Background
The ChAdOx1 nCoV-19 (AZD1222) vaccine has been approved for emergency use by the UK regulatory authority, Medicines and Healthcare products Regulatory Agency, with a regimen of two standard doses given with an interval of 4–12 weeks. The planned roll-out in the UK will involve vaccinating people in high-risk categories with their first dose immediately, and delivering the second dose 12 weeks later. Here, we provide both a further prespecified pooled analysis of trials of ChAdOx1 nCoV-19 and exploratory analyses of the impact on immunogenicity and efficacy of extending the interval between priming and booster doses. In addition, we show the immunogenicity and protection afforded by the first dose, before a booster dose has been offered.
Methods
We present data from three single-blind randomised controlled trials—one phase 1/2 study in the UK (COV001), one phase 2/3 study in the UK (COV002), and a phase 3 study in Brazil (COV003)—and one double-blind phase 1/2 study in South Africa (COV005). As previously described, individuals 18 years and older were randomly assigned 1:1 to receive two standard doses of ChAdOx1 nCoV-19 (5 × 10
10
viral particles) or a control vaccine or saline placebo. In the UK trial, a subset of participants received a lower dose (2·2 × 10
10
viral particles) of the ChAdOx1 nCoV-19 for the first dose. The primary outcome was virologically confirmed symptomatic COVID-19 disease, defined as a nucleic acid amplification test (NAAT)-positive swab combined with at least one qualifying symptom (fever ≥37·8°C, cough, shortness of breath, or anosmia or ageusia) more than 14 days after the second dose. Secondary efficacy analyses included cases occuring at least 22 days after the first dose. Antibody responses measured by immunoassay and by pseudovirus neutralisation were exploratory outcomes. All cases of COVID-19 with a NAAT-positive swab were adjudicated for inclusion in the analysis by a masked independent endpoint review committee. The primary analysis included all participants who were SARS-CoV-2 N protein seronegative at baseline, had had at least 14 days of follow-up after the second dose, and had no evidence of previous SARS-CoV-2 infection from NAAT swabs. Safety was assessed in all participants who received at least one dose. The four trials are registered at ISRCTN89951424 (COV003) and
ClinicalTrials.gov
,
NCT04324606
(COV001),
NCT04400838
(COV002), and
NCT04444674
(COV005).
Findings
Between April 23 and Dec 6, 2020, 24 422 participants were recruited and vaccinated across the four studies, of whom 17 178 were included in the primary analysis (8597 receiving ChAdOx1 nCoV-19 and 8581 receiving control vaccine). The data cutoff for these analyses was Dec 7, 2020. 332 NAAT-positive infections met the primary endpoint of symptomatic infection more t...
The government of Kenya has launched a phased rollout of COVID-19 vaccination. A major barrier is vaccine hesitancy; the refusal or delay of accepting vaccination. This study evaluated the level and determinants of vaccine hesitancy in Kenya. We conducted a cross-sectional study administered through a phone-based survey in February 2021 in four counties of Kenya. Multilevel logistic regression was used to identify individual perceived risks and influences, context-specific factors and vaccine-specific issues associated with COVID-19 vaccine hesitancy. COVID-19 vaccine hesitancy in Kenya was high: 36.5%. Factors associated with vaccine hesitancy included: Rural regions, perceived difficulty in adhering to government regulations on COVID-19 prevention, no perceived COVID-19 infection risk, concerns regarding vaccine safety and effectiveness, and religious and cultural reasons. There is a need for the prioritization of interventions to address vaccine hesitancy and improve vaccine confidence as part of the vaccine roll-out plan. These messaging and/or interventions should be holistic to include the value of other public health measures, be focused and targeted to specific groups, raise awareness on the risks of COVID-19 and effectively communicate the benefits and risks of vaccines.
This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
The data on the burden of invasive bacterial infections and pneumonia from this study suggest that vaccines in development against Salmonella Typhi and the pneumococcus have the potential to significantly improve the health of children in Nepal.
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