🇺🇸 Second dose in United States

10 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. Adrenal Insufficiency Neonatal — 1 report (10%)
  2. Anaemia Neonatal — 1 report (10%)
  3. Cardio-Respiratory Arrest Neonatal — 1 report (10%)
  4. Fungal Sepsis — 1 report (10%)
  5. Haematocrit Decreased — 1 report (10%)
  6. Malaise — 1 report (10%)
  7. Necrotising Enterocolitis Neonatal — 1 report (10%)
  8. Neonatal Cholestasis — 1 report (10%)
  9. Neonatal Disorder — 1 report (10%)
  10. Pulmonary Embolism — 1 report (10%)

Source database →

Second dose 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 Second dose approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Second dose in United States?

BioSyngen Pte Ltd is the originator. The local marketing authorisation holder may differ — check the official source linked above.