Q.01

Which vaccines are licensed by the FDA?

The September 2026 edition of the FDA Purple Book lists 86 vaccine licences (BLAs) as currently Licensed by CBER. Of those, 72 have at least one product on the market (Rx) and 14 are still licensed but every product under them is marked discontinued. The full table (licence holder, BLA number, first approval date, status, and citations for every product line) is in the panel document.

Approach: I pulled every CBER product in the Purple Book with licensure status "Licensed". I kept the vaccines and toxoids, removed immune globulins such as Vaccinia Immune Globulin, and then checked the revoked entries separately.

Licensed and marketed, by disease area

  • COVID-19: Comirnaty [1], Spikevax [2], mNEXSPIKE [3], Nuvaxovid [4]
  • Influenza: Fluad [5], Fluarix [6], Flublok [7], Flucelvax [8], Flulaval [9], FluMist [10], Fluzone family [11], and Moderna's mRNA flu vaccine (flusiva/mflusiva), approved 5 August 2026 [12]
  • RSV: Abrysvo [13], Arexvy [14], mRESVIA [15]
  • Pneumococcal: Capvaxive [16], Pneumovax 23 [17], Prevnar 20 [18], Vaxneuvance [19]
  • Meningococcal: Bexsero [20], Menactra [21], MenQuadfi [22], Menveo [23], Penbraya [24], Penmenvy [25], Trumenba [26]
  • Hib: ActHIB [27], Hiberix [28], PedvaxHIB [29]
  • Diphtheria, tetanus and pertussis combinations: Adacel [30], Boostrix [31], Daptacel [32], Infanrix [33], Kinrix [34], Pediarix [35], Pentacel [36], Quadracel [37], Tenivac [38], Vaxelis [39]
  • Polio: IPOL [40]
  • HPV: Gardasil 9 [41]
  • Hepatitis A and B: Engerix-B [42], Havrix [43], Heplisav-B [44], Recombivax HB [45], Twinrix [46], Vaqta [47]
  • Rotavirus: Rotarix [48], RotaTeq [49]
  • Measles, mumps, rubella and varicella: M-M-R II [50], Priorix [51], ProQuad [52], Varivax [53]
  • Zoster: Shingrix [54]
  • Rabies: Imovax Rabies [55], RabAvert [56]
  • Anthrax: BioThrax [57], Cyfendus [58]
  • Smallpox and mpox: ACAM2000 [59], Jynneos [60]
  • BCG: BCG Vaccine (Merck Teknika) [61]. Tice BCG is also listed, but it is BCG Live given into the bladder (intravesical use) [62].
  • Travel and other: Dengvaxia [63], Ervebo (Ebola) [64], Ixiaro (Japanese encephalitis) [65], oral Adenovirus Type 4 and 7 vaccine (Teva) [66], Ticovac (tick-borne encephalitis) [67], Typhim Vi [68], Vaxchora (cholera) [69], Vimkunya (chikungunya) [70], Vivotif (typhoid) [71], YF-Vax (yellow fever) [72]

Still licensed, but every product discontinued (14):

  • Influenza: Afluria, Agriflu, Arepanrix H5, Audenz, Fluvirin, and Sanofi's H5N1 vaccine
  • Cervarix and Gardasil (the original)
  • Prehevbrio
  • Zostavax
  • Tdvax
  • Poliovax
  • BioRab
  • Greer's Plague Vaccine

Their citations are in the document.

No longer licensed:

  • Revoked: Ixchiq (Valneva's live chikungunya vaccine) [73].
  • Voluntarily revoked (the licence holder gave up the licence), among others:
Q.02

Where can I check manufacturers and package inserts?

I can look up both in three official US sources: the FDA Purple Book names the licence holder for each BLA, the NLM DailyMed holds the current package insert for each vaccine, and the FDA NDC Directory lists who markets each product, with its BLA and NDC codes. I can query any of them for the vaccines on the earlier list.

Approach: I checked these three sources using Shingrix as a worked example.

What each source gives you

NeedSourceWhat it holdsShingrix example
Licence holder (manufacturer of record)FDA Purple Book (CBER)Applicant, BLA number, licensure and marketing status. This is where the earlier table came from.BLA 125614 [54]
Package insert (full prescribing information)NLM DailyMedThe current label, which DailyMed classes as a "Vaccine Label". It gives the labeler, the date the label took effect, a stable label ID and a direct link.GlaxoSmithKline Biologicals SA's label, effective 13 Feb 2026 (DailyMed) [80]
Who markets each product and packFDA NDC DirectoryLabeler name, BLA number and product NDC for every product it lists as marketedGSK under BLA125614, NDCs 58160-849 and 58160-823 [81][82]

Points to watch

  • Repackagers show up as labelers too. In DailyMed and the NDC Directory, a repackager such as A-S Medication Solutions also appears as a labeler of Shingrix under the same BLA [83][84]. Use the label from the licence holder named in the Purple Book as the reference package insert.
  • The NDC Directory names other companies too. Its vaccine entries include contract fillers (for example Patheon, Vetter) and repackagers (for example A-S Medication Solutions, ASCLEMED), so not every company named there is the licence holder.

If you'd like, I can build a panel table for all 72 marketed vaccine licences, with the licence holder, the DailyMed package-insert link and the label's effective date for each.

Q.03

Which COVID vaccines have FDA approval?

Four COVID-19 vaccines currently hold FDA licences (BLAs). All four are licensed by CBER and each has at least one presentation marketed (Rx):

VaccineTypeLicence holder (Purple Book)BLAFirst approved
ComirnatyCOVID-19 Vaccine, mRNABioNTech Manufacturing GmbH12574223 Aug 2021 [1]
SpikevaxCOVID-19 Vaccine, mRNAModernaTX, Inc.12575231 Jan 2022 [2]
NuvaxovidCOVID-19 Vaccine, AdjuvantedSanofi Vaccines US Inc.12581716 May 2025 [4]
mNEXSPIKECOVID-19 Vaccine, mRNAModernaTX, Inc.12583530 May 2025 [3]

Approach: I searched the FDA Purple Book (CBER) and FDA's list of CBER vaccine, blood and tissue approvals for COVID-19 and SARS-CoV-2 products.

Presentations still marketed

  • Comirnaty:
    • 10 µg/0.3 mL single-dose vial (approved 27 Aug 2025) [85]
    • 30 µg/0.3 mL pre-filled syringe [86]
    • The original multi-dose vials, a single-dose vial and an earlier syringe are discontinued, but the licence stays in force [87][88][89].
  • Spikevax:
    • 50 µg/0.5 mL pre-filled syringe [90]
    • 25 µg/0.25 mL pre-filled syringe (approved 9 Jul 2025) [91]
    • The vial presentations are discontinued [92][93].
  • Nuvaxovid: 5 µg pre-filled syringe [4]
  • mNEXSPIKE: 10 µg pre-filled syringe [3]

Who each vaccine is approved for (2025 labelling)

The approvals are restricted to older adults and to younger people at high risk:

  • Spikevax: people 65 and older, or 6 months through 64 years with at least one underlying condition that puts them at high risk for severe COVID-19 [94]

  • mNEXSPIKE: people previously vaccinated with any COVID-19 vaccine who are 65 and older, or 12 through 64 years with at least one high-risk condition [95]

  • Nuvaxovid: adults 65 and older, and people 12 through 64 years with at least one high-risk condition [96]

  • Comirnaty: the 2025-2026 Formula covers:

    • 10 µg for children 5 through 11 years with at least one high-risk condition
    • 30 µg for people 65 and older, or 12 through 64 years with at least one high-risk condition

    [97]

  • 2025-2026 Formula: all four vaccines were approved for it on 27 Aug 2025 [98][99][100]. I found no 2026-2027 formula approval in the CBER approvals list.

Other points

  • Most recent change: the latest COVID-19 vaccine change I found is a Comirnaty package-insert update approved on 20 Feb 2026. It added data on use during pregnancy and in immunocompromised people aged 5 and older [101].
  • Nuvaxovid manufacturer: the 2025 approval names Novavax, Inc. as manufacturer [96]. The current Purple Book entry lists Sanofi Vaccines US Inc. as the applicant [4].
  • Convalescent plasma: CBER has also approved high-titer anti-SARS-CoV-2 convalescent plasma. It is a blood product for treating COVID-19, not a vaccine [102].
Q.04