of the Senate Health, Education, Labor, and Pensions committee (HELP) and ranking member Bernie Sanders (I-VT) wrote to Kennedy today asking him to testify about the HHS restructuring on April 10.

"We are following up on the commitment you made during the confirmation process that as Secretary you would come before the HELP Committee on a quarterly basis, upon request of the Chair," the letter reads. "The hearing will discuss your proposed reorganization of the Department of Health and Human Services."