A New Shingles Vaccine: Prepare for Harsher Side Effects

If you’re 50 or older, you’re advised to get immunized to protect yourself from shingles. If the new shingles vaccine made you feel worse than you expected, you’re not alone. Skin rash, joint pain, flu-like symptoms, headaches and fatigue are some complaints from patients who’ve had the recently approved Shingrix vaccine. Side effects can last two or three days, and the injection site in the upper arm can hurt.

The upside is Shingrix provides stronger protection against shingles — a painful condition that wreaks havoc on the nervous system — than previous vaccines. As people get older, they become increasingly vulnerable to developing shingles. Temporary vaccine side effects pale in comparison to shingles’ long-lasting effects on the body, experts says.

One of every three people in the U.S. will eventually develop shingles, according to the Centers for Disease Control and Prevention. Caused by the varicella zoster virus — also responsible for chickenpox — shingles is notoriously painful. Once someone has chickenpox, the inactive virus dwells in the body. Decades later, the virus can become active again, now causing shingles.

Early shingles symptoms include numbness, tingling or burning and touch sensitivity. A red rash, usually affecting just one side the body, and itching come next. People may develop blisters that fill with fluid, burst open and crust over. Fever and problems such as headache, fatigue and light sensitivity can also occur.

[See: 9 Ways to Boost Your Immune System.]

Weighing Vaccination

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, we knew that it caused more side effects than perhaps some of the other adult vaccines that are recommended.”

In studies, Dooling says, more than 70 percent of people experienced pain 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 outweigh the risks. “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 several weeks while the rash is present, but in about 10 to 20 percent of people, it will go on to postherpetic neuralgia, which is the long-term nerve pain that can last months or years.”

Because of its amplified immune response, the case for using Shingrix is “persuasive,” says Dr. Arthur D. Hayward, a geriatrician in Tualatin, Oregon.

However, he adds that at a recent medical meeting, “What I heard was concern that patients having these reactions may hesitate to have the second of the two-dose series.”

[See: 10 Seemingly Innocent Symptoms You Shouldn’t Ignore.]

How Vaccines Vary

Shingrix and Zostavax are the two vaccines for shingles prevention licensed for use in the U.S. and recommended by the Advisory Committee on Immunization Practices. Zostavax was licensed in 2006. Shingrix was approved by the Food and Drug Administration in October 2017. Both are indicated for adults ages 50 and older.

Zostavax is given in a single, subcutaneous dose: a shallow injection beneath the skin’s surface. By comparison, Shingrix is given in a two-dose series using intramuscular injections, commonly in the deltoid area of the upper arm. The second shot is given two to six months after the first.

On May 25, the CDC released a report on administration errors involving Shingrix. In the first four months of monitoring, the Vaccine Adverse Event Reporting System received reports of 155 instances of problems involving Shingrix. Of these, 13 documented one or more administration errors at locations such as pharmacies and health care providers’ offices.

In nine cases, Shingrix was given under the patient’s skin rather than into the muscle, according to the CDC report. At least two patients under age 50 inappropriately received the vaccine. A few reports referred to patients receiving a dose of the vaccine that was stored improperly (frozen instead of refrigerated) or given on an incorrect schedule.

“Part of the problem is that health care providers may not have fully understood the instructions of administration,” says Dr. Talia Swartz, an assistant professor of infectious diseases with the Icahn School of Medicine at Mount Sinai in New York City.

Providers can refer to the website of Shingrix manufacturer GSK for complete administration instructions for this relatively unfamiliar vaccine, Swartz suggests. “As providers are more comfortable with it, I believe the administration errors would be expected to be reduced,” she says.

Effectiveness vs. Shingles

“The important thing is: The [Shingrix] vaccine is so effective that, despite this, it is still recommended because it’s so powerful in preventing the development of a shingles disease,” Swartz emphasizes.

Dooling offers comparison figures. “These vaccines haven’t been studied in a head-to-head trial,” she says. “But in their own individual trials, we’ve seen that the protection provided from Shingrix was over 90 percent, and that persisted even in the older age groups of people 70 and older. On the other hand, for Zostavax, the protection provided by that vaccine was about 51 percent in clinical trials of people 60 and older.”

“[Another thing clinical trials] demonstrated about the protection afforded by Zostavax was that it decreased over time, dropping anywhere from 15 to 25 percent for the first year after you receive it, and then declining more slowly over time,” Dooling says. “In clinical trials studying Shingrix, the vaccine effectiveness remained at or above 85 percent for the four years that it was studied.”

Published studies on shingles vaccines are industry-funded, although other research may be ongoing.

[See: 11 Things Seniors Should Look for in a Health Provider.]

Before You Get Vaccinated

As a patient looking for shingles protection, here’s what to consider:

— “You are not at risk for developing the shingles-virus infection by getting the [Shingrix] vaccine,” Swartz points out. The vaccine is not a live vaccine, she explains. Instead, it’s made up of proteins. Feeling ill after an injection is due to your immune system generating a response to recognize those proteins, she says. “It then causes a durable response so that when your body sees those proteins again, it will be able to fight the infection and prevent it from causing disease.”

— The CDC recommends Shingrix for adults 50 and older with healthy immune systems. That includes people who’ve had shingles in the past, as well as those who’ve received Zostavax previously. People with chronic conditions like diabetes, kidney disease, rheumatoid arthritis and respiratory diseases should get the vaccine.

— You should not get the Shingrix vaccine if you’ve ever had a severe allergic reaction (like anaphylaxis) after a dose of Shingrix or any component of the vaccine. It’s also not recommended for younger adults under 50. People with compromised immune systems should not get Shingrix.

— “To get the full protection from this vaccine, we need two doses,” Dooling notes. “So be prepared to get the vaccine, but also schedule your follow-up appointment to get the second dose.”

— Even if you had fairly strong side effects with the first Shingrix dose, you’re still advised to get the follow-up dose for full protection. “For individuals who had a bad reaction to the first dose of the vaccine, it wasn’t a good predictor of who was going to have severe reactions to the second dose,” Dooling says.

— Be prepared. “Go into the vaccination knowing what to expect,” Dooling says. “It’s likely you will have pain and you may have more generalized symptoms like tiredness or muscle aches. And [don’t] plan anything that involves strenuous activity in the two to three days after you get the vaccine.”

— Try over-the-counter medicine like acetaminophen or ibuprofen to minimize side effects.

— Contact your doctor if you’re experiencing symptoms like severe pain, severe headaches, severe nausea or a spreading rash after the injection, Swartz says: “It is possible that there may be something else going on.”

The cost for the two-dose Shingrix series is about $280. Check with your insurance plan to see if it’s covered. Medicare Part D covers commercially available vaccines like shingles shots.

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A New Shingles Vaccine: Prepare for Harsher Side Effects originally appeared on usnews.com

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