This page shows what was measured, who it was measured in, and what that does not settle.
What Tozinameran does in the body
COVID-19 prevention in older adults and people at higher risk
The injection carries a recipe, not a virus. Fat droplets about a thousandth the width of a hair carry that recipe into cells near the injection site and in the lymph node that drains it. Those cells build one harmless coronavirus surface protein and show it to the immune system, which learns the shape and keeps a memory of it. The recipe is chewed up by ordinary cellular enzymes within days and never goes near the cell nucleus.
What happened in people
95% relative reduction in symptomatic PCR-confirmed COVID-19 over a median of two months: 8 cases against 162
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.
The marketed product is now strain-updated annually and encodes an omicron spike, not the ancestral spike the pivotal trial tested
Where it acts
Deltoid muscle and the draining axillary lymph node; translation occurs in the cytoplasm of muscle cells and antigen-presenting cells
Kind of result
The kind of result is not recorded
Supervision
Professional supervision is normally required. It is a prescription or clinician-administered medicine where it is approved.
What the registries record it as
The substance registry classes this as nucleicacid.
FDA substance registry · 5085ZFP6SJ · read 2026-08-29
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
A limit recorded against this substance. Not signed off as a reviewed claim.
The four opening statements run to 107 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Messenger RNA
Messenger RNA is a working copy of one gene, carried to where proteins are built.
A picture of it, and where the picture fails
It is like a photocopy of one plan page, taken to the workshop.
Where that stops being true. A photocopy lasts. This copy is destroyed soon after use, on purpose.
What people get wrong. It is often thought to change the gene. It is a copy, and it does not alter the original.
A single-stranded transcript of a gene that ribosomes translate into a protein.
Small interfering RNA
A small interfering RNA is a short piece that makes a cell destroy one working copy.
A picture of it, and where the picture fails
It is like a note telling the workshop to shred one plan page.
Where that stops being true. A note is read once. This keeps working for months after one injection.
What people get wrong. It is often described as gene editing. It leaves the gene untouched.
A short double-stranded RNA that directs the RNA-induced silencing complex to cleave a complementary transcript.
Absolute difference
An absolute difference is how many more people in a hundred were affected.
A picture of it, and where the picture fails
It is like counting heads in two rooms of a hundred.
Where that stops being true. Heads are easy to count. Study results carry a margin of error too.
What people get wrong. It is confused with a percentage change, which can look far larger.
The arithmetic difference in event rates between arms.
Confidence interval
A confidence interval is the range the true answer is likely to sit in.
A picture of it, and where the picture fails
It is like a weather forecast giving a range rather than one number.
Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.
What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.
An interval estimate that would contain the true parameter in a stated proportion of repeated studies.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
PCR-confirmed COVID-19 with at least one symptom, occurring at least 7 days after the second dose, in participants without evidence of prior SARS-CoV-2 infection
✓ The study showed what it set out to show
Who was studied
C4591001 primary analysis (NCT04368728)
How many people
43448
Study design
Phase 2/3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Bayesian success criterion rather than a p-value: 95% efficacy with a 95% credible interval of 90.3 to 97.6
Repeated elsewhere
Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. Myocarditis and pericarditis were not detected in the trial and emerged only in post-authorisation surveillance, at a rate too low for a 43,000-person study to see.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Ionisable lipid nanoparticle, intramuscular
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
RNAWiki holds 2 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What it changes in the body◇Read from sources, not yet reviewed
The path through the body
From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.
Start
Tozinameran
What a person takes: Ionisable lipid nanoparticle, intramuscular.
The measurement behind this step
A 0.3 mL intramuscular dose containing 30 micrograms of nucleoside-modified mRNA encapsulated with ALC-0315, ALC-0159, DSPC and cholesterol, buffered with tromethamine and sucrose. The 5 through 11 year presentation contains 10 micrograms.
Getting in
Intramuscular injection and lipid nanoparticle uptake
The dose goes into the shoulder muscle. Fat droplets carrying the recipe are swallowed by muscle cells and by immune cells that patrol the area and the nearby lymph node.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
ALC-0315 is an ionisable lipid, near neutral at blood pH, so the particle is not a cationic irritant in circulation. Apolipoprotein E adsorbs onto the PEGylated surface in interstitial fluid, and the particle is taken up by myocytes, dendritic cells and macrophages at the injection site and in the draining axillary node.
Inside the cell the droplet is trapped in an acid bubble. The acid flips the lipid to a positive charge, the bubble wall breaks, and some of the recipe spills into the cell body.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Endosomal acidification protonates the tertiary amine of the ionisable lipid. The now-cationic lipid ion-pairs with anionic endosomal phospholipids and drives a lamellar to hexagonal HII phase transition that ruptures the membrane. Only a small fraction of the internalised dose escapes; the rest is degraded in the lysosome.
The cell reads the recipe the same way it reads its own. One chemical swap in the letters keeps the cell from mistaking it for a virus and shutting it down.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
N1-methylpseudouridine replaces every uridine, which lowers activation of TLR7 and TLR8 and of RIG-I, and raises translation yield. The cap-1 structure recruits eIF4E and the 43S preinitiation complex; the engineered 5-prime and 3-prime untranslated regions and human-optimised codon usage extend the working life of the transcript.
A locked-open spike protein is built and displayed
The cell builds one coronavirus surface protein, frozen in the shape the virus wears before it fuses with a cell, and parks it on its own surface where the immune system can study it.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Two consecutive proline substitutions in the S2 subunit hold the trimer in its prefusion conformation, which presents the neutralisation-sensitive receptor-binding domain rather than the postfusion rod. The retained transmembrane anchor keeps spike surface-displayed, and proteasomal processing loads peptides onto MHC class I.
The immune system builds antibodies that stick to that shape, plus memory cells that can rebuild them fast. The recipe itself is gone within days.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Germinal centre reactions in the draining node produce class-switched, affinity-matured IgG against the receptor-binding domain, alongside CD4 and CD8 memory. The transcript is degraded by cytosolic exonucleases; the construct encodes neither reverse transcriptase nor integrase, and never enters the nucleus.
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 5 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
Under the current US label, adults 65 and older, and people aged 5 through 64 who have at least one condition that raises their risk of severe COVID-19.
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
Where the result stopped carrying
Unmodified mRNA triggered innate immune sensors and translated poorly, until uridine was replaced with a modified base
Naked mRNA is destroyed by extracellular nucleases within minutes, which is the entire reason the lipid nanoparticle exists
A 43,000-person trial was too small to detect myocarditis at roughly 27 cases per million doses
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Given by a clinician
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Ionisable lipid nanoparticle, intramuscular
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
Professional supervision is normally required. It is a prescription or clinician-administered medicine where it is approved.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
The identity record classes it as mRNA Vaccine / Therapeutic.
No source is stored against this line.
What is in the pack
3 mL intramuscular dose containing 30 micrograms of nucleoside-modified mRNA encapsulated with ALC-0315, ALC-0159, DSPC and cholesterol, buffered with tromethamine and sucrose. The 5 through 11 year presentation contains 10 micrograms.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take◇Read from sources, not yet reviewed
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
·Worth asking a clinician aboutWritten into the record from the studies named on this page
Injection-site pain, fatigue and headache are common and short-lived. Myocarditis and pericarditis occur, concentrated in males 12 through 24 years, at roughly 27 cases per million doses in that group; most resolve within days, and one fatal fulminant case was recorded in Israeli national surveillance. Anaphylaxis is rare and occurs within minutes, which is why a fifteen-minute observation period exists.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear∅Nothing found in the sources checked
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Ionisable lipid nanoparticle, intramuscular
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
ose. The 5 through 11 year presentation contains 10 micrograms.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on which forms are sold and how they compare.
No source is stored against this line.
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.
Questions worth asking
Which of the trials of Tozinameran studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
Claims that go past the evidence
Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.
✗Goes past the evidence
That the trial showed the vaccine stops transmission: transmission was never an endpoint and was never measured
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That 95% meant 95 of every 100 vaccinated people were protected; it is a relative reduction between two arms, not an absolute one
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That efficacy measured against the ancestral virus carried over to omicron, which it did not
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That a single course confers durable protection: decline was visible inside the trial itself
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
How much did people take in the studies?
The sources RNAWiki checked hold nothing for this field.
Why it matters. A result belongs to an amount. Without the amount the result floats free.
What would answer it
A stored source that records it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
Every line above can be traced to the study named beside it. Follow the link and read it.
C4591001 measured symptomatic disease, and measured it cleanly
In plain words
Eight vaccinated participants and 162 placebo participants developed symptomatic, PCR-confirmed COVID-19. That gap is the 95% figure.
What was measured
95% relative reduction in symptomatic PCR-confirmed COVID-19 (95% credible interval 90.3 to 97.6); 8 cases versus 162
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Multinational, observer-blinded, placebo-controlled trial. 43,548 randomised, 43,448 injected: 21,720 to BNT162b2 and 21,728 to placebo, two 30 microgram doses 21 days apart. The endpoint counted PCR-confirmed COVID-19 with at least one symptom, occurring at least seven days after the second dose, in participants with no serological or virological evidence of prior infection. Median safety follow-up at the primary analysis was two months.
Written into the record, not signed off as a reviewed claim
Six-month follow-up: 91.3%, with the decline already visible inside the trial
In plain words
When the same trial was read out at six months, efficacy against any COVID-19 had slipped to 91.3% and the authors said plainly that it was declining.
What was measured
91.3% efficacy through six months (95% CI 89.0 to 93.2); 96.7% against severe disease
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
44,165 participants aged 16 and over plus 2,264 aged 12 to 15. Efficacy against COVID-19 from seven days after dose two through six months was 91.3% (95% CI 89.0 to 93.2) among participants without evidence of prior infection. Efficacy against severe disease was 96.7% (95% CI 80.3 to 99.9). In South Africa, where beta predominated, efficacy was 100%.
Written into the record, not signed off as a reviewed claim
Stopping transmission was never an endpoint of the pivotal trial
In plain words
The trial counted people who became ill. Nobody was swabbed while they felt well, so it could not see silent infection and could not see whether a vaccinated person passed the virus on.
What was measured
That the pivotal trial demonstrated the vaccine prevents a vaccinated person infecting somebody else.
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
C4591001 defined its primary endpoint as PCR-confirmed illness with at least one symptom in the enrolled participant. There was no routine asymptomatic surveillance arm and no contact-tracing arm, so neither asymptomatic infection nor onward transmission is estimable from it. The evidence that arrived later was observational: among 146,243 traced contacts of 108,498 index patients in England, two BNT162b2 doses in the index patient were associated with an adjusted rate ratio for contact positivity of 0.32 for alpha and 0.50 for delta, and the delta effect declined with time since the second dose.
Written into the record, not signed off as a reviewed claim
95% belonged to the ancestral virus, and did not survive omicron
In plain words
Against omicron, two doses gave about 65% protection from symptomatic illness two to four weeks later, falling to about 9% by six months.
What was measured
Effectiveness against symptomatic omicron after two doses: 65.5% at 2 to 4 weeks, 8.8% at 25 or more weeks
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Test-negative case-control study in England covering 886,774 omicron infections, 204,154 delta infections and 1,572,621 test-negative controls between 27 November 2021 and 12 January 2022. Effectiveness against symptomatic omicron after two BNT162b2 doses was 65.5% (95% CI 63.9 to 67.0) at two to four weeks and 8.8% (95% CI 7.0 to 10.5) at 25 weeks or more. A BNT162b2 booster restored it to 67.2% at two to four weeks before falling again.
Written into the record, not signed off as a reviewed claim
Waning was measurable in a whole population before it was widely accepted
In plain words
Israelis vaccinated in January 2021 were catching COVID-19 at a higher rate that July than Israelis of the same age vaccinated two months later.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
National database analysis of all Israeli residents fully vaccinated before June 2021, covering 11 to 31 July 2021. Among people 60 and older, the rate ratio for confirmed infection comparing those vaccinated in January with those vaccinated in March was 1.6 (95% CI 1.3 to 2.0). Among people 40 to 59 the corresponding ratio was 1.7 (95% CI 1.4 to 2.1). Time since vaccination, not just variant, was doing measurable work.
Written into the record, not signed off as a reviewed claim
Myocarditis: a harm a 43,000-person trial was too small to see
In plain words
Heart-muscle inflammation showed up only once tens of millions of doses had been given, and it is concentrated in teenage boys and young men.
What was measured
Excess of 13.73 myocarditis cases per 100,000 males aged 16 to 19 between dose one and dose two
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Israeli national surveillance from 20 December 2020 to 31 May 2021 identified 283 myocarditis cases, 142 after BNT162b2. The risk difference between the first and second doses was 1.76 per 100,000 persons (95% CI 1.33 to 2.19), rising to 13.73 per 100,000 (95% CI 8.11 to 19.46) in males aged 16 to 19. The standardised incidence ratio against historical expectation was 5.34 (95% CI 4.48 to 6.40). Presentation was mild in 129 of 136 definitive or probable cases; one fulminant case was fatal. The current US label puts the rate at roughly 8 cases per million doses across ages 6 months to 64 years and about 27 per million in males 12 to 24.
Written into the record, not signed off as a reviewed claim
The approved population narrowed in 2025
In plain words
The US label no longer covers everyone. It now covers people 65 and older, and people 5 through 64 with a condition that puts them at high risk.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The current COMIRNATY prescribing information restricts the indication to individuals 65 years of age and older, or 5 through 64 years of age with at least one underlying condition that raises the risk of severe outcomes. The 2025-2026 formula encodes the spike of omicron sublineage LP.8.1, not the ancestral spike the pivotal trial tested. Both facts mean the product on the shelf is not the product the 95% figure was measured on.
Source
COMIRNATY US prescribing information, DailyMed
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
Where else this substance is registered
FDA substance identifier (UNII)
5085ZFP6SJ
CAS registry number
2417899-77-3
WHO international nonproprietary name list entry
11889
EMA substance identifier
300000019018
Checks this page had to pass
✓ Passed
Identity resolved
no open identity hold
✓ Passed
No unresolved merge across substance families
no quarantine open
✓ Passed
Every public sentence names a source
The opening statement carries the origin: Written into the record, not signed off.
✗ Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
✓ Passed
No internal keys in reader text
enforced by the copy-contract test over the rendered page
✓ Passed
Safety mode resolved
The identity record classes it as mRNA Vaccine / Therapeutic.
✓ Passed
Canonical metadata present
slug and display name present
What is missing or unclear◇Read from sources, not yet reviewed
What to learn next
Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.
This order is fixed in code and does not count clicks or time on the page.
What is not here
8 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
What was measured, goal by goal — found nothing in the sources checked.
How close this is to real life — found nothing in the sources checked.
Felt, measured, or meaningful — found nothing in the sources checked.
How long anything takes — found nothing in the sources checked.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
How this medicine reached us — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
The older medicine-wide conclusion held in this record
Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.
Nucleoside-modified mRNA for a prefusion-stabilised spike protein, wrapped in a lipid nanoparticle, which cut symptomatic PCR-confirmed COVID-19 by 95% over a median of two months in 43,448 randomised participants.
Recorded evidence blocks (5)
Q1
9 registered trials of Tozinameran — at which phases?
"Withdrawal of supply of vaccine from one manufacturer"; 1 of 9 registered studies
Show the evidence
TrialNCT05543356
withdrawn; "Withdrawal of supply of vaccine from one manufacturer"
recorded 2026-09-01 · last checked 2026-09-04
Q3
Which 2 trials of Tozinameran posted no result?
Posted no result
2 of 2 completed trials
Registrations
NCT05168709 and NCT05406908
Completion dates
oldest 2022-09-29; newest 2023-05-01
Show the evidence
Trial
NCT05168709
2022-09-29
NCT05406908
2023-05-01
Q4
At the median, Tozinameran's trials enrolled 109 people — anything larger?
Median enrolment
109
Largest enrolment
14302529
Registered trials counted
9
Q5
What do 275 spontaneous reports say about Tozinameran — and not say?
These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.
Tozinameran appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 275 reaction mentions were counted: pulmonary embolism 59; pyrexia 42; vaccination failure 33; ischaemic stroke 29. FAERS via Open Targets · CHEMBL4650429 · 2026-06-24
Show the evidence
pulmonary embolism
59
pyrexia
42
vaccination failure
33
ischaemic stroke
29
thrombocytopenia
26
covid-19 pneumonia
24
4 more recorded rows
deep vein thrombosis
17
covid-19
16
immune thrombocytopenia
16
myocarditis
13
recorded 2026-06-24 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
ChEMBL 37 — CC BY-SA 3.0 Unported · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md
✗ required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 4 source rows
✓ no critical contamination: no quarantine open
✓ canonical metadata passed: slug and display name present
✓ no raw internal fields: enforced by the copy-contract test over the rendered page
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