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Valneva: EMA Leans on IXCHIQ After Serious Cases - News Directory 3

Valneva: EMA Leans on IXCHIQ After Serious Cases

May 7, 2025 Catherine Williams Health
News Context
At a glance
  • PARIS (Circlefinance.com) — Teh European Medicines Agency (EMA) has initiated a ⁢review of Valneva's ⁤IXCHIQ vaccine, designed to protect against the chikungunya ⁣virus, following reports of ⁢serious adverse...
  • To date, over 40,000 doses of the IXCHIQ vaccine have been administered globally.
  • As a precautionary measure, the use of the vaccine has ‍been temporarily suspended for individuals aged 65 and older.
Original source: boursorama.com

Valneva‘s Chikungunya Vaccine Faces EMA Review Over Adverse ‍Effects

Table of Contents

  • Valneva’s Chikungunya Vaccine Faces EMA Review Over Adverse ‍Effects
    • Limited Use, Adverse Reactions ⁤Trigger Review
    • Vaccine Use Suspended for Those Over 65
    • EMA Cites ‘Uncertain’ Link,Highlights Contraindications
    • Valneva Reaffirms Commitment to Safety
  • Valneva’s Chikungunya ‍Vaccine: Answering Your Questions
    • what is the IXCHIQ vaccine?
    • What is the Chikungunya virus?
    • Why is the European ⁢Medicines‍ Agency (EMA) reviewing the IXCHIQ vaccine?
    • What kind ⁣of adverse effects are being reported?
    • Who⁤ is most affected by the adverse effects?
    • How many doses of the vaccine have been⁤ administered?
    • How many cases of serious adverse effects ⁢have been reported?
    • What specific actions are being taken regarding the vaccine?
    • Is the vaccine still available for everyone?
    • What is the EMA’s stance‍ on the link between the vaccine and adverse events?
    • What are the known contraindications⁣ for the ⁤IXCHIQ vaccine?
    • What is Valneva’s response to the review?
    • Summary: Key facts About the IXCHIQ Vaccine

PARIS (Circlefinance.com) — Teh European Medicines Agency (EMA) has initiated a ⁢review of Valneva’s ⁤IXCHIQ vaccine, designed to protect against the chikungunya ⁣virus, following reports of ⁢serious adverse effects, particularly among elderly recipients, Valneva announced.

Limited Use, Adverse Reactions ⁤Trigger Review

To date, over 40,000 doses of the IXCHIQ vaccine have been administered globally. Though, 17 cases of⁤ serious adverse effects have been reported, including two incidents involving individuals over the age of 65.

Vaccine Use Suspended for Those Over 65

As a precautionary measure, the use of the vaccine has ‍been temporarily suspended for individuals aged 65 and older. The vaccine remains available for those between 12 and ‍64 years of⁤ age.

EMA Cites ‘Uncertain’ Link,Highlights Contraindications

The EMA emphasizes that the connection between the reported adverse events⁢ and the IXCHIQ vaccination remains⁤ “uncertain.” The agency also reiterated existing contraindications for‍ the vaccine, specifically in cases ⁤of immunosuppression.

Valneva Reaffirms Commitment to Safety

While adjustments have been implemented in the United States⁤ and France, Valneva has reaffirmed its commitment to vaccine safety. The company maintains that the benefit-risk ratio of ⁢the IXCHIQ vaccine remains ⁤favorable.

Valneva’s Chikungunya ‍Vaccine: Answering Your Questions

This⁣ article provides details‍ about Valneva’s⁢ IXCHIQ chikungunya vaccine, based on the information provided⁣ in the source material.

what is the IXCHIQ vaccine?

The IXCHIQ vaccine, manufactured by Valneva, is designed too protect individuals against the ⁢chikungunya virus.

What is the Chikungunya virus?

The source material doesn’t provide⁢ details on the Chikungunya virus,however here is some additional information you might find useful. The chikungunya virus is transmitted to humans through the ⁢bites of infected mosquitoes, ‍primarily Aedes aegypti and aedes albopictus. Symptoms⁣ often include fever and severe joint pain.

Why is the European ⁢Medicines‍ Agency (EMA) reviewing the IXCHIQ vaccine?

The EMA is reviewing the IXCHIQ vaccine due to reports of serious adverse effects following its administration. This review was initiated after Valneva announced the reports.

What kind ⁣of adverse effects are being reported?

The⁣ article specifies “serious ‍adverse effects” are the primary concern. The full nature of these effects isn’t specified in the⁣ provided document.

Who⁤ is most affected by the adverse effects?

The reports of serious ⁢adverse effects are particularly concentrated among⁣ elderly recipients (those over 65).

How many doses of the vaccine have been⁤ administered?

Over 40,000 doses of the ⁤IXCHIQ vaccine have been administered globally, according to the source material.

How many cases of serious adverse effects ⁢have been reported?

There have‍ been 17 reported cases of serious adverse effects.

What specific actions are being taken regarding the vaccine?

As a ⁣precautionary measure,⁤ the⁢ use of the IXCHIQ vaccine has been temporarily suspended for individuals aged 65 and older.

Is the vaccine still available for everyone?

No. While the vaccine is suspended for those 65⁤ and over, it remains available for individuals between⁤ the ages of⁢ 12 and 64.

What is the EMA’s stance‍ on the link between the vaccine and adverse events?

The EMA ⁤states that the⁢ connection between the reported adverse events and the IXCHIQ vaccination remains “uncertain.”

What are the known contraindications⁣ for the ⁤IXCHIQ vaccine?

The EMA reiterated existing contraindications,particularly for those ⁢with immunosuppression. That is, if you have a weakened immune system, IXCHIQ may not⁤ be appropriate for you.

What is Valneva’s response to the review?

Valneva has reaffirmed its⁣ commitment to vaccine safety. They also ⁣maintain that ⁣the⁢ benefit-risk⁣ ratio of the IXCHIQ vaccine remains⁢ favorable. They have also implemented adjustments in the United States ⁣and France.

Summary: Key facts About the IXCHIQ Vaccine

| Aspect ⁣⁤ ‍ ⁣ | Details ⁢ ⁢ ⁢ ‍ ‍ ‍ ⁣ ⁢ ⁣ ‍ |

|⁤ ————————– | ————————————————————————– |

| ⁤ Vaccine Name | IXCHIQ ⁤ ⁣ ⁣ ⁢ ⁢ |

| Manufacturer ⁣ | Valneva ‍ ⁣ ⁢ ‍ ⁣ ⁣ |

| Target Illness ⁤ ⁢ ⁤ ‍ ⁢| Chikungunya virus ‍ ⁢ ‍ ⁤ ⁤ ‍ ⁣ ⁤ |

| Review trigger | Reports of serious adverse effects ⁤ ‍ ‍ ⁤ |

| ⁤ Specific⁣ Concern ⁣ | Adverse effects in⁣ elderly recipients (over 65) ⁣ ⁢ |

| Doses Administered | Over 40,000 globally ‍ ⁣ ‍ ‍ ⁢ |

| Reported Adverse Events | 17 cases ‍ ⁣ ⁢ ‍ ⁤ ⁤ |

| Age Restrictions ⁣ | suspended for ages 65+,available ages 12-64. ⁢ ⁣ |

| EMA Stance |⁤ Connection to adverse events “uncertain” ⁣⁣ |

| Contraindications | Immunosuppression ⁤ ⁤ ‍⁣ ⁢ ⁤ ⁣ ‍ ⁣ |

|⁣ Valneva’s Position | Reaffirms⁣ commitment to safety; benefit-risk ratio remains favorable. |

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