FDA Approves Shingrix Vaccine for Immunocompromised Patients


The newest FDA indication allows for greater distribution to younger but equally vulnerable immunocompromised patients.

The US Food and Drug Administration (FDA) approved the non-live, recombinant sub-unit adjuvanted vaccine Shingrix for the prevention of shingles in adults aged 18 years and older with increased risk of immunodeficiency or immunosuppression.

The GlaxoSmithKline (GSK) vaccine, which is given intramuscularly to patients through 2 doses, was originally approved by the FDA in 2017 for the prevention of shingles in adults 50 years or older. The newest indication by the FDA is set to expand upon the number of patients who can be protected against shingles.

“We’re proud to offer Shingrix in the US for the prevention of shingles in those who are immunocompromised, with FDA granting a broad indication for use in adults at increased risk of this disease,” said Thomas Breuer, Chief Medical Officer, GSK Vaccines, in a recent statement by the company.

Breuer mentioned that in addition to old age, being immunocompromised is among the most common of risk factors for shingles, and that GSK is committed to aiding this vulnerable group with the Shingrix vaccine.

According to a report by Avalere Health, more than 17 million doses of recommended vaccines were missed by adults during the ongoing COVID-19 pandemic. However, more than 100 million adults 50 years and older received Shingrix prior to COVID-19.

Breuer hopes that individuals who missed their Shingrix vaccine due to the pandemic will catch up on their immunizations soon.

An estimated 1 million cases of shingles are recorded each year in the US, and 1 in 3 Americans will develop shingles in their lifetime.

However, with the 2 recent FDA approvals, and marketing authorization for Shingrix being granted in Europe in August 25, 2020, GlaxoSmithKline remains optimistic that their vaccine can continue to help an ever-growing number immunocompromised patients in the prevention of shingles.

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