Fast Rollout of Shingles Vaccine Planned After FDA's Okay

ROCKVILLE, Md., May 30 - The FDA approved a shingles vaccine, and Merck said it is ready to accept physician orders, with rapid shipment promised.

Zostavax (zoster vaccine live) was okayed by the agency for prevention of herpes zoster in patients 60 and older.

An FDA review of the Zostavax clinical data concluded that the vaccine was effective at curbing shingles pain but did not significantly reduce either shingles-related hospitalizations or death.

In the Shingles Prevention Study, which enrolled 38,546-patients, the vaccine halved the rate of shingles in persons 60 or older and reduced the rate of postherpetic neuralgia by 66.5%. When those results were reported in the New England Journal of Medicine, Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), termed the findings "great news for seniors."

The 5.5-year-trial randomized 19,270 patients to the active vaccine. The vaccine reduced the burden of illness due to herpes zoster by 61.1% (P<0.001), reduced the rate of postherpetic neuralgia by 66.5% (P <0.001), and reduced the rate of herpes zoster by 51.3% (P <0.001).

The most common side effects in people who given Zostavax were redness, pain and tenderness, swelling at the site of injection, itching, and headache. The percent of significant adverse events observed in the study were not different between persons who received the vaccine versus placebo.

As part of the development program, an Adverse Events Monitoring Study (AEMS) was conducted to look more closely at safety. In this smaller study, serious adverse events for all age groups were noted in 1.9% of Zostavax patients, versus 1.3% of patients receiving placebo in the 42 days following vaccination.

Investigator-determined, vaccine-related serious adverse experiences were reported for two participants vaccinated with Zostavax-asthma exacerbation and polymyalgia rhuematica-and in the placebo arm there were three serious adverse experiences (Goodpasture's syndrome, anaphylactic reaction, and polymyalgia rheumatica).

In the entire study population, the rates of overall cardiovascular events (0.4%) including coronary artery disease related conditions (0.2%) were similar in those vaccinated with Zostavax or placebo. In the AEMS substudy, in the first 42 days after vaccination, the rate of overall cardiovascular events was higher after 0.6% after Zostavax versus 0.4% after placebo. Likewise the rate of coronary artery disease-related conditions was slightly higher in Zostavax arm (0.3% versus 0.2%.

Although FDA has concluded that the available data do not establish that these events are related to the vaccine, the manufacturer will perform a Phase 4 (postmarketing) study to provide additional safety information.

In a statement issued by the FDA, Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research, said the vaccine is "an important tool that can help prevent an illness that affects many older Americans and often results in significant chronic pain.

Merck said the catalog price of the vaccine is .35 for a 10-pack of single-dose vials of lyophilized vaccine with sterile diluent and .50 purchased as a single-dose vial of vaccine with sterile diluent