53 - AN OVERVIEW OF REPORTED CASES OF KD ONSET IN EMILIA-ROMAGNA, ITALY AND IN EUROPE AFTER ADMINISTRATION OF ROTAVIRUS AND MENINGOCOCCAL B VACCINES

BACKGROUND.  Vaccines  have been reported as uncommon triggers for KD .

After  a case of  KD onset in the same day after  second dose of Rotavirus vaccine ( Rotateq) and first of meningococcal B vaccine ( Bexsero) , we reviewed  KD cases reported  after administration of these two vaccines  in Emilia- Romagna, Italy, and in Europe ( Eudravigilance) .

METHODS. We reviewed forms of notification of adverse reactions of Italian Agency of Drug  ( Emilia Romagna, 2017-2023) and of Eudravigilance ( Europe, 2001-2023) filled out with KD diagnosis  after administration of Rotavirus and Meningococcal  B vaccines.

RESULTS. In Emilia Romagna,  6 cases of KD onset  after Rotavirus ( Rotateq) and Meningococcus B ( Bexsero) vaccines   have been reported . Two cases  after combination of immunization against Rotateq and Bexsero ; 1 case after combination of Rotateq, hexavalent and Pneumococcal vaccines; 3 cases after Bexsero.

The average of Reporting rate for dose of vaccine administrated  is 0,00001 for Rotateq and 0,000011 for Bexsero.

ROR ( Reportig odds ratio): 1,36 ( IC: 0,72-2,59) for Rotateq and 1,59 ( IC: 0,63- 4,03) for Bexsero.

Of these 6 cases, 5 cases  were male and 1  female. The median age at the  onset of KD was 8,83 months; 3 cases in summer, 2 cases in  spring and 1 case in winter.

4 cases presented  KD in  the same day of the immunization, 1 case after 4 days and 1 case after 6 days with a median day  of KD  onset of 1,6 days  after immunization.

Regarding  the subgroup who received Rotateq , the median age at KD onset  was 2,6 months and the median day of KD appearence after immunization was 2 days. 

Regarding the subgroup who received Bexsero , the median age at KD  onset was 12 months  and the median day of KD  onset was 1 day.

In Europe 364 cases of KD after administration of Rotateq and Rotarix  have been reported from 2001 and the average of reporting rate for dose of vaccine administrated is 0,00002 .

For Bexsero , in Europe, 84 cases of KD after immunization  have been reported from 2011.

CONCLUSIONS. Our review reports very low reporting rate of KD onset in Emilia Romagna , Italy and Europe, after immunization against Rotavirus and meningococcal B vaccines . Monitoring KD onset after immunization remains an important  issue to value safety of vaccines.