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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,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]
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Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“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]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“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]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“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]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“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]
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“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]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“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]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“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]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“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]
Experimental — accuracy not yet measuredThe cited source says what the claim attributes to it.
In the citing paper
“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]
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In the citing paper
“This descriptive safety profile is similar to that described in a report of two trials of avian influenza mRNA vaccines (influenza A/H10N8 and influenza A/H7N9) that were manufactured by Moderna with the use of an earlier lipid nanoparticle capsule formulation11 and is consistent with an interim report of a phase 1–2 evaluation of a Covid-19 mRNA vaccine encoding the S receptor-binding domain.6”
From An mRNA Vaccine against SARS-CoV-2 — Preliminary Report (2020) · cites this paper as [6]
The cited source says what the claim attributes to it.
In the citing paper
“Indeed, the use of high doses of mRNA formulated with lipid nanoparticles (LNPs) resulted in some side effects in the candidates mRNA-1273 and BNT162b1.3,4”
From Combining an optimized mRNA template with a double purification process allows strong expression of in vitro transcribed mRNA (2021) · cites this paper as [4]
In the citing paper
“The majority of COVID-19 vaccines are designed to evoke humoral and cellular immune responses against the SARS-CoV-2 spike protein — responses that may not prevent infection but robustly protect against severe COVID-19, at least for certain periods of time11,150–157.”
From COVID-19 and cellular senescence (2023) · cites this paper as [152]
In the citing paper
“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]
In the citing paper
“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]
In the citing paper
“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 the citing paper
“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]
In the citing paper
“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]
In the citing paper
“8–50-fold higher anti-RBD IgG”
From mRNA vaccines for infectious diseases: principles, delivery and clinical translation (2021) · cites this paper as [123]
In the citing paper
“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 the citing paper
“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]
In the citing paper
“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]
In the citing paper
“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]
In the citing paper
“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]
In the citing paper
“despite the lower mRNA-doses used, AEs were reported more frequently with BNT162b1 as compared to mRNA-1273”
From The dawn of mRNA vaccines: the COVID-19 case (2021) · cites this paper as [82]
In the citing paper
“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]
In the citing paper
“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]
In the citing paper
“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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Metadata
- 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
- 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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