The DOI matches its Crossref record; 26 of the 26 references it cites were found in a registry or an index; 6 of the 10 sources its claims cite were checked for support.
Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2
Open accessAbstract
The coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) threatens global public health. The development of a vaccine is urgently needed for the prevention and control of COVID-19. Here, we report the pilot-scale production of an inactivated SARS-CoV-2 vaccine candidate (BBIBP-CorV) that induces high levels of neutralizing antibodies titers in mice, rats, guinea pigs, rabbits, and nonhuman primates (cynomolgus monkeys and rhesus macaques) to provide protection against SARS-CoV-2. Two-dose immunizations using 2 μg/dose of BBIBP-CorV provided highly efficient protection against SARS-CoV-2 intratracheal challenge in rhesus macaques, without detectable antibody-dependent enhancement of infection. In addition, BBIBP-CorV exhibits efficient productivity and good genetic stability for vaccine manufacture. These results support the further evaluation of BBIBP-CorV in a clinical trial.
Overview
AI snapshot
Written from the paper’s full text.
TL;DR
BBIBP-CorV is an inactivated SARS-CoV-2 vaccine candidate that induced neutralizing antibodies across six mammalian species and protected rhesus macaques against intratracheal SARS-CoV-2 challenge. Two-dose immunization with 2 μg/dose provided highly efficient protection without detectable antibody-dependent enhancement of infection.
Key findings
- The HB02 strain was selected for BBIBP-CorV; it reached peak titers over 7.0 log10 CCID50 at 48–72 hpi in Vero cells, and the P10 stock showed >99.95% whole-genome sequence homology to HB02 with no amino acid variation.
- BBIBP-CorV induced 100% seroconversion in mice, rats, guinea pigs, rabbits, and nonhuman primates; in rhesus macaques before challenge, geometric mean neutralizing antibody titers were 215 in the 2 μg/dose group and 256 in the 8 μg/dose group.
- After intratracheal challenge, low-dose macaques had throat viral load peak at 5.33 log10 copies/mL at 5 dpi and fall to 1.12 log10 copies/mL at 7 dpi; all high-dose macaques had negative throat swabs, and no macaque in either vaccinated group had detectable viral load in any lung lobe.
- Safety studies reported a rat maximum tolerated dose of 24 μg/rat, equivalent to 900 times the human dose, and a no observed adverse effect level of 8 μg/dose in cynomolgus monkeys; no ADE was observed in vaccinated macaques.
Methods
- Three SARS-CoV-2 strains were isolated from patient bronchoalveolar lavage or throat swabs; HB02 was adapted in Vero cells, produced in a basket reactor, inactivated with β-propiolactone at 1:4,000 at 2°C–8°C, and formulated with aluminum hydroxide adjuvant.
- Immunogenicity was tested in mice, rats, guinea pigs, rabbits, and cynomolgus monkeys with 2, 4, or 8 μg/dose using one-, two-, or three-dose regimens; neutralizing antibody levels were measured by microtitration CPE assay.
- Rhesus macaques received two intramuscular immunizations on days 0 and 14 with placebo (n = 2), 2 μg/dose (n = 4), or 8 μg/dose (n = 4), then were intratracheally challenged with 10^6 TCID50 SARS-CoV-2 on day 24; viral loads were measured by RT-PCR in throat and anal swabs and lung lobes, with histopathology at 7 dpi.
Limitations
- The paper states that protection effects on the upper respiratory tract were not assessed and warrant further evaluation.
- Evident from the text: this is preclinical animal data only; clinical efficacy and human safety were not yet established, with Phase I in progress and Phase II recently initiated.
- Evident from the text: nonhuman primate challenge groups were small (n = 2 placebo; n = 4 per vaccinated group) and follow-up after challenge was short (euthanasia at 7 dpi), limiting assessment of durability and late outcomes.
Model-written summary. Check it against the paper before relying on it.
Integrity signals
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Statistics
Verification
Claims the paper makes
6 of 10 cited sources checked · 4 supported · 1 flagged · accuracy not yet measured
Every source the paper cites for this claim was checked and supports it.
In the paper
“Because a recent study showed that SARS-CoV-2 infection does not affect host blood chemistry (Munster et al., 2020), this result suggests that inoculation with BBIBP-CorV does not result in side effects on serum biochemical parameters.”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Results > Protection in a Nonhuman Primate Animal Model
What the sources say
- Supportedcites Munster et al., 2020 source
The Clinical, respiratory disease section reports that blood chemistry values in SARS-CoV-2-inoculated rhesus macaques remained within the normal range, supporting the point attributed to Munster et al. The later conclusion about BBIBP-CorV is the citing authors’ own inference, not a finding attributed to this source. No page number is available in our copy. (LLM, conf=0.88)
Load-bearingStrength:hedged· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passes- 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
“All placebo macaques showed and maintained a high viral load during the whole evaluation period after virus challenge by both throat and anal swabs (Figures 3D and 3E; Figures S4B and S4C).”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Results > Protection in a Nonhuman Primate Animal Model
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesA 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
“Moreover, use of the D0/D21 interval obtained the highest NAb level at 7 days after the second immunization.”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Results > Immunogenicity of BBIBP-CorV
Strength:plain· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesA 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
“Moreover, the serum biochemical parameters in rhesus macaques after vaccination and challenge with living virus remained constant (Figure S3).”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Results > Protection in a Nonhuman Primate Animal Model
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesA 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 results showed that the three-dose (D0/D7/D14) immunization program resulted in higher NAb levels than the one-dose (D0) program in all three groups at days 28 (Figures 2A and 2C).”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Results > Immunogenicity of BBIBP-CorV
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesA 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
“without detectable antibody-dependent enhancement of infection.”
- Also stated in: § Protection in a Nonhuman Primate Animal Model · plain
“without observed antibody-dependent enhancement of infection.”
- Also stated in: § Discussion · plain
“without observable ADE or immunopathological exacerbation.”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Abstract
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passes- Rests on an assumption: Absence of detectable antibody-dependent enhancement in rhesus macaques indicates absence of ADE in humans.
- Also stated in: § Protection in a Nonhuman Primate Animal Model · 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
“Before virus challenge at D24, the geometric mean titer of NAb in the low-dose and high-dose groups reached 215 and 256, respectively (Figure 3B).”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Results > Protection in a Nonhuman Primate Animal Model
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesA 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
“Furthermore, no amino acid variation was found in the full sequence, including the position near the furin cleavage site, in the P10 stock.”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Results > Vaccine Design and Production
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesA 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 histopathologic changes were observed after euthanasia.”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Results > Safety
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesA 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 results demonstrated that BBIBP-CorV has good immunogenicity, and the seroconversion rate reached 100% at day 21 after immunization in all animal models (Figure 2E; Table S1).”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Results > Immunogenicity of BBIBP-CorV
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passes
- Probably not a substantial claim. 23
- It may state two separate claims as one. 26
- The quote only partly states this claim. 1
At least one cited source doesn’t support this claim or points to a different paper, and none confirmed it — see the verdicts below.
In the paper
“however, the concerns on their immunogenicity and safety still remain (Gary and Weiner, 2020).”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Results > Discussion
What the sources say
- Disputedcites Gary and Weiner, 2020 sourceExperimental — accuracy not yet measured
The Introduction (page not available) describes a highly consistent safety record, and the Clinical review of recent DNA vaccines (page not available) says all the constructs it reports were safe and immunogenic in clinical studies. Rather than stating that concerns about both properties still remain, the paper presents recent results as evidence of improved immunogenicity and tolerability. (LLM, conf=0.87)
Checked by a reasoning model — may be wrong.
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
- Disputed
Every source the paper cites for this claim was checked and supports it.
In the paper
“but the neutralizing antibody against the carrier vector virus is still a challenge (Zhang and Zhou, 2016).”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Results > Discussion
What the sources say
- Supportedcites Zhang and Zhou, 2016 source
The Abstract says pre-existing neutralizing antibodies dampen the immunogenicity of adenovirus-based vaccines. The “Capsid-incorporation of foreign antigen into ad virions as vaccine candidate” section adds that pre-existing antibodies to the vectors may cause vaccine failure. No page numbers are provided in our copy. (LLM, conf=0.93)
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
- Supported
The sources with a verdict support this claim; the rest weren’t checked yet, have no full text we could read, or their verdicts aren’t rated yet.
In the paper
“Prior to our reporting of this BBIBP-CorV study, three candidate vaccines against SARS-CoV-2 were reported, including an adenovirus-vectored vaccine (ChAdOx1 nCoV-19), a DNA vaccine, and an inactivated vaccine (PiCoVacc) (Gao et al., 2020, Lurie et al., 2020, van Doremalen et al., 2020, Yu et al., 2020a).”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Results > Discussion
What the sources say
- Supportedcites Gao et al., 2020 source
The source is the study reporting PiCoVacc. Its Abstract identifies PiCoVacc as a purified inactivated SARS-CoV-2 vaccine candidate, supporting the part of the multi-citation sentence attributed to Gao et al. (LLM, conf=0.94)
- Not checked — no full text of the sourcecites Lurie et al., 2020 source
- Not matchedcites van Doremalen et al., 2020
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
- Supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“The DNA vaccine is easy to be produced and is stable for storage with limited recovery or residual toxicity”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Results > Discussion
What the sources say
- Partly supportedcites Gary and Weiner, 2020 sourceExperimental — accuracy not yet measured
The Introduction describes synthetic DNA vaccines as rapidly synthesized and scalable, and says the platform addresses goals of temperature stability and consistent manufacture. It also reports a consistent safety record, but does not establish the more specific claim of limited recovery or residual toxicity. (LLM, conf=0.84)
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
- Partly supported
Every source the paper cites for this claim was checked and supports it.
In the paper
“The recombinant adenovirus-vectored vaccine is easily manipulated for genetic modification and capable of inducing potent antigen-specific immune responses”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Results > Discussion
What the sources say
- Supportedcites Zhang and Zhou, 2016 source
The Outlook and conclusions section states that adenoviral vectors are easy to manipulate for genetic modification and can induce potent antigen-specific immune responses. This directly supports the claim about recombinant adenovirus-vectored vaccines. (LLM, conf=0.95)
Strength:plain· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
- Supported
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“In addition, BBIBP-CorV exhibits efficient productivity and good genetic stability for vaccine manufacture.”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Abstract
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
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 macaques in the low-dose and high-dose groups had a detectable viral load in any lung lobe, which was significantly different from the results in the placebo group (Figure 3F).”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Results > Protection in a Nonhuman Primate Animal Model
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt 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 results showed that the seroconversion rate in the high-, middle-, and low-dose groups reached 100% at 7 days after immunization, and the immunization effect was time dependent (Figure 2 A; Table S1).”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Results > Immunogenicity of BBIBP-CorV
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt 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
“To note, only 3 of 7 sections of the lung lobes were detected to have infection in the placebo group, possibly because the virus infection in the lung lobes is dynamically changing.”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Results > Protection in a Nonhuman Primate Animal Model
Strength:hedged· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
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
“Growth kinetic analysis of the P7 stock in Vero cells showed that the stock virus could replicate efficiently and reached a peak titer over 7.0 log10 CCID50 by 48–72 h post-infection (hpi) at multiplicities of infection (MOI) of 0.01–0.3 (Figure 1C).”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Results > Vaccine Design and Production
Load-bearingStrength:hedged· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt 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 7 dpi, the macaques treated with placebo produced low-level NAb with a titer of 1:16, whereas the NAb levels of the vaccinated macaques were highest at 1:2,048 (average 1:860) in the high-dose group and 1:1,024 in the low-dose group (average 1:512) (Figure 3B).”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Results > Protection in a Nonhuman Primate Animal Model
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt 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
“In the placebo group, a high viral load was detected in the left lower lung, right lower lung, and right accessory lung, and the pathological histology analysis results showed severe interstitial pneumonia.”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Results > Protection in a Nonhuman Primate Animal Model
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt 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
“A negatively stained electron microscopy image visualized oval viral particles with spikes with the diameters of approximately 100 nm (Figure 1F).”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Results > Vaccine Design and Production
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it. 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
“Moreover, there was no significant difference in weight or feeding state between the experimental groups and control groups (Figure 4 A; Figure S4D).”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Results > Safety
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt 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
“In contrast, the viral load in the throat swabs of the low-dose group peaked (5.33 log10copies/mL) at 5 dpi and then decreased to 1.12 log10copies/mL at 7 dpi, which was significantly lower than that of the placebo group.”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Results > Protection in a Nonhuman Primate Animal Model
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt 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
“Taken together, all these results demonstrated that both low-dose and high-dose BBIBP-CorV conferred highly efficient protection against SARS-CoV-2 in macaques without observed antibody-dependent enhancement of infection.”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Results > Protection in a Nonhuman Primate Animal Model
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt may state two separate claims as one.
- Rests on an assumption: The rhesus macaque intratracheal challenge model with 10^6 TCID50 SARS-CoV-2 reproduces human COVID-19 disease sufficiently to assess vaccine protection.
- Rests on an assumption: Absence of detectable antibody-dependent enhancement in rhesus macaques indicates absence of ADE in humans.
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 first found that the HB02 strain showed the most optimal replication and generated highest virus yields in Vero cells among three viral strains (Figure 1 A).”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Results > Vaccine Design and Production
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt 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 NAb levels at 7, 14, and 21 days in the low- and middle-dose groups show significant variation, whereas no significant variation between 21 and 28 days was observed.”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Results > Immunogenicity of BBIBP-CorV
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt 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 inactivation of three batches of virus eliminated viral infectivity, validating the good stability, and repeatability of the inactivation process (Figure 1D).”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Results > Vaccine Design and Production
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt 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
“Granulomatous inflammation was observed in the 2, 4, and 8 μg/dose groups on D25 and remained at the end of the recovery period (D36), with a slight improvement compared to that observed on D25.”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Results > Safety
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt 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
“In sharp contrast, in the low- and high-dose groups, no allergic reactions at D19 and D26 were found, and the allergic reactions were negative.”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Results > Safety
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt 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 animals showed only local irritation characterized by mild to severe granulomatous inflammation due to injection, but this reaction was absent at 2 weeks after injection.”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Results > Safety
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt 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 no observed adverse effect level was found to be 8 μg/dose in this trial.”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Results > Safety
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesThe 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
“both BBIBP-CorV and ChAdOx1 nCoV-19 conferred effective protection and prevented all vaccinated macaques from viral interstitial pneumonia.”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Results > Discussion
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt 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
“demonstrating the BBIBP-CorV vaccination could efficiently block the infection of SARS-CoV-2 and COVID-19 disease in monkey.”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Results > Protection in a Nonhuman Primate Animal Model
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt may state two separate claims as one.
- Rests on an assumption: The rhesus macaque intratracheal challenge model with 10^6 TCID50 SARS-CoV-2 reproduces human COVID-19 disease sufficiently to assess vaccine protection.
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 results support the further evaluation of BBIBP-CorV in a clinical trial.”
- Also stated in: § Introduction · plain
“Here, we report the study of an inactivated SARS-CoV-2 vaccine candidate (BBIBP-CorV) and show that its potency and safety in preclinical studies warrants further clinical evaluation.”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Abstract
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✗ Checkable: fails✓ Load-bearing: passes✓ Based: passesProbably not a substantial claim. It may be too vague to check against evidence.
- Rests on an assumption: The immunogenicity and protective efficacy observed in animal models predict immunogenicity and protection in humans.
- Also stated in: § Introduction · plain
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
“Rhesus macaque studies were performed in an animal biosafety level 3 (ABSL-3) laboratory and approved by the IACUC of the Institute of Laboratory Animal Science, Chinese Academy of Medical Sciences with approval number GH20008.”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > STAR★Methods > Experimental Model and Subject Details
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably 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
“The sample size and statistical method were indicated in Method Details or Figure Legends.”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > STAR★Methods > Method Details
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
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
“and the pipeline used for BBIBP-CorV pilot-scale production also sheds light on rapid vaccine developing against other coronavirus.”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Results > Discussion
Strength:plain· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✗ Checkable: fails✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. It may be too vague to check against evidence. 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 cynomolgus monkey experiments were approved by the institutional animal ethics committee (IACUC) prior to operation.”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > STAR★Methods > Experimental Model and Subject Details
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably 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 experiments were randomized and no data was excluded from data analysis.”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > STAR★Methods > Method Details
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably 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
“All experiments in this study were performed with replications numbers indicated in Method Details or Figure Legends.”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > STAR★Methods > Method Details
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably 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 animals participate in this research are in good health and are not involved in other experimental procedure.”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > STAR★Methods > Experimental Model and Subject Details
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✗ Based: failsProbably not a substantial claim. The paper’s conclusions may not depend on it. The paper may give no 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
“All animals involved in this study were housed and cared for in an Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC)-accredited facility.”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > STAR★Methods > Experimental Model and Subject Details
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably 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
“Cynomolgus monkeys, rabbits, guinea pigs, rats and mice were randomly divided into three groups”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > STAR★Methods > Method Details
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesProbably not a substantial claim.
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
“Of note, the protection effects on the upper respiratory tract are not assessed in this study and warrant further evaluation.”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Results > Discussion
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
In the paper
“both BBIBP-CorV and ChAdOx1 nCoV-19 conferred effective protection and prevented all vaccinated macaques from viral interstitial pneumonia.”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Results > Discussion
What the sources say
- Not matchedcites van Doremalen et al., 2020
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
Strength:plain· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt may state two separate claims as one.
- Not matched
In the paper
“For ChAdOx1 nCoV-19, 5 of 6 lung lobes in vaccinated group showed the detectable viral load (van Doremalen et al., 2020)”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Results > Discussion
What the sources say
- Not matchedcites van Doremalen et al., 2020
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably 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
“All experimental procedures with mice, rats, rabbits, guinea pigs, and nonhuman primates were conducted according to Chinese animal use guidelines and were approved by the Institutional Animal Care and Use Committee (IACUC).”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > STAR★Methods > Experimental Model and Subject Details
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“In the protection studies, ChAdOx1 nCoV-19 and the DNA vaccine were challenged by both lower and upper respiratory tract, whereas PiCoVacc and BBIBP-CorV were intratracheally challenged.”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Results > Discussion
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably 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
“which might benefit the further clinical usage of the inactivated vaccine with less adverse effects.”
§ Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2 > Results > Discussion
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesProbably not a substantial claim.
The paper relies on this without support.
The immunogenicity and protective efficacy observed in animal models predict immunogenicity and protection in humans.
“These results support the further evaluation of BBIBP-CorV in a clinical trial.”
“indicating the potential good safety of BBIBP-CorV in humans.”
The paper relies on this without support.
The rhesus macaque intratracheal challenge model with 10^6 TCID50 SARS-CoV-2 reproduces human COVID-19 disease sufficiently to assess vaccine protection.
“At D24 (10 days after the second immunization), all macaques were intratracheally challenged with l06 TCID50 of SARS-CoV-2 per monkey under anesthesia.”
“demonstrating the BBIBP-CorV vaccination could efficiently block the infection of SARS-CoV-2 and COVID-19 disease in monkey.”
The paper relies on this without support.
Absence of detectable antibody-dependent enhancement in rhesus macaques indicates absence of ADE in humans.
“without detectable antibody-dependent enhancement of infection.”
“without observed antibody-dependent enhancement of infection.”
The paper relies on this without support.
The Vero cells used for virus isolation and vaccine production are certified by WHO for vaccine production.
“Notably, all of these strains were isolated from Vero cells, which have been certified by WHO for vaccine production.”
The paper relies on this without support.
No effective antiviral drug against SARS-CoV-2 exists.
“In the absence of an effective antiviral drug against SARS-CoV-2, vaccines with good potency and safety will be needed to effectively establish immunity in population.”
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 cited source says what the claim attributes to it.
In the citing paper
“Inactivated SARS-CoV-2 vaccine candidates have shown promising results in preclinical trials.13, 14, 15”
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
Each contradiction between two passages listed here was confirmed by an independent check.
Local inflammation is both present and absent at two weeks
MajorGranulomatous inflammation is said to remain on day 36, which is two weeks after the final injection on day 22. The next sentence says that this injection-site reaction was absent two weeks after injection.
“Granulomatous inflammation was observed in the 2, 4, and 8 μg/dose groups on D25 and remained at the end of the recovery period (D36), with a slight improvement compared to that observed on D25.”
“The animals showed only local irritation characterized by mild to severe granulomatous inflammation due to injection, but this reaction was absent at 2 weeks after injection.”
Day 25 is misidentified as three days after the third vaccination
MinorThe stated vaccination days make day 25 three days after the fourth vaccination on day 22, not the third vaccination on day 15.
“day 25 (3 days after the third vaccination), and day 36 (14 days after the fourth vaccination)”
“Cynomolgus monkeys were intramuscularly injected four times on days 1, 8, 15, and 22”
Citations
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Self-citation
Flagged first, then by citations
Cited by
Sorted by citations
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Self-citation
Metadata
- Authors
- Wang, H., Zhang, Y., Huang, B., Deng, W., Quan, Y., Wang, W., Xu, W., Zhao, Y., Li, N., Zhang, J., Liang, H., Bao, L., Xu, Y., Ding, L., Zhou, W., Gao, H., Liu, J., Niu, P., Zhao, L., Zhen, W., Fu, H., Yu, S., Zhang, Z., Xu, G., Li, C., Lou, Z., Xu, M., Qin, C., Wu, G., Gao, G. F., Tan, W., & Yang, X.
- Affiliations
- National Vaccine and Serum Institute (CN)
- Chinese Center For Disease Control and Prevention (CN)
- Chinese Academy of Medical Sciences & Peking Union Medical College (CN)
- National Institutes for Food and Drug Control (CN)
- Tsinghua University (CN)
- China National Pharmaceutical Group Corporation (China) (CN)
- Corresponding author
- Li, Changgui
- Lou, Zhiyong
- Xu, Miao
- Qin, Chuan
- Wu, Guizhen
- Gao, George Fu
- Tan, Wenjie
- Yang, Xiaoming
- ORCID
- Venue
- Cell
- Publisher
- Elsevier BV
- Published
- 2020-08
- Volume
- 182
- Issue
- 3
- Pages
- 713-721.e9
- ISSN
- 0092-8674 (ISSN-L)
- PMC
- PMC7275151
- OpenAlex
- W3034173374
- Semantic Scholar
- 6f16ad05c488ce92ac0c56e4f8b5a81cb7c39d0d
- Cited by
- 748
- References
- 26
- Citations by year
- 2026: 12 · 2025: 37 · 2024: 55 · 2023: 83 · 2022: 212 · 2021: 270 · 2020: 78
- FWCI
- 21.16
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Cell (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Natural Science Foundation of China
- Beijing Science and Technology Planning Project
- Topics
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Life Sciences › Agricultural and Biological Sciences › Animal Science and Zoology › Animal Virus Infections Studies
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Viral Infectious Diseases and Gene Expression in Insects
- Keywords
- BBIBP-CorV, inactivated vaccine, SARS-CoV-2, COVID-19 vaccines, neutralizing antibodies, vaccine production, genetic stability, antibody-dependent enhancement, rhesus monkeys, Macaca fascicularis, intratracheal challenge, vaccine safety
- MeSH terms
- Immunogenicity, Vaccine, Betacoronavirus, COVID-19, SARS-CoV-2, COVID-19 Vaccines, Animals, Antibodies, Viral, Chlorocebus aethiops, Disease Models, Animal, Drug Evaluation, Preclinical, Female, Guinea Pigs, Macaca fascicularis, Macaca mulatta, Male, Mice, Inbred BALB C, Phylogeny, Pneumonia, Viral, Rabbits, Vero Cells, Viral Vaccines, Vaccines, Inactivated, Rats, Wistar, Coronavirus Infections, Mice, Rats, Antibodies, Neutralizing, Pandemics
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 2026-10-28, under version 3 of the claim definition (model deepseek-v4.1-flash, prompt extract-v3).
A second model labelled each claim on 2026-10-28 (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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