The DOI matches its Crossref record; 32 of the 32 references it cites were found in a registry or an index; 16 of the 19 sources its claims cite were checked for support.
Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey
Open accessAbstract
Background CoronaVac, an inactivated whole-virion SARS-CoV-2 vaccine, has been shown to be well tolerated with a good safety profile in individuals aged 18 years and older in phase 1/2 trials, and provided a good humoral response against SARS-CoV-2. We present the interim efficacy and safety results of a phase 3 clinical trial of CoronaVac in Turkey. Methods This was a double-blind, randomised, placebo-controlled phase 3 trial. Volunteers aged 18-59 years with no history of COVID-19 and with negative PCR and antibody test results for SARS-CoV-2 were enrolled at 24 centres in Turkey. Exclusion criteria included (but were not limited to) immunosuppressive therapy (including steroids) within the past 6 months, bleeding disorders, asplenia, and receipt of any blood products or immunoglobulins within the past 3 months. The K1 cohort consisted of health-care workers (randomised in a 1:1 ratio), and individuals other than health-care workers were also recruited into the K2 cohort (randomised in a 2:1 ratio) using an interactive web response system. The study vaccine was 3 μg inactivated SARS-CoV-2 virion adsorbed to aluminium hydroxide in a 0·5 mL aqueous suspension. Participants received either vaccine or placebo (consisting of all vaccine components except inactivated virus) intramuscularly on days 0 and 14. The primary efficacy outcome was the prevention of PCR-confirmed symptomatic COVID-19 at least 14 days after the second dose in the per protocol population. Safety analyses were done in the intention-to-treat population. This study is registered with ClinicalTrials.gov (NCT04582344) and is active but no longer recruiting. Findings Among 11 303 volunteers screened between Sept 14, 2020, and Jan 5, 2021, 10 218 were randomly allocated. After exclusion of four participants from the vaccine group because of protocol deviations, the intention-to-treat group consisted of 10 214 participants (6646 [65·1%] in the vaccine group and 3568 [34·9%] in the placebo group) and the per protocol group consisted of 10 029 participants (6559 [65·4%] and 3470 [34·6%]) who received two doses of vaccine or placebo. During a median follow-up period of 43 days (IQR 36-48), nine cases of PCR-confirmed symptomatic COVID-19 were reported in the vaccine group (31·7 cases [14·6-59·3] per 1000 person-years) and 32 cases were reported in the placebo group (192·3 cases [135·7-261·1] per 1000 person-years) 14 days or more after the second dose, yielding a vaccine efficacy of 83·5% (95% CI 65·4-92·1; p<0·0001). The frequencies of any adverse events were 1259 (18·9%) in the vaccine group and 603 (16·9%) in the placebo group (p=0·0108) with no fatalities or grade 4 adverse events. The most common systemic adverse event was fatigue (546 [8·2%] participants in the vaccine group and 248 [7·0%] the placebo group, p=0·0228). Injection-site pain was the most frequent local adverse event (157 [2·4%] in the vaccine group and 40 [1·1%] in the placebo group, p<0·0001). Interpretation CoronaVac has high efficacy against PCR-confirmed symptomatic COVID-19 with a good safety and tolerability profile. Funding Turkish Health Institutes Association.
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Written from the paper’s full text.
TL;DR
In this interim analysis of a double-blind, randomised, placebo-controlled phase 3 trial in Turkey, CoronaVac showed 83·5% efficacy against PCR-confirmed symptomatic COVID-19 at least 14 days after the second dose in adults aged 18–59 years, with no COVID-19 hospitalisations in vaccine recipients. The vaccine had a good safety profile, with no grade 4 adverse events or deaths and low adverse event incidence.
Key findings
- Among the per protocol population (n=10,029), 41 symptomatic COVID-19 cases occurred ≥14 days after the second dose: 9 in the vaccine group (31·7 cases [14·6–59·3] per 1000 person-years) versus 32 in the placebo group (192·3 cases [135·7–261·1] per 1000 person-years), yielding vaccine efficacy of 83·5% (95% CI 65·4–92·1; p<0·0001).
- Hospitalisation for COVID-19 occurred in none of the vaccine group and six in the placebo group, giving vaccine efficacy of 100% (20·4–100·0; p=0·0344); there were no fatal COVID-19 cases.
- Immunogenicity: 880 (89·7%) vaccine recipients versus 19 (4·4%) placebo recipients were seropositive for RBD-specific total antibody (p<0·0001); among selected seropositive vaccine samples (n=387), 356 (92·0%) had SN50 of at least 1/15.
- Safety: any adverse events occurred in 1259 (18·9%) vaccine recipients versus 603 (16·9%) placebo recipients (p=0·0108); there were no grade 4 adverse events or deaths. The most common systemic adverse event was fatigue (546 [8·2%] vs 248 [7·0%], p=0·0228), and injection-site pain was the most frequent local adverse event (157 [2·4%] vs 40 [1·1%], p<0·0001).
Methods
- Double-blind, randomised, placebo-controlled phase 3 trial at 24 centres in Turkey. Volunteers aged 18–59 years with no history of COVID-19 and negative PCR and antibody results were enrolled; K1 healthcare workers were randomised 1:1 and K2 participants (community plus healthcare workers) were randomised 2:1. Of 11,303 screened, 10,218 were randomly allocated; the intention-to-treat population was 10,214 and the per protocol population was 10,029.
- The vaccine was 3 μg inactivated SARS-CoV-2 virion adsorbed to aluminium hydroxide in a 0·5 mL aqueous suspension, given intramuscularly on days 0 and 14; placebo contained all vaccine components except inactivated virus.
- The primary efficacy outcome was PCR-confirmed symptomatic COVID-19 at least 14 days after the second dose in the per protocol population; safety analyses were done in the intention-to-treat population. Efficacy was calculated using COVID-19-free person-years; median follow-up from randomisation to unmasking was 43 days (IQR 36–48).
Limitations
- Stated: median follow-up after randomisation to unmasking was 43 days (IQR 36–48), which is very short; long-term protective effects of the two-dose schedule cannot be assessed from this interim analysis.
- Stated: the study population was relatively young (median age 45 years [IQR 37–51]) and healthy with low chronic disease prevalence and a very low event rate; few participants were hospitalised and the population was at relatively low risk of severe or critical COVID-19, limiting generalisability, especially for severe disease.
- Stated: the trial used a 14-day interval whereas community immunisation used 28 days; results predate variants of concern, so efficacy against mutant viruses cannot be assessed; the report lacks sequential serum neutralising antibody titres, T-cell response magnitude, and duration of protectivity, and used a semiquantitative immunoassay. The target sample size was not reached because emergency use authorisation and vaccination began during recruitment. Evident from the text: this is an interim analysis, and subgroup efficacy analyses were not designed or powered.
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47 Own result · 25 Own method · 13 Own interpretation · 6 Partly supported · 3 No full text of the sources · 2 Supported · 2 Not checked yet · 2 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
“Phase 1/2 trials of CoronaVac in volunteers aged 18–59 years and older than 60 years showed that the vaccine doses and schedules investigated (3 μg or 6 μg, applied 14 days or 28 days apart) all had similar safety and immunogenicity profiles.20, 21”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Discussion
What the sources say
- Partly supportedcites [20] Zhang, 2021, Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18–59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial, Lancet Infect Dis 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.
- Partly supportedcites [21] Wu, 2021, Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy adults aged 60 years and older: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial, Lancet Infect Dis 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.
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.
- Partly supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“The interim phase 3 results of other COVID-19 vaccines have shown efficacies ranging from 62·1% to 95%.24, 25, 26, 27, 28”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Discussion
What the sources say
- Supportedcites [24] Logunov, 2021, Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia, Lancet source
The Discussion reports interim efficacy results for other COVID-19 vaccines, including 62·1% for the two-standard-dose ChAdOx1 regimen and 95% for BNT162b2. These match the stated range. The supplied passage has no page number. (LLM, conf=0.93)
- Partly supportedcites [25] Baden, 2021, Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine, N Engl J Med sourceExperimental — accuracy not yet measured
The Statistical Analysis section (p. 4) reports 94.5% efficacy for mRNA-1273 at the first interim analysis, supporting the approximately 95% end of the stated range. This paper does not report a 62.1% efficacy result or establish the full range across COVID-19 vaccines. (LLM, conf=0.88)
- Supportedcites [26] Polack, 2020, Safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine, N Engl J Med source
The Results > Efficacy passage reports 95.0% efficacy for BNT162b2, supporting the upper end of the range attributed to this paper. The sentence has several citations; this paper need not establish the 62.1% figure for another vaccine. (LLM, conf=0.92)
- Partly supportedcites [27] Voysey, 2021, Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK, Lancet sourceExperimental — accuracy not yet measured
Table 2 in the Results reports 62·1% efficacy for standard-dose ChAdOx1 recipients in this interim analysis. The Research in context passage reports 95% for Pfizer/BioNTech, but identifies that figure as coming from a primary analysis, not an interim analysis. Thus the range is supported, but the sentence's 'interim' qualifier does not fit both endpoints. (LLM, conf=0.86)
- Could not verifycites [28] Sadoff, 2021, Safety and efficacy of single-dose Ad26.COV2.S vaccine against COVID-19, N Engl J Med sourceExperimental — accuracy not yet measured
The Results > Efficacy and Discussion (page unavailable) report efficacy for Ad26.COV2.S, not the interim phase 3 efficacy range for other COVID-19 vaccines. Searches for 62.1%, 95%, and other vaccine trials found no passage in our copy establishing the claimed range. (LLM, conf=0.76)
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.
- 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
“Preliminary immunogenicity results revealed that CoronaVac induced anti-receptor-binding domain antibodies in 89·7% of participants.”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Introduction
plaindirect- 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.
- 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
“with no cases of COVID-19 requiring hospitalisation”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Introduction
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
“During a median follow-up period of 43 days (IQR 36–48), nine cases of PCR-confirmed symptomatic COVID-19 were reported in the vaccine group”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Abstract > Findings
plainn = 9- 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
“The most common systemic adverse event was fatigue (546 [8·2%] participants in the vaccine group and 248 [7·0%] the placebo group, p=0·0228).”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Abstract > Findings
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
“(192·3 cases [135·7–261·1] per 1000 person-years)”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Abstract > Findings
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
“The frequencies of any adverse events were 1259 (18·9%) in the vaccine group and 603 (16·9%) in the placebo group (p=0·0108)”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Abstract > Findings
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
“yielding a vaccine efficacy of 83·5% (95% CI 65·4–92·1; p<0·0001)”
- Also stated in: § Introduction · plain
“CoronaVac showed an efficacy of 83·5% for preventing PCR-confirmed symptomatic COVID-19”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Abstract > Findings
plaindirectn = 32- Asserted: passes — The authors put it forward as true.
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- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Also stated in: § Introduction · 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
“(31·7 cases [14·6–59·3] per 1000 person-years)”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Abstract > Findings
plainn = 9- 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. 25
- It may state two separate claims as one. 35
- The quote only partly states this claim. 3
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“The entire study protocol was published previously and is available on the Hacettepe University Vaccine Institute website.10”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Methods > Study design and participants
What the sources say
- Partly supportedcites [10] Akova, 2021, A randomized, double-blind, placebo-controlled phase III clinical trial to evaluate the efficacy and safety of SARS-CoV-2 vaccine (inactivated, Vero cell): a structured summary of a study protocol for a randomised controlled trial, Trials sourceExperimental — accuracy not yet measured
The Full Protocol section (page not specified) says the complete protocol is attached to this article as Additional file 1 and is accessible from the Trials website. It does not say the protocol was published previously or is available on the Hacettepe University Vaccine Institute website. (LLM, conf=0.88)
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.
- Partly supported
Every source the paper cites for this claim was checked and supports it.
In the paper
“Inactivated SARS-CoV-2 vaccine candidates have shown promising results in preclinical trials.13, 14, 15”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Discussion
What the sources say
- Supportedcites [13] Gao, 2020, Development of an inactivated vaccine candidate for SARS-CoV-2, Science source
The paper reports promising preclinical results for its inactivated SARS-CoV-2 vaccine candidate, PiCoVacc. In the passages labeled Abstract (page not provided), it reports neutralizing antibodies in mice, rats, and non-human primates, and partial or complete protection in challenged macaques, depending on dose. (LLM, conf=0.92)
- Supportedcites [14] Wang, 2020, Development of an inactivated vaccine candidate, BBIBP-CorV, with potent protection against SARS-CoV-2, Cell source
The Introduction reports that an inactivated vaccine candidate protected rhesus macaques in preclinical testing. The Discussion reports that BBIBP-CorV induced neutralizing antibodies in six mammalian species and protected rhesus macaques against SARS-CoV-2, supporting the broad claim of promising preclinical results. Page numbers are not provided in our copy. (LLM, conf=0.92)
- Supportedcites [15] Mohandas, 2021, Immunogenicity and protective efficacy of BBV152, whole virion inactivated SARS-CoV-2 vaccine candidates in the Syrian hamster model, iScience source
The Introduction explicitly states that inactivated SARS-CoV-2 vaccine candidates had shown promising results in preclinical trials. The Discussion also reports protective efficacy for the BBV152 candidates in immunized hamsters. (LLM, conf=0.94)
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.
- Supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“Disadvantages include limited immunogenicity requiring adjuvants to enhance the immune response, large quantities of live virus to be handled, and the integrity of antigens or epitopes that should be verified.8”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Introduction
What the sources say
- Partly supportedcites [8] Awadasseid, 2021, Current advances in the development of SARS-CoV-2 vaccines, Int J Biol Sci sourceExperimental — accuracy not yet measured
The Safety section (page unavailable) says adjuvants can improve vaccine immunogenicity, and Selection of antigens > Whole-cell antigen says killed-virus vaccines require careful quality assurance. Neither passage says inactivated vaccines have limited immunogenicity requiring adjuvants, require handling large quantities of live virus, or specifically require verification of antigen or epitope integrity. Searches for those terms found no more direct support. (LLM, conf=0.82)
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.
- Partly supported
Every source the paper cites for this claim was checked and supports it.
In the paper
“Considering the production capacity and emergent need for vaccines, the 3 μg dose of CoronaVac has been suggested for efficacy assessment.20”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Discussion
What the sources say
- Supportedcites [20] Zhang, 2021, Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18–59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial, Lancet Infect Dis source
The Abstract’s Interpretation explicitly suggests the 3 μg dose of CoronaVac for efficacy assessment, taking production capacity into account. The Discussion also describes the importance of emergency use during the COVID-19 pandemic, consistent with the citing sentence’s urgency framing. (LLM, conf=0.88)
hedged- Asserted: passes — The authors put it forward as true.
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- 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.
- Supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“Higher and more rapidly established efficacies were observed with mRNA-based vaccines.25, 26”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Discussion
What the sources say
- Partly supportedcites [25] Baden, 2021, Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine, N Engl J Med sourceExperimental — accuracy not yet measured
The Efficacy section (p. 9) reports 94.1% efficacy for mRNA-1273 and 95.2% in an analysis starting 14 days after the first dose. The Discussion (p. 11) describes rapid case accrual and compares its high efficacy with influenza-vaccine efficacy, but the paper does not establish that mRNA vaccines achieved efficacy more rapidly than other vaccine types. (LLM, conf=0.82)
- Partly supportedcites [26] Polack, 2020, Safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine, N Engl J Med sourceExperimental — accuracy not yet measured
The Discussion (page not provided) reports 95% efficacy for BNT162b2 and describes both early protection after vaccination and a demonstration of efficacy less than 11 months after development began. It does not compare efficacy or the speed of establishing it with other vaccine types, and its findings concern one mRNA vaccine rather than mRNA-based vaccines generally. (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.
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
“Gao and colleagues13 showed that, in mice, rats, and rhesus monkeys, 6 μg CoronaVac induced SARS-CoV-2-specific neutralising antibodies that effectively neutralised ten representative SARS-CoV-2 strains and provided complete protection against SARS-CoV-2 challenge in non-human primates.”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Discussion
What the sources say
- Partly supportedcites [13] Gao, 2020, Development of an inactivated vaccine candidate for SARS-CoV-2, Science sourceExperimental — accuracy not yet measured
Split into 2 atoms — 0 confirmed, 2 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.
- 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.
- 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
“11 303 volunteers were screened for eligibility, and 10 218 were randomly allocated”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Results
plainn = 11,303- Asserted: passes — The authors put it forward as true.
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Probably 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
“10 029 participants who received two doses of CoronaVac (6559 [65·4%] participants) or placebo (3470 [34·6%] participants) formed the per protocol population.”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Results
plainn = 10,029- 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
“and 32 cases were reported in the placebo group”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Abstract > Findings
plainn = 32- 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
“with no fatalities or grade 4 adverse events”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Abstract > Findings
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
“Second, one should bear in mind that the study population consisted of relatively young (median age 45 years [37–51]) and healthy individuals with a low prevalence of chronic diseases, and the overall event rate was very low.”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > 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
“Other local adverse events, including erythema, paraesthesia, and swelling, were rare and did not differ significantly in incidence between groups (figure 5B).”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Results
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.
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
“There were no fatal cases of COVID-19.”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Results
plainn = 150- 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.
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
“Seropositivity decreased with increasing age in women (ptrend=0·0003) and men (ptrend=0·0084).”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Results
plaincorrelationaln = 1,413 ·- 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.
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
“Hospitalisation was recorded in none of the participants in the vaccine group and six in the placebo group (36·4 hospitalisations [13·5–77·5] per 1000 person-years)”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Results
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.
- 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 first participant had a grade 3 systemic allergic reaction that occurred more than 24 h after the administration of the first dose of vaccine and resolved uneventfully in the following 24 h.”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Results
plainSingle case- 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.
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 vaccine showed a satisfactory safety profile, with no grade 4 adverse events or deaths during the study period.”
- Also stated in: § Discussion · plain
“No grade 4 adverse events were observed and there was only one adverse event (an allergic reaction) that required hospitalisation.”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Results
plainn = 10- 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.
- Also stated in: § Discussion · 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
“The most common solicited local reaction was inoculation site pain, which occurred significantly more frequently in the vaccine group (157 [2·4%] participants) than in the placebo group (40 [1·1%], p<0·0001).”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Results
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.
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 other participant presented with seizure 43 days after the second dose of the vaccine; however, after an extensive work-up, this patient was diagnosed with an infiltrative glial neoplasm and, in the final assessment, this adverse event was judged to be unrelated to the vaccine.”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Results
plainSingle case- 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.
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
“Of these cases, nine were reported in the vaccine group (n=6559; 31·7 cases [14·6–59·3] per 1000 person-years) and 32 in the placebo group (n=3470; 192·3 cases [135·7–261·1] per 1000 person-years)”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Results
plainn = 41- 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
“Participants and practitioners were masked to the group allocation.”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Methods > Randomisation and masking
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.
Probably not a substantial claim.
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
“and provided a good humoral response against SARS-CoV-2.”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Abstract > Background
plaindirect- 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
“As the placebo and study vaccine looked exactly the same, they were administered by staff masked to group allocation.”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Methods > Procedures
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
“The study protocol was approved by the clinical research ethics board of Hacettepe University (approval number 2020/10-26, July 16, 2020).”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Methods > Study 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
“Safety analyses were done in the intention-to-treat population.”
- Also stated in: § Statistical analysis · plain
“Safety analyses were done in the intention-to-treat population.”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Abstract > Methods
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.
- Also stated in: § Statistical analysis · 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
“This study is registered with ClinicalTrials.gov (NCT04582344)”
- Also stated in: § Statistical analysis · plain
“This study is registered with ClinicalTrials.gov (NCT04582344).”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Abstract > Methods
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.
- Also stated in: § Statistical analysis · 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
“CoronaVac has high efficacy against PCR-confirmed symptomatic COVID-19 with a good safety and tolerability profile.”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Abstract > Interpretation
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
“This was a double-blind, randomised, placebo-controlled phase 3 trial.”
- Also stated in: § Study design and participants · plain
“We did a double-blind, randomised, placebo-controlled, case-driven phase 3 clinical trial”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Abstract > Methods
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.
- Also stated in: § Study design and participants · 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
“Randomisation into vaccine and placebo groups was done on day 0, at a 1:1 ratio in K1 and a 2:1 ratio in K2, using an interactive web response system (Omega-CRO, Ankara, Turkey).”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Methods > Randomisation and masking
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
“The independent data and safety monitoring board monitored the quality of evidence, adverse events, revisions in line with the current literature, individual privacy, and data reliability from the planning stage to the end of the study.”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Methods > Statistical analysis
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
“Total sample sizes were calculated as 7545 for the vaccine group and 3773 for the placebo group in order to be able to detect a minimum clinically significant difference of 1% (with estimated incidence rates of 1% for the vaccine group and 2% for the placebo group) in a two-sided hypothesis testing design with 95% CIs.”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Methods > Statistical analysis
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.
Probably 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
“Signed informed consent was obtained from participants before screening.”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Methods > Study 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
“The potential advantages of inactivated vaccines are non-replicability in the host, non-transmissibility, and the induction of a broad range of humoral and cellular responses against different epitopes.”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Introduction
What the sources say
- Not checked — no full text of the sourcecites [7] Krammer, 2020, SARS-CoV-2 vaccines in development, Nature source
plaindirect- 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
“Clinical outcomes were assessed in a blinded manner.”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Methods > Procedures
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.
Probably not a substantial claim.
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 results of this interim analysis have shown that CoronaVac fulfils the critical or minimal requirement of vaccines for the indication of pandemic use, hitting above the minimum efficacy of 50% as specified by the WHO target product profile as an option for mass vaccination.”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Introduction
boosteddirect- 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
“However, we could not exclude the possibility that some samples with antibody levels below a sample-to-cutoff ratio of 1 might have very low concentrations of established antibodies.”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Discussion
hedged- 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
“Palacios and colleagues22 reported an overall efficacy of CoronaVac against symptomatic COVID-19 of 50·7% (95% CI 36·0–62·0) 14 days or more after the second dose”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Discussion
What the sources say
- Not checked — no full text of the sourcecites [22] Palacios, 2021, Efficacy and safety of a COVID-19 inactivated vaccine in healthcare professionals in Brazil: the PROFISCOV Study, SSRN source
plaindirect- 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
“Although one of the prespecified outcomes was seroconversion, we have avoided using this term in our reporting of the results because the immunoassay we used was a semiquantitative assay.”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Discussion
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
“First, the median follow-up period after randomisation to the date of unmasking was 43 days (IQR 36–48), which is a very short duration of follow-up.”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Discussion
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.
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 adverse events were assessed by study investigators for severity and causality.”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Methods > Outcomes
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 targeted sample size could not be reached because CoronaVac was granted emergency use authorisation by the Turkish Ministry of Health while the study recruitment was ongoing, and an immediate vaccination programme was initiated for health-care workers and later for the general public in Turkey.”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > 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
“All PCR and serum antibody tests were done at two central laboratories.”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Methods > Procedures
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.
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
“In particular, the number of patients hospitalised with COVID-19 was quite low and the study population consisted of individuals at relatively low risk of severe or critical COVID-19, restricting our ability to make generalised conclusions about severe disease.”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > 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
“Additionally, active symptom surveillance was pursued to detect COVID-19 cases.”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Discussion
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.
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
“Therefore, the generalisability of the findings of this interim analysis needs to be evaluated cautiously.”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Discussion
hedgeddirect- 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.
The quote only partly states this claim.
In the paper
“Their production and scale-up are relatively easy in the context of good yield production systems and the availability of biosafety level 3 facilities.7”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Introduction
What the sources say
- Not checked — no full text of the sourcecites [7] Krammer, 2020, SARS-CoV-2 vaccines in development, Nature source
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 strengths of this study include the low dropout rate, reflecting the good tolerability of the vaccine.”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Discussion
plaindirect- 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.
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
“In fact, all of the participants were seronegative at the time of screening; therefore, the seropositivity 14 days after the second dose of vaccine would indicate seroconversion.”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Discussion
hedgeddirect- 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
“Efficacy in subgroups was not a secondary outcome and the trial was not designed or powered to analyse the efficacy of the vaccine with regard to demographic variables and risk factors.”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Discussion
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.
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 tolerability of CoronaVac in this study was excellent and the incidence of adverse events, most of which were solicited systemic events, was low.”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Discussion
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.
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 current report neither involves data on the sequential serum neutralising antibody titres nor the magnitude of T-cell responses or the duration of protectivity.”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Discussion
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
“In summary, our results show that CoronaVac has good efficacy against symptomatic SARS-CoV-2 infection and severe COVID-19 (ie, that requiring hospitalisation), along with a very good safety profile in a population aged 18–59 years.”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > 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
“Third, the study used a 14-day interval immunisation scheme, whereas the community immunisation was with a 28-day interval.”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Discussion
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 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
“Additionally, the participants were from different risk groups and occupations, rendering the results of the study more generalisable to the real-world context.”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > 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.
A single dose of an inactivated vaccine is not expected to be as efficacious as two doses.
“Because the study product is an inactivated vaccine, a single dose was not expected to be as efficacious as two doses, and the primary efficacy analysis was therefore done in the per protocol population”
The paper relies on this without support.
A SN50 titre of at least 1/15 is a protective level of neutralising antibodies.
“Virus neutralisation assays in selected samples (n=387) from seropositive participants in the vaccine group showed SN50s of at least 1/15 in 356 (92·0%) of the tested samples (figure 4 ).”
“92·0% of those who were seropositive also produced protective levels of neutralising antibodies at least 14 days after the second dose of vaccine.”
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.
Rated minor: it would not touch a result — a value no result rests on, a p-value that stays on the same side of the significance level, or a conflict that is clerical, resolved elsewhere in the paper, or outside its own findings.
In the paper
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Methods > Outcomes
“Total person-years were divided by the number of participants diagnosed with COVID-19 to ascertain the vaccine efficacy in intervention and placebo groups.”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Methods > Statistical analysis
“95% CI was presented for efficacy, calculated as events per COVID-19-free person-years (ie, the sum of RT-PCR-confirmed COVID-19 cases divided by the sum of time from vaccine protection to diagnosis or unmasking).”
Rated minor: it would not touch a result — a value no result rests on, a p-value that stays on the same side of the significance level, or a conflict that is clerical, resolved elsewhere in the paper, or outside its own findings.
In the paper
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Discussion
“we did not expect to and could not show an early protective effect after the first dose”
§ Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey > Results
“20 PCR-confirmed symptomatic COVID-19 cases occurred between days 14 and 27 after the first dose in both groups (efficacy 46·4% [0·4–71·2], p=0·0486).”
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Metadata
- Authors
- Tanriover, M. D., Doğanay, H. L., Akova, M., Güner, H. R., Azap, A., Akhan, S., Köse, Ş., Erdinç, F. Ş., Akalın, E. H., Tabak, Ö. F., Pullukçu, H., Batum, Ö., Şimşek Yavuz, S., Turhan, Ö., Yıldırmak, M. T., Köksal, İ., Taşova, Y., Korten, V., Yılmaz, G., Çelen, M. K., Altın, S., Çelik, İ., Bayındır, Y., Karaoğlan, İ., Yılmaz, A., Özkul, A., Gür, H., Unal, S., Kayaaslan, B., Hasanoğlu, İ., Dalkıran, A., Aydos, Ö., Çınar, G., Akdemir-Kalkan, İ., İnkaya, A. Ç., Aydin, M., Çakir, H., Yıldız, J., Kocabıyık, Ö., Arslan, S., Nallı, B., Demir, Ö., Singil, S., Ataman-Hatipoğlu, Ç., Tuncer-Ertem, G., Kınıklı, S., Önal, U., Mete, B., Dalgan, G., Taşbakan, M., Yamazhan, T., Kömürcüoğlu, B., Yalnız, E., Benli, A., Keskin-Sarıtaş, Ç., Ertosun, M. G., Özkan, Ö., Emre, S., Arıca, S., Kuşçu, F., Candevir, A., Ertürk-Şengel, B., Ayvaz, F., Aksoy, F., Mermutluoğlu, Ç., Demir, Y., Günlüoğlu, G., Tural-Önür, S., Kılıç-Toker, A., Eren, E., Otlu, B., Mete, A. Ö., Koçak, K., Ateş, H., Koca-Kalkan, İ., & Aksu, K.
- Affiliations
- Ümraniye Eğitim ve Araştırma Hastanesi (TR)
- Hacettepe University (TR)
- Ankara University (TR)
- Kocaeli Üniversitesi (TR)
- Izmir University (TR)
- Ministry of Health (TR)
- Istanbul University-Cerrahpaşa (TR)
- Ege University (TR)
- Sağlık Bilimleri Üniversitesi (TR)
- Akdeniz University (TR)
- Acıbadem University (TR)
- Cukurova University (TR)
- Marmara University (TR)
- Dicle University (TR)
- Inonu University (TR)
- Gaziantep University (TR)
- Corresponding author
- Akova, Murat
- ORCID
- Doğanay, Hamdi Levent
- Akova, Murat
- Azap, Alpay
- Akhan, Sıla
- Köse, Şükran
- Erdinç, Fatma Şebnem
- Pullukçu, Hüsnü
- Batum, Özgür
- Turhan, Özge
- Köksal, İftihar
- Taşova, Yeşim
- Korten, Volkan
- Yılmaz, Gürdal
- Çelen, Mustafa Kemal
- Altın, Sedat
- Bayındır, Yaşar
- Karaoğlan, İlkay
- Yılmaz, Aydın
- Özkul, Aykut
- Kayaaslan, Bircan
- Hasanoğlu, İmran
- Aydos, Ömer
- Çınar, Güle
- İnkaya, Ahmet Çağkan
- Yıldız, Jale
- Singil, Sarp
- Önal, Uğur
- Mete, Bilgül
- Dalgan, Gözde
- Yamazhan, Tansu
- Yalnız, Enver
- Benli, Aysun
- Ertosun, Mustafa Gökhan
- Özkan, Özlenen
- Emre, Salih
- Kuşçu, Ferit
- Candevir, Aslıhan
- Aksoy, Firdevs
- Mermutluoğlu, Çiğdem
- Demir, Yakup
- Günlüoğlu, Gülşah
- Eren, Esma
- Otlu, Barış
- Mete, Ayşe Özlem
- Koçak, Kübra
- Ateş, Hale
- Aksu, Kurtuluş
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2021-07
- Volume
- 398
- Issue
- 10296
- Pages
- 213-222
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- PMC
- PMC8266301
- OpenAlex
- W3178010802
- Cited by
- 898
- References
- 31
- Citations by year
- 2026: 17 · 2025: 47 · 2024: 113 · 2023: 221 · 2022: 390 · 2021: 110
- FWCI
- 66.15
- Type
- journal article
- Language
- en
- Update notices
- erratum (2022-01-29)
- Open access
- bronze
- doi.org
- Licence
- Locations
- The Lancet (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Bursa Uludag University - AVESIS (submittedVersion, cc-by-nc-nd)
- Acibadem University Open Access Repository (submittedVersion)
- Bursa Uludag University - AVESIS (submittedVersion)
- Dspace Repository (Marmara Üniversitesi) (submittedVersion, other-oa)
- Topics
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
- Physical Sciences › Mathematics › Modeling and Simulation › COVID-19 epidemiological studies
- Keywords
- CoronaVac, COVID-19 vaccine efficacy, vaccine safety, healthcare workers, aluminum hydroxide adjuvant, humoral immune response, SARS-CoV-2, Turkey, interim results
- MeSH terms
- COVID-19, SARS-CoV-2, COVID-19 Vaccines, Antibodies, Viral, Double-Blind Method, Health Personnel, Humans, Male, Middle Aged, Turkey, Vaccination, Virion, Vaccines, Inactivated, Antibodies, Neutralizing
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).
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