FDA — authorised 22 April 2019
- Application: ANDA211547
- Marketing authorisation holder: SPECGX LLC
- Status: supplemented
🇺🇸 A single "booster" dose of the Moderna mRNA COVID-19 vaccine in United States
FDA authorised A single "booster" dose of the Moderna mRNA COVID-19 vaccine on 22 April 2019
Marketing authorisations
FDA — authorised 31 August 2023
- Application: ANDA211546
- Marketing authorisation holder: SPECGX LLC
- Status: approved
FDA
- Status: approved
A single "booster" dose of the Moderna mRNA COVID-19 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 A single "booster" dose of the Moderna mRNA COVID-19 vaccine approved in United States?
Yes. FDA authorised it on 22 April 2019; FDA authorised it on 31 August 2023; FDA has authorised it.
Who is the marketing authorisation holder for A single "booster" dose of the Moderna mRNA COVID-19 vaccine in United States?
SPECGX LLC holds the US marketing authorisation.