Revised: 16 February 2021

COVID-19

Approval status of COVID vaccines applications received by Medsafe

Comirnaty (COVID-19 mRNA vaccine) (Pfizer-BioNTech) 0.5 mg/mL concentrate for injection (TT50-10853)

Approval pathway: rolling abbreviated application

Status: Approved under section 23 of the Medicines Act, with conditions.

Documents:

• Gazette notice
• Datasheet
• Consumer Medicine Information
• Dear Healthcare Professional Letter

See also: mRNA Vaccines

Janssen COVID-19 (Ad26.COV2.S), Vaccine suspension 5 x 1010 VP/0.5 mL (TT50-10862)

Approval pathway: rolling abbreviated application

Status: Application received, some data under evaluation, further data to be provided by sponsor.