Table 1.
Timeline of the Fluad-case. Abbreviations: AIFA (Italian Medicines Agency); EMA (European Medicines Agency); FIMMG (Italian Federation of General Practitioners); ISS (Italian Institute of Health); LHU (Local Health Unit); NNP (National Network of Pharmacovigilance); PRAC (Pharmacovigilance Risk Assessment Committee); WHO (World Health Organization).
| DAY | EVENT |
|---|---|
| 7th-18th November 2014 | A first cluster of 3 deaths allegedly associated with the Fluad vaccine administration occurred on 7th, 12th and 16th November was reported through the NNP (2 deaths in Sicily – a man of 68 years and a woman of 87 years – and 1 death in Molise – a woman of 79 years) |
| 15th-28th November 2014 | A second cluster of 8 deaths possibly linked to the Fluad vaccine administration was reported through the NNP |
| 26th November 2014 | Death of a 83-year old woman in Spoleto (Umbria), with several co-morbidities, 24 hours after the immunization |
| 27th November 2014 | AIFA decided to suspend two Fluad batches (ID 142701 and ID 143301) on the basis of the precautionary principle |
| AIFA issued two press releases (number 401 and number 402), commenting on the decision of recalling two Fluad batches and emphasizing that the withdrawal was on a precautionary basis and vaccines represent an effective tool, being “a unique and irreplaceable resource” | |
| 28th November 2014 | AIFA issued three press releases (n. 403, n. 404, and n. 405), commenting on 11 deaths allegedly associated to Fluad vaccination and emphasizing the urgent need of going on with the influenza vaccination campaign. Lazio Region decided to suspend and recall all Fluad batches (protocol number 664796/GR/11/02, entitled “Precautionary recall of anti-influenza Fluad vaccine”). Liguria Region decided to suspend temporarily the entire anti-influenza vaccination campaign |
| 29th November 2014 | AIFA issued two press releases (n. 406 and n. 407), listing 12 deaths potentially linked to Fluad administration reported through NNP |
| 30th November 2014 | A 83-year old woman with several co-morbidities died apparently some hours after receiving the anti-influenza immunization |
| NNP listed 13 deaths as potentially related to the Fluad vaccine administration, distributed among 8 different Regions | |
| AIFA issued a press release (n. 407), commenting on the 13 deaths reported through NNP | |
| 1st December 2014 | ISS released the first safety results, which showed no anomalies |
| AIFA issued a press release (n. 409), reporting 19 safety concerns regarding 8 Fluad batches and commenting on ISS preliminary safety results | |
| Italian television and newspaper journalist Bruno Vespa, Professor Dr. Luca Pani, Director General of AIFA, Prof. Dr. Walter Ricciardi of the ISS, and Dr. Giacomo Milillo Secretary General of the FIMMG were publicly vaccinated in TV, to reinsure public opinion about Fluad safety | |
| 2nd December 2014 | 20 deaths allegedly associated to Fluad administration reported through NNP and related to 8 Fluad batches |
| 3rd December 2014 | EMA released the PRAC conclusion (“PRAC advice”): on the basis of the WHO causality assessment, 45 deaths resulted uncorrelated with the vaccine administration (the remaining 21 deaths were considered as unclassifiable, because of the dearth of clinical information) |
| AIFA issued a press release (n. 410), commenting on the PRAC conclusion Professor Dr. Sergio Pecorelli, President of AIFA, stated that it is of extreme importance to work for rebuilding a sense of confidence and trust towards vaccines | |
| 19th December 2014 | Questions tabled in Parliament (question Dellai and Binetti n. 2–00770; question Silvia Giordano and Cecconi n. 2–00772) |
| 23rd December 2014 | ISS released the final safety results AIFA issued a press release (n. 413), communicating the final safety results carried out by ISS and stopping the recall and withdrawal of Fluad batches ID 142701 and ID 143301 |