Long Island Business News
February 17th, 2014
Medical Experts Blast Shingles Vaccine Usage
Featuring: Dr. Bruce Hirsch, Infectious Disease Specialist, North Shore University Hospital
Eight years ago, the Food and Drug Administration struck a potentially fatal blow against shingles, approving the vaccine Zostavax. But nearly a decade later, the disease is still going strong – and the vaccine is sparingly used.
Shingles – basically, a painful reactivation of the chicken pox virus that occurs primarily in adults – met its match in Zostavax, which was first approved by the FDA as a preventative inoculation for patients 60 and up and later for patients 50 and up. The vaccine has proved itself; drug-maker Merck reports 69.8 effectiveness in inoculated patients between 50 and 59 and better than 51 percent effectiveness in those 60 and up.
But feuding regulators, poor awareness, vaccine shortages and high costs have significantly lowered the number of adults getting inoculated. So while the disease is spreading, the vaccine is yet to catch on.
“I see tons of people who come in with shingles,” said Dr. David Deutsch, an emergency room physician and co-owner of the Cure Urgent Care center opening in Huntington who blames several factors for the vaccine’s low profile.
Right at the top: old thinking.
“This is a relatively new vaccine,” Deutsch said. “When you’re practicing medicine for 20 years, you may not incorporate it in everybody’s routine care plan.”
Annually, there are still about 1 million shingles cases nationwide, according to the Centers for Disease Control, which estimate that roughly one-third of the U.S. population will get shingles – some more than once. But despite those scary numbers, a 2011 National Health Immunization Survey showed that only 15.5 percent of the 60-plus population was vaccinated with the one-time-only Zostavax shot, compared to 60 percent who get annual flu shots.
A lack of knowledge is another big setback, Deutsch said.
“People don’t know the vaccine exists until they have shingles,” he said.
By then it’s too late, and because of that slow response “the rates of shingles are increasing,” said Dr. Rafael Harpaz, medical epidemiologist in CDC’s viral disease division.
“This has been a steady increase that doesn’t make sense,” Harpaz said.
It’s especially befuddling since other adult vaccinations have become bona fide industries unto themselves. Flu inoculations for adults, for instance, are extremely popular, thanks to a combination of promotion and acceptance.
But some insiders suggest the reason flu inoculations are more common than shingles inoculations is that, despite the spread of shingles, flu is a more common diagnosis.
“Flu is an annual event,” said Louis Ferraro, a vice president and general manager of merchandising and product management at Melville-based Henry Schein. “So it becomes a bigger product.”
Even the CDC bears some responsibility for Zostavax’s slow proliferation. In 2006, the FDA approved the drug for patients 60 and over, and in 2009 the CDC’s Advisory Committee on Immunization Practices followed suit. However, in 2011, the FDA also licensed the vaccination for patients in their 50s – but the ACIP, which meets three times annually, never modified its recommendations.
Harpaz, who led an ACIP working group on the shingles vaccination in 2011, said the group was at least partially influenced by the potential for a Zostavax shortage. Merck is the only U.S. supplier of vaccines for chicken pox and shingles and a combined vaccine designed to prevent measles, mumps, rubella and chicken pox, and according to the working group was already “experiencing production shortfalls” in 2011, making wider use of any of those vaccines a potential problem.
The CDC will monitor supplies and might update recommendations for 50-somethings “when an adequate and stable supply of the vaccine is assured,” Harpaz added.
According to Merck, that time has come. After improving existing facilities and investing $1 billion to build a North Carolina production facility, the supply issue was resolved, according to Dr. Eddy Bresnitz, Merck’s executive director of global medical affairs and policy.
“Since late 2011, we have had no supply issues whatsoever,” Bresnitz said.
Still, the CDC has not updated its recommendations to include patients in their 50s. And as the debate continues, one in five Americans between 50 and 59 – a population that increased by over 10 million, to 42 million, between 2000 and 2010 – contracts shingles annually.
The biggest factor in the Zostavax’s lukewarm circulation may be the drug’s cost. The vaccine wholesales for $173.84 per dosage, or $169.69 per dosage in packs of 10, and “insurance coverage isn’t so good,” noted Dr. Bruce Hirsch, attending physician in infectious diseases at North Shore University Hospital.
“The expense is a real disincentive,” Hirsch said.
Despite all these factors, Zostavax demand and profits are rising. The drug generated $651 million in revenues in 2012, up from $332 million in 2011 and $243 million in 2010, a steady rise Ferraro credits to a national increase in preventative thinking.
“With the new outlook, healthier people are trying to prevent disease,” Ferraro said.
Still, many insiders believe more needs to be done to spread knowledge of the vaccine to younger patients.
“Everyone over age 50 should get it,” Hirsch said. “This is an important health problem. It’s a real detriment to quality of life when a person gets shingles.”