Vaccine Makers Alarmed by US Advisory Panel’s Hepatitis B Shift

Vaccine manufacturers have voiced significant concerns following a recent decision by a US advisory panel that alters the long-standing recommendation for administering the hepatitis B vaccine to newborns. On December 5, 2023, the CDC’s Advisory Committee on Immunization Practices (ACIP) voted to limit the birth dose of the hepatitis B vaccine only to infants born to mothers who test positive for the virus. This shift has raised alarm among public health experts who fear it could reverse decades of progress in combating this serious viral infection.

Merck, the producer of the widely used Recombivax HB vaccine, expressed its “deep concern” over the ACIP’s decision. The company emphasized that this change could expose infants to increased risks of chronic hepatitis B infection, liver cancer, and even death. Since the universal birth dose was introduced in 1991, cases of acute hepatitis B among children and young adults have plummeted by 99 percent, according to Merck. The company asserted that there is no evidence supporting the notion that delaying the vaccine provides any benefits.

Public health professionals, alongside organizations representing pediatricians and pharmacists, criticized the committee’s decision. Hepatitis B can be transmitted from mother to child during childbirth and can lead to severe liver disease and premature death. The National Foundation for Infectious Diseases reported that the universal birth dose has prevented over 500,000 childhood infections, reduced infant cases by 95 percent, and averted an estimated 90,100 deaths.

Many members of the ACIP, appointed by Robert F. Kennedy Jr., the US Health and Human Services Secretary known for his skepticism towards vaccines, raised concerns regarding the safety data surrounding hepatitis B vaccines. They argued that the current US vaccination schedule diverges from practices in other countries, particularly in Denmark, which has seen lower rates of hepatitis B.

In response to the advisory panel’s recommendation, GSK, the manufacturer of Engerix-B, reaffirmed its commitment to the scientific evidence supporting its vaccine. GSK is currently awaiting the CDC’s formal adoption of the new guidelines to evaluate its implications on public health. Engerix-B has been in use since 1989, with approximately 1.4 billion doses administered globally.

Following the advisory vote, shares of both Merck and GSK fell by approximately 1 percent, while the US-listed shares of Sanofi, another hepatitis B vaccine producer, saw a modest increase of about 0.7 percent.

The revised recommendation suggests that parents of infants born to mothers who test negative for hepatitis B should consult healthcare providers to determine when or whether to begin the vaccination series. Merck has urged ACIP to reintegrate liaison organizations and frontline clinicians into its work groups. The company emphasized that discussions led by medical and scientific experts are vital for creating evidence-based recommendations that prioritize public health.

As this situation develops, the implications of the advisory panel’s decision on public health strategies and vaccination rates will warrant close observation. The potential erosion of the universal hepatitis B vaccination program could have lasting effects on infant health and safety across the United States.