Zoster vaccine

A Cochrane review concluded that Zostavax is "effective in preventing herpes zoster disease for up to three years".[7] The duration of protection beyond four years after vaccination with the zoster vaccine is unknown. The need for re-vaccination has not been defined.

Zostavax was shown to reduce the incidence of shingles by 51% in a study of 38,000 adults aged 60 and older who received the vaccine. The vaccine also reduced by 67% the number of cases of postherpetic neuralgia (PHN) and reduced the severity and duration of pain and discomfort associated with shingles, by 61%.[8][9][10] The FDA originally recommended it for individuals 60 years of age or older who are not severely allergic to any of its components and who meet the following requirements:[11][12]

• does not have a weakened immune system due to HIV/AIDS or another disease or medications (such as steroids, radiation and chemotherapy) that affect the immune system;
• does not have a history of cancer affecting the bone marrow or lymphatic system, such as leukemia or lymphoma; and
• does not have active, untreated tuberculosis.

In 2006, the U.S. Advisory Committee on Immunization Practices (ACIP) recommended that the live vaccine be given to all adults age 60 and over, including those who have had a previous episode of shingles,[13] and those who do not recall having had chickenpox, since more than 99% of Americans ages 40 and older have had chickenpox.[14]

The Advisory Committee on Immunization Practices (ACIP) in the United States recommends Shingrix for adults over the age of 50, including those who have already received Zostavax. The Committee voted that Shingrix is preferred over Zostavax for the prevention of zoster and related complications because data showed vaccine efficacy of more than 90% against shingles across all age groups, as well as sustained efficacy over a 4-year follow-up. Unlike Zostavax, which is given as a single shot, Shingrix is given as two intramuscular doses, two to six months apart.[15]

The absolute decrease in risk of herpes zoster following immunization over three and a half years is 3.3% (3.54% down to 0.28%) while the decrease in the risk of postherpetic neuralgia is 0.3% (0.34% down to 0.06%).[16]

The live vaccine (Zostavax) is very safe; one to a few percent of people develop a mild form of chickenpox, often with about five or six blisters around the injection site, and without fever. The blisters are harmless and temporary.[17][18] In one study 64% of the Zostavax group and 14% of the controls had some adverse reaction. However, the rates of serious adverse events were comparable between the Zostavax group (0.6%) and those receiving the placebo (0.5%).[19] A study including children with leukaemia found that the risk of getting shingles after vaccination is much lower than the risk of getting shingles for children with natural chicken pox in their history. Data from healthy children and adults point in the same direction.[17]

Zostavax should not be used in people with compromised immune function.[20][21]

Temporary side effects from the Shingrix shots are likely, and can be severe enough in one out of six people to affect normal daily activities for up to three days.[22] Mild to moderate pain at the injection site is common, and some may have redness or swelling.[22] Side effects include fatigue, muscle pain, headache, shivering, fever, and nausea.[22] Symptoms usually resolve in two to three days.[22] Side effects with Shingrix are greater than those with Zostavax and occur more frequently in individuals aged 50 to 69 years compared with those 70 years and older.[6][23]

In Canada the cost of Shingrix is about CA$300 for the two doses.[16]

A 2007 study found that the live vaccine is likely to be cost-effective in the U.S., projecting an annual savings of US$82 to US$103 million in healthcare costs with cost-effectiveness ratios ranging from US$16,229 to US$27,609 per quality-adjusted life year gained.[28] In 2007, the live vaccine was officially recommended in the U.S. for healthy adults aged 60 and over.[29][30]

In 2006, the European Medicines Agency (EMA) issued a marketing authorization for the zoster vaccine to Sanofi Pasteur for routine vaccination in individuals aged 60 and over.[31][32] In 2007, the EMA updated the marketing authorization for routine vaccination in individuals aged 50 and over.[33][32]

Shingrix was approved for medical use in the European Union in March 2018, with an indication for the prevention of herpes zoster (HZ) and post-herpetic neuralgia (PHN) in adults 50 years of age or older.[34]

From 2013, the UK National Health Service (NHS) started offering shingles vaccination to elderly people. People aged either 70 or 79 on 1 September 2013, were offered the vaccine. People aged 71 to 78 on that date would only have an opportunity to have the shingles vaccine after reaching the age of 79.[35] The original intention was for people aged between 70 and 79 to be vaccinated, but the NHS later said that the vaccination program was being staggered as it would be impractical to vaccinate everyone in their 70s in a single year.[36]

Zostavax was developed by Merck & Co. and approved and licensed by the U.S. Food and Drug Administration (FDA) in May 2006,[8] In 2011, the FDA approved the live vaccine for use in individuals 50 to 59 years of age.[10][37] Shingrix is a zoster vaccine developed by GlaxoSmithKline that was approved in the United States in October 2017.[38]

As of June 30, 2020, Merck discontinued the sale of Zostavax in the U.S. market. Existing vaccine already in the hands of practitioners, none having expiration dates later than November 2020, could still be administered up to the expiration date.[39] It was "no longer available for use in the United States, as of November 18, 2020." [40]

The U.S. Centers for Disease Control and Prevention (CDC) recommends that healthy adults 50 years and older get two doses of Shingrix, at least two months apart. Initial clinical trials only tested a gap of less than six months between doses, but unexpected popularity and resulting shortages caused further testing to validate wider spacing of the two doses.[41][42] Shingrix, which provides strong protection against shingles and PHN, is preferred over Zostavax.[43]