- 3vaccine applications a regulator's own list says are under review
- 3further candidates with a company-announced filing, across 7 jurisdictions
- 119registered trial readouts due in the next 24 months
- 5vaccines with a regulator-confirmed licence in the last 24 months
- 211active candidates tracked, of 335 records
Jump to: applications under review ·
company-announced filings ·
readout calendar ·
recently licensed ·
by target disease ·
how to read this
Applications a regulator says are under review
These are taken from the lists the regulators publish themselves, so
the fact that an application is open is the regulator's statement, not a company's.
An application under review is not an approval and carries no promised decision date.
Each list is a snapshot: it says what was pending on the day it was published, named
in the heading, and a decision may have been taken since.
EU — 3 applications
Applications for new human medicines under evaluation by the CHMP, 2026-10; list as of
5 October 2026
Initial EU marketing-authorisation applications whose CHMP evaluation has started. Extensions of an existing authorisation are published separately and are not in this file.
Source: Applications for new human medicines under evaluation by the CHMP, 2026-10.
One source could not be read for this build. Health Canada's list of new drug submissions under review did not respond to this build, so any application pending there is missing from the table above. That is a gap in what could be fetched, not a statement that nothing is pending.
The United States is missing from
this section by necessity. The FDA publishes no list of pending licence
applications, so there is no equivalent source to read; a US filing can only ever
reach this page as a company statement, below. Japan, the UK, China and India publish
no list this build can read either.
Filings a company has announced
Hand-curated from company disclosures, and kept apart from the
regulator lists above on purpose: a company saying it has filed is weaker evidence
than a regulator saying it is reviewing. The chip after each date says which it is.
Company-announced timelines slip often, and where a date here is old the row says so
rather than implying the filing is still open. A candidate's development stage may
also lag what a regulator's list shows — the stage comes from trial records,
not from the filing.
Valneva · Chikungunya
· Live attenuated
- Australia — under review, 1 September 2024 company estimateTGA submission under evaluationRecorded 25 months ago and not re-confirmed since; the regulator may have decided.
Post-marketing safety surveillance; adolescent trial data readout
Virus page · FDA vaccines licensed / safety communications (verify live)
Moderna · Seasonal influenza
· mRNA
- US — submission filed, January 2026 company estimateCompany-reported filing; confirm against FDA docket before treating as regulator-confirmed
- EU — submission filed, January 2026 company estimate
- Canada — submission filed, January 2026 company estimate
- Australia — submission filed, January 2026 company estimate
Regulatory decision(s) pending across filed jurisdictions (company projection)
Licensed seasonal influenza vaccines · Virus page · Moderna Analyst Day pipeline update (press summary)
Moderna · Seasonal influenza + COVID-19 (combination)
· mRNA
- US — under review, 15 October 2024 regulator-confirmedBLA submitted to FDA following positive Phase 3 immunogenicity data vs separate flu & COVID vaccinesRecorded 24 months ago and not re-confirmed since; the regulator may have decided.
- EU — under review, 1 November 2024 company estimateEMA regulatory submission planned/under reviewRecorded 23 months ago and not re-confirmed since; the regulator may have decided.
FDA target PDUFA action date and ACIP review for 2025-2026 respiratory season
Licensed seasonal influenza + covid-19 (combination) vaccines · Virus page · Moderna Analyst Day / pipeline disclosures
Readout calendar: the next 24 months
Primary completion dates for registered trials of candidates that are
still active, straight from ClinicalTrials.gov. A readout is not an
approval — it is the date the sponsor expects to finish collecting the
primary outcome, and sponsors revise these dates routinely. Trials marked terminated,
withdrawn or suspended are left out, and a date that names no month (such as a bare
“2025–2026”) is left out rather than guessed.
Licensed in the last 24 months
Only licences and authorisations whose date is marked
regulator-confirmed in the pipeline file. A vaccine licensed outside the jurisdictions
tracked here (US, EU, Canada, Australia, UK) will not appear.
By target disease
Active candidates per target, with the nearest expected readout.
“Phase 3” counts candidates whose most advanced active trial is phase 3.
Where this site has a guide to the vaccines already licensed for a disease, it is
linked; where it says none yet, that means no guide here, not that no vaccine
exists.
How to read this page
- Applications under review come from the regulators. The EU
rows are the European Medicines Agency's monthly list of applications under
evaluation by its human medicines committee; the Canadian rows are Health
Canada's list of new drug submissions under review, filtered to the rows whose
own therapeutic-area field reads “Vaccines”. Both are copied, with
the date each list was published. Neither list gives a developer's internal
candidate code, so a link from an application to a candidate tracked here is a
judgement someone made once and recorded, with the published wording it rests
on shown beside it. An application with no link is still listed: it is pending
whether or not this site tracks the product.
- Where the records come from. One file,
vaccine_pipeline_data.json, built by
fetch_vaccine_pipeline_from_ctgov.py from the ClinicalTrials.gov API
v2 (interventional BIOLOGICAL vaccine trials, grouped per candidate) plus
hand-curated rows for FDA CBER licences and company filing announcements. This
page is generated from that file by build_upcoming_vaccines.py and
adds nothing of its own: a date that is not in the file is not on the page.
- Two kinds of date, never mixed.
regulator-confirmed a regulator published it.
company estimate a company announced it.
registry estimate a sponsor's estimated completion date in the trial
registry. Only the first is a fact about a regulator's action.
- Registry phase is not regulatory status. A candidate's stage
here is read from its most advanced active trial. A licensed vaccine
whose only running studies are early-phase therefore reads as early-phase. Check
the licence sections, not the phase, for what is approved.
- 19 records are left out as stale. When
every registered trial under a candidate has finished, the candidate stops
coming back from the registry query. Its page stays published and the full
dashboard still lists it, but its dates were last confirmed at an earlier fetch,
so it is excluded from every section above rather than presented as current.
- Absence means absence of a record, not absence of a programme.
Trials that are not registered, or are registered outside ClinicalTrials.gov, do
not appear; nor do regulatory actions outside the jurisdictions the curated rows
cover. Chinese, Indian and Russian registries are not ingested.
- No recommendations. Nothing here says a candidate will be
approved, will work, or should be taken. For licensed vaccines and their reported
adverse events, use the vaccine matrix and the
individual guides.
The full filterable table of all
335 candidate records, including discontinued programmes, is
at the vaccine pipeline dashboard; each
candidate also has its own page. Viruses and what exists against them are in the
Virus Navigator, and the gap matrix lists targets
with no vaccine and no antiviral at
/virus-navigator/gaps.html.