Shingrix Shingles Vaccine Description
GSK's Shingrix is an adjuvanted recombinant zoster vaccine, consisting of the varicella-zoster virus glycoprotein E antigen and the AS01B adjuvant system, and a proprietary adjuvant containing QS-21 and MPL with liposomes.
Shingrix is the only shingles vaccine proven to be up to 90% effective in various clinical trials, says GSK. Shingles, also known as herpes zoster, is a painful skin rash caused by reactivation of the varicella-zoster virus the same virus that causes chickenpox.
Shingrix works to boost your body’s protection against shingles. Your immune system declines as you age, and that puts you at an increased risk for shingles. For those who are 50 years and older, Shingrix helps your immune system defend against shingles regardless of age.
Pain, redness, and swelling at the injection site, muscle pain, tiredness, headache, shivering, fever, and upset stomach are all common side effects of Shingrix.
There are two vaccines licensed in the USA and recommended by the Advisory Committee on Immunization Practices to prevent shingles. The Zoster vaccine live (ZVL, Zostavax) has been used since 2006. And, recombinant zoster vaccine (RZV, Shingrix) has been used since 2017, says the U.S. CDC. On October 20, 2017, the U.S. FDA issued its authorization.
On May 22, 2020, Merck issued a letter stating it would no longer sell Zostavax in the USA, effective July 1, 2020. This decision is not related to any product safety or manufacturing issues, and only affects customers in the USA.
A study published on May 15, 2020, in ACR Open Rheumatology, showed that the vaccine did not prompt flares of rheumatoid conditions.
London, England based GlaxoSmithKline (GSK) is the producer of Shingrix, which produced about $2.2 billion in revenues during 2019. The global shingles vaccine market is poised to grow by USD 1.08 billion during 2020-2024, progressing at a CAGR of over 7% during the forecast period.
Shingrix Shingles Vaccine Indication
No matter how healthy you feel, your immune system declines as you age, and that puts you at an increased risk for shingles. Shingrix is a vaccine for the prevention of shingles (herpes zoster) in adults 50 years and older. If you’re one of the 99% of adults over 50 years old who have had chickenpox, the virus that causes shingles is inside your body and can reactivate at any time. 1 in every 3 people in the US will get shingles in their lifetime, says GSK.
People should not receive Shingrix if they are allergic to any of its ingredients or had an allergic reaction to a previous dose of Shingrix. And, Shingrix was not studied in pregnant or nursing women. Tell your healthcare provider if you are pregnant, plan to become pregnant, or are breastfeeding, says GSK.
Shingrix is not used to prevent primary varicella infection (chickenpox).
Shingles is a painful rash that develops on the face or body. The rash consists of blisters that typically scab over in 7 to 10 days and fully clears up within 2 to 4 weeks. Before the rash appears, people often have pain, itching, or tingling in the area where it will develop. This may happen several days before the rash appears.
Most commonly, the rash occurs in a single stripe around either the left or the right side of the body. In other cases, the rash occurs on one side of the face. Shingles on the face can affect the eye and cause vision loss. In rare cases (usually in people with weakened immune systems), the rash may be more widespread on the body and look similar to a chickenpox rash.
Complications can arise with Shingles especially in older adults.
The most common complication of shingles is long-term nerve pain called postherpetic neuralgia (PHN). PHN occurs in the areas where the shingles rash was, even after the rash clears up. It can last for months or years after the rash goes away. The pain from PHN can be so severe and debilitating that it interferes with daily life.
About 10 to 18% of people who get shingles will experience PHN. Your risk of PHN increases with age. An older adult with shingles is more likely to develop PHN and have longer-lasting and more severe pain than a younger person with shingles. People younger than 40 rarely experience PHN.
Shingrix Shingles Vaccine Dosage
Shingrix is a suspension for intramuscular injection only. It is supplied in 2 vials (0.5 mL each) that must be combined prior to administration. Two doses are necessary to provide strong protection, up to 90%, the first dose at Month 0 followed by a second dose administered anytime between 2 and 6 months later.
The Shingrix vaccine series is administered as an injection into the muscle in the upper arm. It is important to complete the 2‑dose series to help prevent shingles. The CDC has stated: If more than 6 months have elapsed since the 1st Shingrix dose, administer the 2nd dose as soon as possible. Do not restart the Shingrix vaccine series.
Shingrix Shingles Vaccine News
- November 23, 2020 - Updated study: Recombinant Zoster Vaccine Is Efficacious and Safe in Frail Individuals. The relatively nonrestrictive inclusion/exclusion criteria in the parent ZOE studies resulted in a range of participants that included frail and pre‐frail older adults. RZV significantly reduced the risk of herpes zoster across all frailty subgroups.
- October 9, 2020 - The new GSK campaign for its shingles vaccine coalesced their message around a very simple statement: “Shingles Doesn’t Care.” They are telling consumers that you can do everything right health-wise and still get shingles.
October 8, 2020 - Shingles vaccine: Should I get it? People looking to receive the shingles vaccine now have two options. The Food and Drug Administration in 2017 approved Shingrix. It's the preferred alternative to Zostavax, which was approved in 2006.
- September 30, 2020 - The Government of Yukon is publicly funding a shingles vaccine for Yukoners between the ages of 65 and 70, the age at which the vaccine is most effective. The shingles vaccine, Shingrix, will be publicly funded in Yukon beginning January 1, 2021.
- August 5, 2020 - GSK launched a national campaign to help increase low rates of vaccination among older adults. The campaign, Brought to You By Vaccines, will educate adults ages 50 and older about the value of vaccines and the urgent need to talk to their healthcare provider or pharmacist about the recommended vaccines they need or may have recently missed. Since the declaration of the COVID-19 pandemic and public health measures to slow the spread of the disease in the US, ordering rates across adult vaccines among healthcare practices have dropped an average of 62 percent.
- July 9, 2020 - The number of senior Americans who report receiving a shingles vaccination had risen steadily since 2008, new data from the US Centers for Disease Control and Prevention's (CDC's) National Center for Health Statistics revealed. The proportion of people in this age group (60+) who were vaccinated rose from 6.7 percent in 2008 to 34.5 percent in 2018, reported the CDC.
- June 9, 2020 - The U.S. CDC says 'The COVID-19 pandemic has caused healthcare providers to change how they operate to continue to provide essential services to patients. Ensuring immunization services are maintained or reinitiated is essential for protecting individuals and communities from vaccine-preventable diseases.'
- July 3, 2020 - The Science and Technology Daily reported the vaccine, Shingrix, was developed by British pharmaceutical giant GlaxoSmithKline. China's National Medical Products Administration approved it for the market in May. It is on a list of 48 "clinically urgently needed new drugs" for fast-track approval by the administration, and is currently the only recombinant shingles vaccine on China's market.
- June 2020 - Harvard Health: Shingles vaccine may also reduce stroke risk.
- May 15, 2020 - Safety of the Zoster Vaccine Recombinant Adjuvanted in Rheumatoid Arthritis and Other Systemic Rheumatic Disease Patients.
- April 29, 2020 - GSK announced Shingrix sales grew 81% AER, 79% CER to £647 million, primarily driven by continued strong uptake in the US. Germany and Canada also contributed to growth.
- April 26, 2020 - Shingrix induces persistent immune responses in older adults, regardless of a Zostavax vaccine dose.
- March 2, 2020 - Shringrix was no longer listed on the CDC's vaccine shortage list.
- February 27, 2020 - The Adjuvanted Recombinant Zoster Vaccine in Adults Aged ≥65 Years Previously Vaccinated With a Live-Attenuated Herpes Zoster Vaccine.
- February 2020 - Aggregate health and economic burden of herpes zoster in the United States.
- November 29, 2019 - This study suggests that exogenous boosting provides some protection from the risk of herpes zoster, but not complete immunity, as assumed by previous cost-effectiveness estimates of varicella immunization.
- October 23, 2019 - Long-term Immunological Persistence of the Adjuvanted Recombinant Zoster Vaccine: Clinical Data and Mathematical Modeling.
- May 22, 2019 - China’s National Medical Product Administration (NMPA) announced the ‘conditional approval’ for Shingrix.
- August 16, 2019 - The availability of the new shingles vaccine is improving across the Military Health System, according to Defense Health Agency Immunization Healthcare. The vaccine, Shingrix, is recommended for healthy adults 50 and older to prevent the painful skin rash that can have debilitating long-term effects for older people. "But availability to the Department of Defense has improved from a year ago and continues to get better," he said, adding that beneficiaries should contact their local MTF to confirm supplies. "Now is the time to get your shingles immunization."
- July 9, 2019 - GSK Herpes Zoster Vaccine Shingrix reduced the incidence of herpes zoster in autologous stem cell transplant recipients. Among adults who had undergone autologous HSCT, a 2-dose course of recombinant zoster vaccine compared with placebo significantly reduced the incidence of herpes zoster over a median follow-up of 21 months.
- September 22, 2018 - The Journal of Infectious Diseases, Volume 218.
- January 26, 2018 - Recommendations of the CDC's Advisory Committee on Immunization Practices for Use of Herpes Zoster Vaccines.
Shingrix Shingles Vaccine Clinical Trials
ClinicalTrials.gov Identifier: NCT04169009 - Last updated on Last Update Posted: July 30, 2020.
The phase 1 study plans to learn more about how the shingles vaccine, Shingrix (SRX), successfully prevents shingles in older people. Two vaccines are currently approved by the Food and Drug Administration (FDA) to prevent shingles. Zostavax is a live virus vaccine that has been available since 2006 and prevents shingles about 50% of the time, though it is less effective the older a person is when they receive it. Shingrix, which was approved by the FDA in 2017, is not a live virus but has an additive in the vaccine to boost immune response. It is about 97% effective at preventing shingles regardless of a person's age and so far has been effective for at least 4 years after vaccination. Because Zostavax has a live virus in it, giving a "challenge" dose of Zostavax - vOka varicella-zoster virus - to people who have received both vaccines (Zostavax or Shingrix) in the past, will allow researchers to learn more about how the body works to prevent shingles and how any shingles vaccination helps protect against shingles.
ClinicalTrials.gov Identifier: NCT01165177 - Last Update Posted: March 31, 2020.
The phase 3 observer-blind study is to evaluate the efficacy, safety, and immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in adults aged ≥ 50 years. Two studies [ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229)] are being conducted concurrently to evaluate the efficacy of GSK1437173A vaccine. A pooled analysis of data from both studies combined will be conducted contingent on each study achieving its objectives. The protocol posting of study ZOSTER-022 also deals with the outcome measures related to the pooled analysis.
ClinicalTrials.gov Identifier: NCT03563183 - Last Update Posted: April 30, 2020.
The purpose of this very large observational study is to allow for the encoding and analysis of questionnaires for all subjects enrolled in ZOSTER-006 and ZOSTER-022. The aim is to assess the baseline frailty of subjects enrolled in these studies and to investigate whether this population is representative of the general population.