COMMENTARY

Shingrix Update: Common Shingrix Reactions--Which Can Be Prevented?

Kathleen Dooling, MD, MPH

Disclosures

February 01, 2019

Editorial Collaboration

Medscape &

Hello. I'm Dr Kathleen Dooling, a medical officer and shingles disease expert at CDC. I'm here to talk to you about the new, highly protective shingles vaccine and what we've learned post-licensure regarding reactogenicity. The recombinant zoster vaccine (brand name Shingrix) is a two-dose vaccine that is more than 90% protective against shingles, even among the elderly.[1,2] CDC now recommends Shingrix as the preferred shingles vaccine for immunocompetent adults aged 50 years and older.[3]

I'll start with a reminder of the recommendations for use and the proper administration of Shingrix, which are quite different from those of Zostavax, a shingles vaccine recommended since 2006. A table describing differences between Shingrix and Zostavax is provided below.

CDC recommends that immunocompetent adults aged 50 years and older receive two doses of Shingrix, with the second dose given 2 -6 months after the first dose.[3] Shingrix must be administered intramuscularly (for example, in the deltoid region of the upper arm). This is very important because if Shingrix is administered subcutaneously, the patient is more likely to develop an injection-site reaction with pain, redness, or swelling, which is what happened to this patient, who received a subcutaneous dose of Shingrix over the triceps area.

Figure 1. Pain, redness, and swelling from an incorrectly administered Shingrix vaccination.

Both local and systemic reactions to Shingrix are quite common. The clinical trials of Shingrix and reports to the Vaccine Adverse Event Reporting System (VAERS) have provided a detailed picture of reactions to this vaccine. In eight clinical trials of more than 10,000 people who completed reaction diaries, 78% of those who got Shingrix reported at least some pain near the injection site, 38% reported redness, and 26% reported swelling.[1,2] For 1%-3% people, the area of redness and swelling exceeded 4 inches.[1,2]

In this figure, you can see the degree of redness that patients may experience within a few days after receiving a correctly administered dose of Shingrix.

Figure 2. Redness even when Shingrix was administered correctly.

In addition to local reactions, about 1 in 10 people who received Shingrix in clinical trials reported systemic effects severe enough to limit activity, such as myalgia, fatigue, headache, shivering, fever, or gastrointestinal illness.[1,2]

From October 2017 to June 2018, healthcare providers and patients have submitted just over 4000 reports to VAERS of events involving Shingrix.[4,5] About 3.2 million doses of Shingrix were distributed during that timeframe.[4] The most common symptoms reported to VAERS were fever, injection-site pain, and erythema. Reassuringly, the results of early monitoring of Shingrix are consistent with the safety profile observed in clinical trials; serious adverse events were rare and no unusual patterns were detected.[4,5]

Before you administer Shingrix, CDC recommends counseling your patients about the common reactions to the vaccine. You should tell patients to expect such reactions as pain, swelling, and redness at the injection site, along with possible body aches, fever, and chills. Most reactions to Shingrix are self-limited and resolve in 2 -3 days.[3]

You should encourage patients to complete the two-dose series for Shingrix, even if they experience a reaction to the first dose. In trials, a reaction to the first dose did not predict a reaction to the second dose. Moreover, the effectiveness of just one dose of Shingrix has not been studied. If you don't have Shingrix in stock, you or your patients can check vaccinefinder.org to locate it. And finally, please report any clinically significant reactions to VAERS so we can continue to monitor the safety of Shingrix.

For more information, visit CDC's shingles vaccine website. As a healthcare provider, your recommendations for vaccination have the biggest impact on the decisions your patients make. So help protect your patients aged 50 and older against shingles and its complications by strongly recommending shingles vaccination. Thank you.

Table. Differences Between Shingrix and Zostavax

Web Resources

Recommendations of the Advisory Committee on Immunization Practices for Use of Herpes Zoster Vaccines

Shingles Vaccine Information for Healthcare Professionals

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