As with most vaccines, during clinical development Repevax was not evaluated for use in pregnancy. A similar vaccine, without the inactivated poliomyelitis component, has been routinely recommended during pregnancy in the United States since 2011, with some evidence of safety8 9 10; and the potential benefits11 in reducing neonatal morbidity and mortality were expected to outweigh any theoretical risks. Nonetheless, it was essential that plans for active safety surveillance were implemented to rapidly identify potential risks.In line with its statutory responsibility for vaccine safety https://www.charmspandora-canada.com/, the Medicines and Healthcare products Regulatory Agency undertook a tailored proactive approach to pharmacovigilance, starting as soon as the vaccination campaign began, using electronic medical record data on a monthly basis to identify a large number of vaccinated women in as real time a manner as possible.We describe the growing identified cohort, after the first six months of the programme, and present comparative analyses investigating the risk of a range of predefined events.
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