Vaccine Makers Alarmed by US Panel’s Shift on Hepatitis B for Newborns

Vaccine manufacturers have voiced strong concerns following a decision by a US advisory panel to discontinue its longstanding recommendation for administering the hepatitis B vaccine to all infants at birth. The vote, which took place on December 5, 2023, has raised alarms among public health experts who fear that this shift could reverse significant progress made in combating hepatitis B infections.

Merck, the producer of the Recombivax HB vaccine, expressed its “deep concern” regarding the decision made by the CDC’s Advisory Committee on Immunization Practices (ACIP). The company warned that this change could “put infants at unnecessary risk of chronic infection, liver cancer, and even death.” Since the introduction of the universal birth dose in 1991, there has been a remarkable 99 percent decrease in acute hepatitis B cases among children and young adults, according to Merck.

Public health advocates and infectious disease experts, along with associations representing pediatricians and pharmacists, have condemned the committee’s decision. Hepatitis B can be transmitted from mother to child during birth and can lead to severe liver disease and premature death, with no known cure. The National Foundation for Infectious Diseases reports that the universal hepatitis B birth dose has prevented over 500,000 childhood infections and reduced infant cases by 95 percent, potentially averting around 90,100 deaths.

The panel’s recommendation now states that only infants born to mothers who test positive for hepatitis B should receive the vaccine at birth. For infants born to mothers who test negative, parents are advised to consult with healthcare providers to determine when or whether to start the vaccination series. This change has sparked significant debate, particularly as many committee members, appointed by US Health and Human Services Secretary Robert F. Kennedy Jr., a noted vaccine skeptic, questioned the safety data surrounding the vaccine and claimed that the US vaccination schedule is misaligned with other countries, such as Denmark, which have lower rates of hepatitis B.

In response to the committee’s decision, GSK, which produces the Engerix-B vaccine, reiterated its commitment to the scientific evidence supporting its vaccine. The company is currently awaiting the CDC’s formal adoption of the new recommendation to assess its potential impact. Engerix-B has been in use since 1989 and has seen 1.4 billion doses administered globally.

Following the ACIP vote, shares of Merck and GSK each experienced a decline of about 1 percent, while US-listed shares of Sanofi, another manufacturer of hepatitis B vaccines, saw a slight rise of approximately 0.7 percent.

Merck has urged the committee to reintegrate liaison organizations and frontline clinicians into its working groups. The company asserts that discussions led by medical and scientific experts are crucial for developing evidence-based recommendations that protect public health. As the implications of this decision unfold, the health community continues to advocate for measures that safeguard the well-being of infants and the broader population.