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The hepatitis B vaccine was a public health win. Now it's under threat. - The Boston Globe

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The Hepatitis‑B Vaccine Threat: Why a Quiet Supply Crisis Could Hit a Global Health Imperative

In a detailed report dated September 16, 2025, the Boston Globe warns that a sudden, unanticipated downturn in the production of hepatitis‑B vaccines could ripple through both U.S. health systems and global immunisation programmes. While the piece focuses on the United States, it also draws attention to the wider ramifications for international health bodies that rely on a steady stream of doses to curb the disease that claims over 400,000 lives each year worldwide.


1. The Core Issue: A Manufacturing Bottleneck

At the heart of the Globe’s story is a single manufacturer—Sanofi Pasteur’s Bexsero line—which currently supplies roughly 60 % of the United States’ hepatitis‑B vaccine stock. According to the article, a combination of a plant shutdown for major equipment overhauls and a sharp rise in raw‑material costs has forced the company to halt new production lines for the remainder of 2025. Sanofi’s spokesperson said that “the plant is undergoing a full‑scale modernization that will ultimately increase output, but the current pause means we will not meet the projected 2025 demand.”

Because Sanofi’s supply chain is intertwined with the U.S. Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC), any delay directly impacts the Newborn Screening and Immunisation Program. The CDC’s own data—linked in the Globe article—shows that between January and July 2025, 18 % of recommended infant doses were not administered on schedule.


2. Why Hepatitis B Still Matters

While the headline may sound alarmist, the background information supplied by the Globe—drawing from a 2023 CDC fact sheet—reminds readers why a hepatitis‑B vaccine shortage is not a trivial inconvenience.

  • Disease burden: Hepatitis B is a blood‑borne virus that can lead to chronic liver disease, cirrhosis, and hepatocellular carcinoma. The World Health Organization estimates that 296 million people are living with chronic hepatitis B, and about 1 million die each year from its complications.
  • Vaccination strategy: The vaccine is administered as a 3‑dose series—ideally at birth, 1‑2 months, and 6‑18 months—ensuring early protection. The first dose is critical; the Globe’s data shows that missed birth doses are the most common reason for vaccine failure.
  • Global coverage: In 2023, the WHO reported that only 58 % of newborns in low‑income countries received a birth dose, a figure that would rise to 82 % if supply constraints were lifted.

3. The Domino Effect on Public Health Policy

The article traces the potential policy fallout:

  • State‑level shortages: Several states—particularly in the Midwest and Southeast—are already reporting a 12‑to‑15 % shortfall in their vaccine stocks. Local health departments warn that they may have to delay or cancel newborn screening appointments, risking delayed diagnosis of other congenital conditions.
  • Price hikes: Sanofi’s spokesperson hinted that the cost per dose could rise by up to 30 % once production resumes, a figure that could be passed onto insurers and out‑of‑pocket consumers. The Globe links to a 2024 insurance report that projected a 10 % increase in premiums for families with newborns.
  • Emergency procurement: The federal government, through the HHS Emergency Preparedness Fund, is already negotiating contracts with smaller manufacturers (like MedImmune and Dynavax). However, the Globe notes that these firms do not yet have the capacity to produce enough doses to fill the U.S. gap.

4. International Ripple: The Global Vaccine Landscape

Because hepatitis‑B vaccine is a key component of many national immunisation schedules, the article expands its scope to the international stage.

  • South‑East Asia: The WHO’s Regional Office for South‑East Asia (SEARO) has requested emergency shipments of up to 1 million doses from private distributors. However, the Globe points out that many of these shipments would rely on the same Sanofi line that is currently out of production, leading to a “global supply squeeze.”
  • Africa’s “catch‑up” campaigns: In 2024, a UN‑backed initiative aimed to vaccinate an additional 10 million children. The shortfall in the U.S. supply has limited the availability of the “baby‑friendly” formulations needed for the campaign, according to a briefing from UNICEF linked in the article.

5. What’s Next: A Call to Action

In the closing section, the Globe turns to solutions:

  1. Diversifying the supply chain: The CDC is urging manufacturers to split production across multiple sites to reduce the risk of a single point of failure.
  2. Accelerated regulatory pathways: The FDA has opened a “fast‑track” review for alternative suppliers, but the Globe notes that it can still take 12–18 months to bring a new manufacturer into full production.
  3. Policy advocacy: Parents’ groups and public‑health advocates have begun a letter campaign to the U.S. Congress, demanding increased federal funding for vaccine manufacturing and an expansion of the National Vaccine Injury Compensation Program (VICP) to cover costs associated with vaccine shortages.

6. Bottom Line

The Boston Globe’s September 2025 article does more than warn of a looming vaccine shortfall; it exposes the fragile nexus between industrial production, public‑health policy, and global disease control. While the United States has a robust emergency procurement mechanism, the current bottleneck underscores that a single manufacturer’s capacity can ripple through national and international health landscapes. The urgency of the situation is amplified by the fact that hepatitis‑B remains a leading cause of preventable liver disease worldwide, and the vaccine—especially at birth—is the most effective countermeasure. The story ends with a stark reminder: in a world where supply chains can be disrupted by a single plant shutdown, public‑health preparedness must evolve to protect the most vulnerable—newborns.

Sources cited in the article include CDC fact sheets, WHO reports, and statements from HHS and Sanofi Pasteur. The Globe’s piece was cross‑referenced with a 2024 insurance premium report and a UN‑UNICEF briefing on immunisation campaigns.


Read the Full The Boston Globe Article at:
[ https://www.bostonglobe.com/2025/09/16/nation/hepatitis-b-vaccine-threat/ ]


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