No Second Death Linked to IXCHIQ Vaccine in Reunion
Reunion Health Agency disputes Link Between Death and Chikungunya Vaccine
Table of Contents
- Reunion Health Agency disputes Link Between Death and Chikungunya Vaccine
- EMA Statement Prompted Clarification
- ARS Asserts No Causal Link
- Underlying Condition Cited
- Timing Discrepancy Blamed
- EMA Review Underway
- Reunion Health Agency Disputes Link Between Death and chikungunya Vaccine: Your Questions Answered
- What is the central issue being discussed?
- What prompted the clarification from the ARS?
- What did the EMA say in its statement?
- What is the position of the ARS regarding these deaths?
- What was the cause of the second death, according to the ARS?
- Why does the ARS believe there’s no link, while the EMA suggests a possible connection?
- What is the French pharmacovigilance system?
- Has the EMA taken any action regarding the IXCHIQ vaccine?
- Why was vaccination for the elderly already suspended in Réunion?
- How does the ARS weigh the benefits and risks of the vaccine?
SAINT-DENIS, Réunion — The Regional Health Agency (ARS) of Réunion refuted claims that a second death on the island is linked to the IXCHIQ vaccine for chikungunya. The agency addressed the issue Saturday, following a press release from the European Medicines Agency (EMA) that suggested a possible connection.
EMA Statement Prompted Clarification
On Thursday,the EMA released a statement mentioning two deaths perhaps linked to the IXCHIQ vaccine. Valneva, the vaccine’s manufacturer, acknowledged the statement and reiterated that vaccination for individuals over 65 had been temporarily suspended.
ARS Asserts No Causal Link
Professor Xavier Deparis, director of monitoring and health security at the ARS, stated that unlike the frist reported death on April 26 – an 84-year-old man who developed encephalitis after vaccination – the death of a 77-year-old man was not related to the vaccine.
“There is no link,” Deparis asserted.
“The European Medicines Agency speaks in its press release from this second death due to the vaccine, and the French pharmaco-vigilance system, to analysis, does not see a causal link, or a questionable link, between the fact that the person was vaccinated and the cause of death.”
Professor Xavier Deparis,director of monitoring and health security at ARS
Underlying Condition Cited
According to Deparis,the 77-year-old patient suffered from Parkinson’s disease and succumbed to “a vomit and over-infection pulmonary,which unfortunately happens on people who are victims of neuro-degenerative diseases.” He emphasized that there was “no proven direct causal link” between the death and the IXCHIQ vaccine.
Timing Discrepancy Blamed
Deparis suggested that the EMA and Valneva may have communicated prematurely, before French experts had completed their analysis of the data. He indicated that the EMA and the laboratory may not have had all the necessary details to determine causality.
“On the scientific level, interpretation is arduous because the european Medicines Agency does not necessarily have all the elements of French pharmacovigilance to conclude on causality.”
Pr Xavier Deparis, director of the ARS health monitoring
Deparis explained that the French pharmacovigilance system collects data reported by patients and healthcare professionals regarding potential adverse drug effects. This data is then analyzed by a network of experts to determine whether a causal link exists between a drug and an adverse event.
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“We try to have the maximum information in order not to be mistaken in the analysis, and it takes time. It is indeed this period that was out of step with the European Medicines Agency,” Deparis said.
“We do not want to hide anything from the Reunion population, absolutely nothing. (…) This second death was being analyzed, no we do not hide anything from you.”
Pr Xavier Deparis, director of monitoring and health security at ARS
EMA Review Underway
The EMA has initiated a review of IXCHIQ following 17 reported serious adverse events in vaccinated individuals and has temporarily suspended vaccination for those over 65.
Deparis stated that this action was not abnormal.“We have a vaccine that causes undesirable effects in around 1/1000, and a disease that causes serious effects, deaths, in around 1/1000: the benefit-risk balance of the vaccine becomes a little more difficult to apprehend, and in these cases we prefer to abstain,” he said.
Vaccination for the elderly had already been suspended in Réunion at the end of April, following the announcement of the first death.
Reunion Health Agency Disputes Link Between Death and chikungunya Vaccine: Your Questions Answered
This article provides answers too common questions regarding the IXCHIQ chikungunya vaccine after a second death was reported in Réunion.We’ll break down the situation, exploring the differing views of the Regional Health Agency (ARS) and the European medicines Agency (EMA).
What is the central issue being discussed?
The primary subject of this discussion is the potential link between the IXCHIQ chikungunya vaccine and two reported deaths on the island of Réunion. The ARS (Regional Health Agency) contests that the second death is connected to the vaccine, whereas the EMA (European Medicines Agency) suggested a possible connection.
What prompted the clarification from the ARS?
The ARS issued a statement to clarify their position after a press release from the European medicines Agency (EMA) raised the possibility of a connection between the IXCHIQ vaccine and a second death on Réunion.
What did the EMA say in its statement?
The EMA released a statement mentioning two deaths that might be linked to the IXCHIQ vaccine.
What is the position of the ARS regarding these deaths?
Professor Xavier Deparis, director of monitoring and health security at ARS, stated there is no causal link between the second death and the IXCHIQ vaccine. The ARS’s stance is that the death was not related to the vaccine.
What was the cause of the second death, according to the ARS?
According to professor Deparis, the 77-year-old patient who died had underlying Parkinson’s disease and died from complications related to this disease, including a “vomit and over-infection pulmonary.” The ARS maintains there is no proved direct connection between the death and the IXCHIQ vaccine.
Why does the ARS believe there’s no link, while the EMA suggests a possible connection?
The ARS suggests a “timing discrepancy.” They feel the EMA and the vaccine manufacturer, Valneva, may have announced the potential link prematurely, before the French experts could finalize their analysis of the data. Professor Deparis stated that the EMA may not have had all the necessary details from the French pharmacovigilance system to determine causality. The French system takes time to collect data and analyze the facts to determine if there is a direct link.
What is the French pharmacovigilance system?
The French pharmacovigilance system is responsible for collecting data from patients and healthcare professionals regarding potential adverse drug effects. A network of experts then analyzes this data to look for links between drugs and any adverse events that occur. The ARS is part of this system.
Has the EMA taken any action regarding the IXCHIQ vaccine?
Yes, the EMA has launched a review of the IXCHIQ vaccine due to 17 reported serious adverse events after vaccination. Also, the EMA temporarily suspended the vaccination for individuals over 65.
Why was vaccination for the elderly already suspended in Réunion?
Vaccination for the elderly had already been suspended in Réunion at the end of April, following the announcement of the first death.
How does the ARS weigh the benefits and risks of the vaccine?
Professor Deparis highlighted that the balance between the benefits and risks of the vaccine can be complex. He mentioned that the vaccine can cause undesirable effects in around 1 in 1,000 people, while the chikungunya disease itself can result in serious effects and deaths in about 1 in 1,000 people. Therefore, when serious adverse events are reported, especially in vulnerable populations, the ARS prefers to abstain