(1) What is Shingrix?

Shingrix is an FDA-approved vaccine for the prevention of shingles (herpes zoster) in adults 50 years and older. Shingrix is not used to prevent chickenpox. Shingles is an itchy and painful skin rash caused by reactivation of the varicella zoster virus [the same virus still in your body from childhood chickenpox]. GSK’s Shingrix uses your body’s own immune cells to boost your immune system’s defenses against shingles. It is the only shingles vaccine proven to be up to 90% effective in clinical trials. [1]

(2) If I feel healthy am I really at risk for shingles?

If you’re one of the more than 95% of adults over 50 years old who have had chickenpox, the virus that causes shingles is inside your body and can reactivate at any time. One in every three people in the US will get shingles in their lifetime. No matter how healthy you feel, your immune system declines as you age, and that puts you at an increased risk for shingles. [1]

(3) What protection against shingles does Shingrix provide?

Dr. William Schaffner, professor of preventive medicine at Vanderbilt University School of Medicine, says this vaccine has spectacular initial protection rates in every age group. The immune system of a 70 or 80 year-old responds to Shingrix as if the person were only 25 or 30 years-old; thus protecting nearly as well in older groups as in the middle-aged. Shingrix racked up a 97% effectiveness rate in adults over age 50 and, in a separate study of people over age 70, prevented 90% of shingles in those 70 to well past age 80. [2]

(4) Must I take two shots of Shingrix for it to be effective, and how far apart?

Shingrix is given as a two-dose series, with the second shot administered two to six months after the first shot. It’s important to receive both shots of Shingrix. [1] The CDC tells health care providers, HCPs, to give Shingrix in a two-dose series, regardless of whether a patient has had shingles or received Merck’s Zostavax (zoster vaccine live) in the past. [3]

 (5) What side effects should I expect and how might they influence my completing the essential two-dose regimen?

Shingrix's 2017 FDA label specifies that 78% of vaccine recipients experienced pain at the injection site in clinical tests. Thirty-eight percent experienced redness and 25.9% experienced swelling. Other adverse reactions include muscle pain in 44.7% of recipients, fatigue in 44.5% of recipients, and headache in 37.7% of recipients. According to the FDA, a smaller number of recipients experienced shivering, fever and gastrointestinal symptoms. Vanderbilt’s Dr. William Schaffner says, prodding older people to get even the original shingles vaccine [Zostavax since 2006] has been tough: barely 31% of those over age 60 receive that vaccine. How much harder will it be to persuade people to get two Shingrix injections? In studies, most older recipients said they’d experienced pain, redness or swelling in their upper arms for a day or two after the shot, and 8.5% of those over age 70 deemed those symptoms uncomfortable enough to interfere with normal activities. Dr. Schaffner elaborated that Shingrix tends to be a bit of an ouch-y vaccine . . . About half of those over age 70 reported systemic side effects such as fatigue, fever or aching joints, lasting one to two days . . . Physicians and pharmacists should prepare people for such reactions. If people expect it, they’ll cope with it better. They’ll take a couple of Tylenol — and not worry that something is seriously wrong. [2]

(6) How long after I received Merck’s Zostavax do I need to wait to get GSK’s Shingrix?

The CDC tells health care providers - HCPs: Studies confirmed that Shingrix was safe and immunogenic when administered five or more years after Zostavax [Merck’s shingles vaccine in use since 2006]. Intervals shorter than five years have not been studied. However, there are no data or theoretical concerns to indicate Shingrix would be less safe or effective when given less than five years after Zostavax. You may consider an interval shorter than five years, especially if you were more than 70 years-old when you received Zostavax. CDC says to wait at least eight weeks after receiving Zostavax to get Shingrix. [3]

(7) If I am immunocompromised can I be given Shingrix?

The CDC told health care providers, HCPs: While Shingrix is not contraindicated in immunocompromised persons, it is not recommended by the CDC’s Advisory Committee on Immunization Practices, ACIP, at this time. ACIP will begin reviewing evidence for Shingrix in immunocompromised people as soon as it becomes available [from GSK’s post-market studies] and will modify vaccine policy as necessary. HCPs can still give Shingrix to someone who is taking low-dose immunosuppressive medication or expecting immunosuppression, or has recovered from an immunocompromising illness. [3] According to the NY Times, a substantial number of older Americans have suppressed immunity because they’re undergoing chemotherapy or transplants, have H.I.V. or take steroids. For them, the original vaccine [Zostavax] was off-limits because it was made with a weakened live virus. Yet immune suppression itself leaves the people vulnerable to shingles. Shingrix, a recombinant vaccine made from a [non-live] glycoprotein and a combination of immunity boosters called adjuvants, does not pose the same danger. [2]

(8) What have CDC officers said about Shingrix?

Beyond the CDC director’s promulgated recommendations, anecdotal reports of Shingrix side effects don't come as a surprise, says Dr. Kathleen Dooling, a medical officer and shingles expert with the CDC's Division of Viral Diseases. In clinical trials that have studied this vaccine [Shingrix], we knew that it caused more side effects than some of the other adult vaccines that are recommended. In studies, Dooling says, more than 70% of people experienced pain [at the injection site] following the Shingrix vaccine, and almost half experienced some type of muscle pain or fatigue. About one in six people experienced side effects so severe that it actually prevented their normal activities, she says. So these side effects were in fact substantial. But for most people, they only tend to last about two or three days. However, benefits [from Shingrix] outweigh the risks [discomfort]. It still is worthwhile to get the vaccine, nonetheless, Dooling says, because as we age, our risk of shingles continues to go up. Shingles can be a very devastating infection that can not only cause extreme pain and discomfort for several weeks while the rash is present, but in about 10 to 20% of people, it will go on to postherpetic neuralgia, PHN, which is the long-term nerve pain that can last months or years. [4]

(9) What should I know about Shingrix’s safety?

•    You should not receive Shingrix if you are allergic to any of its ingredients or had an allergic reaction to a previous dose of Shingrix.

•    The most common side effects are pain, redness, and swelling at the injection site, muscle pain, tiredness, headache, shivering, fever, and upset stomach.

•    Shingrix was not studied in pregnant or nursing women. Tell your healthcare provider if you are pregnant, plan to become pregnant, or are breastfeeding.

•    Vaccination with Shingrix may not protect all individuals.

•    Ask your healthcare provider about the risks and benefits of Shingrix. Only a healthcare provider can decide if Shingrix is right for you. [1]

Footnotes for Shingrix FAQs

(1) GSK: Shingrix FAQs

(2) NY Times: “No Excuses, People: Get the New Shingles Vaccine”

(3)  CDC: Frequently Asked Questions About Shingrix for Health Care Providers

(4)  US News: “A New Shingles Vaccine: Prepare for Harsher Side Effects”