UK Revokes Marketing Authorization for IXCHIQ®; Valneva Continues Brazil Trials
What happened
The Medicines and Healthcare products Regulatory Agency revoked the UK marketing authorization for IXCHIQ® following a benefit-risk assessment of the vaccine for travelers. This decision was based on a review of previous safety data and did not identify any new safety signals. The product licenses for IXCHIQ® remain valid in the EU, Canada, and Brazil.
From manilatimes.net
Why it matters
Valneva expects minimal impact on its overall sales revenue due to the revocation, as the product was not actively distributed in the UK. The company continues its pilot vaccination strategy in Brazil, where over 61,000 people have been vaccinated without new safety concerns.
From manilatimes.net
Who's involved
- European Medicines AgencyThe European Medicines Agency conducted similar safety reviews regarding the vaccine.
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The entities involved
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European Medicines Agency
highest regulatory authority on medicines in the European Union