RNA-Based COVID-19 Vaccine BNT162b2 Selected for a Pivotal Efficacy Study
Open accessAbstract
Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections and the resulting disease, coronavirus disease 2019 (COVID-19), have spread to millions of people globally. Multiple vaccine candidates are under development, but no vaccine is currently available. Methods: Healthy adults 18–55 and 65–85 years of age were randomized in an ongoing, placebo-controlled, observer-blinded dose-escalation study to receive 2 doses at 21-day intervals of placebo or either of 2 lipid nanoparticle–formulated, nucleoside-modified RNA vaccine candidates: BNT162b1, which encodes a secreted trimerized SARS-CoV-2 receptor-binding domain, or BNT162b2, which encodes a prefusion stabilized membrane-anchored SARS-CoV-2 full-length spike. In each of 13 groups of 15 participants, 12 received vaccine and 3 received placebo. Groups were distinguished by vaccine candidate, age of participant, and vaccine dose level. Interim safety and immunogenicity data of BNT162b1 in younger adults have been reported previously from US and German trials. We now present additional safety and immunogenicity data from the US Phase 1 trial that supported selection of the vaccine candidate advanced to a pivotal Phase 2/3 safety and efficacy evaluation. Results: In both younger and older adults, the 2 vaccine candidates elicited similar dose- dependent SARS-CoV-2-neutralizing geometric mean titers (GMTs), comparable to or higher than the GMT of a panel of SARS-CoV-2 convalescent sera. BNT162b2 was associated with less systemic reactogenicity, particularly in older adults. Conclusion: These results support selection of the BNT162b2 vaccine candidate for Phase 2/3 large-scale safety and efficacy evaluation, currently underway.
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The favorable safety profile observed during phase 1 testing of BNT162b2 was confirmed in the phase 2/3 portion of the trial.
“The favorable safety profile observed during phase 1 testing of BNT162b24,8 was confirmed in the phase 2/3 portion of the trial.”
From Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine (2020) · cites this paper as [4]
The Introduction reports safety data from the Phase 1 portion of the trial, and the Discussion says those data helped select BNT162b2 for Phase 2/3 evaluation. The Discussion describes Phase 2/3 safety assessment as ongoing; this paper does not report Phase 2/3 results confirming the Phase 1 safety profile. No page numbers are available in our copy. (LLM, conf=0.90)
Experimental — accuracy not yet measuredBNT162b2 was chosen as the pivotal candidate based on all data from the two phase-I/II trials and non-human primate challenge studies.
“BNT162b2 was selected as pivotal candidate on the basis of the totality of data obtained in the two phase-I/II trials and challenge studies in non-human primates 2,18 .”
From BNT162b2 vaccine induces neutralizing antibodies and poly-specific T cells in humans (2021) · cites this paper as [2]
The Introduction describes German and US clinical studies, and the Discussion says the clinical data guided the decision to advance BNT162b2 to the pivotal Phase 2/3 evaluation. Our copy does not say that non-human-primate challenge studies formed part of that decision, so the stated basis for selection is only partly supported. Page numbers are unavailable in our copy. (LLM, conf=0.86)
Experimental — accuracy not yet measuredThe US trial elicited robust S1-binding IgG concentrations and neutralizing titres against wild-type Wuhan-Hu-1 SARS-CoV-2.
“Robust concentrations of S1-binding immunoglobulin G (IgG) and neutralizing titres against a SARS-CoV-2 strain with the wild-type (Wuhan-Hu-1) S sequence were elicited.”
From BNT162b2 vaccine induces neutralizing antibodies and poly-specific T cells in humans (2021) · cites this paper as [2]
The Immunogenicity section (page unavailable) reports boosted antigen-binding IgG and neutralizing responses in the US trial; Figure 4 identifies the IgG measure as S1-binding. The methods identify the neutralization-test strain as USA_WA1/2020, but our copy does not establish that it had the wild-type Wuhan-Hu-1 S sequence. (LLM, conf=0.84)
Experimental — accuracy not yet measuredAs in the US phase-I/II trial, prime-boost vaccination with 10-30 μg BNT162b2 elicited serum GMTs that after an initial decline remained stable for the entire nine-week post-booster follow-up, at or above the GMTs of COVID-19 convalescent individuals.
“As reported for the phase-I/II trial in the USA 2 , prime-boost vaccination with 10 to 30 μg of BNT162b2 elicited GMTs of sera that-after an initial decline-remained stable for the entire follow-up of nine weeks after the booster dose, in the range of or higher than GMTs in individuals who had recovered from COVID-19.”
From BNT162b2 vaccine induces neutralizing antibodies and poly-specific T cells in humans (2021) · cites this paper as [2]
Split into 2 atoms — 0 confirmed, 2 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredTogether with reports of preserved neutralization of SARS-CoV-2 with key B.1.1.7 and B.1.351 spike mutations and of pseudovirus with the full B.1.1.7 spike mutation set, our data indicate broad BNT162b2-elicited immune recognition.
“Together with recent reports of the preserved neutralization of SARS-CoV-2 with key S mutations found in the B.1.1.7 and the B.1.351lineage 39,40 , and neutralization of pseudovirus bearing the full set of mutations of B.1.1.7 S 41 , our data indicate broad BNT162b2-elicited immune recognition 2,13,14 .”
From BNT162b2 vaccine induces neutralizing antibodies and poly-specific T cells in humans (2021) · cites this paper as [2]
The Immunogenicity section reports BNT162b2-elicited antigen-binding and neutralizing responses, supporting immune recognition of the virus tested. It does not establish broad recognition across spike variants: the assay used the USA_WA1/2020 strain, and the Discussion says BNT162b2 cellular responses were still being studied. The variant-neutralization reports in the citing sentence have separate citations, not this one. (LLM, conf=0.86)
Experimental — accuracy not yet measured
The incidence of grade 3 fever of BNT162b1 varied significantly in the same 30 μg group in adults aged 18-55 years, with none (0%) of 12 in the USA, one (8%) of 12 in Germany, and four (17%) of 24 in China, suggesting varying tolerability in different populations.
“The incidence of grade 3 fever of BNT162b1 varied significantly in the same 30 μg group in adults aged 18–55 years, with none (0%) of 12 in the USA,17 one (8%) of 12 in Germany,18 and four (17%) of 24 in China,16 suggesting varying tolerability in different populations.”
From Safety and immunogenicity of the SARS-CoV-2 ARCoV mRNA vaccine in Chinese adults: a randomised, double-blind, placebo-controlled, phase 1 trial (2022) · cites this paper as [17]
Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredPrevious studies showed that solicited systemic adverse events were more frequent and more severe at higher doses.
“Previous studies17, 18, 19 showed that solicited systemic adverse events were more frequent and more severe at higher doses”
From Safety and immunogenicity of the SARS-CoV-2 ARCoV mRNA vaccine in Chinese adults: a randomised, double-blind, placebo-controlled, phase 1 trial (2022) · cites this paper as [17]
The Systemic events section says systemic events were dose-dependent, supporting an association between higher doses and more events. It does not explicitly say that their severity increased with dose; its severity comparisons concern age groups and vaccine candidates instead. No page number is available in our copy. (LLM, conf=0.82)
Experimental — accuracy not yet measuredThe lack of immunogenicity improvement from 20 μg to 25 μg was similar to BNT162b1 and BNT162b2.
“which was similar to BNT162b1 and BNT162b2.17”
From Safety and immunogenicity of the SARS-CoV-2 ARCoV mRNA vaccine in Chinese adults: a randomised, double-blind, placebo-controlled, phase 1 trial (2022) · cites this paper as [17]
The Immunogenicity section reports that the dose response from 20 to 30 µg was not consistent across the two vaccine candidates or age groups, and the Discussion describes an apparent plateau. The paper did not test 25 µg, and it does not establish a lack of improvement for both vaccines in every age group. (LLM, conf=0.88)
Experimental — accuracy not yet measuredThe incidence of grade 3 fever of the two spike protein-based mRNA vaccines, mRNA-1273 and BNT162b2, also varied between the phase 1 and 3 trials.
“Additionally, the incidence of grade 3 fever of the two spike protein-based mRNA vaccines, mRNA-127319, 20 and BNT162b2,17, 21 also varied between the phase 1 and 3 trials.”
From Safety and immunogenicity of the SARS-CoV-2 ARCoV mRNA vaccine in Chinese adults: a randomised, double-blind, placebo-controlled, phase 1 trial (2022) · cites this paper as [17]
The Introduction identifies this as a Phase 1 study of BNT162b2, and the Systemic events section reports fever rates after vaccination. It does not give an explicit incidence of grade 3 fever or compare that incidence with a Phase 3 trial. The separate citations attached to mRNA-1273 are outside this source's remit. (LLM, conf=0.78)
Experimental — accuracy not yet measuredBNT162b2 and mRNA-1273 used a mixture of altered nucleotide 1mΨ modifications and dsRNA fragment eviction in the mRNA manufacturing procedure to significantly lower innate immune signaling in response to mRNA.
“BNT162b2 (BioNTech/Pfizer) and mRNA-1273 (Moderna) used a mixture of altered nucleotide 1mΨ modifications and dsRNA fragment eviction in the mRNA manufacturing procedure to significantly lower innate immune signaling in response to mRNA (Walsh et al. 2020; Jackson et al. 2020b).”
From Modifications of mRNA vaccine structural elements for improving mRNA stability and translation efficiency (2022) · cites this paper as Walsh et al. 2020
The Introduction identifies BNT162b2 as a nucleoside-modified RNA vaccine, and the Discussion says it shares an RNA production and purification process with BNT162b1. Neither section specifies 1mΨ modification or dsRNA-fragment removal, demonstrates a significant reduction in innate immune signaling from those steps, or describes mRNA-1273’s manufacturing process. (LLM, conf=0.84)
Experimental — accuracy not yet measuredSeven days after a 30-μg booster, sera from younger (18-55 years) and older (65-85 years) adults had 50% neutralizing GMTs 3.8-fold and 1.6-fold the GMT of COVID-19 convalescent samples, respectively.
“Geometric mean 50% neutralizing titres (GMTs) of sera drawn from younger (18-55 years) and older (65-85 years) adults seven days after the booster dose of 30 μg BNT162b2 were 3.8-fold and 1.6-fold, respectively, the GMT of samples from individuals who had recovered from COVID-19.”
From BNT162b2 vaccine induces neutralizing antibodies and poly-specific T cells in humans (2021) · cites this paper as [2]
In the US phase-I/II trial, BNT162b2 at doses up to 30 μg was associated with generally mild-to-moderate local injection-site reactions and systemic events such as fatigue, headache and myalgia.
“In the phase-I/II trial in the USA (NCT04368728), immunization with BNT162b2 at dose levels of up to 30 μg was associated with generally mild-to-moderate local reactions at the injection site as well as systemic events, such as fatigue, headache and myalgia 2 .”
From BNT162b2 vaccine induces neutralizing antibodies and poly-specific T cells in humans (2021) · cites this paper as [2]
To allow comparison with previously reported data on BioNTech-Pfizer RNA COVID-19 vaccines, sera for S1- and RBD-binding IgG were analyzed as previously described.
“To enable the comparison of vaccine-induced S1-and RBD-binding IgG responses to previously reported data on the BioNTech-Pfizer RNA vaccines for COVID-19, sera were analysed as previously described 2,13,14 .”
From BNT162b2 vaccine induces neutralizing antibodies and poly-specific T cells in humans (2021) · cites this paper as [2]
Among convalescent serum donors, geometric mean neutralizing titers were 90 for symptomatic infections (n=35), 156 for asymptomatic infections (n=3), and 618 for hospitalized individuals (n=1).
“GMTs in subgroups of the donors were as follows: symptomatic infections, 90 (n = 35); asymptomatic infections, 156 (n = 3); hospitalized, 618 (n = 1).”
From BNT162b2 vaccine induces neutralizing antibodies and poly-specific T cells in humans (2021) · cites this paper as [2]
To allow comparison with previously reported data on BioNTech-Pfizer RNA COVID-19 vaccines, sera for neutralizing titers were analyzed as previously described.
“To enable the comparison of vaccine-induced serum neutralizing titres to those previously reported for BioNTech-Pfizer RNA vaccines for COVID-19, sera were analysed as previously described 2,13,14 .”
From BNT162b2 vaccine induces neutralizing antibodies and poly-specific T cells in humans (2021) · cites this paper as [2]
Several studies have reported more frequent and severe solicited systemic adverse events following the second vaccination than we found.
“Meanwhile, several studies17, 18, 19 have reported more frequent and severe solicited systemic adverse events following the second vaccination than we found.”
From Safety and immunogenicity of the SARS-CoV-2 ARCoV mRNA vaccine in Chinese adults: a randomised, double-blind, placebo-controlled, phase 1 trial (2022) · cites this paper as [17]
Peak neutralizing antibody levels after licensed SARS-CoV-2 vaccination are about half to four times those observed in convalescent individuals.
“the currently licensed vaccines have been shown to produce peak neutralizing antibody responses that range from approximately half to four-times those seen in convalescent patients24,64–67 (preprint data, not yet peer reviewed)68.”
From Prospects for durable immune control of SARS-CoV-2 and prevention of reinfection (2021) · cites this paper as [66]
The two approved mRNA vaccines are efficacious after a single dose at a time when non-neutralizing antibodies and moderate Th1 responses are present but neutralizing antibodies are nearly absent.
“The two mRNA vaccines approved to date show efficacy even after only one dose, when non-NAbs and moderate T helper 1 cell responses are detectable, but almost no NAbs.”
From Immunological mechanisms of vaccine-induced protection against COVID-19 in humans (2021) · cites this paper as [124]
The B.1.351 lineage virus was neutralized robustly, with a geometric mean titer well above the level seen after a single BNT162b2 dose, a point at which the C4591001 trial had already shown strong efficacy.
“Neutralizing activity against the B.1.351 lineage virus was robust at a geometric mean titer that was much higher than that obtained after one dose of BNT162b2, when strong efficacy was already observed in the C4591001 efficacy trial.1-3”
From Neutralizing Activity of BNT162b2-Elicited Serum (2021) · cites this paper as [2]
The two mRNA vaccines elicit nAbs.
“and elicit nAbs (48, 49).”
From mRNA vaccination boosts cross-variant neutralizing antibodies elicited by SARS-CoV-2 infection (2021) · cites this paper as [49]
These titers were associated with 95% protection from COVID-19 in phase 3 trials.
“This is notable, as these titers were associated with 95% protection from COVID-19 in phase 3 trials (44, 46, 48, 49).”
From mRNA vaccination boosts cross-variant neutralizing antibodies elicited by SARS-CoV-2 infection (2021) · cites this paper as [49]
Vaccination can cause systemic reactions, including fever and fatigue, which might prompt more testing for covid-19 in the first few days after vaccination, leading to an artificially low vaccine effectiveness in that period.
“Vaccination can also cause systemic reactions, including fever and fatigue.23 24 This might prompt more testing for covid-19 in the first few days after vaccination, which, if due to a vaccine reaction, will produce a negative result. This is likely to explain the increased testing immediately after vaccination with ChAdOx1-S and leads to an artificially low vaccine effectiveness in that period.25”
In phase 1 trials, Pfizer BNT162b2 elicited neutralizing antibody titers somewhat better than natural SARS-CoV-2 infection over the short term.
“In phase 1 trials, the Pfizer BNT162b2 COVID-19 vaccine elicited neutralizing antibody titers somewhat better than SARS-CoV-2 natural infection, over the short term”
From Adaptive immunity to SARS-CoV-2 and COVID-19 (2021) · cites this paper as Walsh et al., 2020
Pfizer BNT162b2 has been tested for immunogenicity in individuals over 65 years old, with limited but encouraging results; antibody responses were similar in both age groups.
“The Pfizer BNT162b2 vaccine has been tested for immunogenicity in individuals >65 years old, and the results were limited but encouraging. Antibody responses were similar in both age groups”
From Adaptive immunity to SARS-CoV-2 and COVID-19 (2021) · cites this paper as Walsh et al., 2020
The safety of the Pfizer vaccine is consistent with the safety observed in its phase 1 trial.
“That is consistent with the safety of the phase 1 vaccine trial”
From Adaptive immunity to SARS-CoV-2 and COVID-19 (2021) · cites this paper as Walsh et al., 2020
BNT162b2 elicited dose-dependent SARS-CoV-2-neutralizing GMTs that were similar to or higher than the GMT of a panel of SARS-CoV-2 convalescent human serum samples.
“BNT162b2, a nucleoside-modified RNA vaccine that encodes the SARS-CoV-2 full-length, prefusion-stabilized spike glycoprotein, elicited dose-dependent SARS-CoV-2-neutralizing GMTs that were similar to or higher than the GMT of a panel of SARS-CoV-2 convalescent human serum samples 1 .”
From Neutralization of SARS-CoV-2 spike 69/70 deletion, E484K and N501Y variants by BNT162b2 vaccine-elicited sera (2021) · cites this paper as [1]
In a large cohort study using BNT162b2 and BNT162b1, humoral responses in adults aged 18-55 and 65-85 were compared after the second vaccination, and immunogenicity including neutralization titers was lower in the elderly cohort.
“In a large cohort study using the Biontech/Pfizer vaccine BNT162b2 and the related BNT162b1 vaccine candidate, the humoral responses in 2 adult age groups (18-55 and 65-85 years) were compared after the second vaccination.They reported that immunogenicity as measured by antibody responses including neutralization titers was lower in the elderly cohort and also discussed immunosenescence as”
From Age-dependent Immune Response to the Biontech/Pfizer BNT162b2 Coronavirus Disease 2019 Vaccination (2021) · cites this paper as [34]
In a clinical study that specifically looked at older adults vaccinated with BNT162b2, the GMT after the first dose was 12 in a set of 12 subjects between ages of 65 and 85 years, rising to 149 seven days after the second dose.
“In a clinical study that specifically looked at older adults vaccinated with BNT162b2, the GMT after the first dose was 12 in a set of 12 subjects between ages of 65 and 85 years, rising to 149 seven days after the second dose 1 .”
From Age-related immune response heterogeneity to SARS-CoV-2 vaccine BNT162b2 (2021) · cites this paper as [1]
Few trial data on neutralizing responses or vaccine efficacy in individuals above the age of 80 are available.
“Few trial data on neutralizing responses or vaccine efficacy in individuals above the age of 80 are available 1 .”
From Age-related immune response heterogeneity to SARS-CoV-2 vaccine BNT162b2 (2021) · cites this paper as [1]
The trimeric motif of T4 bacteriophage fibritin introduced at the 3′ end of the coding region of the S protein or RBD protein can mimic the native structure of S protein and enhance antigen immunogenicity.
“Moreover, since the S protein is trimeric, studies have shown that the trimeric motif of T4 bacteriophage fibritin introduced at the 3′ end of the coding region of the S protein or RBD protein can mimic the native structure of S protein and enhance antigen immunogenicity.141,277,278”
From Advances in COVID-19 mRNA vaccine development (2022) · cites this paper as [278]
The trimeric motif of T4 bacteriophage fibritin introduced at the 3′ end of the coding region of the S protein or RBD protein can mimic the native structure of S protein and enhance antigen immunogenicity.
“Moreover, since the S protein is trimeric, studies have shown that the trimeric motif of T4 bacteriophage fibritin introduced at the 3′ end of the coding region of the S protein or RBD protein can mimic the native structure of S protein and enhance antigen immunogenicity.141,277,278”
From Advances in COVID-19 mRNA vaccine development (2022) · cites this paper as [277]
In a phase I clinical trial, both BNT162b1 and BNT162b2 induced neutralizing antibodies at a comparable level.
“Clinical trial data indicated that both mRNA vaccine candidates induced neutralizing antibodies at a comparable level.”
From Advances in COVID-19 mRNA vaccine development (2022) · cites this paper as [277]
The vaccine developers decided to proceed with BNT162b2 to phase II/III international clinical trials because of its milder reactogenicity.
“However, the vaccine developers eventually decide to proceed with BNT162b2 to phase II/III international clinical trials in view of its milder reactogenicity.277,278,378”
From Advances in COVID-19 mRNA vaccine development (2022) · cites this paper as [278]
The vaccine developers decided to proceed with BNT162b2 to phase II/III international clinical trials because of its milder reactogenicity.
“However, the vaccine developers eventually decide to proceed with BNT162b2 to phase II/III international clinical trials in view of its milder reactogenicity.277,278,378”
From Advances in COVID-19 mRNA vaccine development (2022) · cites this paper as [277]
In a phase I clinical trial, both BNT162b1 and BNT162b2 induced neutralizing antibodies at a comparable level.
“Clinical trial data indicated that both mRNA vaccine candidates induced neutralizing antibodies at a comparable level.”
From Advances in COVID-19 mRNA vaccine development (2022) · cites this paper as [278]
Safety and immunogenicity data of phase I/II trials of BNT162b1 and BNT162b2 supported the selection of BNT162b2 for a phase II/III trial based on milder systemic reactions and strong adaptive humoral and poly-specific cellular immune responses against epitopes conserved in diverse SARS-CoV-2 variants.
“The safety and immunogenicity data of the phase I/II trials of BNT162b1 and BNT162b2 supported the selection of BNT162b2 for a phase II/III trial based on milder systemic reactions82 and strong adaptive humoral and poly-specific cellular immune responses against epitopes conserved in diverse SARS-CoV-2 virus variants.81”
From COVID-19 mRNA vaccines: Platforms and current developments (2022) · cites this paper as [82]
The two vaccines against COVID-19 to first gain accelerated approvals and meet the required safety and efficacy standards were mRNA vaccines.
“The two vaccines against COVID-19 to first gain accelerated approvals and meet the required safety and efficacy standards were mRNA vaccines.8,81,82”
From COVID-19 mRNA vaccines: Platforms and current developments (2022) · cites this paper as [82]
BNT162b2 induced 1.7-4.6-fold higher neutralizing titres than convalescent serum in 18-55-year old participants in phase I trials.
“1.7–4.6-fold higher neutralizing titres than convalescent serum in 18–55-year old participants”
From mRNA vaccines for infectious diseases: principles, delivery and clinical translation (2021) · cites this paper as [124]
BNT162b2 induced 1.1-2.2-fold higher neutralizing titres than convalescent serum in 65-85-year old participants in phase I trials.
“1.1–2.2-fold higher titres in 65–85-year old in phase I trials124”
From mRNA vaccines for infectious diseases: principles, delivery and clinical translation (2021) · cites this paper as [124]
Both BNT162b1 and BNT162b2 were well tolerated and efficacious, but only BNT162b2 advanced to phase II/III trials owing to its milder systemic and local adverse reactions.
“Both candidates were well tolerated and efficacious, but only the BNT162b2 vaccine advanced to phase II/III trials owing to its milder systemic and local adverse reactions124.”
From mRNA vaccines for infectious diseases: principles, delivery and clinical translation (2021) · cites this paper as [124]
BNT162b1 had a higher frequency of fever, fatigue and chills in participants than BNT162b2.
“higher frequency of fever, fatigue and chills in participants than BNT162b2 (ref.124)”
From mRNA vaccines for infectious diseases: principles, delivery and clinical translation (2021) · cites this paper as [124]
In phase I trials of BNT162b1 and BNT162b2, two 30 μg doses delivered 21 days apart induced high antibody and neutralizing titres and a robust CD4+ and CD8+ response with mild to moderate adverse events.
“In phase I trials of the two candidates, two 30 μg doses delivered 21 days apart induced high antibody and neutralizing titres and a robust CD4+ and CD8+ response with mild to moderate adverse events27,28,123,124.”
From mRNA vaccines for infectious diseases: principles, delivery and clinical translation (2021) · cites this paper as [124]
In healthy adults, two 30-μg doses of BNT162b2 elicited high neutralizing titers and robust antigen-specific CD4+ and CD8+ T-cell responses against SARS-CoV-2.
“In healthy adults, two 30-μg doses of BNT162b2 elicited high neutralizing titers and robust, antigen-specific CD4+ and CD8+ T-cell responses against SARS-CoV-2.3,4”
From Safety, immunogenicity, and efficacy of the BNT162b2 covid-19 vaccine in adolescents (2021) · cites this paper as [3]
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Günl, F., Mecate-Zambrano, A., Rehländer, S., Hinse, S., Ludwig, S., & Brunotte, L. (2021) · Vaccines · doi:10.3390/vaccines9101052 · Cited by 27 · see citing works
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Relating In Vitro Neutralization Level and Protection in the CVnCoV (CUREVAC) Trial
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- Authors
- Walsh, E. E., Frenck, R., Falsey, A. R., Kitchin, N., Absalon, J., Gurtman, A., Lockhart, S., Neuzil, K., Mulligan, M. J., Bailey, R., Swanson, K. A., Li, P., Koury, K., Kalina, W., Cooper, D., Fontes-Garfias, C., Shi, P.-Y., Türeci, Ö., Tompkins, K. R., Lyke, K. E., Raabe, V., Dormitzer, P. R., Jansen, K. U., Şahin, U., & Gruber, W. C.
- Affiliations
- Cincinnati Children's Hospital Medical Center (US)
- Corresponding author
- Absalon, Judith
- ORCID
- Walsh, Edward E.
- Frenck, Robert
- Falsey, Ann R.
- Kitchin, Nicholas
- Absalon, Judith
- Gurtman, Alejandra
- Lockhart, Stephen
- Neuzil, Kathleen
- Mulligan, Mark J.
- Swanson, Kena A.
- Li, Ping
- Cooper, David
- Fontes-Garfias, Camila
- Shi, Pei-Yong
- Türeci, Özlem
- Tompkins, Kristin R.
- Lyke, Kirsten E.
- Raabe, Vanessa
- Dormitzer, Philip R.
- Jansen, Kathrin U.
- Şahin, Uğur
- Gruber, William C.
- Venue
- New England Journal of Medicine
- Publisher
- openRxiv
- Published
- 2020-08-20
- Volume
- 383
- Issue
- 25
- Pages
- 2439-2450
- ISSN
- 0028-4793 (ISSN-L)
- PMC
- PMC7444302
- OpenAlex
- W3093367571
- Cited by
- 2,615
- References
- 21
- Citations by year
- 2026: 76 · 2025: 133 · 2024: 229 · 2023: 353 · 2022: 696 · 2021: 1039 · 2020: 85 · 2012: 1
- FWCI
- 71.32
- Type
- journal article
- Language
- en
- Open access
- green
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- medRxiv (acceptedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (submittedVersion)
- Funders
- BioNTech
- Pfizer
- Georgia Clinical and Translational Science Alliance
- National Institutes of Health (UL1TR001445)
- National Center for Advancing Translational Sciences
- Topics
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
- Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
- Keywords
- COVID-19 vaccines, SARS-CoV-2, BNT162b2, mRNA vaccines, lipid nanoparticle formulation, vaccine safety, immunogenicity, neutralizing antibodies, spike protein, receptor binding domain, prefusion spike, dose escalation, older adults, young adults, adverse events, systemic reactions
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