Is Cameron Dean Hansen Registered On Tinder

Clinical Trial

. 2021 Feb 4;384(v):403-416.

doi: ten.1056/NEJMoa2035389. Epub 2020 Dec 30.

Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine

Hana M El Sahly¹ , Brandon Essink¹ , Karen Kotloff¹ , Sharon Frey^ane , Rick Novakⁱ , David Diemert¹ , Stephen A Spector¹ , Nadine Rouphael¹ , C Buddy Creech¹ , John McGettigan¹ , Shishir Khetan^one , Nathan Segall^one , Joel Solisⁱ , Adam Brosz^ane , Carlos Fierro¹ , Howard Schwartz^one , Kathleen Neuzil¹ , Larry Corey¹ , Peter Gilbertⁱ , Holly Janesⁱ , Dean Follmann¹ , Mary Marovich¹ , John Mascola¹ , Laura Polakowski¹ , Julie Ledgerwood¹ , Barney S Grahamⁱ , Hamilton Bennett¹ , Rolando Pajon^one , Conor Knightly¹ , Brett Leav¹ , Weiping Deng¹ , Honghong Zhou¹ , Shu Hanⁱ , Melanie Ivarsson¹ , Jacqueline Miller¹ , Tal Zaks¹ , COVE Written report Group

Collaborators, Affiliations

PMID: 33378609
PMCID: PMC7787219
DOI: 10.1056/NEJMoa2035389

Free PMC article

Clinical Trial

Efficacy and Prophylactic of the mRNA-1273 SARS-CoV-2 Vaccine

Lindsey R Baden et al. N Engl J Med. 2021 .

Gratuitous PMC commodity

Abstruse

Background: Vaccines are needed to prevent coronavirus disease 2019 (Covid-19) and to protect persons who are at high risk for complications. The mRNA-1273 vaccine is a lipid nanoparticle-encapsulated mRNA-based vaccine that encodes the prefusion stabilized total-length spike poly peptide of the severe acute respiratory syndrome coronavirus two (SARS-CoV-2), the virus that causes Covid-xix.

Methods: This stage 3 randomized, observer-blinded, placebo-controlled trial was conducted at 99 centers across the United States. Persons at high hazard for SARS-CoV-two infection or its complications were randomly assigned in a ane:1 ratio to receive two intramuscular injections of mRNA-1273 (100 μg) or placebo 28 days apart. The primary finish betoken was prevention of Covid-19 illness with onset at least xiv days afterward the second injection in participants who had not previously been infected with SARS-CoV-2.

Results: The trial enrolled 30,420 volunteers who were randomly assigned in a 1:ane ratio to receive either vaccine or placebo (fifteen,210 participants in each group). More than than 96% of participants received both injections, and two.2% had evidence (serologic, virologic, or both) of SARS-CoV-2 infection at baseline. Symptomatic Covid-19 disease was confirmed in 185 participants in the placebo group (56.v per 1000 person-years; 95% confidence interval [CI], 48.7 to 65.3) and in 11 participants in the mRNA-1273 group (3.3 per one thousand person-years; 95% CI, 1.vii to vi.0); vaccine efficacy was 94.1% (95% CI, 89.three to 96.8%; P<0.001). Efficacy was similar across primal secondary analyses, including assessment 14 days afterward the first dose, analyses that included participants who had prove of SARS-CoV-2 infection at baseline, and analyses in participants 65 years of age or older. Severe Covid-19 occurred in xxx participants, with 1 fatality; all xxx were in the placebo grouping. Moderate, transient reactogenicity later vaccination occurred more frequently in the mRNA-1273 group. Serious adverse events were rare, and the incidence was like in the two groups.

Conclusions: The mRNA-1273 vaccine showed 94.i% efficacy at preventing Covid-19 disease, including severe affliction. Bated from transient local and systemic reactions, no safety concerns were identified. (Funded by the Biomedical Advanced Research and Development Authority and the National Plant of Allergy and Infectious Diseases; COVE ClinicalTrials.gov number, NCT04470427.).

Conflict of interest statement

Dr. Baden reports being funded past the NIH to conduct clinical trials in collaboration with Crucell/Janssen and Moderna; Dr. Rouphael, receiving grant support from Pfizer, Merck, Sanofi–Pasteur, Eli Lilly, and Quidel; Dr. Creech, receiving grant back up from Merck, consulting fees from Horizon Pharma and GSK, and fees for serving on a data and rubber monitoring lath from Astellas; Dr. Neuzil, receiving grant back up from Pfizer; Dr. Graham, holding pending patent WO/2018/081318 on prefusion coronavirus fasten proteins and their use and pending patent 62/972,886 on 2019-nCoV vaccine; Dr. Bennett, existence employed by and owning stock and stock options in Moderna; Dr. Pajon, beingness employed by and owning stock in Moderna; Dr. Knightly, beingness employed by and owning stock and stock options in Moderna; Drs. Leav, Deng, and Zhou existence employees of Moderna; Dr. Han, being employed by and owning stock and stock options in Moderna; Dr. Ivarsson, being employed past and owning share options in Moderna; Dr. Miller, beingness employed by and owning stock and stock options in Moderna; and Dr. Zaks, beingness employed past and owning stock options in Moderna. No other potential conflict of interest relevant to this commodity was reported.

Figures

**Figure 1. Randomization and Assay Populations.**
The data cutoff for the primary analysis occurred on Nov 25, 2020. The full analysis population consisted of participants who underwent randomization and received at least 1 dose of mRNA-1273 or placebo; the modified intention-to-treat population comprised participants in the full assay population who had no immunologic or virologic show of Covid-19 on twenty-four hour period 1, before the first dose; and the per-protocol analysis population included participants in the modified intention-to-treat population who received ii doses, with no major protocol deviations. The safe population included all participants who received at least i injection. Amid participants who received an incorrect injection, iii participants in the mRNA-1273 grouping received at least i dose of placebo and no dose of mRNA-1273 and were included in the placebo safety population, and three received one dose of placebo and i dose of mRNA-1273 and were included in the mRNA-1273 safety population; in the placebo group all seven received mRNA-1273 and were included in the mRNA-1273 safety population. Participants who received dose 2 outside the window for the per-protocol analysis are those who did not receive the second dose between 7 days before and 14 days after mean solar day 29.

**Figure 2. Solicited Local and Systemic Adverse Events.**
Shown is the percentage of participants who had a solicited local or systemic adverse event inside vii days after injection i or injection 2 of either the placebo or the mRNA-1273 vaccine.

**Figure 3. Vaccine Efficacy of mRNA-1273 to Prevent Covid-19.**
Shown is the cumulative incidence of Covid-xix events in the principal analysis based on adjudicated assessment starting 14 days after the second vaccination in the per-protocol population (Panel A) and after randomization in the modified intention-to-treat population (Panel B) (run across the Supplementary Appendix). The dotted line in Panel A indicates day 42 (14 days after vaccination two), when the per-protocol follow-up began, and arrows in both panels indicate days one and 29, when injections were administered. Tick marks indicate censored data. Vaccine efficacy was defined every bit 1 minus the hazard ratio (mRNA vs. placebo), and the 95% confidence interval was estimated with the use of a stratified Cox proportional hazards model, with Efron'southward method of tie treatment and with treatment group as a covariate, with adjustment for stratification factor. Incidence was defined equally the number of events divided by number of participants at take chances and was adjusted past person-years. Symptomatic Covid-xix case accrual for placebo and vaccine in the modified intention-to-treat population is displayed (does not include asymptomatic cases of SARS-CoV-ii detected at the day 29 by nasopharyngeal swab).

**Figure 4. Vaccine Efficacy of mRNA-1273 to Forestall Covid-19 in Subgroups.**
The efficacy of the RNA-1273 vaccine in preventing Covid-19 in various subgroups in the per-protocol population was based on adjudicated assessments starting xiv days later the second injection. Vaccine efficacy, defined equally 1 minus the gamble ratio (mRNA-1273 vs. placebo), and 95% conviction intervals were estimated with the use of a stratified Cox proportional hazards model, with Efron's method of necktie handling and with the treatment group as a covariate, adjusting for stratification factor if applicable. Race and indigenous group categories shown are White (non-Hispanic) and communities of color (all others, including those whose race and ethnicity were both reported as unknown, were not reported, or were both missing at screening). Data for communities of colour were pooled owing to express numbers of participants in each racial or ethnic grouping, to ensure that the subpopulations would be large enough for meaningful analyses.

None — Download a PDF of the Research Summary.

Comment in

A New Vaccine to Battle Covid-19.

Haynes BF. Haynes BF. N Engl J Med. 2021 Feb 4;384(5):470-471. doi: x.1056/NEJMe2035557. Epub 2020 December 30. Northward Engl J Med. 2021. PMID: 33378607 Free PMC commodity. No abstract available.
COVID-19: Nobelpreiswürdiger Erfolg in der Impfstoff-Forschung.

Holzgreve H. Holzgreve H. MMW Fortschr Med. 2021 February;163(2):24-25. doi: 10.1007/s15006-021-9577-iv. MMW Fortschr Med. 2021. PMID: 33527275 Gratuitous PMC article. Review. German. No abstract available.
In high-risk adults, the Moderna vaccine had 94% efficacy against COVID-nineteen ≥14 d later the 2d dose.

Chagla Z. Chagla Z. Ann Intern Med. 2021 Mar;174(iii):JC28. doi: 10.7326/ACPJ202103160-028. Epub 2021 Mar 2. Ann Intern Med. 2021. PMID: 33646836
Delayed Large Local Reactions to mRNA-1273 Vaccine confronting SARS-CoV-2.

Blumenthal KG, Freeman EE, Saff RR, Robinson LB, Wolfson AR, Foreman RK, Hashimoto D, Banerji A, Li L, Anvari S, Shenoy ES. Blumenthal KG, et al. N Engl J Med. 2021 Apr ane;384(13):1273-1277. doi: x.1056/NEJMc2102131. Epub 2021 Mar 3. North Engl J Med. 2021. PMID: 33657292 Free PMC article. No abstract available.

Cited by 2,832 articles

Phage-similar particle vaccines are highly immunogenic and protect confronting pathogenic coronavirus infection and illness.

Davenport BJ, Catala A, Weston SM, Johnson RM, Ardanuy J, Hammond HL, Dillen C, Frieman MB, Catalano CE, Morrison TE. Davenport BJ, et al. NPJ Vaccines. 2022 May 26;seven(1):57. doi: ten.1038/s41541-022-00481-1. NPJ Vaccines. 2022. PMID: 35618725 Free PMC article.
Immune Response to COVID-19 and mRNA Vaccination in Immunocompromised Individuals: A Narrative Review.

Napuri NI, Curcio D, Swerdlow DL, Srivastava A. Napuri NI, et al. Infect Dis Ther. 2022 May 25:ane-24. doi: 10.1007/s40121-022-00648-two. Online alee of print. Infect Dis Ther. 2022. PMID: 35614299 Costless PMC article. Review.
Effectiveness of COVID-19 vaccines against SARS-CoV-2 variants of concern: a systematic review and meta-analysis.

Zeng B, Gao L, Zhou Q, Yu Thousand, Sun F. Zeng B, et al. BMC Med. 2022 May 23;20(1):200. doi: 10.1186/s12916-022-02397-y. BMC Med. 2022. PMID: 35606843 Complimentary PMC article.
Modelling the touch on of vaccine hesitancy in prolonging the demand for Non-Pharmaceutical Interventions to command the COVID-19 pandemic.

Olivera Mesa D, Hogan AB, Watson OJ, Charles GD, Hauck K, Ghani Ac, Winskill P. Olivera Mesa D, et al. Commun Med (Lond). 2022 Feb x;2:14. doi: x.1038/s43856-022-00075-10. eCollection 2022. Commun Med (Lond). 2022. PMID: 35603311 Gratis PMC article.
Utilizing wearable sensors for continuous and highly-sensitive monitoring of reactions to the BNT162b2 mRNA COVID-19 vaccine.

Gepner Y, Mofaz Yard, Oved S, Yechezkel One thousand, Constantini K, Goldstein N, Eisenkraft A, Shmueli E, Yamin D. Gepner Y, et al. Commun Med (Lond). 2022 Mar fourteen;2:27. doi: 10.1038/s43856-022-00090-y. eCollection 2022. Commun Med (Lond). 2022. PMID: 35603274 Free PMC commodity.

References

1. Jackson LA, Anderson EJ, Rouphael NG, et al. An mRNA vaccine against SARS-CoV-two — preliminary report. N Engl J Med 2020;383:1920-1931. - PMC - PubMed
1. Keech C, Albert Thousand, Cho I, et al. Phase 1–2 trial of a SARS-CoV-2 recombinant spike poly peptide nanoparticle vaccine. North Engl J Med 2020;383:2320-2332. - PMC - PubMed
1. Walsh EE, Frenck RW Jr, Falsey AR, et al. Safe and immunogenicity of ii RNA-based Covid-19 vaccine candidates. Northward Engl J Med 2020;383:2439-2450. - PMC - PubMed
1. Anderson EJ, Rouphael NG, Widge AT, et al. Prophylactic and immunogenicity of SARS-CoV-ii mRNA-1273 vaccine in older adults. N Engl J Med 2020;383:2427-2438. - PMC - PubMed
1. Folegatti PM, Ewer KJ, Aley PK, et al. Condom and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial. Lancet 2020;396:467-478. - PMC - PubMed

Publication types

MeSH terms

Substances

Grant support

LinkOut - more resources

Full Text Sources
- Atypon
- Europe PubMed Cardinal
- Ovid Technologies, Inc.
- PubMed Cardinal
Other Literature Sources
- Faculty Opinions
- The Lens - Patent Citations
- scite Smart Citations
Medical
- ClinicalTrials.gov
- Genetic Brotherhood
- MedlinePlus Health Information
Miscellaneous
- NCI CPTAC Assay Portal