Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, has announced that following a review of the benefits and risks of the Company’s single-dose chikungunya vaccine, IXCHIQ® , the United Kingdom’s (UK) Commission on Human Medicines (CHM) has updated its recommendations for use of the vaccine.
The updated Prescribing Information (PI) will reflect these recommendations, which now include a restriction for individuals over 60 years of age, for people with specified health conditions, as well as timing of vaccination prior to travel.
The MHRA confirmed that the benefit–risk profile of IXCHIQ® remains favorable for individuals aged 18 to 59 years who are at risk of chikungunya infection and do not have the contraindicated underlying medical conditions.
The update follows MHRA’s temporary suspension on the use of IXCHIQ® in older individuals, which was based on reports of serious adverse events (SAEs), mainly in elderly people with significant underlying medical conditions during an outbreak vaccination campaign on the French island of La Reunion.
READ MORE: Valneva provides update on Chikungunya vaccine IXCHIQ®
Valneva said it is committed to upholding the highest safety standards and will continue monitoring post marketing safety data of IXCHIQ® and work in a collaborative way with all relevant authorities to potentially further update recommendations and restrictions of use, if justified.
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