When your baby gets that first hepatitis B shot in the delivery room, it can feel like a lot—especially when you are still catching your breath as new parents. The good news from a new Indian Phase IV study is reassuring: a widely used Indian vaccine, BEVAC®, protected nearly all babies who completed the early schedule, with only mild side effects and no serious vaccine-related problems reported.
What the new research found
Researchers published a multicentre, randomised Phase IV trial in the open-access journal Viruses (MDPI) comparing Biological E’s monovalent recombinant hepatitis B vaccine BEVAC® with another licensed Indian vaccine (GeneVac-B®). The study enrolled 468 healthy term newborns across seven Indian sites. Babies received three 0.5 mL intramuscular doses: at birth (within 24 hours), at 6 weeks, and at 14 weeks.
About a month after the third dose (Day 126), 98.2% of infants in the BEVAC® group had protective antibody levels (anti-HBs ≥10 mIU/mL), compared with 99.1% in the comparator group. The difference met the study’s non-inferiority goal. Common reactions—mainly mild fever, injection-site pain, or swelling—occurred in about 29% of BEVAC® recipients and were mild to moderate. No serious adverse events were reported. BEVAC® has been used in India for more than a decade and is WHO-prequalified.
You can read the full paper here: doi.org/10.3390/v18040472.
Why the birth dose matters
Hepatitis B is a virus that can quietly damage the liver over years. Babies who catch it early—often around birth from a mother who has the infection, or later from household contact—are more likely to develop long-term (chronic) infection than older children or adults.
That is why timing matters. WHO recommends a monovalent hepatitis B birth dose as soon as possible, ideally within 24 hours. India’s Universal Immunization Programme follows the same principle: a birth dose preferably within 24 hours, followed by later doses in the infant schedule. The CDC likewise emphasises that hepatitis B vaccine is safe and effective, and that all infants should start the series at birth.
What parents can expect
- A small shot in the thigh soon after birth (and later doses as per your baby’s card).
- Mild fussiness, low-grade fever, or a sore thigh for a day or two in some babies—usually settles with comfort care.
- Strong protection for most babies who complete the series on time—this new Indian data sits alongside long-standing global evidence.
What you can do
- Ask the birth team whether the hepatitis B birth dose was given, and note the time on your baby’s vaccination card.
- Keep the follow-up doses on schedule (in India’s UIP these typically continue with the infant immunisation visits).
- If you know—or worry—that mother has hepatitis B, tell the obstetric and newborn teams early; extra steps (including immunoglobulin when advised) may be needed promptly.
- For personalised guidance on your newborn’s immunisation plan, you can book an appointment with Dr. Vannala Raju.
When to seek care
Call your paediatrician promptly if your baby has a high or lasting fever, unusual lethargy, poor feeding, breathing difficulty, a rash that worries you, or swelling/redness that is spreading at the injection site. Vaccine reactions are usually mild—but newborns deserve a low threshold for review.
This article is for general parent information based on published research and public-health guidance. It is not a substitute for personal medical advice for your child.
Sources: MDPI Viruses — BEVAC® Phase IV trial (2026); WHO Hepatitis B vaccines position paper; CDC — Hepatitis B perinatal vaccine information; India’s Universal Immunization Programme birth-dose guidance (NHM/MoHFW).
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