🇺🇸 Spikevax in United States

557 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. Fatigue — 110 reports (19.75%)
  2. Covid-19 — 65 reports (11.67%)
  3. Headache — 59 reports (10.59%)
  4. Pyrexia — 52 reports (9.34%)
  5. Nausea — 50 reports (8.98%)
  6. Dizziness — 47 reports (8.44%)
  7. Off Label Use — 47 reports (8.44%)
  8. Dyspnoea — 44 reports (7.9%)
  9. Arthralgia — 42 reports (7.54%)
  10. Malaise — 41 reports (7.36%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Spikevax approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Spikevax in United States?

Jules Bordet Institute is the originator. The local marketing authorisation holder may differ — check the official source linked above.