Thursday, June 21, 2018

New Shingles Vaccine is Highly Effective, Long-lasting — and in Short Supply
By Lena H. Sun
Washington Post
June 20 at 10:20 AM

A national shortage of a new and more effective vaccine to protect adults older than 50 from the painful rash known as shingles is prompting retailers to create waiting lists and the manufacturer to delay additional promotion.

Shingrix, licensed in the fall by the Food and Drug Administration, is the preferred vaccine recommended by the Centers for Disease Control and Prevention for protection from a disease that affects 1 in 3 adults in their lifetime. By recommending that healthy adults start receiving the vaccine at age 50 — a decade earlier than the previous recommendation — federal health officials are hoping that millions more people will be protected from shingles, which is caused by the reactivation of the same virus that causes chickenpox.

One of the most common complications of shingles in those 50 and older is nerve pain that can last for months or even years after a shingles rash goes away and can be so debilitating that the touch of clothing on skin can cause searing pain. It has no treatment or cure.

The new two-dose vaccine provides greater protection — more than 90 percent — and lasts longer than the older single-shot vaccine that has been in use since 2006. The CDC recommends that people should get the new vaccine if they have had shingles, have previously received the old vaccine or have had or are unsure if they have had chickenpox. There are an estimated 1 million cases of shingles in the United States each year; the risk of the disease increases as people age.

Since the new vaccine became broadly available in the United States earlier this year, demand has soared. Supply has not kept pace. Manufacturer GlaxoSmithKline “implemented order limits and providers have experienced shipping delays,” according to a note posted on the CDC’s vaccine shortage list earlier this month. Even though GSK is working to increase supply, those order limits and shipping delays will continue through 2018, the note said. The CDC began reporting shortages in early May.

The scarce supply of Shingrix is likely to be mentioned at a regularly scheduled meeting Wednesday of the federal panel that advises the CDC on immunizations.

Drugstore chain CVS said it began offering the vaccine to patients broadly in mid-March. But because of high demand, “it has become challenging to keep an ample supply across all of our more than 9,800 stores due to supply restrictions from the manufacturer,” CVS spokeswoman Amy Lanctot said in an email on Tuesday. “We are still getting shipments intermittently,” she wrote. She said patients should call their local store to find out if the vaccine is in stock.

People who called their CVS pharmacies in recent weeks and were put on hold were likely to hear a recorded message about the new vaccine, saying that it is up to 97 percent effective and recommended for adults older than 50. “Talk to your pharmacy team today,” the message says.

Several CVS pharmacies in suburban Maryland reported the vaccine has been on back order for weeks. Shipments are limited to one box of 10 doses. At the CVS pharmacy in a Target store in Rockville, a person who answered the telephone said the pharmacy had not received any doses since a first shipment “a couple months ago.” He offered to put a customer on a waiting list.

A nearby Harris Teeter grocery store that had signs advertising the vaccine was also low on stock, also limited to receiving one box of 10 doses at a time and also had a waiting list.

Like other providers, the Kaiser Permanente health system said it has also experienced “high demand” since May. Physicians and pharmacists have been working to “provide vaccine to members most at risk, according to CDC guidelines,” a spokeswoman said.

GSK spokesman Sean Clements said officials are seeing immunization rates “many times that of previous years,” leading to “extremely high” demand for the vaccine. Since Shingrix  became available at the end of October, more than 1.5 million people have received at least one dose as of early May, he said.

The company is shipping more doses this week, he said. The manufacturer is increasing the U.S. supply available for 2018 and plans to release doses to all customer types on a consistent and predictable schedule for the remainder of the year. “People will be able to plan,” he said.

He declined to disclose how many doses of the vaccine GSK planned to bring to market this year. For the first quarter of the year, Shingrix had a “strong and fast start” and earned more than $150 million, company officials said in an earnings call in April. Officials suggested annual revenue of about $600 million for the vaccine.

The company relied on historical demand for shingles vaccine to predict demand for the new vaccine, Clements said. The company has informed the CDC and FDA that there is enough supply to vaccinate more patients in 2018 than were vaccinated against shingles during 2017.

The CDC recommendation is for two doses of Shingrix, two to six months apart. For patients who received both doses, Shingrix is 97 percent effective against shingles for those ages 50 to 59, compared with about 70 percent effectiveness for the older vaccine, Zostavax, industry-sponsored data show. For those in their 60s, the new vaccine is 97 percent effective, compared with 64 percent for Zostavax. For those in their 70s, Shingrix is 91 percent effective, compared with about 41 percent for Zostavax. (Data have not been provided for the effectiveness of a single dose of Shingrix.)

For those in their 80s, who are most at risk of developing complications from shingles, the new vaccine is about five times as effective: 91 percent vs. 18 percent. Protection stays above 85 percent for at least the first four years after vaccination.

Each dose costs $140. Most private health insurance covers recommended adult vaccines, including shingles vaccine. All Medicare Part D plans cover the shingles vaccine. But depending on the plan, individuals may need to pay a portion of the total cost.

Unlike the older Zostavax, which is injected under the skin, the new vaccine is supposed to be a shot in the muscle of the upper arm, like the annual flu vaccine. That difference has apparently led to some errors in giving the vaccine. During the four-month period from October to February, of 155 reports about problems associated with the vaccine, 13 instances involved at least one error, according to a CDC report last month. Nine involved Shingrix being given under the skin instead of in the muscle; eight of those nine injections caused reactions such as pain, redness and itching at the injection site.

The remaining 142 reports were patients reporting temporary side effects, such as joint pain, flulike symptoms, headaches, fatigue and soreness in the upper arm.

GSK said it is focusing its efforts on educating providers and pharmacists to stress the importance of two-dose compliance, and holding off on additional promotion, such as television commercials, until the shortage is under control.

“We want to make sure there is the right level of things out there for education, making sure we’re not driving excessive demand when we have to catch up with supply,” Clements said.

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