What vaccines should be administered to Indian patients with Inflammatory Bowel Disease (IBD) before initiating biologic therapy?

Vaccination Protocol for Indian IBD Patients Before Initiating Biologics

All Indian IBD patients should receive a comprehensive vaccination schedule before starting biologic therapy, including hepatitis B, influenza, pneumococcal, herpes zoster, tetanus-diphtheria-pertussis, HPV (if age-appropriate), and MMR/varicella if not immune—with live vaccines administered at least 4 weeks before immunosuppression begins. 1

Critical Timing Principle

Inactivated vaccines are safe and should be administered at the earliest opportunity, preferably before starting biologics or while off corticosteroids (or at the lowest tolerable dose). 1 However, vaccination should never delay initiation of necessary biologic therapy. 2 Inactivated vaccines do not cause IBD flares and can be given during any clinic visit. 1

Essential Vaccines Before Biologics

Hepatitis B Vaccine (Universal Priority)

• All Indian IBD patients aged 19-59 years require hepatitis B vaccination before biologics. 1 This is particularly critical in India given the higher HBV prevalence in the region. 1
• Preferred regimen: HEPLISAV-B (2-dose series at 0 and 1 month) for all adults starting immune-modifying therapy. 1
• Alternative: ENGERIX-B, Recombivax HB, or PreHevbrio (3-dose series at 0,1, and 6 months). 1
• Screen for latent HBV infection before vaccination. 1 HBV reactivation during immunosuppression can cause death in approximately 5% of patients. 1
• Check anti-HBs levels 4-8 weeks after completion. 1 If anti-HBs <10 mIU/mL, give a single challenge dose and recheck in 4-8 weeks. 1 If still non-protective, complete a second full vaccine series. 1

Influenza Vaccine (Annual)

• All IBD patients require annual inactivated influenza vaccine regardless of treatment status. 1
• Standard-dose quadrivalent inactivated vaccine for adults 18-64 years. 1
• High-dose, recombinant, or adjuvanted vaccine for adults ≥65 years. 1
• Never use live attenuated intranasal vaccines. 1
• Timing relative to biologic infusion does not matter—administer at any visit. 1, 2

Pneumococcal Vaccine

• All adults aged 19-64 years starting biologics should receive pneumococcal vaccination. 1
• Strong recommendation for those on immunosuppressive therapy. 1
• Use PCV15, PCV20, PCV21, or PPSV23 according to current CDC schedules. 1
• Second dose required at age ≥65 years. 1

Herpes Zoster Vaccine (Critical Before Biologics)

• All adults ≥19 years receiving or planning to receive biologics must receive recombinant zoster vaccine (Shingrix) 2-dose series. 1, 2
• Administer 4-8 weeks apart, regardless of prior varicella vaccination status. 2
• Do not delay biologics for zoster vaccination, and do not pause biologics for vaccination. 2
• This adjuvanted vaccine is safe and does not cause IBD flares. 2

Tetanus-Diphtheria-Pertussis (Tdap/Td)

• All adult IBD patients require Tdap or Td vaccination. 1
• Follow standard ACIP recommendations for the general population. 1
• Booster every 10 years. 3

HPV Vaccine (Age-Dependent)

• Strong recommendation for all patients aged 18-26 years (both males and females). 1
• For ages 27-45 years, vaccinate if likely to have new sexual partners. 1
• Particularly important given increased cervical dysplasia risk in immunosuppressed women. 1

MMR and Varicella (Live Vaccines—Special Considerations)

• If not immune: Administer at least 4 weeks before starting biologics. 1
• MMR: 2-dose series, at least 4 weeks apart. 1
• Varicella: 2-dose series for non-immune patients. 1
• Immunization history is presumptive evidence of immunity—serologic screening is discouraged due to false negatives. 1
• Absolutely contraindicated once on biologics or immunosuppression. 1, 2

Additional Vaccines for Specific Populations

Meningococcal Vaccine

• Recommended for patients with risk factors for invasive meningococcal disease. 1
• Age-appropriate meningococcal ACWY and B vaccines. 1

Hepatitis A Vaccine

• Consider for patients with chronic liver disease, travel to endemic areas, or other risk factors. 1

Respiratory Syncytial Virus (RSV)

• For patients ≥60 years: single dose of RSV vaccine (Abrysvo or Arexvy). 1, 2

Critical Pitfalls to Avoid

Live Vaccine Contraindication

Never administer live vaccines (MMR, varicella, yellow fever, intranasal influenza) to patients already on biologics or immunosuppression. 1, 2 This includes patients on anti-TNF agents, vedolizumab, ustekinumab, tofacitinib, or combination therapy. 4, 3, 5

Timing Errors

• Do not delay necessary biologic therapy to complete vaccination schedules. 2 Inactivated vaccines can be given during biologic therapy, though response may be reduced. 3, 6
• Ideally complete all vaccinations, especially live vaccines, before diagnosis or during disease remission before immunosuppression. 4, 5, 6

Inadequate Screening

• Screen for latent infections before vaccination and biologics: HBV, HCV, HIV, tuberculosis. 1
• Check vaccination history at IBD diagnosis and update immediately. 3, 6

Shared Responsibility Gap

Vaccination uptake is suboptimal when responsibility is unclear between gastroenterologists and primary care providers. 7 Gastroenterologists should actively assess and initiate vaccination at diagnosis, not defer to primary care. 1, 6

Practical Implementation Algorithm

1. At IBD diagnosis: Obtain complete vaccination history and serologic screening (HBV, HCV, HIV, varicella, MMR if uncertain). 4, 3, 6

2. Before biologics planned:

   • Administer all indicated inactivated vaccines immediately (hepatitis B, influenza, pneumococcal, herpes zoster, Tdap, HPV). 1
   • If non-immune to MMR/varicella: Give live vaccines at least 4 weeks before starting biologics. 1

3. Already on biologics:

   • Give all inactivated vaccines at any visit. 2
   • Never give live vaccines. 1, 2
   • Consider higher doses or additional boosters for hepatitis B if non-responsive. 1

4. Annual review: Influenza vaccine yearly, update other vaccines per CDC schedule. 1, 6

Special Considerations for Indian Population

Given India's epidemiological context with higher prevalence of hepatitis B and tuberculosis, hepatitis B vaccination and tuberculosis screening are particularly critical before biologics. 1 The universal hepatitis B vaccination recommendation for adults 19-59 years is especially relevant. 1