Controversies around the statistical presentation of data on mRNA-COVID 19 vaccine safety in pregnant women

• The work entitled "Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons" published on April 21, 2021, in The New England Journal of Medicine, presented data collected from American surveillance systems and registries. However, problems with an unanimous interpretation of those results appeared in the public debate and citing articles. Some stated that the risk of miscarriage in vaccinated women was similar to historical values reported before the vaccines approval. The others stated that risk was highly above-normative in women vaccinated during the first and second trimesters. We found several problems with the statistical treatment/interpretation of the originally presented values: a substantial percentage (up to 95.6%) of missing data, an incorrect denominator used for risk estimation, and too short follow-up that disabled the evaluation of the studys endpoint in numerous participants. Eventually, the Authors published a corrigendum on September 8, 2021, and pointed to updated data. Herein, we explain the statistical controversies raised by the original presentation and stress that analyzing the trade-off between knowledge and confusion brought by the release of incomplete results of such a high social interest, should aid in solving the dilemma of whether to publish preliminary data or none.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Endokrinologi och diabetes (hsv//swe)

MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Endocrinology and Diabetes (hsv//eng)

Nyckelord

COVID-19; mRNA vaccine; Spontaneous abortion; Drug safety; Statistics

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