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Efficacy of NVX-CoV2373 Covid-19 Vaccine against the B.1.351 Variant.
Shinde, Vivek; Bhikha, Sutika; Hoosain, Zaheer; Archary, Moherndran; Bhorat, Qasim; Fairlie, Lee; Lalloo, Umesh; Masilela, Mduduzi S L; Moodley, Dhayendre; Hanley, Sherika; Fouche, Leon; Louw, Cheryl; Tameris, Michele; Singh, Nishanta; Goga, Ameena; Dheda, Keertan; Grobbelaar, Coert; Kruger, Gertruida; Carrim-Ganey, Nazira; Baillie, Vicky; de Oliveira, Tulio; Lombard Koen, Anthonet; Lombaard, Johan J; Mngqibisa, Rosie; Bhorat, As'ad E; Benadé, Gabriella; Lalloo, Natasha; Pitsi, Annah; Vollgraaff, Pieter-Louis; Luabeya, Angelique; Esmail, Aliasgar; Petrick, Friedrich G; Oommen-Jose, Aylin; Foulkes, Sharne; Ahmed, Khatija; Thombrayil, Asha; Fries, Lou; Cloney-Clark, Shane; Zhu, Mingzhu; Bennett, Chijioke; Albert, Gary; Faust, Emmanuel; Plested, Joyce S; Robertson, Andreana; Neal, Susan; Cho, Iksung; Glenn, Greg M; Dubovsky, Filip; Madhi, Shabir A.
  • Shinde V; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Bhikha S; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Hoosain Z; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Archary M; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Bhorat Q; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Fairlie L; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Lalloo U; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Masilela MSL; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Moodley D; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Hanley S; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Fouche L; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Louw C; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Tameris M; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Singh N; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Goga A; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Dheda K; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Grobbelaar C; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Kruger G; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Carrim-Ganey N; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Baillie V; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • de Oliveira T; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Lombard Koen A; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Lombaard JJ; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Mngqibisa R; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Bhorat AE; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Benadé G; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Lalloo N; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Pitsi A; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Vollgraaff PL; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Luabeya A; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Esmail A; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Petrick FG; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Oommen-Jose A; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Foulkes S; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Ahmed K; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Thombrayil A; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Fries L; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Cloney-Clark S; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Zhu M; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Bennett C; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Albert G; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Faust E; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Plested JS; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Robertson A; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Neal S; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Cho I; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Glenn GM; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Dubovsky F; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
  • Madhi SA; From Novavax, Gaithersburg, MD (V.S., L. Fries, S.C.-C., M.Z., C.B., G.A., E.F., J.S.P., A.R., S.N., I.C., G.M.G., F.D.); and the South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences (S.B., V.B., A.L.K., A.O.-J., A.T., S.A.M.),
N Engl J Med ; 384(20): 1899-1909, 2021 05 20.
Article in English | MEDLINE | ID: covidwho-1216484
Preprint
This scientific journal article is probably based on a previously available preprint. It has been identified through a machine matching algorithm, human confirmation is still pending.
See preprint
ABSTRACT

BACKGROUND:

The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants threatens progress toward control of the coronavirus disease 2019 (Covid-19) pandemic. In a phase 1-2 trial involving healthy adults, the NVX-CoV2373 nanoparticle vaccine had an acceptable safety profile and was associated with strong neutralizing-antibody and antigen-specific polyfunctional CD4+ T-cell responses. Evaluation of vaccine efficacy was needed in a setting of ongoing SARS-CoV-2 transmission.

METHODS:

In this phase 2a-b trial in South Africa, we randomly assigned human immunodeficiency virus (HIV)-negative adults between the ages of 18 and 84 years or medically stable HIV-positive participants between the ages of 18 and 64 years in a 11 ratio to receive two doses of either the NVX-CoV2373 vaccine (5 µg of recombinant spike protein with 50 µg of Matrix-M1 adjuvant) or placebo. The primary end points were safety and vaccine efficacy against laboratory-confirmed symptomatic Covid-19 at 7 days or more after the second dose among participants without previous SARS-CoV-2 infection.

RESULTS:

Of 6324 participants who underwent screening, 4387 received at least one injection of vaccine or placebo. Approximately 30% of the participants were seropositive for SARS-CoV-2 at baseline. Among 2684 baseline seronegative participants (94% HIV-negative and 6% HIV-positive), predominantly mild-to-moderate Covid-19 developed in 15 participants in the vaccine group and in 29 in the placebo group (vaccine efficacy, 49.4%; 95% confidence interval [CI], 6.1 to 72.8). Vaccine efficacy among HIV-negative participants was 60.1% (95% CI, 19.9 to 80.1). Of 41 sequenced isolates, 38 (92.7%) were the B.1.351 variant. Post hoc vaccine efficacy against B.1.351 was 51.0% (95% CI, -0.6 to 76.2) among the HIV-negative participants. Preliminary local and systemic reactogenicity events were more common in the vaccine group; serious adverse events were rare in both groups.

CONCLUSIONS:

The NVX-CoV2373 vaccine was efficacious in preventing Covid-19, with higher vaccine efficacy observed among HIV-negative participants. Most infections were caused by the B.1.351 variant. (Funded by Novavax and the Bill and Melinda Gates Foundation; ClinicalTrials.gov number, NCT04533399.).
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunogenicity, Vaccine / COVID-19 Vaccines / SARS-CoV-2 / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines / Variants Limits: Adolescent / Adult / Aged / Humans / Middle aged / Young adult Country/Region as subject: Africa Language: English Journal: N Engl J Med Year: 2021 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunogenicity, Vaccine / COVID-19 Vaccines / SARS-CoV-2 / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines / Variants Limits: Adolescent / Adult / Aged / Humans / Middle aged / Young adult Country/Region as subject: Africa Language: English Journal: N Engl J Med Year: 2021 Document Type: Article