FDA Approves New Vaccines Amid HHS Leadership Change

The pharmaceutical industry witnessed significant developments this week as the U.S. Food and Drug Administration (FDA) granted approvals for two new vaccines, coinciding with a controversial change in leadership at the Department of Health and Human Services (HHS).

GSK's Penmenvy Receives FDA Approval

GlaxoSmithKline (GSK) announced the FDA approval of Penmenvy, a pentavalent meningococcal vaccine designed to protect against five major Neisseria meningitidis serogroups: A, B, C, W, and Y. The vaccine is indicated for use in patients aged 10 through 25 years to prevent invasive meningococcal disease (IMD).

Penmenvy's approval is based on data from two Phase III studies involving over 4,800 participants. The trials demonstrated that the vaccine elicited an immune response comparable to one dose of Menveo (covering serogroups A, C, Y, and W) and two doses of Bexsero (targeting serogroup B), both of which are also manufactured by GSK.

Tony Wood, GSK's Chief Scientific Officer, expressed enthusiasm about the approval, stating that Penmenvy will "help improve meningococcal vaccination coverage in the United States, especially for IMD caused by serogroup B," which is the leading cause of the disease in adolescents and young adults.

The Centers for Disease Control and Prevention (CDC) currently recommends that adolescents receive a vaccine covering serogroups A, C, W, and Y at ages 11-12, with a booster at 16. The CDC also suggests considering a serogroup B vaccine for individuals aged 16-18, subject to clinical decision-making.

Bavarian Nordic's Chikungunya Vaccine Vikmunya Gains FDA Approval

In a separate development, the FDA approved Bavarian Nordic's Vikmunya, the first virus-like particle single-dose vaccine in the U.S. for the prevention of chikungunya in individuals aged 12 and above. The approval is supported by Phase III data from a study involving more than 3,500 participants, which showed that 97.8% of subjects developed neutralizing antibodies 21 days after immunization.

Vikmunya demonstrated a favorable safety profile, with reported side effects being predominantly mild to moderate. Bavarian Nordic plans to make the vaccine commercially available in the U.S. during the first half of this year.

Vaccine Approvals Amidst HHS Leadership Change

These vaccine approvals come at a time of significant change in the leadership of the U.S. Department of Health and Human Services. Robert F. Kennedy Jr., known for his skepticism towards vaccines, was recently confirmed as the new HHS Secretary in a narrow 52-48 Senate vote along party lines.

Kennedy's appointment has raised concerns among some lawmakers and public health experts due to his history of questioning vaccine safety. During his confirmation hearings, Kennedy attempted to allay these concerns, stating, "All of my kids are vaccinated, and I believe vaccines have a critical role in healthcare."

However, Senator Mitch McConnell (R-Ky), who voted against Kennedy's confirmation, cited the new secretary's vaccine skepticism and history of "dangerous conspiracy theories" as reasons for his opposition.

As the pharmaceutical industry continues to advance vaccine development and approval, the impact of this leadership change on public health policy and vaccine confidence remains to be seen.