Concerns raised by vaccine manufacturers over US panel's decision to move away from administering hepatitis B shots to newborns

Vaccine producers voiced serious concerns following the U.S. advisory panel's recent decision to revise its long-standing guideline recommending hepatitis B vaccination for all newborns. Public health specialists warn this change could threaten decades of progress in preventing the disease.

Merck, maker of Recombivax HBa key component of the U.S. childhood immunization schedulestated it is "deeply troubled" by the CDC's Advisory Committee on Immunization Practices (ACIP) decision. The company emphasized that postponing the birth dose may expose infants to higher risks of chronic hepatitis B infection, liver cancer, and even death.

Merck highlighted that the universal birth vaccination, implemented in 1991, has led to a 99% decline in acute hepatitis B cases among children and young adults. The company added that no evidence exists suggesting a delay in vaccination provides any benefit.

Infectious disease specialists, alongside organizations representing pediatricians, pharmacists, and public health officials, criticized the policy shift. Hepatitis B, which can be transmitted from mother to child during birth, can result in serious liver disease and premature death, and currently has no cure. According to the National Foundation for Infectious Diseases, the universal birth dose has prevented over 500,000 childhood infections, reduced infant cases by 95%, and averted an estimated 90,100 deaths.

Several committee members, appointed by U.S. Health and Human Services Secretary Robert F. Kennedy Jr., who has expressed vaccine skepticism, questioned the safety data for the vaccine. They also argued that the U.S. immunization schedule is misaligned with countries like Denmark, which maintain low hepatitis B rates without universal birth doses.

GSK reaffirmed its confidence in the scientific backing for its vaccine, Engerix-B, which has been in use since 1989 and administered in over 1.4 billion doses worldwide. The company awaits the CDCs official adoption of the updated guidance to evaluate its implications.

Following the panel's vote, shares of Merck and GSK declined by roughly 1%, while U.S.-listed shares of Sanofi, another hepatitis B vaccine producer, increased by approximately 0.7%.

The updated recommendation specifies that only infants born to mothers who test positive for hepatitis B should receive the vaccine at birth. For infants of mothers who test negative, parents are advised to consult healthcare providers to decide the timing or necessity of the vaccination series.

Merck urged the ACIP to reintegrate liaison organizations and frontline clinicians into its discussions, emphasizing that input from medical and scientific experts is crucial to developing evidence-based guidance that protects public health.

Author: Riley Thompson