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To what extent AstraZeneca ChAdOx1 nCoV-19 vaccine is safe and effective? Rapid systematic review

ABSTRACT: Until now, there are more than two hundred million confirmed cases of COVID-19 including more than seven million deaths. Clinical trials of all three vaccines authorized for use in the UK (Pfizer–BioNTech, Oxford–AstraZeneca, and Moderna) have reported high vaccine efficacy. This rapid systematic review was initiated because no systematic review had been conducted to determine the safety and efficacy of AstraZeneca ChAdOx1 nCoV-19 vaccine. Evidence acquisition: A systematic search in the following platforms: PubMed, Google Scholar, Scopus, WOS, and MEDLINE databases for all articles in the English language regarding safety and efficacy of SARS-CoV-2 vaccine ChAdOx1 nCoV-19 was performed. Papers published up to end of June were included. Evidence synthesis: Out of 477 retrieved articles, fifteen are included. All the selected articles are concerned with evaluation of AstraZeneca ChAdOx1 nCoV-19 vaccine. Three of them discussed the effectiveness of ChAdOx1 nCoV-19 vaccine, while thirteen (one is common with the group of the effectiveness) measured the adverse effects associated with the vaccine. Because thrombosis was recorded as a serious adverse effect developed after ChAdOx1 nCoV-19 vaccination, it was emphasized in a special group to be analyzed separately. In conclusion: the main message of selected papers was that the value of ChAdOx1 nCoV-19 vaccination to provide critical protection should be considered higher compared to the significant worldwide burden of the emerging COVID-19 infection. No causal relations were found to link cases- having thrombotic adverse reactions to the vaccine.

Supplementary Information

The online version contains supplementary material available at 10.1186/s43168-021-00109-3.

SUBMITTER: Mohamed Hussein A

PROVIDER: S-EPMC8795963 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThe safety and efficacy of the AZD1222 (ChAdOx1 nCoV-19) vaccine in a large, diverse population at increased risk for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the United States, Chile, and Peru has not been known.MethodsIn this ongoing, double-blind, randomized, placebo-controlled, phase 3 clinical trial, we investigated the safety, vaccine efficacy, and immunogenicity of two doses of AZD1222 as compared with placebo in preventing the onset of symptomatic and severe coronavirus disease 2019 (Covid-19) 15 days or more after the second dose in adults, including older adults, in the United States, Chile, and Peru.ResultsA total of 32,451 participants underwent randomization, in a 2:1 ratio, to receive AZD1222 (21,635 participants) or placebo (10,816 participants). AZD1222 was safe, with low incidences of serious and medically attended adverse events and adverse events of special interest; the incidences were similar to those observed in the placebo group. Solicited local and systemic reactions were generally mild or moderate in both groups. Overall estimated vaccine efficacy was 74.0% (95% confidence interval [CI], 65.3 to 80.5; P<0.001) and estimated vaccine efficacy was 83.5% (95% CI, 54.2 to 94.1) in participants 65 years of age or older. High vaccine efficacy was consistent across a range of demographic subgroups. In the fully vaccinated analysis subgroup, no severe or critical symptomatic Covid-19 cases were observed among the 17,662 participants in the AZD1222 group; 8 cases were noted among the 8550 participants in the placebo group (<0.1%). The estimated vaccine efficacy for preventing SARS-CoV-2 infection (nucleocapsid antibody seroconversion) was 64.3% (95% CI, 56.1 to 71.0; P<0.001). SARS-CoV-2 spike protein binding and neutralizing antibodies increased after the first dose and increased further when measured 28 days after the second dose.ConclusionsAZD1222 was safe and efficacious in preventing symptomatic and severe Covid-19 across diverse populations that included older adults. (Funded by AstraZeneca and others; ClinicalTrials.gov number, NCT04516746.).

Project description:BackgroundAssessment of the safety and efficacy of vaccines against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in different populations is essential, as is investigation of the efficacy of the vaccines against emerging SARS-CoV-2 variants of concern, including the B.1.351 (501Y.V2) variant first identified in South Africa.MethodsWe conducted a multicenter, double-blind, randomized, controlled trial to assess the safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) in people not infected with the human immunodeficiency virus (HIV) in South Africa. Participants 18 to less than 65 years of age were assigned in a 1:1 ratio to receive two doses of vaccine containing 5×1010 viral particles or placebo (0.9% sodium chloride solution) 21 to 35 days apart. Serum samples obtained from 25 participants after the second dose were tested by pseudovirus and live-virus neutralization assays against the original D614G virus and the B.1.351 variant. The primary end points were safety and efficacy of the vaccine against laboratory-confirmed symptomatic coronavirus 2019 illness (Covid-19) more than 14 days after the second dose.ResultsBetween June 24 and November 9, 2020, we enrolled 2026 HIV-negative adults (median age, 30 years); 1010 and 1011 participants received at least one dose of placebo or vaccine, respectively. Both the pseudovirus and the live-virus neutralization assays showed greater resistance to the B.1.351 variant in serum samples obtained from vaccine recipients than in samples from placebo recipients. In the primary end-point analysis, mild-to-moderate Covid-19 developed in 23 of 717 placebo recipients (3.2%) and in 19 of 750 vaccine recipients (2.5%), for an efficacy of 21.9% (95% confidence interval [CI], -49.9 to 59.8). Among the 42 participants with Covid-19, 39 cases (95.1% of 41 with sequencing data) were caused by the B.1.351 variant; vaccine efficacy against this variant, analyzed as a secondary end point, was 10.4% (95% CI, -76.8 to 54.8). The incidence of serious adverse events was balanced between the vaccine and placebo groups.ConclusionsA two-dose regimen of the ChAdOx1 nCoV-19 vaccine did not show protection against mild-to-moderate Covid-19 due to the B.1.351 variant. (Funded by the Bill and Melinda Gates Foundation and others; ClinicalTrials.gov number, NCT04444674; Pan African Clinical Trials Registry number, PACTR202006922165132).

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To what extent AstraZeneca ChAdOx1 nCoV-19 vaccine is safe and effective? Rapid systematic review

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