Abstract
The presented meta-analysis (MA) aims at identifying the vaccine safety and immunogenicity in published trials about SARS-CoV-2 vaccines.
All relevant publications were systematically searched and collected from different databases (Embase, Scopus, EBSCO, MEDLINE central/PubMed, Science Direct, Cochrane Central Register for Clinical Trials (CENTRAL), Clinical Trials.gov, WHO International Clinical Trials Registry Platform (ICTRP), COVID Trial, COVID Inato, Web of Science, ProQuest Thesis, ProQuest Coronavirus Database, SAGE Thesis, Google Scholar, Research Square, and Medxriv) up to January 10, 2021. The pooled vaccine safety and immunogenicity following vaccination in phase 1 and 2 vaccine clinical trials, as well as their 95% confidence intervals (CI), were estimated using the random-effects model.
The predefined inclusion criteria were met in 22 out of 8592 articles. The proportion of anti-severe acute respiratory distress coronavirus 2 (SARS-CoV-2) antibody responses after 7 days among 72 vaccinated persons included in 1 study was 81% (95% CI: 70-89), after 14 days among 888 vaccinated persons included in 6 studies was 80% (95% CI: 58-92), after 28 days among 1589 vaccinated persons included in 6 studies was 63% (95% CI: 59-67), after 42 days among 478 vaccinated persons included in 5 studies was 93% (95% CI: 80-98), and after 56 days among 432 vaccinated persons included in 2 studies was 93% (95% CI: 83-97). Meta regression explains more than 80% of this heterogeneity, where the main predictors were; the inactivated vaccine type (β = 2.027,
= 0.0007), measurement of antibodies at week 1 (β = -4.327,
< 0.0001) and at week 3 of the first dose (β = -2.02,
= 0.0025). Furthermore, the pooled proportion adverse effects 7 days after vaccination was 0.01 (0.08-0.14) for fever, headache 0.23 (0.19-0.27), fatigue 0.10 (0.07-0.13), and 0.18 (0.14-0.23) for muscle pain.
Immunogenicity following vaccination ranged from 63% to 93% depending on the time at which the antibody levels were measured.