Shingrix Approved to Prevent Shingles
October 20, 2017 – The U.S. FDA has approved Shingrix (zoster vaccine recombinant, adjuvanted), manufactured by GlaxoSmithKline, and indicated for the prevention of shingles (herpes zoster) in adults who are at least 50 years of age. Caused by varicella-zoster virus—the same virus that causes chickenpox—shingles can lead to signs and symptoms including painful sensitivity to touch; sensations of burning, numbness, or tingling; and rash and blisters. The disease is believed to affect 1 in 3 people in the United States.
Patients who develop shingles have typically already had chickenpox in the past; the virus remains in the body, and can become active again when the immune system weakens, often as an individual ages. Complications from shingles may include neurological damage, skin infections, and loss of vision. The most common complication is postherpetic neuralgia (PHN), a condition caused by damaged nerves sending pain signals to the brain for months or even years after other signs and symptoms of shingles have resolved.
After Shingrix proved more effective than Merck’s Zostavax® (zoster vaccine, live)—previously the only shingles vaccine available in the U.S.—the Advisory Council on Immunization Practices of the Centers for Disease Control and Prevention (CDC) recommended that Shingrix be considered the preferred shingles vaccine in the United States. The council also recommended that individuals who have previously been vaccinated with Zostavax be inoculated with Shingrix. A clinical study showed Shingrix to be 90% effective in preventing acute shingles, as well as PHN.
Shingrix is delivered as two intramuscular injections, given between two to six months apart. Studies indicate that the vaccine offers long-term protection, as it was still effective in study participants after four years. Although the vaccine is designed to work against the same virus that causes chickenpox, Shingrix is not approved to prevent chickenpox, and should not be given to children.
List price for the vaccine is anticipated to be $140 per injection.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.