Purpose: To evaluate whether existing data and evidence support a causal link between maternal Zika virus (ZIKV) infection and newborn microcephaly.
Methods: I quantified and compared the prevalence of all and severe microcephaly in Brazil, during and before 2015-2016, to assess whether an outbreak has occurred, used time series analysis to evaluate if the presumed outbreak was linked to a previous outbreak of ZIKV infections, and quantitatively synthesized published data from observational studies testing this association.
Results: The prevalences of microcephaly in 2015-2016 were similar or lower than background levels (prevalence ratio [PR] for all microcephaly: 0.19; 95% confidence intervals [CI]: 0.17, 0.20). Changes in the number of cases of ZIKV infections at times matching 11-18 weeks of pregnancy were not followed by changes in the number of microcephaly cases (PR for infection at 12 weeks: 1.02; 95% CI: 0.99, 1.05). In observational studies, the prevalence of microcephaly was not significantly increased in newborns of Zika-infected mothers (average PR: 1.30; 95% CI: 0.84, 2.02).
Conclusions: Existing evidence is insufficient to claim maternal ZIKV infection causes microcephaly. Although a public health response seems sensible, it should be consistent with existing knowledge and consider risks, potential benefits and harm, and competing priorities.
Keywords: Brazil; Disease outbreaks; Microcephaly; Time series analysis; Zika virus.
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