Rx
🏭 Bharat Biotech
❄️ Cold Chain 2–8°C
👶 Oral – 0.5 mL PFS
🧬 116E – India's Own Strain
🇮🇳 Made in India
💰 MRP ₹897
Rotavac 5D® · Bharat Biotech · 0.5 mL PFS · Vero Cell-Derived · For Oral Administration Only · Not for Injection
Vero cell Rotavirus 116E · NLT 10⁵·⁰ FFU · Neomycin Sulphate 15 µg · Kanamycin Acid Sulphate 15 µg · MRP ₹897 · Bharat Biotech, Hyderabad
🦠 About Rotavirus & Why Vaccinate
India's #1 Infant Diarrhoea Killer
Rotavirus causes ~98,000 child deaths and millions of hospitalisations annually in India. Nearly every child is infected by age 5. Dehydration from simultaneous vomiting + diarrhoea is life-threatening within hours.
Why Rotavac 5D is Special
Rotavac 5D uses the 116E neonatal strain — discovered in Delhi newborns who naturally developed immunity without disease. This Indian strain provides broad cross-serotype protection uniquely suited to India's rotavirus diversity.
Proven Efficacy
The original Rotavac (116E) showed ~56% efficacy against severe rotavirus gastroenteritis and ~83% efficacy against very severe disease in Indian Phase III trials — with a robust safety profile across >8,000 infants.
Pride of India
Rotavac was the first vaccine developed entirely in India and licensed by DCGI. Bharat Biotech's Rotavac 5D is the next-generation Vero cell-derived PFS formulation — continuing this indigenous legacy with improved manufacturability.
👥 Who Should Get Rotavac 5D?
All Infants from 6 Weeks ⭐
Primary target: all healthy infants starting at 6 weeks of age. IAP 2024 recommends rotavirus vaccination as routine infant immunisation. First dose must begin before 15 weeks.
Premature Infants
Given at chronological age (6 weeks), not corrected gestational age. Rotavac's 116E strain was discovered in Indian neonates — its natural origin makes it particularly relevant for early-age protection.
Urban & Peri-Urban Families
Delhi NCR families face rotavirus from daycare, parks, shared spaces. Rotavac 5D's broad cross-protection covers multiple circulating G-types beyond just the 5 strain-specific types in pentavalent vaccines.
Value-Conscious Families
At MRP ₹897, Rotavac 5D provides WHO-endorsed rotavirus protection from India's pioneering vaccine company. Bharat Biotech's commitment to Indian public health at accessible pricing.
Catch-Up (Age Window)
If Dose 1 was missed: can catch up if baby is still under 15 weeks. All 3 doses must be complete before 32 weeks. Call VacciHub immediately if approaching these limits.
Families Supporting Indigenous Science
Parents who prefer India's own strain — discovered in Delhi newborns, developed by Indian scientists, manufactured in Hyderabad — a genuine Made-in-India success story.
🔬 Rotavac 5D Composition – Per 0.5 mL Oral Dose
As per Bharat Biotech manufacturer label. Each 0.5 mL dose (single-dose PFS) contains:
| Component | Quantity | Notes |
|---|---|---|
| ACTIVE INGREDIENT | ||
| Vero cell-derived Rotavirus 116E Bulk, Live Attenuated | NLT 10⁵·⁰ FFU | India's indigenous neonatal rotavirus strain · Monovalent · Broad cross-protective immunity across G-types |
| ANTIBIOTICS (RESIDUAL — PRODUCTION) | ||
| Neomycin Sulphate IP | 15 µg | Residual from Vero cell culture production — standard for Vero cell-derived vaccines |
| Kanamycin Acid Sulphate IP | 15 µg | Residual from Vero cell culture production |
| EXCIPIENTS | ||
| Water for Injections IP | q.s. | Vehicle |
| Excipients | q.s. | As per formulation |
| KEY PRODUCT DETAILS | ||
| Cell substrate | Vero cells | WHO-approved cell line |
| Dose volume | 0.5 mL | Single-dose PFS — smaller volume vs 2 mL liquid competitors |
| MRP | ₹897 | Inclusive of all taxes · As printed on label |
| Mfg. Lic. No. | 03/HD/AP/98/V/R | Bharat Biotech International Ltd. |
💡 NLT 10⁵·⁰ FFU: "Not Less Than" 10⁵·⁰ (=100,000) FFU (Focus Forming Units) of live 116E rotavirus per dose. This is the minimum potency guaranteed at time of release. The Vero cell-derived formulation achieves consistent, reproducible potency vs egg or primary cell substrates.
🧬 Neomycin & Kanamycin: These antibiotics are residuals from the Vero cell culture process — present at trace levels (15 µg each). Persons with known aminoglycoside allergy should discuss with their doctor before receiving Rotavac 5D.
⚠️ Storage: +2°C to +8°C. Do NOT freeze. Discard if frozen. Read enclosed leaflet before use. VacciHub cold chain is maintained at 2–8°C throughout every home visit.
📅 Rotavac 5D – IAP 2024 Oral Schedule
| Dose | Age | Route | Critical Notes |
|---|---|---|---|
| ⛔ Dose 1 MUST begin before 15 weeks · All 3 doses MUST be complete before 32 weeks | |||
| Dose 1 | 6 weeks | Oral (0.5 mL PFS) | Not before 6 weeks · Not after 15 weeks |
| Dose 2 | 10 weeks | Oral (0.5 mL PFS) | Minimum 4 weeks from Dose 1 |
| Dose 3 | 14 weeks | Oral (0.5 mL PFS) | Must be complete before 32 weeks of age |
🚨 Age limits are WHO/IAP mandated — non-negotiable. Dose 1 before 15 weeks and all doses before 32 weeks exist specifically to minimise intussusception risk. Call VacciHub immediately if baby is 12–14 weeks without Dose 1 — same-day slots available.
ℹ️ Rotavac 5D (0.5 mL oral PFS) can be co-administered on the same day as injectable vaccines (PCV, Hexasiil, Tetraxim) per IAP 2024 — administered orally before or alongside injectable doses.
⚙️ How Does Rotavac 5D Work?
1
0.5 mL PFS Administered Orally
The nurse gently expresses all 0.5 mL from the prefilled syringe into the baby's cheek. The live attenuated 116E strain is swallowed and reaches the small intestinal epithelium — the exact site of natural rotavirus infection.
2
116E Replicates Mildly in the Gut
Unlike the original wild-type 116E (which infected Indian neonates naturally without disease), the live attenuated Rotavac 5D strain replicates even more mildly in the intestinal lining — mimicking natural infection while being safe. This gut replication directly stimulates mucosal immunity.
3
Secretory IgA + Cross-Protective Immunity
The gut generates secretory IgA (sIgA) antibodies against rotavirus that coat the intestinal wall. Crucially, 116E's unique neonatal origin generates broad cross-reactive immunity across multiple G-types — providing protection beyond just G1 through natural immune priming mechanisms.
4
3 Doses Build Complete Protection
Each of the 3 doses amplifies gut and systemic immunity. After Dose 3 at 14 weeks, the baby has robust protection against severe rotavirus gastroenteritis. Phase III data showed ~56% efficacy against severe RV disease and ~83% against very severe disease — notably higher protection where it matters most.
⚠️ Rotavac 5D Side Effects
Rotavac 5D has an excellent safety profile demonstrated across large Indian Phase III trials (>8,000 infants) and post-licensure surveillance.
🟡 Common (Mild, Transient)
- 💩 Mild temporary diarrhoea
- 🤮 Vomiting / regurgitation
- 😢 Irritability / fussiness
- 🌡️ Low-grade fever
🔴 RARE — SEEK EMERGENCY CARE
- 🚨 Intussusception (bowel obstruction)
- 😰 Severe abdominal pain / knees drawn up
- 🩸 Bloody or jelly-like stool
- 😵 Persistent vomiting + extreme paleness
🚨 Intussusception: Very rare (1–2 per 100,000 vaccinated) but life-threatening. Risk highest in 7 days after Dose 1 — strict 15-week age limit minimises this. The original Rotavac Phase III trial showed no statistically significant increase in intussusception compared to placebo — a key safety milestone for this Indian strain. Still: seek emergency care immediately for severe abdominal pain, bloody stool, persistent vomiting or extreme lethargy.
ℹ️ Aminoglycoside sensitivity: Rotavac 5D contains trace Neomycin Sulphate (15 µg) and Kanamycin Acid Sulphate (15 µg) from the Vero cell production process. Persons with known allergy to aminoglycoside antibiotics should discuss with their doctor before receiving this vaccine.
⚖️ Rotavac 5D vs Rotasiil vs RotaTeq
| Feature | Rotavac 5D (BB) | Rotasiil-Liquid (SII) | RotaTeq (MSD) |
|---|---|---|---|
| Manufacturer | ✓ Bharat Biotech, India | SII, India | Merck, USA |
| Strain | 116E (India indigenous) | G1, G2, G3, G4, G9 | G1, G2, G3, G4, P[8] |
| Type | Monovalent (1 strain) | Pentavalent (5 strains) | Pentavalent (5 strains) |
| Dose volume | ✓ 0.5 mL PFS | 2 mL oral liquid | 2 mL oral tube |
| MRP | ₹897 | Varies | Higher (imported) |
| Cell substrate | ✓ Vero cells | ✓ Vero cells | ✓ Vero cells |
| Made in India | ✓ Yes – Hyderabad | ✓ Yes – Pune | No – USA |
| WHO Prequalified | ✓ Yes | ✓ Yes | ✓ Yes |
| IAP 2024 Accepted | ✓ Yes | ✓ Yes | ✓ Yes |
| Schedule | 3 doses: 6, 10, 14 wks | 3 doses: 6, 10, 14 wks | 3 doses: 6, 10, 14 wks |
| Phase III efficacy | ~56% (severe) / ~83% (very severe) | ~66–80% | ~74% |
| Indigenous origin | ✓ India's own 116E strain | Bovine-Human reassortant | Human-Bovine reassortant |
💡 Monovalent vs Pentavalent: Rotavac 5D protects through broad cross-reactive immunity generated by the 116E strain — India's natural neonatal rotavirus. Pentavalent vaccines (Rotasiil, RotaTeq) protect through 5 specific G-type antigens. Both approaches are WHO-accepted. The 116E strain's natural Indian origin may confer additional contextual advantages in Indian populations.
🚫 Precautions & Contraindications
Do NOT give Rotavac 5D if:
- Known history of intussusception or intestinal malrotation
- Severe Combined Immunodeficiency (SCID) — live vaccine absolutely contraindicated
- Known allergy to aminoglycosides (Neomycin, Kanamycin) — present as residuals
- Baby older than 15 weeks for Dose 1 (strict age limit)
- Acute severe gastroenteritis on vaccination day — defer until recovery
Use with Caution:
- Immunocompromised infants (not SCID) — discuss risk-benefit with paediatrician
- Discard if vial/syringe has been frozen
- Viral shedding possible for ~7–10 days post-dose; good hand hygiene for caregivers
⚠️ ORAL ONLY — NOT FOR INJECTION. Store +2°C to +8°C. Do NOT freeze. Discard if frozen. Read enclosed leaflet before use. VacciHub nurses verify cold chain before every dose and administer orally only.
🏥 Why Book Rotavac 5D with VacciHub?
Trained Infant Nurses
Nurses trained in oral PFS administration — 0.5 mL expressed into baby's cheek. Pre-dose health screen. 30-minute post-dose observation. Fever management guidance given.
Never Frozen — Cold Chain
Rotavac 5D must NEVER be frozen — discard if frozen. Our validated cold boxes maintain exactly 2–8°C. Temperature verified before every dose. Nurse checks PFS for freeze indicators.
Age-Critical Reminders
We track your baby's date of birth. WhatsApp reminders ensure Dose 1 before 15 weeks and all 3 doses complete before 32 weeks. Never miss the critical window.
Genuine Bharat Biotech
Sourced from authorised BB distributors. Batch number, MFG date, EXP date all transparent on your WhatsApp vaccination record after every dose.
Home Comfort
Oral vaccines at home — calmer baby, no hospital queues, no infection-risk waiting rooms. 0.5 mL PFS is quick and easy — entire dose done in seconds.
Multi-Vaccine Visit
Rotavac 5D oral + injectable vaccines (PCV, Hexasiil, Tetraxim) in one home visit per IAP — oral first, then injections. Minimise total home visits for baby's full schedule.
📍 Rotavac 5D Home Vaccination – Cities We Cover
🏛️Delhi (All Areas)
🏙️Gurgaon
🌆Noida
🏘️Ghaziabad
🏗️Faridabad
🌇Greater Noida
Call +91 92050 04114 to confirm your area — same-day slots available.
❓ Frequently Asked Questions – Rotavac 5D
Rotavac 5D is a Rotavirus Vaccine (Live Attenuated, Oral) IP by Bharat Biotech (BB), Hyderabad. It uses India's own indigenous 116E neonatal rotavirus strain — discovered in Delhi newborns in the 1980s. It is a monovalent vaccine (1 strain) in a 0.5 mL PFS. Rotasiil (SII) is pentavalent (5 G-types including G9) in 2 mL liquid. Both are WHO prequalified and IAP accepted — different strain strategies, both effective.
The 116E strain was discovered in the 1980s in neonates at AIIMS, New Delhi. It's a naturally occurring bovine-human reassortant rotavirus that infected Indian newborns without causing disease — providing natural immunity. Bharat Biotech, working with the US NIH and DCGI, developed it into Rotavac — India's first indigenously developed vaccine. 116E's Indian origin means it is naturally adapted to Indian rotavirus diversity, and its cross-reactive immunity covers multiple G-types beyond the single strain.
As printed on the Bharat Biotech manufacturer label: M.R.P. Rs. 897 — Inclusive of All Taxes. This is for a single 0.5 mL PFS. Call VacciHub at +91 92050 04114 for current home vaccination pricing inclusive of nurse visit and cold chain delivery.
3 oral doses of 0.5 mL each: Dose 1 at 6 weeks · Dose 2 at 10 weeks · Dose 3 at 14 weeks.
⛔ Critical age limits: Dose 1 MUST begin before 15 weeks. All 3 doses MUST be complete before 32 weeks (8 months). These are WHO and IAP mandated non-negotiable limits.
⛔ Critical age limits: Dose 1 MUST begin before 15 weeks. All 3 doses MUST be complete before 32 weeks (8 months). These are WHO and IAP mandated non-negotiable limits.
Yes — Rotavac 5D contains trace residuals of Neomycin Sulphate IP (15 µg) and Kanamycin Acid Sulphate IP (15 µg) from the Vero cell culture production process. These are standard residuals in Vero cell-derived vaccines. They are safe at these concentrations for the vast majority of infants. However, if your baby has a known allergy to aminoglycoside antibiotics (Neomycin, Kanamycin), discuss with your paediatrician before vaccination.
Yes. VacciHub provides home administration of genuine Bharat Biotech Rotavac 5D across Delhi, Gurgaon, Noida, Ghaziabad, Faridabad and Greater Noida. Our trained nurses maintain cold chain (2–8°C, never frozen), administer 0.5 mL PFS orally, track baby's age for all 3 doses and send reminders. Call +91 92050 04114 to book.
Intussusception is a rare bowel obstruction. The original Rotavac (116E) Phase III trial in India showed no statistically significant increase in intussusception vs placebo — a notable safety advantage. All rotavirus vaccines carry a very small estimated risk (~1–2 per 100,000) but the benefit (preventing ~1000 deaths per 100,000) vastly outweighs this. Seek emergency care immediately for: severe abdominal pain, bloody stool, persistent vomiting, extreme paleness.