The United States’ Centers for Disease Control and Prevention (CDC) has adopted the Advisory Committee on Immunisation Practices (ACIP) recommendation to end the universal birth-dose of the hepatitis B vaccine.
This article captures our conversation on this 35-year policy reversal and its implications on the health of infants vis-a-vis Hepatitis B Virus (HBV) infection and its relevance to the Malaysian context.
The hepatitis B virus mainly affects the liver. The damage arises from the body’s immune system attacking the infected cells to try to clear the virus, which causes liver inflammation.
Repeated cycles of injury and healing lead to liver scarring/fibrosis, and eventually leading to cirrhosis, liver failure, and liver cancer.
Unlike adults, who clear the HBV more than 95 per cent of the time, infants are immunologically defenseless. Approximately 90 per cent of those infected in the first months of life will develop chronic infection. One in four will die prematurely from cirrhosis or liver cancer.
The most common mode of HBV transmission is at birth due to contact with the infected mother’s blood or secretions. Intrauterine transmission of the HBV across the placenta, is less common (5 per cent).
One third occurs after birth from close contact with the HBV-infected mother, her bodily fluids, her chewing food and feeding the baby, breastfeeding (2 per cent) and from other household contacts who are “silent HBV-infected”.
Hepatitis B Immunoglobulin (HBIg) and the hepatitis B vaccine are given to babies born to HBV-infected mothers within 24 hours and has been shown to be 94 per cent effective
Hepatitis B immunisation protects for as long as 20 years (maybe lifelong) and a protective anamnestic (memory) response occurs after exposure to the HBV, even if protective antibodies have been undetectable by laboratory tests over time.
The World Health Organization (WHO) does not recommend booster vaccination, as it has been shown that the 3-dose series is protective.
In Malaysia, the hepatitis B vaccine is given to all newborns at birth as part of the universal Hepatitis B National Immunisation Programme (NIP) implemented in 1989.
It is then given at 2, 3, 5, and 18 months as part of the 6 in 1 vaccine including Diphtheira, Pertussis, Tetanus, Polio, Haemophilus Influenza B and Hepatitis B.
Adults are administered the hepatitis B vaccines as a 3-dose regimen at 0,1, and 6 months.
The Advisory Committee on Immunisation Practices (ACIP) of the CDC voted to limit vaccination of newborns to those whose mothers tested positive for the HBV.
For mothers who tested negative during pregnancy, they are recommended to wait until their infants are two months of age to give them the first dose.
Antenatal screening of mothers for the HBV is vital to understand the risk of transmission of the virus to their babies and taking the necessary actions to mitigate this risk. HBsAg (Australia Antigen) and HBeAg (e-Antigen) positive mothers have a 70 to 90 per cent risk of infecting their newborn babies. HBsAg-positive and HBeAg-negative mothers have a lower risk of 10 to 40 per cent.
About 2 per cent of pregnant women in the US do not receive antenatal care at all. About 14% of pregnant women in the United States are never tested for hepatitis B. And test results are not always available at delivery. Many who tested positive are lost to follow up.
The Advisory Committee on Immunisation Practices (ACIP) decision assumes that antenatal screening reliably identifies the at-risk infants. It does not. These are the gaps that would put the babies at risk of hepatitis B infection.
Safety nets exists for patients the system fails to catch and plug these gaps. The birth dose is the vaccine safety net. The birth dose addressed every one of these vulnerabilities. It did not require perfect screening, perfect records, or perfect follow-up. It simply vaccinated every newborn.
Apparently, the two-month wait for the other infants was to allow the parents to make an informed choice on the need for the vaccine if the mother is hepatitis B negative at screening.
In1982, when the US first introduced the vaccine, it was only given to babies born to HBV positive mothers. 30 thousand babies continued to be infected every year, half from vertical transmission and another 15,000 postnatally from household contacts.
Due to the lack of impact, universal coverage was implemented in 1992 which reduced HBV in infants by 99%, down to 20 cases per year
People who test positive for the HBV for more than six months (after their first blood test result) are diagnosed as having a chronic infection. This means their immune system was not able to get rid of the HBV and it still remains in their blood and liver.
About 90 per cent of infected newborns and babies will develop a chronic hepatitis B infection. 50 per cent of infected children (1 to 5 years) will develop a chronic hepatitis B infection. About 5 to 10 per cent of infected adults will develop a chronic hepatitis B infection (with a 90 to 95 per cent recovery rate).
Children who are infected at birth, and who do not receive any medical intervention or treatment, can have up to a 25 per cent lifetime risk of developing liver cancer. Of babies who were infected at birth, one in four will die, usually after decades of persistent liver injury, from cirrhosis, liver failure and liver cancer.
Chronic hepatitis B infection can also be silent and have no symptoms. They risk transmitting hepatitis B to others such as close contacts, sexual partners and unborn babies.
They have nearly a one-in-four risk of dying from cirrhosis, liver failure, or liver cancer. Tests are done to classify the phase of the chronic HB infection.
Regular health checks, which includes blood tests and liver ultrasound, and appropriate treatment with anti-viral medication, helps to reduce the risk of liver damage and reduces the risk of liver cancer. A healthy lifestyle includes avoidance of alcohol and safe sex.
Presently, we do not have universal screening of all pregnant patients in the MOH antenatal programmes.
The Ministry of Health (MOH) is in the process of initiating HBV screening for all their antenatal mothers following the pilot studies done in four states from 2019 to 2024.
However, virtually all pregnant mothers in the private settings get their Hep B screening to identify those who are HBV positive.
All adults, especially those born before 1989 (prior to the implementation of the universal Hepatitis B vaccination programme), should check their HBV at least once to recognise their status and get the vaccine if HBV negative or seek medical attention if HBV positive.
What could be the reasoning behind the CDC’s move?
In June 2025, the Secretary of Health and Human Services, Robert F. Kennedy Jr, fired 17 expert members from the ACIP and replaced them with anti-vaccine and anti-science members.
Even before this, the new administration in the CDC removed the tagline “Vaccines do not cause autism” on their website. Now it is the removal of the universal birth dose of the Hep B vaccine.
They maybe imitating many European Union (EU) countries who vaccinate infants born to hepatitis B-positive mothers only. But the EU have higher hepatitis B screening coverage than the United States, along with universal health care coverage.
However, the EU is not the best to benchmark for Hepatitis B immunisation policies.
Only five European countries (Bulgaria, Lithuania, Poland, Portugal, and Romania) vaccinate all their newborns. Others rely on maternal screening to identify infants who need vaccination.
Up until last year, 115 out of 194 WHO member states recommend a universal hepatitis B birth dose.
Thirteen EU countries had data on antenatal screening. 10 (77%) achieved the target of 90% coverage. 6 countries had data on the coverage of birth dose vaccine for infants born to mothers who have HBV, which ranged from 82% to 100%.
The US has more people living with chronic hepatitis B. The population demography is more diverse with varying risk levels. And the lack of a unified national health system and consistent medical record tracking, increases the risk of gaps in healthcare.
There has been no new safety signals related to the HB vaccine. It is safe, effective and one of the great success stories of modern public health. Forty years of randomised trials, national surveillance, and long-term follow-up have consistently found the birth dose to be safe and effective
Virtually every health care professional and institution in the US are rejecting the ACIP recommendations and are following the guidance from the American Association of Pediatrics (AAP), who has reaffirmed that universal birth-dose Hepatitis B vaccination remains the standard of care.
Clearly, universal hep B vaccination has been so successful for decades that we no longer realise the dangers of hep B infection. The false narrative that vaccines causes autism has been responsible for the major outbreaks of measles (two thousand cases and three deaths) and whooping cough (26,000 cases and 13 deaths) in the US this year.
Modeling estimates project the following situation with hepatitis B in the US:
- 1,400 additional chronic pediatric hepatitis B infections per year.
- 300 additional cases of liver cancer.
- 480 preventable deaths over the lifetimes of these children.
- US$222 million in excess annual health care costs.
In Malaysia virtually every newborn receives the birth-dose of the hepatitis B vccine. Our third dose Hepatitis B vaccine coverage is 99 per cent.
The seroprevalence of hepatitis B has dropped more than 80 per cent since the introduction of the vaccine in 1989 and this can be dropped further if we introduce HBV screenings for all our pregnant mothers and encourage adults who did not participate in the neonatal Hep B vaccination programme to screen for Hep B and get the vaccine if they are not protected or get themselves checked if they are positive for HBV infection.
In conclusion, the Hepatitis B vaccines are safe and effective. They prevent an incurable chronic liver infection that leads to cirrhosis, liver failure and liver cancer. And Malaysia has an opportunity to eliminate HB for future generations.
Dr Musa Mohd Nordin is a paediatrician, Prof Dr Rosmawati Mohamed is a hepatologist, Dr George Lee is an urologist, and Tee Shiao Eek is a producer and presenter at BFM.
- This is the personal opinion of the writer or publication and does not necessarily represent the views of CodeBlue.
