TY - JOUR
AU - Heath, Paul T.
AU - Galiza, Eva
AU - Baxter, David
AU - Boffito, Marta
AU - Browne, Duncan
AU - Burns, Fiona
AU - Chadwick, David R
AU - Clark, Rebecca
AU - Cosgrove, Catherine
AU - Galloway, James
AU - Goodman, Anna L.
AU - Heer, Amardeep
AU - Higham, Andrew
AU - Iyengar, Shalini
AU - Jeanes, Christopher
AU - Kalra, Philip A
AU - Kyriakidou, Christina
AU - Bradley, Judy M
AU - Munthali, Chigomezgo
AU - Minassian, Angela M.
AU - McGill, Fiona
AU - Moore, Patrick
AU - Munsoor, Imrozia
AU - Nicholls, Helen
AU - Osanlou, Orod
AU - Packham, Jonathan
AU - Pretswell, Carol H
AU - Francisco Ramos, Alberto San
AU - Saralaya, Dinesh
AU - Sheridan, Ray P
AU - Smith, Richard
AU - Soiza, Roy L
AU - Swift, Pauline A
AU - Thomson, Emma C
AU - Turner, Jeremy
AU - Viljoen, Marianne Elizabeth
AU - Fries, Louis
AU - Cho, Iksung
AU - McKnight, Irene
AU - Glenn, Greg
AU - Rivers, E Joy
AU - Robertson, Andreana
AU - Alves, Katia
AU - Smith, Kathy
AU - Toback, Seth
PY - 2022
DA - October
TI - Safety and efficacy of the NVX-CoV2373 coronavirus disease 2019 vaccine at completion of the placebo-controlled phase of a randomized controlled trial
JO - Clinical Infectious Diseases
EP - 407
VL - 76
IS - 3
DO - https://doi.org/10.1093/cid/ciac803
AB - Background: The recombinant protein-based vaccine, NVX-CoV2373, demonstrated 89.7% efficacy against coronavirus disease 2019 (COVID-19) in a phase 3, randomized, observer-blinded, placebo-controlled trial in the United Kingdom. The protocol was amended to include a blinded crossover. Data to the end of the placebo-controlled phase are reported. Methods: Adults aged 18–84 years received 2 doses of NVX-CoV2373 or placebo (1:1) and were monitored for virologically confirmed mild, moderate, or severe COVID-19 (onset from 7 days after second vaccination). Participants who developed immunoglobulin G (IgG) against nucleocapsid protein but did not show symptomatic COVID-19 were considered asymptomatic. Secondary outcomes included anti-spike (S) IgG responses, wild-type virus neutralization, and T-cell responses. Results: Of 15 185 participants, 13 989 remained in the per-protocol efficacy population (6989 NVX-CoV2373, 7000 placebo). At a maximum of 7.5 months (median, 4.5) postvaccination, there were 24 cases of COVID-19 among NVX-CoV2373 recipients and 134 cases among placebo recipients, a vaccine efficacy of 82.7% (95% confidence interval [CI], 73.3%–88.8%). Vaccine efficacy was 100% (95% CI, 17.9%–100.0%) against severe disease and 76.3% (95% CI, 57.4%–86.8%) against asymptomatic disease. High anti-S and neutralization responses to vaccination were evident, together with S-protein–specific induction of interferon-γ secretion in peripheral blood T cells. Incidence of serious adverse events and adverse events of special interest were similar between groups. Conclusions: A 2-dose regimen of NVX-CoV2373 conferred a high level of ongoing protection against asymptomatic, symptomatic, and severe COVID-19 through &gt;6 months postvaccination. A gradual decrease of protection suggests that a booster may be indicated.
PB - Oxford University Press
UR - https://eprints.gla.ac.uk/282537/
KW - Coronavirus (COVID-19)
KW - Immunisation and screening
ER