Maternal Immunization in Argentina: The Importance of a Safety Profile Analysis

Abstract

Background. Vaccination against flu and whooping cough (WC) is a priority within the comprehensive care strategy for pregnant women (PW) and small infants in Argentina. Flu vaccine was included in the National Immunization Schedule (NIS) in 2011. Argentina recommended a vaccination strategy for PW against WC in 2012, with the aim of reducing complications and deaths related to these diseases. Our objective was to describe the national strategy of maternal immunization, 2011-2015. Methods. Descriptive study. National vaccination coverages (NVC) and vaccines safety profile between 2011 and 2015 were analyzed. Influenza and Tdap impact was evaluated. Adverse events following immunization (AEFI) notifications were performed passively. Results. Since 2011 1,813,270 doses of flu vaccine were applied (NVC >95% most years). Table 1. There were no notifications of influenza related deaths in vaccinated PW during this period. Eleven AEFI were notified (rate-r- 0.6/100,000): 4 mild reactions vaccine related and 5 program errors. A flaccid paralysis was classified as non- conclusive event due to lack of complementary studies. Figure 1. infants less than 2 months decreased 82.2 % (p < 0.001). Figure 2. In 2012, Tdap was recommended after the 20th gestation week. Between 2012 and 2015 1,845,379 doses were applied reaching NVC of 50.9%, 67.1%, 70.9% and 61.6%. Table 1. 27 AEFI were reported (r: 1.46/100.00), 7 vaccine related and 1 anxiety disorder. Eighteen events were program errors (66%). One event was notified after flu and Tdap vaccination as Guillain-Barre syndrome, without sequelae. This event was classified as related to one or both vaccines. Conclusion. Both vaccines presented a suitable safety profile. Since 2012 a downward trend in pertussis mortality was evident and no deaths from influenza in vaccinated were notified in pregnant women. Our country became the first Latin-American country to have a strategy of vaccination againstWC universally and consolidated as an example of influenza vaccination in the region. (Figure Presented) .