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The European Medicines Agency (EMA) has accepted for consideration the regulatory application of a prefilled syringe formulation of GSK's Recombinant Zoster Vaccine. The vaccine, branded Shingrix, is recommended for use in the prevention of shingles.

This follows a similar acceptance from the US Food and Drugs Administration only a few weeks back.

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.

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RELATED: FDA accepts for review GSK’s new fully liquid shingles vaccine

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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

Since 2018 and 2020, GSK's shingles vaccine has been authorized in the European Union to prevent herpes zoster and post-herpetic neuralgia in people 50 years of age and older, as well as in persons 18 years of age and older who are at heightened risk of developing.

This prefilled formulation will only serve to make the administration process to these groups more efficient.