Phase 1/2 Study to Describe the Safety and Immunogenicity of a COVID-19 RNA Vaccine Candidate (BNT162b1) in Adults 18 to 55 Years of Age: Interim Report
Open accessPreprint — published as 10.1038/s41586-020-2639-4 · Paper page
Abstract
In March 2020, the WHO declared a pandemic of coronavirus disease 2019 (COVID-19), due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). 1 With >8.8 million cases and >450,000 deaths reported globally, a vaccine is urgently needed. We report the available safety, tolerability, and immunogenicity data from an ongoing placebo-controlled, observer-blinded dose escalation study among healthy adults, 18-55 years of age, randomized to receive 2 doses, separated by 21 days, of 10 μg, 30 μg, or 100 μg of BNT162b1, a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD. Local reactions and systemic events were dose-dependent, generally mild to moderate, and transient. RBD-binding IgG concentrations and SARS-CoV-2 neutralizing titers in sera increased with dose level and after a second dose. Geometric mean neutralizing titers reached 1.8-to 2.8-fold that of a panel of COVID-19 convalescent human sera. These results support further evaluation of this mRNA vaccine candidate.
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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 [18]
Split into 2 atoms — 0 confirmed, 0 partially supported, 2 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
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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 [13]
The Discussion (p. 5) reports substantial SARS-CoV-2 neutralization after vaccination with BNT162b1, supporting the general point that vaccination elicited an immune response. It does not establish broad BNT162b2-elicited recognition: the study tested a different vaccine candidate, and its Methods describe an assay using the USA_WA1/2020 strain. The variant-neutralization reports in the citing sentence are attached to other citations (39–41), not this source. (LLM, conf=0.88)
Experimental — accuracy not yet measuredTo 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 [13]
The Methods describe how vaccine-induced RBD-binding IgG was measured in sera, and Figure 4 reports those responses. Our copy does not describe an S1-binding IgG assay, so this source supports the RBD part of the cited method but not the S1 part. (LLM, conf=0.86)
Experimental — accuracy not yet measuredAmong 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 [13]
The Methods section describes 38 convalescent serum donors, including 35 who had symptomatic infections and one who had been hospitalized; the remaining three were asymptomatic. The Immunogenicity section reports a neutralizing GMT of 94 for the panel as a whole, but our copy does not report subgroup GMTs of 90, 156, or 618. Page numbers are not available for these passages. (LLM, conf=0.86)
Experimental — accuracy not yet measuredSeveral 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 [18]
The Results (p. 3) report that solicited systemic events affected more participants after the second BNT162b1 dose, and the Discussion says reactogenicity was generally higher after that dose. The paper does not compare its findings with the citing authors’ findings, so it cannot establish the claim’s “than we found” comparison; the passages also do not establish that systemic events were more severe after the second dose. (LLM, conf=0.84)
Experimental — accuracy not yet measured
Previous 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 [18]
The Results (p. 3) state that systemic events increased with dose level and report higher fever rates at higher doses, supporting the frequency claim. The copy does not establish that the solicited systemic events were also more severe at higher doses; its dose-response statement does not distinguish frequency from severity. (LLM, conf=0.84)
Experimental — accuracy not yet measuredRecent mRNA-LNP vaccines against SARS-CoV-2 had similar rates of reactogenicity and reactogenicity noticeably increased after a second dose.
“This contrasts with recent reports of mRNA-LNP vaccines against the SARS-CoV-2 virus responsible for the COVID-19 pandemic which had similar rates of reactogenicity and in which reactogenicity noticeably increased after a second dose [17], [18].”
From Proof-of-concept of a low-dose unmodified mRNA-based rabies vaccine formulated with lipid nanoparticles in human volunteers: A phase 1 trial (2021) · cites this paper as [17]
The Discussion says BNT162b1 had a safety and tolerability profile consistent with earlier mRNA vaccines and that reactogenicity was generally higher after the second dose at the 10 µg and 30 µg levels. The safety results (p. 3) likewise report systemic events in more participants after dose two. The paper does not establish that its reactogenicity rates were similar to those of the vaccine discussed by the citing authors. (LLM, conf=0.83)
Experimental — accuracy not yet measuredThe S glycoprotein is the primary vaccine target for many candidate SARS-CoV-2 vaccines.
“The S glycoprotein mediates host cell attachment and is required for viral entry3; it is the primary vaccine target for many candidate SARS-CoV-2 vaccines.4-7”
From An mRNA Vaccine against SARS-CoV-2 — Preliminary Report (2020) · cites this paper as [6]
The Main section describes the spike protein’s receptor-binding domain as a key target of neutralizing antibodies, and the Methods identify it as the antigen encoded by BNT162b1 (page numbers not provided). This supports spike-derived antigen as a target for this candidate, but the paper does not establish that it is the primary target for many SARS-CoV-2 vaccine candidates. (LLM, conf=0.85)
Experimental — accuracy not yet measuredPrior studies showed that solicited systemic adverse events tended to be more frequent and more severe with higher doses and after the second vaccination.
“Those studies showed that solicited systemic adverse events tended to be more frequent and more severe with higher doses and after the second vaccination.”
From An mRNA Vaccine against SARS-CoV-2 — Preliminary Report (2020) · cites this paper as [6]
The results (p. 3) say systemic events increased with dose level and were reported by more participants after the second dose; the Discussion also describes generally higher reactogenicity after dose two. Our copy does not establish that solicited systemic events tended to be more severe with higher doses and after the second vaccination. Participants in the 100 µg group did not receive a second dose. (LLM, conf=0.84)
Experimental — accuracy not yet measuredTo 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 [13]
The descriptive safety profile of mRNA-1273 is similar to that of avian influenza mRNA vaccines and consistent with an interim report of a Covid-19 mRNA vaccine encoding the S receptor-binding domain.
“This descriptive safety profile is similar to that described in a report of two trials of avian influenza mRNA vaccines (influenza A/H10N8 and influenza A/H7N9) that were manufactured by Moderna with the use of an earlier lipid nanoparticle capsule formulation11 and is consistent with an interim report of a phase 1–2 evaluation of a Covid-19 mRNA vaccine encoding the S receptor-binding domain.6”
From An mRNA Vaccine against SARS-CoV-2 — Preliminary Report (2020) · cites this paper as [6]
High doses of mRNA formulated with lipid nanoparticles caused side effects in the clinical trial candidates mRNA-1273 and BNT162b1.
“Indeed, the use of high doses of mRNA formulated with lipid nanoparticles (LNPs) resulted in some side effects in the candidates mRNA-1273 and BNT162b1.3,4”
From Combining an optimized mRNA template with a double purification process allows strong expression of in vitro transcribed mRNA (2021) · cites this paper as [4]
The majority of COVID-19 vaccines evoke humoral and cellular immune responses against the SARS-CoV-2 spike protein; these responses may not prevent infection but robustly protect against severe COVID-19 for certain periods of time.
“The majority of COVID-19 vaccines are designed to evoke humoral and cellular immune responses against the SARS-CoV-2 spike protein — responses that may not prevent infection but robustly protect against severe COVID-19, at least for certain periods of time11,150–157.”
From COVID-19 and cellular senescence (2023) · cites this paper as [152]
BNT162b2 is an mRNA vaccine that encodes the full-length SARS-CoV-2 spike gene.
“an mRNA-based vaccine that encodes the full-length SARS-CoV-2 spike (S) gene1”
From SARS-CoV-2 mRNA vaccines induce persistent human germinal centre responses (2021) · cites this paper as [1]
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 [378]
BioNTech and Pfizer collaborated to develop five COVID-19 mRNA vaccine candidates at the beginning of the pandemic, based on nucleoside-modified mRNA (BNT162b2, BNT162b1, BNT162b3), non-modified mRNA (BNT162a1) and self-amplifying mRNA (BNT162c2).
“BioNTech and Pfizer collaborated to develop five COVID-19 mRNA vaccine candidates at the beginning of the pandemic, which were based on nucleoside-modified mRNA (BNT162b2, BNT162b1, BNT162b3), non-modified mRNA (BNT162a1) and self-amplifying mRNA (BNT162c2).”
From Advances in COVID-19 mRNA vaccine development (2022) · cites this paper as [376]
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 [378]
All five BioNTech/Pfizer COVID-19 mRNA vaccine candidates have entered clinical trials.
“Till now, all of these candidates have entered clinical trials (Table 5).130,376,377”
From Advances in COVID-19 mRNA vaccine development (2022) · cites this paper as [376]
BNT162b1 induced 8-50-fold higher anti-RBD IgG than convalescent serum.
“8–50-fold higher anti-RBD IgG”
From mRNA vaccines for infectious diseases: principles, delivery and clinical translation (2021) · cites this paper as [123]
BNT162b1 induced 1.9-4.6-fold higher neutralization titres than convalescent serum.
“1.9–4.6-fold higher neutralization titres than convalescent serum27,123”
From mRNA vaccines for infectious diseases: principles, delivery and clinical translation (2021) · cites this paper as [123]
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 [123]
Up to 75% of participants showed moderate fever after a 30 μg BNT162b1 boost vaccine.
“with up to 75% showing moderate fever after a 30 μg boost vaccine [82].”
From The dawn of mRNA vaccines: the COVID-19 case (2021) · cites this paper as [82]
Both local and systemic AEs occurred dose-dependently, were mostly mild to moderate, and were more common after boost vaccination.
“Both local and systemic AE occurred dose-dependently, were mostly mild to moderate and more common after boost vaccination.”
From The dawn of mRNA vaccines: the COVID-19 case (2021) · cites this paper as [82]
Adverse events peaked at day 2 after dosing and were resolved by day 7.
“events also peaked at day 2 after dosing and were resolved by day 7.”
From The dawn of mRNA vaccines: the COVID-19 case (2021) · cites this paper as [82]
Despite lower mRNA doses, AEs were reported more frequently with BNT162b1 compared to mRNA-1273.
“despite the lower mRNA-doses used, AEs were reported more frequently with BNT162b1 as compared to mRNA-1273”
From The dawn of mRNA vaccines: the COVID-19 case (2021) · cites this paper as [82]
No boost vaccination was performed at the 100 μg dose of BNT162b1 because of reactogenicity.
“Based on the reactogenicity to the 100 μg dose, no boost vaccination was performed at this dosage.”
From The dawn of mRNA vaccines: the COVID-19 case (2021) · cites this paper as [82]
Fever was reported after the first vaccination for all BNT162b1 dose groups (8% for the 10 and 30 μg doses, 50% for the 100 μg dose).
“fever was already reported after the first vaccination for all dose groups (8% for the 10 and 30 μg doses, 50% for the 100 μg dose)”
From The dawn of mRNA vaccines: the COVID-19 case (2021) · cites this paper as [82]
A phase 1/2 dose-escalation study of BNT162b1 (mRNA doses of 10-30-100 μg) revealed similar tolerability and safety.
“Results of a phase 1/2 dose-escalation study (mRNA doses of 10–30-100 μg) revealed similar tolerability and safety.”
From The dawn of mRNA vaccines: the COVID-19 case (2021) · cites this paper as [82]
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Zhang, G., Tang, T., Chen, Y., Huang, X., & Liang, T. (2023) · Signal Transduction and Targeted Therapy · doi:10.1038/s41392-023-01579-1 · Cited by 253 · see citing works
- Authors
- Mulligan, M. J., Lyke, K. E., Kitchin, N., Absalon, J., Gurtman, A., Lockhart, S., Neuzil, K., Raabe, V., Bailey, R., Swanson, K. A., Li, P., Koury, K., Kalina, W., Cooper, D., Fontes-Garfias, C., Shi, P.-Y., Türeci, Ӧ., Tompkins, K. R., Walsh, E. E., Frenck, R., Falsey, A. R., Dormitzer, P. R., Gruber, W. C., Şahin, U., & Jansen, K. U.
- Affiliations
- NYU Langone Health (US)
- University of Maryland, Baltimore (US)
- Pfizer (United Kingdom) (GB)
- Pfizer (United States) (US)
- The University of Texas Medical Branch at Galveston (US)
- Rochester General Hospital (US)
- Cincinnati Children's Hospital Medical Center (US)
- BioNTech (Germany) (DE)
- Corresponding author
- Absalon, Judith
- ORCID
- Mulligan, Mark J.
- Lyke, Kirsten E.
- Kitchin, Nicholas
- Absalon, Judith
- Gurtman, Alejandra
- Lockhart, Stephen
- Neuzil, Kathleen
- Raabe, Vanessa
- Swanson, Kena A.
- Li, Ping
- Cooper, David
- Fontes-Garfias, Camila
- Shi, Pei-Yong
- Tompkins, Kristin R.
- Walsh, Edward E.
- Frenck, Robert
- Falsey, Ann R.
- Dormitzer, Philip R.
- Gruber, William C.
- Şahin, Uğur
- Jansen, Kathrin U.
- Venue
- Nature
- Publisher
- openRxiv
- Published
- 2020-07-01
- Volume
- 586
- Issue
- 7830
- Pages
- 589-593
- ISSN
- 0028-0836 (ISSN-L)
- OpenAlex
- W3048620154
- Cited by
- 1,569
- References
- 24
- Citations by year
- 2026: 47 · 2025: 92 · 2024: 111 · 2023: 183 · 2022: 355 · 2021: 623 · 2020: 152 · 2019: 1 · 2013: 2
- FWCI
- 43.08
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Nature (publishedVersion)
- medRxiv (acceptedVersion)
- PubMed (publishedVersion)
- RePEc: Research Papers in Economics (submittedVersion)
- Funders
- Pfizer
- Cincinnati Children's Hospital Medical Center
- University of Rochester
- 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 › Immune responses and vaccinations
- Keywords
- COVID-19 vaccines, SARS-CoV-2, mRNA vaccines, lipid nanoparticle formulation, dose escalation, vaccine safety, vaccine immunogenicity, neutralizing antibodies, reactogenicity, healthy adults
- MeSH terms
- COVID-19, COVID-19 Vaccines, COVID-19 Serotherapy, Adult, Antibodies, Viral, Female, Humans, Immunoglobulin G, Immunization, Passive, Male, Middle Aged, Pneumonia, Viral, Time Factors, Viral Vaccines, Coronavirus Infections, Young Adult, Antibodies, Neutralizing, Pandemics, Spike Glycoprotein, Coronavirus
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