🇺🇸 HBV vaccine in United States

12 US adverse-event reports

Marketing authorisation

FDA

  • Status: approved

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Foetal Exposure During Pregnancy — 3 reports (25%)
  2. Adverse Event — 1 report (8.33%)
  3. Atrial Septal Defect — 1 report (8.33%)
  4. Drug Hypersensitivity — 1 report (8.33%)
  5. Ebstein^S Anomaly — 1 report (8.33%)
  6. Gingivitis — 1 report (8.33%)
  7. Hepatitis B Surface Antigen Positive — 1 report (8.33%)
  8. Mouth Ulceration — 1 report (8.33%)
  9. Oral Herpes — 1 report (8.33%)
  10. Pneumothorax — 1 report (8.33%)

Source database →

HBV vaccine in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is HBV vaccine approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for HBV vaccine in United States?

Qin Ning is the originator. The local marketing authorisation holder may differ — check the official source linked above.