The DOI matches its Crossref record; 33 of the 35 references it cites were found in a registry or an index; 27 of the 35 sources its claims cite were checked for support.
An mRNA Vaccine against SARS-CoV-2 — Preliminary Report
Open accessAbstract
BACKGROUND: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged in late 2019 and spread globally, prompting an international effort to accelerate development of a vaccine. The candidate vaccine mRNA-1273 encodes the stabilized prefusion SARS-CoV-2 spike protein. METHODS: We conducted a phase 1, dose-escalation, open-label trial including 45 healthy adults, 18 to 55 years of age, who received two vaccinations, 28 days apart, with mRNA-1273 in a dose of 25 μg, 100 μg, or 250 μg. There were 15 participants in each dose group. RESULTS: After the first vaccination, antibody responses were higher with higher dose (day 29 enzyme-linked immunosorbent assay anti-S-2P antibody geometric mean titer [GMT], 40,227 in the 25-μg group, 109,209 in the 100-μg group, and 213,526 in the 250-μg group). After the second vaccination, the titers increased (day 57 GMT, 299,751, 782,719, and 1,192,154, respectively). After the second vaccination, serum-neutralizing activity was detected by two methods in all participants evaluated, with values generally similar to those in the upper half of the distribution of a panel of control convalescent serum specimens. Solicited adverse events that occurred in more than half the participants included fatigue, chills, headache, myalgia, and pain at the injection site. Systemic adverse events were more common after the second vaccination, particularly with the highest dose, and three participants (21%) in the 250-μg dose group reported one or more severe adverse events. CONCLUSIONS: The mRNA-1273 vaccine induced anti-SARS-CoV-2 immune responses in all participants, and no trial-limiting safety concerns were identified. These findings support further development of this vaccine. (Funded by the National Institute of Allergy and Infectious Diseases and others; mRNA-1273 ClinicalTrials.gov number, NCT04283461).
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36 Own result · 10 Partly supported · 9 Own method · 9 Own interpretation · 4 Supported · 3 No full text of the sources · 1 Sources not found · 1 No basis given · accuracy not yet measured
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“Moreover, S-2P conformational stability translates into greater immunogenicity,27-29 based on preservation of neutralization-sensitive epitopes at the apex of the prefusion molecule, as shown for respiratory syncytial virus F glycoprotein,30 and improved protein expression,27 which is particularly advantageous for gene-based antigen delivery.”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Discussion
What the sources say
- Supportedcites [27] Pallesen J, Wang N, Corbett KS, et al. Immunogenicity and structures of a rationally designed prefusion MERS-CoV spike antigen. Proc Natl Acad Sci U S A 2017; 114: E7348- E7357. 28807998 PMC5584442 source
The Results (p. 3) report stronger neutralizing responses in mice vaccinated with MERS S-2P than with S1 or WT S, and a greater than 50-fold improvement in protein yield. The Discussion (p. 7) links prefusion stabilization to preservation of neutralization-sensitive epitopes. The specific apex example is attributed separately to the RSV citation, not to this paper. (LLM, conf=0.88)
- Partly supportedcites [28] Wrapp D, De Vlieger D, Corbett KS, et al. Structural basis for potent neutralization of betacoronaviruses by single-domain camelid antibodies. Cell 2020; 181(5): 1004.e15- 1015.e15. 32375025 PMC7199733 sourceExperimental — accuracy not yet measured
The Introduction and Discussion report that immunization with prefusion-stabilized SARS-CoV-1 and MERS-CoV spikes elicited neutralizing antibodies. They do not compare S-2P immunogenicity with an unstabilized spike or show that S-2P stability improved protein expression; the expression yield reported in the Discussion is for the engineered VHH-72-Fc antibody, not S-2P. No page numbers are available in our copy. (LLM, conf=0.84)
- Could not verifycites [29] Wang N, Rosen O, Wang L, et al. Structural definition of a neutralization-sensitive epitope on the MERS-CoV S1-NTD. Cell Rep 2019; 28(13): 3395.e6- 3405.e6. 31553909 PMC6935267 sourceExperimental — accuracy not yet measured
The Methods describe S-2P as a stabilized MERS-CoV spike protein, and the Discussion says the S1-NTD is immunogenic. Neither passage reports that S-2P’s conformational stability increases immunogenicity; a search for an S-2P immunogenicity comparison and improved expression found no such result in our copy. The citing sentence attaches the preservation-of-epitopes and expression explanations to other citations. (LLM, conf=0.74)
- Not checked — no full text of the sourcecites [30] Crank MC, Ruckwardt TJ, Chen M, et al. A proof of concept for structure-based vaccine design targeting RSV in humans. Science 2019; 365: 505- 509. 31371616 source
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Supported
Every source the paper cites for this claim was checked and supports it.
In the paper
“Humoral and cell-mediated immune responses have been associated with vaccine-induced protection against challenge18 or subsequent rechallenge after SARS-CoV-2 infection in a rhesus macaque model.19”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Discussion
What the sources say
- Supportedcites [18] van Doremalen N, Lambe T, Spencer A, et al. ChAdOx1 nCoV-19 vaccination prevents SARS-CoV-2 pneumonia in rhesus macaques. May 13, 2020 (https://www.biorxiv.org/content/10.1101/2020.05.13.093195v1). preprint. 33469217 source
Citation 18 supports the vaccine-challenge part of the sentence, not the separately cited rechallenge part. In “Immunogenicity in rhesus macaques,” vaccinated animals had neutralising antibodies and spike-specific T-cell responses before challenge; “Pulmonary pathology” reports that none developed pulmonary pathology after challenge, whereas two of three controls developed viral pneumonia. The demonstrated protection is against pneumonia, not necessarily infection. (LLM, conf=0.90)
- Supportedcites [19] Chandrashekar A, Liu J, Martinot AJ, et al. SARS-CoV-2 infection protects against rechallenge in rhesus macaques. Science 2020 May 20 (Epub ahead of print). 32434946 PMC7243369 source
Citation 19 attaches to the rechallenge-after-infection finding, not the vaccine-challenge finding. The Discussion reports that SARS-CoV-2 infection induced humoral and cellular immune responses and protected rhesus macaques against rechallenge. It also cautions that the study could not determine which immune responses were correlates of protection. (LLM, conf=0.90)
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“Stabilizing coronavirus spike proteins by substituting two prolines at the top of heptad repeat 1 prevents structural rearrangements of the fusion (S2) subunit.”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Discussion
What the sources say
- Partly supportedcites [25] Kirchdoerfer RN, Cottrell CA, Wang N, et al. Pre-fusion structure of a human coronavirus spike protein. Nature 2016; 531: 118- 121. 26935699 PMC4860016 sourceExperimental — accuracy not yet measured
The Main section describes HR1 rearranging during S2-mediated fusion and suggests that the pre-fusion structure could guide engineering of stabilized spike proteins. It does not report substituting two prolines at the top of HR1 or show that this substitution prevents S2 rearrangements. (LLM, conf=0.83)
- Partly supportedcites [26] Kirchdoerfer RN, Wang N, Pallesen J, et al. Stabilized coronavirus spikes are resistant to conformational changes induced by receptor recognition or proteolysis. Sci Rep 2018; 8: 15701- 15701. 30356097 PMC6200764 sourceExperimental — accuracy not yet measured
The Methods describe two proline substitutions, and the Results report that the stabilized SARS-CoV spike retains its prefusion conformation without large changes in S2 after receptor binding. But the Results also observe a subtle rearrangement in the S2 central helix and say only that the mutations may block further propagation. The claim’s unqualified statement that they prevent S2 rearrangements overstates the evidence; page numbers are unavailable in our copy. (LLM, conf=0.88)
- Partly supportedcites [27] Pallesen J, Wang N, Corbett KS, et al. Immunogenicity and structures of a rationally designed prefusion MERS-CoV spike antigen. Proc Natl Acad Sci U S A 2017; 114: E7348- E7357. 28807998 PMC5584442 sourceExperimental — accuracy not yet measured
The Results (p. 3) describe two proline substitutions near HR1 that retain the prefusion shape of MERS-CoV spike, with similar effects in two other betacoronavirus spikes. The Discussion (p. 5) says proline substitution can disfavor refolding of the HR1–central-helix linker and impair or abolish fusion; it does not establish that the substitutions prevent all structural rearrangements of S2. (LLM, conf=0.84)
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Partly supported
Every source the paper cites for this claim was checked and supports it.
In the paper
“In rhesus macaques given DNA vaccine candidates expressing different forms of the SARS-CoV-2 spike protein, post-vaccination neutralizing antibody titers were correlated with protection against SARS-CoV-2 challenge.17”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Discussion
What the sources say
- Supportedcites [17] Yu J, Tostanoski LH, Peter L, et al. DNA vaccine protection against SARS-CoV-2 in rhesus macaques. Science 2020 May 20 (Epub ahead of print). 32434945 PMC7243363 source
The Construction and immunogenicity section describes rhesus macaques vaccinated with candidates expressing different spike forms. The Immune correlates of vaccine-induced protection section reports that post-vaccination neutralizing antibody titers correlated with lower viral loads after SARS-CoV-2 challenge. (LLM, conf=0.94)
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“This longitudinal assessment is relevant given that natural history studies suggest that SARS-CoV and MERS-CoV (Middle East respiratory syndrome coronavirus) infections, particularly mild illnesses, may not generate long-lived antibody responses.20-22”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Discussion
What the sources say
- Supportedcites [20] Choe PG, Perera RAPM, Park WB, et al. MERS-CoV antibody responses 1 year after symptom onset, South Korea, 2015. Emerg Infect Dis 2017; 23: 1079- 1084. 28585916 PMC5512479 source
The Discussion reports that MERS-CoV antibody responses are often undetectable after mild illness, with several nonsevere patients remaining seronegative or having only marginal titers at one year. It also reports waning SARS-CoV antibody titers, including some becoming undetectable by 30 months. Together, these passages support the citing sentence’s hedged claim. (LLM, conf=0.91)
- Not checked — no full text of the sourcecites [21] Cao W-C, Liu W, Zhang P-H, Zhang F, Richardus JH. Disappearance of antibodies to SARS-associated coronavirus after recovery. N Engl J Med 2007; 357: 1162- 1163. 17855683 source
- Partly supportedcites [22] Wu L-P, Wang N-C, Chang Y-H, et al. Duration of antibody responses after severe acute respiratory syndrome. Emerg Infect Dis 2007; 13: 1562- 1564. 18258008 PMC2851497 sourceExperimental — accuracy not yet measured
The Study and Conclusions (pages not provided) support the SARS-CoV portion: antibody levels declined substantially by the third year after illness. This paper does not assess MERS-CoV or compare mild with more severe illness, so it does not support those parts of the cited sentence. (LLM, conf=0.86)
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Supported
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“CD8 T-cell responses to S-2P were detected at low levels after the second vaccination in the 100-μg dose group (Fig. S11).”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Results > SARS-CoV-2 T-Cell Responses
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“After the first vaccination, antibody responses were higher with higher dose (day 29 enzyme-linked immunosorbent assay anti–S-2P antibody geometric mean titer [GMT], 40,227 in the 25-μg group, 109,209 in the 100-μg group, and 213,526 in the 250-μg group).”
- Also stated in: § SARS-CoV-2 Binding Antibody Responses · plain
“Binding antibody IgG geometric mean titers (GMTs) to S-2P increased rapidly after the first vaccination, with seroconversion in all participants by day 15 (Table 2 and Figure 2A). Dose-dependent responses to the first and second vaccinations were evident.”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Abstract > Results
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Also stated in: § SARS-CoV-2 Binding Antibody Responses · plain
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Good agreement was noted within and between the values from binding assays for S-2P and receptor-binding domain and neutralizing activity measured by PsVNA and PRNT (Figs. S3 through S7), which provides orthogonal support for each assay in characterizing the humoral response induced by mRNA-1273.”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Results > SARS-CoV-2 Neutralization Responses
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Evaluation of safety clinical laboratory values of grade 2 or higher and unsolicited adverse events revealed no patterns of concern (Supplementary Appendix and Table S3).”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Results > Vaccine Safety
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Commensurately high neutralizing antibody responses were also elicited in a dose-dependent fashion.”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Discussion
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- It may state two separate claims as one. 25
- Probably not a substantial claim. 13
- The quote only partly states this claim. 1
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“The S glycoprotein mediates host cell attachment and is required for viral entry3; it is the primary vaccine target for many candidate SARS-CoV-2 vaccines.4-7”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Abstract > Conclusions
What the sources say
- Partly supportedcites [3] Belouzard S, Millet JK, Licitra BN, Whittaker GR. Mechanisms of coronavirus cell entry mediated by the viral spike protein. Viruses 2012; 4: 1011- 1033. 22816037 PMC3397359 sourceExperimental — accuracy not yet measured
Section 2, “Spike Protein” (page unavailable), says coronavirus spike proteins have an S1 domain responsible for receptor binding and an S2 domain responsible for fusion, supporting the attachment-and-entry mechanism. The paper does not address SARS-CoV-2 specifically, so it does not directly establish the claim for that virus. The vaccine-target statement is attributed to other citations, not this source. (LLM, conf=0.85)
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Partly supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“Those studies showed that solicited systemic adverse events tended to be more frequent and more severe with higher doses and after the second vaccination.”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Discussion
What the sources say
- Partly supportedcites [11] Feldman RA, Fuhr R, Smolenov I, et al. mRNA vaccines against H10N8 and H7N9 influenza viruses of pandemic potential are immunogenic and well tolerated in healthy adults in phase 1 randomized clinical trials. Vaccine 2019; 37: 3326- 3334. 31079849 sourceExperimental — accuracy not yet measured
The H10N8 Results (§3.2.1; page unavailable) report that fever increased with dose and was more frequent after the second dose in the 100-mg group. The H7N9 Results (§3.2.2; page unavailable) report that 11 of 12 severe solicited events occurred in the highest-dose group, but explicitly state that, except for fever in that group, solicited-event frequency did not increase after the second vaccination. The source therefore supports a dose-related pattern and limited post-second-dose increases, not a general increase in the frequency and severity of systemic events after the second vaccination. (LLM, conf=0.88)
- Partly supportedcites [6] Mulligan MJ, Lyke KE, Kitchin N, et al. Phase 1/2 study to describe the safety and immunogenicity of a COVID-19 RNA vaccine candidate (BNT162b1) in adults 18 to 55 years of age: interim report. July 1, 2020 (https://www.medrxiv.org/content/10.1101/2020.06.30.20142570v1). preprint. sourceExperimental — accuracy not yet measured
The results (p. 3) say systemic events increased with dose level and were reported by more participants after the second dose; the Discussion also describes generally higher reactogenicity after dose two. Our copy does not establish that solicited systemic events tended to be more severe with higher doses and after the second vaccination. Participants in the 100 µg group did not receive a second dose. (LLM, conf=0.84)
hedgedcorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
- Partly supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“The rapid and robust immunogenicity profile of the mRNA-1273 vaccine most likely results from an innovative structure-based vaccine antigen design,23 coupled with a potent lipid-nanoparticle delivery system, and the use of modified nucleotides that avoid early intracellular activation of interferon-associated genes.”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Discussion
What the sources say
- Partly supportedcites [23] Graham BS, Gilman MSA, McLellan JS. Structure-based vaccine antigen design. Annu Rev Med 2019; 70: 91- 104. 30691364 PMC6936610 sourceExperimental — accuracy not yet measured
The section on stabilizing class I fusion proteins reports that structure-guided, prefusion-stabilized coronavirus spike antigens improved immune responses in mice. That supports the antigen-design rationale for citation 23, but the paper does not establish that this design caused mRNA-1273’s rapid and robust immunogenicity. The citation is attached to antigen design, not to the sentence’s separate claims about lipid-nanoparticle delivery or modified nucleotides. (LLM, conf=0.86)
- Partly supportedcites [24] Pardi N, Hogan MJ, Naradikian MS, et al. Nucleoside-modified mRNA vaccines induce potent T follicular helper and germinal center B cell responses. J Exp Med 2018; 215: 1571- 1588. 29739835 PMC5987916 sourceExperimental — accuracy not yet measured
The Introduction and Discussion report that lipid nanoparticles and modified nucleosides contribute to potent immune responses from the mRNA vaccine platform studied. They do not study mRNA-1273 or attribute its immunogenicity to structure-based antigen design, and they do not establish the claimed avoidance of early interferon-associated gene activation. (LLM, conf=0.88)
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Partly supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“The S glycoprotein mediates host cell attachment and is required for viral entry3; it is the primary vaccine target for many candidate SARS-CoV-2 vaccines.4-7”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Abstract > Conclusions
What the sources say
- Not checked — no full text of the sourcecites [4] Callaway E. The race for coronavirus vaccines: a graphical guide. Nature 2020; 580: 576- 577. 32346146 source
- Supportedcites [5] Zhu F-C, Li Y-H, Guan X-H, et al. Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial. Lancet 2020; 395: 1845- 1854. 32450106 PMC7255193 source
The Discussion (page not specified) says that the full-length spike glycoprotein was chosen for most viral-vectored, mRNA, and DNA COVID-19 vaccines in development. This supports the attributed claim that it was a primary target for many candidate vaccines. (LLM, conf=0.93)
- Partly supportedcites [6] Mulligan MJ, Lyke KE, Kitchin N, et al. Phase 1/2 study to describe the safety and immunogenicity of a COVID-19 RNA vaccine candidate (BNT162b1) in adults 18 to 55 years of age: interim report. July 1, 2020 (https://www.medrxiv.org/content/10.1101/2020.06.30.20142570v1). preprint. sourceExperimental — accuracy not yet measured
The Main section describes the spike protein’s receptor-binding domain as a key target of neutralizing antibodies, and the Methods identify it as the antigen encoded by BNT162b1 (page numbers not provided). This supports spike-derived antigen as a target for this candidate, but the paper does not establish that it is the primary target for many SARS-CoV-2 vaccine candidates. (LLM, conf=0.85)
- Partly supportedcites [7] Smith TRF, Patel A, Ramos S, et al. Immunogenicity of a DNA vaccine candidate for COVID-19. Nat Commun 2020; 11: 2601- 2601. 32433465 PMC7239918 sourceExperimental — accuracy not yet measured
The Discussion says the authors chose SARS-CoV-2 S protein as the antigen target for their vaccine candidate, and the Results describe constructs encoding it. Our copy does not establish that S is the primary target for many SARS-CoV-2 vaccine candidates, so the broader claim is not fully supported. (LLM, conf=0.84)
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
Every source the paper cites for this claim was checked and supports it.
In the paper
“This descriptive safety profile is similar to that described in a report of two trials of avian influenza mRNA vaccines (influenza A/H10N8 and influenza A/H7N9) that were manufactured by Moderna with the use of an earlier lipid nanoparticle capsule formulation11 and is consistent with an interim report of a phase 1–2 evaluation of a Covid-19 mRNA vaccine encoding the S receptor-binding domain.6”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Discussion
What the sources say
- Supportedcites [11] Feldman RA, Fuhr R, Smolenov I, et al. mRNA vaccines against H10N8 and H7N9 influenza viruses of pandemic potential are immunogenic and well tolerated in healthy adults in phase 1 randomized clinical trials. Vaccine 2019; 37: 3326- 3334. 31079849 source
The Introduction identifies two phase 1 trials of LNP-formulated H10N8 and H7N9 mRNA vaccines. The Results (sections 3.2.1 and 3.2.2) describe their adverse-event profiles, providing the safety report cited for the comparison. The separate claim about a Covid-19 vaccine is attached to citation 6, not this source. (LLM, conf=0.90)
- Supportedcites [6] Mulligan MJ, Lyke KE, Kitchin N, et al. Phase 1/2 study to describe the safety and immunogenicity of a COVID-19 RNA vaccine candidate (BNT162b1) in adults 18 to 55 years of age: interim report. July 1, 2020 (https://www.medrxiv.org/content/10.1101/2020.06.30.20142570v1). preprint. source
The Main section identifies BNT162b1 as an RNA vaccine encoding the SARS-CoV-2 spike receptor-binding domain. The Abstract describes this interim study and its safety findings, while the Discussion reports its tolerability and safety profile. The avian-influenza comparison is attached to a different citation, not this source. (LLM, conf=0.93)
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“Though correlates of protection from SARS-CoV-2 infection have not yet been determined, measurement of serum neutralizing activity has been shown to be a mechanistic correlate of protection for other respiratory viruses, such as influenza14 and respiratory syncytial virus,15 and is generally accepted as a functional biomarker of the in vivo humoral response.16”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Discussion
What the sources say
- Partly supportedcites [14] Verschoor CP, Singh P, Russell ML, et al. Microneutralization assay titres correlate with protection against seasonal influenza H1N1 and H3N2 in children. PLoS One 2015; 10(6): e0131531- e0131531. 26107625 PMC4479562 sourceExperimental — accuracy not yet measured
Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
- Not checked — no full text of the sourcecites [15] Kulkarni PS, Hurwitz JL, Simões EAF, Piedra PA. Establishing correlates of protection for vaccine development: considerations for the respiratory syncytial virus vaccine field. Viral Immunol 2018; 31: 195- 203. 29336703 PMC5863081 source
- Partly supportedcites [16] Okba NMA, Müller MA, Li W, et al. Severe acute respiratory syndrome coronavirus 2-specific antibody responses in coronavirus disease patients. Emerging Infect Dis 2020; 26: 1478- 1488. 32267220 PMC7323511 sourceExperimental — accuracy not yet measured
Split into 2 atoms — 1 confirmed, 0 partially supported, 0 disputed, 0 misattributed, 1 unverifiable. Expand the claim to see per-atom verdicts.
boostedcorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Rests on an assumption: Correlates of protection from SARS-CoV-2 infection have not yet been determined.
- Partly supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“However, interpretation of the significance of those comparisons must account for the variability in Covid-19 convalescent antibody titers according to factors such as patient age, disease severity, and time since disease onset and for the number of samples in the panel.12,13”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Discussion
What the sources say
- Partly supportedcites [12] Wang X, Guo X, Xin Q, et al. Neutralizing antibodies responses to SARS-CoV-2 in COVID-19 inpatients and convalescent patients. Clin Infect Dis 2020 June 4 (Epub ahead of print). 32497196 PMC7314147 sourceExperimental — accuracy not yet measured
The Results (Dynamic Changes in Neutralizing Antibodies Against SARS-CoV-2; page unavailable) show that titers varied among patients and changed with time since symptom onset. The Discussion notes a small sample size but says the study could not establish correlations between titer dynamics and clinical characteristics. This source therefore does not establish age or disease severity as factors in titer variability, or specifically assess how the number of samples in a comparison panel affects interpretation. (LLM, conf=0.86)
- Partly supportedcites [13] Wu F, Wang A, Liu M, et al. Neutralizing antibody responses to SARS-CoV-2 in a COVID-19 recovered patient cohort and their implications. April 20, 2020 (https://www.medrxiv.org/content/10.1101/2020.03.30.20047365v2). preprint. sourceExperimental — accuracy not yet measured
The age-group results (p. 7) show that neutralizing-antibody titers vary with patient age, and the kinetics results (p. 6) show that titers change after disease onset. The paper reports a cohort of 175 recovered patients (Figure 3, p. 12), but does not say how panel size affects comparisons; it also excluded severe and critical patients (Discussion, p. 9), so it does not establish variation by disease severity. (LLM, conf=0.86)
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
- Partly supported
Every source the paper cites for this claim was checked and supports it.
In the paper
“These features of the mRNA composition and formulation have been associated with prolonged protein expression, induction of antigen-specific T-follicular helper cells, and activation of germinal center B cells.24”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Discussion
What the sources say
- Supportedcites [24] Pardi N, Hogan MJ, Naradikian MS, et al. Nucleoside-modified mRNA vaccines induce potent T follicular helper and germinal center B cell responses. J Exp Med 2018; 215: 1571- 1588. 29739835 PMC5987916 source
The Introduction states that modified nucleosides are essential for high and sustained protein production from mRNA-LNPs, associated with potent Tfh and B cell responses. The antigen-specific Tfh results and Discussion further document Tfh induction and GC B cell activation. Page numbers are not provided in the supplied passages. (LLM, conf=0.93)
plaincorrelational- Asserted: passes — The authors put it forward as true.
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It may state two separate claims as one.
- Supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“Studies of mRNA-1273 in mice show that the structurally defined spike antigen induces robust neutralizing activity and that the gene-based delivery promotes Th1-biased responses, including CD8 T cells that protect against virus replication in lung and nose without evidence of immunopathology.32”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Discussion
What the sources say
- Partly supportedcites [32] Corbett KS, Edwards D, Leist SR, et al. SARS-CoV-2 mRNA vaccine development enabled by prototype pathogen preparedness. June 11, 2020 (https://www.biorxiv.org/content/10.1101/2020.06.11.145920v1). preprint. PMC7581537 32756549 sourceExperimental — accuracy not yet measured
Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
plaindirect- Asserted: passes — The authors put it forward as true.
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It may state two separate claims as one.
- Partly supported
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“We found strong correlations between the binding and neutralization assays and between the live virus and pseudovirus neutralization assays.”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Discussion
boostedcorrelational- Asserted: passes — The authors put it forward as true.
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It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The two-dose vaccine series was generally without serious toxicity; systemic adverse events after the first vaccination, when reported, were all graded mild or moderate.”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Discussion
plain- Asserted: passes — The authors put it forward as true.
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It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Systemic adverse events were more common after the second vaccination, particularly with the highest dose, and three participants (21%) in the 250-μg dose group reported one or more severe adverse events.”
- Also stated in: § Vaccine Safety · plain
“Solicited systemic adverse events were more common after the second vaccination and occurred in 7 of 13 participants (54%) in the 25-μg group, all 15 in the 100-μg group, and all 14 in the 250-μg group, with 3 of those participants (21%) reporting one or more severe events.”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Abstract > Results
plaincorrelationaln = 3- Asserted: passes — The authors put it forward as true.
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It may state two separate claims as one.
- Also stated in: § Vaccine Safety · plain
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Dose-dependent responses to the first and second vaccinations were evident.”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Results > SARS-CoV-2 Binding Antibody Responses
plaincorrelational- Asserted: passes — The authors put it forward as true.
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The quote only partly states this claim.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Local adverse events, when present, were nearly all mild or moderate, and pain at the injection site was common.”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Results > Vaccine Safety
plain- Asserted: passes — The authors put it forward as true.
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It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“After the second vaccination, no participants in the 25-μg group, 6 (40%) in the 100-μg group, and 8 (57%) in the 250-μg group reported fever; one of the events (maximum temperature, 39.6°C) in the 250-μg group was graded severe.”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Results > Vaccine Safety
plain- Asserted: passes — The authors put it forward as true.
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- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
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It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“At day 43, wild-type virus–neutralizing activity capable of reducing SARS-CoV-2 infectivity by 80% or more (PRNT80) was detected in all participants, with geometric mean PRNT80 responses of 339.7 (95% CI, 184.0 to 627.1) in the 25-μg group and 654.3 (95% CI, 460.1 to 930.5) in the 100-μg group (Figure 2D).”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Results > SARS-CoV-2 Neutralization Responses
plain- Asserted: passes — The authors put it forward as true.
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It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“After the first vaccination, PsVNA responses were detected in less than half the participants, and a dose effect was seen (50% inhibitory dilution [ID50]: Figure 2C, Fig. S8, and Table 2; 80% inhibitory dilution [ID80]: Fig. S2 and Table S6).”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Results > SARS-CoV-2 Neutralization Responses
plaincorrelational- Asserted: passes — The authors put it forward as true.
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It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Binding antibody IgG geometric mean titers (GMTs) to S-2P increased rapidly after the first vaccination, with seroconversion in all participants by day 15 (Table 2 and Figure 2A).”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Results > SARS-CoV-2 Binding Antibody Responses
plaindirect- Asserted: passes — The authors put it forward as true.
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It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“For both assays, the median magnitude of antibody responses after the first vaccination in the 100-μg and 250-μg dose groups was similar to the median magnitude in convalescent serum specimens, and in all dose groups the median magnitude after the second vaccination was in the upper quartile of values in the convalescent serum specimens.”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Results > SARS-CoV-2 Binding Antibody Responses
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The lowest responses were in the 25-μg dose group, with a geometric mean ID50 of 112.3 (95% CI, 71.2 to 177.1) at day 43; the higher responses in the 100-μg and 250-μg groups were similar in magnitude (geometric mean ID50, 343.8 [95% CI, 261.2 to 452.7] and 332.2 [95% CI, 266.3 to 414.5], respectively, at day 43).”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Results > SARS-CoV-2 Neutralization Responses
plaincorrelational- Asserted: passes — The authors put it forward as true.
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- Load-bearing: passes — The paper’s conclusions depend on it.
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It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“No serious adverse events were noted, and no prespecified trial halting rules were met.”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Results > Vaccine Safety
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Solicited systemic adverse events were more common after the second vaccination and occurred in 7 of 13 participants (54%) in the 25-μg group, all 15 in the 100-μg group, and all 14 in the 250-μg group, with 3 of those participants (21%) reporting one or more severe events.”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Results > Vaccine Safety
plainn = 13- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“After the first vaccination, solicited systemic adverse events were reported by 5 participants (33%) in the 25-μg group, 10 (67%) in the 100-μg group, and 8 (53%) in the 250-μg group; all were mild or moderate in severity (Figure 1 and Table S2).”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Results > Vaccine Safety
plainn = 5- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
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It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“These findings support further development of this vaccine.”
- Also stated in: § Discussion · plain
“These safety and immunogenicity findings support advancement of the mRNA-1273 vaccine to later-stage clinical trials.”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Abstract > Conclusions
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
- Also stated in: § Discussion · plain
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The mRNA-1273 vaccine was immunogenic, inducing robust binding antibody responses to both full-length S-2P and receptor-binding domain in all participants after the first vaccination in a time- and dose-dependent fashion.”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Discussion
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
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It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Thus, presentation of the naturally folded prefusion conformation of the S glycoprotein to the immune system from an mRNA template enables efficient within-host antigen production and promotes both high-quality and high-magnitude antibody responses to SARS-CoV-2.”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Discussion
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“For this report of the interim analysis, results were available only for the 25-μg and 100-μg dose groups.”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Methods > Assessment of SARS-CoV-2 T-Cell Responses
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“These events were associated either with macrophage-tropic coronaviruses susceptible to antibody-dependent enhancement of replication or with vaccine antigens that induced antibodies with poor neutralizing activity and Th2-biased responses.31”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Discussion
What the sources say
- Not checked — no full text of the sourcecites [31] Graham BS. Rapid COVID-19 vaccine development. Science 2020; 368: 945- 946. 32385100 source
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“The protocol, available with the full text of this article at NEJM.org, permitted interim analyses to inform decisions regarding vaccine strategy and public health; this interim analysis reports findings through day 57.”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Methods > Trial Design and Participants
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“Adverse events were graded according to a standard toxicity grading scale (Table S1 in the Supplementary Appendix).9”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Methods > Trial Procedures
What the sources say
- Not matchedcites [9] Food and Drug Administration. Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials: guidance for industry. September 2007 (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/toxicity-grading-scale-healthy-adult-and-adolescent-volunteers-enrolled-preventive-vaccine-clinical). 37532612
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
- Not matched
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“The authors had full access to the data reports, which were prepared from the raw data by the statistical and data coordinating center, and vouch for the completeness and accuracy of the data and for the fidelity of the trial to the protocol.”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Methods > Trial Design and Participants
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Because of the time-intensive nature of the PRNT assay, for this report of the interim analysis, results were available only for the day 1 and day 43 time points in the 25-μg and 100-μg dose groups.”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Methods > Assessment of SARS-CoV-2 Binding Antibody and Neutralizing Responses
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“The trial was conducted under an Investigational New Drug application submitted to the Food and Drug Administration.”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Methods > Trial Design and Participants
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Participants were not screened for SARS-CoV-2 infection by serology or polymerase chain reaction before enrollment.”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Methods > Trial Design and Participants
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“All participants provided written informed consent before enrollment.”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Methods > Trial Design and Participants
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“The trial was reviewed and approved by the Advarra institutional review board, which functioned as a single board and was overseen by an independent safety monitoring committee.”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Methods > Trial Design and Participants
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Of the three doses evaluated, the 100-μg dose elicits high neutralization responses and Th1-skewed CD4 T cell responses, coupled with a reactogenicity profile that is more favorable than that of the higher dose.”
§ An mRNA Vaccine against SARS-CoV-2 — Preliminary Report > Discussion
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
The paper relies on this without support.
Correlates of protection from SARS-CoV-2 infection have not yet been determined.
“Though correlates of protection from SARS-CoV-2 infection have not yet been determined, measurement of serum neutralizing activity has been shown to be a mechanistic correlate of protection for other respiratory viruses, such as influenza14 and respiratory syncytial virus,15 and is generally accepted as a functional biomarker of the in vivo humoral response.16”
The paper relies on this without support.
The convalescent serum specimens used as a comparator are representative of immune responses after SARS-CoV-2 infection.
“For comparison of the participants’ immune responses with those induced by SARS-CoV-2 infection, 41 convalescent serum specimens were also tested.”
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
The source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Additionally, the incidence of grade 3 fever of the two spike protein-based mRNA vaccines, mRNA-127319, 20 and BNT162b2,17, 21 also varied between the phase 1 and 3 trials.”
From Safety and immunogenicity of the SARS-CoV-2 ARCoV mRNA vaccine in Chinese adults: a randomised, double-blind, placebo-controlled, phase 1 trial (2022) · cites this paper as [19]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“BNT162b2 (BioNTech/Pfizer) and mRNA-1273 (Moderna) used a mixture of altered nucleotide 1mΨ modifications and dsRNA fragment eviction in the mRNA manufacturing procedure to significantly lower innate immune signaling in response to mRNA (Walsh et al. 2020; Jackson et al. 2020b).”
From Modifications of mRNA vaccine structural elements for improving mRNA stability and translation efficiency (2022) · cites this paper as Jackson et al. 2020b
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Both mRNA encodes the same S-2P protein [5,6] which differ from the spike protein in the reference SARS-CoV-2 genome (NC_045512) by two amino acids, i.e., amino acids KV at sites 986 and 987 were replaced by PP to stabilize the resulting spike protein in the prefusion state to train the host immune system to recognize the virus before its entry into the host cell [7,8].”
From Detailed Dissection and Critical Evaluation of the Pfizer/BioNTech and Moderna mRNA Vaccines (2021) · cites this paper as [6]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Both mRNA encodes the same S-2P protein [5,6] which differ from the spike protein in the reference SARS-CoV-2 genome (NC_045512) by two amino acids, i.e., amino acids KV at sites 986 and 987 were replaced by PP to stabilize the resulting spike protein in the prefusion state to train the host immune system to recognize the virus before its entry into the host cell [7,8].”
From Detailed Dissection and Critical Evaluation of the Pfizer/BioNTech and Moderna mRNA Vaccines (2021) · cites this paper as [6]
Experimental — accuracy not yet measuredThe cited source says what the claim attributes to it.
In the citing paper
“The reactogenicity associated with immunization with mRNA-1273 in this trial is similar to that in the phase 1 data reported previously. 1,4”
From Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine (2021) · cites this paper as [1]
The cited source says what the claim attributes to it.
In the citing paper
“and elicit nAbs (48, 49).”
From mRNA vaccination boosts cross-variant neutralizing antibodies elicited by SARS-CoV-2 infection (2021) · cites this paper as [48]
The cited source says what the claim attributes to it.
In the citing paper
“The mRNA-1273 vaccine demonstrated protection in animal-challenge experiments 15 and encouraging safety and immunogenicity in early-stage human testing. 1,4”
From Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine (2021) · cites this paper as [1]
The cited source says what the claim attributes to it.
In the citing paper
“Meanwhile, several studies17, 18, 19 have reported more frequent and severe solicited systemic adverse events following the second vaccination than we found.”
From Safety and immunogenicity of the SARS-CoV-2 ARCoV mRNA vaccine in Chinese adults: a randomised, double-blind, placebo-controlled, phase 1 trial (2022) · cites this paper as [19]
The cited source says what the claim attributes to it.
In the citing paper
“Previous studies17, 18, 19 showed that solicited systemic adverse events were more frequent and more severe at higher doses”
From Safety and immunogenicity of the SARS-CoV-2 ARCoV mRNA vaccine in Chinese adults: a randomised, double-blind, placebo-controlled, phase 1 trial (2022) · cites this paper as [19]
The cited source says what the claim attributes to it.
In the citing paper
“This contrasts with recent reports of mRNA-LNP vaccines against the SARS-CoV-2 virus responsible for the COVID-19 pandemic which had similar rates of reactogenicity and in which reactogenicity noticeably increased after a second dose [17], [18].”
From Proof-of-concept of a low-dose unmodified mRNA-based rabies vaccine formulated with lipid nanoparticles in human volunteers: A phase 1 trial (2021) · cites this paper as [18]
The cited source says what the claim attributes to it.
In the citing paper
“Indeed, the use of high doses of mRNA formulated with lipid nanoparticles (LNPs) resulted in some side effects in the candidates mRNA-1273 and BNT162b1.3,4”
From Combining an optimized mRNA template with a double purification process allows strong expression of in vitro transcribed mRNA (2021) · cites this paper as [3]
The check wasn’t confident either way, so it gives no verdict — never disputed.
In the citing paper
“despite the lower mRNA-doses used, AEs were reported more frequently with BNT162b1 as compared to mRNA-1273”
From The dawn of mRNA vaccines: the COVID-19 case (2021) · cites this paper as [53]
Experimental — accuracy not yet measuredIn the citing paper
“The majority of COVID-19 vaccines are designed to evoke humoral and cellular immune responses against the SARS-CoV-2 spike protein — responses that may not prevent infection but robustly protect against severe COVID-19, at least for certain periods of time11,150–157.”
From COVID-19 and cellular senescence (2023) · cites this paper as [151]
In the citing paper
“the currently licensed vaccines have been shown to produce peak neutralizing antibody responses that range from approximately half to four-times those seen in convalescent patients24,64–67 (preprint data, not yet peer reviewed)68.”
From Prospects for durable immune control of SARS-CoV-2 and prevention of reinfection (2021) · cites this paper as [67]
In the citing paper
“In animal models of infections with other coronaviruses and for previous whole-cell inactivated vaccines developed for respiratory syncytial virus and measles virus, VAERD has usually been associated with the development of T helper 2 cell (TH2 cell)-biased CD4+ T cell responses, with significantly increased levels of interleukin-4 (IL-4), IL-5 and/or IL-13 (refs12,126,165–174).”
From Immunological mechanisms of vaccine-induced protection against COVID-19 in humans (2021) · cites this paper as [126]
In the citing paper
“This is notable, as these titers were associated with 95% protection from COVID-19 in phase 3 trials (44, 46, 48, 49).”
From mRNA vaccination boosts cross-variant neutralizing antibodies elicited by SARS-CoV-2 infection (2021) · cites this paper as [48]
In the citing paper
“This observation may be noteworthy given the gradual development of antigen-specific CD8+ T cells observed here and the previous observations for humoral responses (Goel et al., 2021; Jackson et al., 2020), which only consistently reach maximal levels after the second vaccine dose.”
From Rapid induction of antigen-specific CD4+ T cells is associated with coordinated humoral and cellular immunity to SARS-CoV-2 mRNA vaccination (2021) · cites this paper as Jackson et al., 2020
In the citing paper
“Multiple candidate vaccines had similar immunogenicity profiles to the COVID-19 RNA vaccines in humans, with equivalent or better neutralizing antibody titers or CD4+ T cell responses”
From Adaptive immunity to SARS-CoV-2 and COVID-19 (2021) · cites this paper as Jackson et al., 2020
In the citing paper
“dose-dependent increase in S2-P-binding antibodies and serum-neutralizing titres in phase I trials130”
From mRNA vaccines for infectious diseases: principles, delivery and clinical translation (2021) · cites this paper as [130]
In the citing paper
“Titers of SARS-CoV-2 Spike and RBD IgG, IgA and IgM were quantified in participant sera (N=131), umbilical cord sera (N=10), and breastmilk (N=31) at baseline, 2nd vaccine dose, 2-6 weeks post 2nd vaccine, and delivery by Luminex, and confirmed by ELISA.”
From Coronavirus disease 2019 vaccine response in pregnant and lactating women: a cohort study (2021) · cites this paper as [13]
In the citing paper
“the nucleoside-modified mRNA vaccines BNT162b2 (30 μg mRNA dose) and mRNA-1273 (100 μg mRNA dose) generally surpassed the titers from convalescent COVID-19 patient samples, even in the elderly trial group”
From The dawn of mRNA vaccines: the COVID-19 case (2021) · cites this paper as [53]
In the citing paper
“In humans, both BNT162b2 and mRNA-1273 elicited S-specific CD4+ T cell responses directed against the S1 (including RBD) and S2 regions of the S glycoprotein”
From The dawn of mRNA vaccines: the COVID-19 case (2021) · cites this paper as [53]
In the citing paper
“The magnitude of CD4+ T cell responses correlated with the levels of S-binding IgG antibodies”
From The dawn of mRNA vaccines: the COVID-19 case (2021) · cites this paper as [53]
In the citing paper
“as compared to low or undetectable levels in the clinical evaluation of mRNA-1273 [53].”
From The dawn of mRNA vaccines: the COVID-19 case (2021) · cites this paper as [53]
In the citing paper
“study results indicate that BNT162b2 outperforms mRNA-1273.”
From The dawn of mRNA vaccines: the COVID-19 case (2021) · cites this paper as [53]
In the citing paper
“which again highlights the benefit of delivering mRNA encoding the full-length S protein [50,53].”
From The dawn of mRNA vaccines: the COVID-19 case (2021) · cites this paper as [53]
In the citing paper
“the majority of the activated CD4+ T cells displayed a Th1 skewed profile (i.e. cells producing IFN-ɣ, TNF-α, and IL-2)”
From The dawn of mRNA vaccines: the COVID-19 case (2021) · cites this paper as [53]
In the citing paper
“Typical other systemic AEs that occurred in more than half of the dosed participants were fatigue, chills, myalgia and headache, which were all increasingly reported for higher dosages, particularly after the boost vaccine [53].”
From The dawn of mRNA vaccines: the COVID-19 case (2021) · cites this paper as [53]
In the citing paper
“Furthermore, AEs were more common after the boost vaccine compared to the prime dose.”
From The dawn of mRNA vaccines: the COVID-19 case (2021) · cites this paper as [53]
In the citing paper
“fever was only reported after the second vaccination of Moderna's mRNA-1273 vaccine at the higher doses of 100 μg (fever in 40% of participants) and 250 μg (57% of participants, with 1/8 events graded as severe).”
From The dawn of mRNA vaccines: the COVID-19 case (2021) · cites this paper as [53]
In the citing paper
“No fever was reported for the 25 μg vaccine dose.”
From The dawn of mRNA vaccines: the COVID-19 case (2021) · cites this paper as [53]
In the citing paper
“The mRNA vaccines that contain nucleoside-modified mRNA (BioNTech/Pfizer and Moderna) both report a clear dose-dependency in the occurrence of localized and systemic adverse events (AEs).”
From The dawn of mRNA vaccines: the COVID-19 case (2021) · cites this paper as [53]
In the citing paper
“Initial results with lipid-nanoparticle-formulated mRNA vaccines against H10N8 and H7N9 influenza viruses and SARS-CoV-2 indicate that these vaccines are well tolerated and that they produce a robust humoral response 76,77 .”
From Nanotechnology approaches for global infectious diseases (2021) · cites this paper as [76]
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Different Potential Vaccine Candidates of Covid-19 Diseases and their Immunological Aspect
Abebe, B. M. (2023) · Vaccines & Vaccination Open Access · doi:10.23880/vvoa-16000160
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Prime-boost protein subunit vaccines against SARS-CoV-2 are highly immunogenic in mice and macaquesPreprint
Tan, H., Juno, J. A., Lee, W. S., Barber-Axthelm, I. M., Kelly, H. G., Wragg, K. M., Esterbauer, R., Amarasena, T. H., Mordant, F. L., Subbarao, K., et al. (2020) · bioRxiv (Cold Spring Harbor Laboratory) · doi:10.1101/2020.09.01.278630 · Cited by 1
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Kinetics and correlates of the neutralizing antibody response to SARS-CoV-2Preprint
Klein, F., Vanshylla, K., Cristanziano, V. D., Kleipass, F., Dewald, F., Schommers, P., Gieselmann, L., Gruell, H., Schlotz, M., Ercanoglu, M. S., et al. (2021) · Research Square · doi:10.21203/rs.3.rs-148929/v1 · Cited by 1
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Subunit Vaccine Against Sars-Cov-2 Using CTL and HTL EpitopesPreprint
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IL-1β and IL-1ra are key regulators of the inflammatory response to RNA vaccinesPreprint
Mellman, I., Tähtinen, S., Tong, A.-J., Himmels, P., Oh, J., Paler-Martı́nez, A., Kim, L., Wichner, S. M., Oei, Y. A., McCarron, M. J., et al. (2021) · Research Square · doi:10.21203/rs.3.rs-378991/v1 · Cited by 1
Immunological heterogeneity informs estimation of the durability of COVID-19 vaccine protectionPreprint
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Predicting the Effectiveness of Covid-19 Vaccines from SARS-CoV-2 Variants Neutralisation DataPreprint
Volkov, O., Borozdenkova, S., & Gray, A. (2021) · medRxiv · doi:10.1101/2021.09.06.21263160 · Cited by 1
Gene Delivery Using Nanocarriers
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Construction of a potent pan-vaccine based on the evolutionary tendency of SARS-CoV-2 spike proteinPreprint
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Macaque-human differences in SARS-CoV-2 Spike antibody response elicited by vaccination or infectionPreprint
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Statistical Inferences and Analysis based on the COVID-19 Data from the United StatesPreprint
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Broadly neutralizing and protective nanobodies against diverse sarbecovirusesPreprint
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Metadata
- Authors
- Jackson, L. A., Anderson, E. J., Rouphael, N. G., Roberts, P. C., Makhene, M., Coler, R. N., McCullough, M. P., Chappell, J. D., Denison, M. R., Stevens, L. J., Pruijssers, A. J., McDermott, A., Flach, B., Doria-Rose, N. A., Corbett, K. S., Morabito, K. M., O’Dell, S., Schmidt, S. D., Swanson, P. A., Padilla, M., Mascola, J. R., Neuzil, K. M., Bennett, H., Sun, W., Peters, E., Makowski, M., Albert, J., Cross, K., Buchanan, W., Pikaart-Tautges, R., Ledgerwood, J. E., Graham, B. S., & Beigel, J. H.
- Affiliations
- Kaiser Permanente Washington Health Research Institute (US)
- From Kaiser Permanente Washington Health Research Institute (L.A.J.) and the Center for Global Infectious Disease Research (CGIDR), Seattle Children’s Research Institute (R.N.C.) — both in Seattle; the Department of Medicine, Center for Childhood Infections and Vaccines (CCIV) of Children’s Healthcare of Atlanta and Emory University Department of Pediatrics, Atlanta (E.J.A., E.P.), and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (N.G.R., M.P.M.) — both in...
- ORCID
- Jackson, Lisa A.
- Anderson, Evan J.
- Rouphael, Nadine G.
- Roberts, Paul C.
- Coler, Rhea N.
- Chappell, James D.
- Denison, Mark R.
- Stevens, Laura J.
- Pruijssers, Andrea J.
- McDermott, Adrian
- Doria-Rose, Nicole A.
- Corbett, Kizzmekia S.
- Morabito, Kaitlyn M.
- O’Dell, Sijy
- Schmidt, Stephen D.
- Swanson, Phillip A.
- Mascola, John R.
- Neuzil, Kathleen M.
- Bennett, Hamilton
- Makowski, Mat
- Cross, Kaitlyn
- Ledgerwood, Julie E.
- Graham, Barney S.
- Beigel, John H.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2020-11-12
- Volume
- 383
- Issue
- 20
- Pages
- 1920-1931
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC7377258
- OpenAlex
- W3043722389
- Semantic Scholar
- 7551d80ae7ea66f37f25aca464c7e7400adddc9c
- Cited by
- 3,237
- References
- 34
- Citations by year
- 2026: 111 · 2025: 172 · 2024: 222 · 2023: 399 · 2022: 712 · 2021: 1230 · 2020: 378
- FWCI
- 82.04
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (submittedVersion)
- Funders
- National Institute of Allergy and Infectious Diseases (HHSN272201500002C, UM1AI148373, UM1AI148576, UM1AI148684)
- National Center for Advancing Translational Sciences (UL1 TR002243)
- Dolly Parton COVID-19 Research Fund
- Topics
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 detection and testing
- Keywords
- mRNA-1273, SARS-CoV-2, COVID-19 vaccines, mRNA vaccines, dose escalation, antibody response, neutralizing antibodies, vaccine safety, adverse events
- MeSH terms
- Betacoronavirus, COVID-19, SARS-CoV-2, COVID-19 Vaccines, 2019-nCoV Vaccine mRNA-1273, Adult, Antibodies, Viral, Antibody Formation, Female, Humans, Immunization, Secondary, Male, Pneumonia, Viral, RNA, Messenger, T-Lymphocytes, Viral Vaccines, Coronavirus Infections, Young Adult, Antibodies, Neutralizing, Pandemics, Spike Glycoprotein, Coronavirus
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
A language model drew the claims from the paper on 2026-10-14, under version 3 of the claim definition (model deepseek-v4.1-flash, prompt extract-v3).
A second model labelled each claim on 2026-10-14 (model jev-1.13-20260917, definition revision gold-guideline-v0.2).
Cited sources are checked with a language model’s help (gpt-6-sol).
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
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