The US Food and Drug Administration (FDA) has accepted for consideration the regulatory application of a novel fully liquid prefilled syringe presentation of GSK's Recombinant Zoster Vaccine, or RZV (branded Shingrix) for the prevention of shingles (herpes zoster), GSK has announced.
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About Shingles
Shingles is a painful, blistering rash caused by the reactivation of the varicella-zoster virus (VZV), the same virus that causes chickenpox.
By age 50, VZV is present in most adults and may reactivate with advancing age. This is because as people age, the strength of the immune system response to infection wanes, increasing the risk of developing shingles.
About Shingrix vaccine
As a non-live recombinant subunit vaccine, Shingrix is recommended for individuals 50 years of age and older to prevent shingles.
This combination of an adjuvant system (AS01B) and an antigen (glycoprotein E) may assist overcome the age-related reduction in immune responses that is a natural part of the issue of protecting persons 50 years of age and older from shingles.
Shingrix is not recommended for prevention against primary varicella infection (chickenpox) but
it is authorized for individuals who are 18 years of age or older and at a higher risk of developing shingles in a number of countries.
The New formulation
The new prefilled syringe gives doctors, pharmacists, and other medical professionals who deliver immunizations a convenient alternative by eliminating the need to reconstitute individual vials before administration.
A lyophilized (powder) antigen and a liquid adjuvant make up the vaccine's current formulation, which medical practitioners mix before giving.
The reconstituted vaccine and the new presentation are identical in composition, and the submission is supported by data showing that the two are comparable.
Conclusion
It is expected that the FDA will make a decision on the application by 20 June 2025.
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APR Team
African Pharmaceutical Review team dedicated to providing the latest news, insights and developments from the pharma, biotech and medtech industries.
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