🇺🇸 mRNA COVID-19 in United States

9 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. Varicella Zoster Virus Infection — 2 reports (22.22%)
  2. Acute Kidney Injury — 1 report (11.11%)
  3. Altered State Of Consciousness — 1 report (11.11%)
  4. Bradycardia — 1 report (11.11%)
  5. Drug Ineffective — 1 report (11.11%)
  6. Gait Disturbance — 1 report (11.11%)
  7. Therapy Non-Responder — 1 report (11.11%)
  8. Uraemic Encephalopathy — 1 report (11.11%)

Source database →

mRNA COVID-19 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 mRNA COVID-19 approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for mRNA COVID-19 in United States?

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