Shingrix Shingles Vaccine Description
GSK's Shingrix is a non-live, adjuvanted recombinant shingles vaccine (zoster), consisting of the varicella-zoster virus glycoprotein E antigen and the AS01B adjuvant system, a proprietary adjuvant containing QS-21 and MPL with liposomes.
Shingrix has been 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, which causes chickenpox, says the U.S. CDC. In addition, Shingrix works to boost immune systems as people age, which increases the risk for shingles.
Recombinant zoster vaccine (RZV, Shingrix) has been used since 2017. On October 20, 2017, the U.S. FDA issued its authorization: STN: 125614. The EMA issued EMEA/H/C/004336 on March 21, 2018.
The American Academy of Dermatology Journal reported that among people who had a first-time shingles attack, approximately 4% had another outbreak later. In addition, those ages 45 to 54 had a recurrence after two years on average, while people ages 55 and older had one three years later on average. Given the recurrence rates, the researchers said that people who'd already had shingles would still benefit from getting the vaccine, stated Harvard Health. Furthermore, a separate study reported two cases of de novo disseminated varicella-zoster virus infection, without expansion from an initial dermatomal presentation, after receiving an mRNA-based COVID-19 vaccine in patients who were not actively on immunosuppression.
GlaxoSmithKline plc announced on July 26, 2021, that the U.S. FDA had approved Shingrix (Zoster Vaccine Recombinant, Adjuvanted) for the prevention of shingles (herpes zoster) in adults aged 18 years and older who are or who will be at increased risk of shingles due to immunodeficiency or immunosuppression caused by known disease or therapy. And the UK Health Security Agency confirmed beginning September 2021, people who are 70 to 79 years of age with weakened immune systems will be offered the Shingrix vaccine to help protect them against shingles.
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. GSK's top priority is patient safety. "We are committed to monitoring and ensuring the safety of all our products, including SHINGRIX (Recombinant Zoster Vaccine/RZV)."
Shingrix Shingles Vaccine Indication
Shingrix is a non-live vaccine for preventing shingles (herpes zoster) in adults 50 years and older. If you're one of the 99% of adults over 50 years old who has had chickenpox, the virus that causes shingles is inside your body and can reactivate at any time. Shingrix is not used to prevent primary varicella infection (chickenpox).
On June 25, 2021, the CDC's ACIP meeting reviewed 'Zoster Vaccines Session: Burden of Herpes Zoster in Immunocompromised Adults' and GSK's presentation: 'Use of Recombinant Zoster Vaccine in Immunocompromised Populations.'
The US FDA approved Shingrix on July 26, 2021, to prevent shingles in adults 18 years and older who will be at increased risk of shingles due to immunodeficiency or immunosuppression caused by known disease or therapy. However, for adults who are or will be immunodeficient or immunosuppressed due to known disease or treatment and who would benefit from a shorter vaccination schedule, the second dose can be administered 1 to 2 months after the first dose.
GSK says 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. So tell your healthcare provider if you are pregnant, plan to become pregnant, or are breastfeeding, says GSK.
Shingles (Herpes Zoster) is a painful rash that develops on the face or body. The rash consists of blisters that typically scab over 7 to 10 days and fully clear up within 2 to 4 weeks, says the U.S.CDC. 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. 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. However, the National Insitute on Aging says 'the shingles vaccine is safe and easy, and it may keep you from getting shingles and ongoing pain called postherpetic neuralgia, or PHN. Healthy adults age 50 and older should get vaccinated with a shingles vaccine called Shingrix.'
The most common shingles complication 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.
A study published on May 15, 2020, in ACR Open Rheumatology showed that the vaccine did not prompt flares of rheumatoid conditions.
On June 3, 2021, the journal Nature published a study that concluded, 'This nationwide population-based cohort study yielded real-world evidence of HZ risk in psoriasis patients receiving systemic therapy. We observed that treatment with etanercept, adalimumab, and MTX plus AZA were significantly associated with a higher risk of HZ. Furthermore, MTX combined with any biologic agent is non-significantly associated with HZ risk. By contrast, acitretin and phototherapy were associated with a lower risk of HZ. The patients' characteristics associated with increased HZ include age, female sex, steroid use, hypertension, dyslipidemia, and psoriatic arthritis.'
On August 18, 2021, Public Health England announced beginning September 2021, GPs should offer the non-live shingles vaccine Shingrix to all eligible for shingles vaccination but are clinically contraindicated to receive the live vaccine Zostavax® due to their immunocompromised status.
Shingrix Shingles Vaccine Use For Immunocompromised Adults
During the U.S. CDC's Advisory Committee on Immunization Practices (ACIP) meeting on October 20, 2021, Tara Anderson, DVM, MPH, Ph.D., presented: Interpretation of the EtR Regarding Use of RZV in Immunocompromised Adults, Considerations for Use, and Proposed Policy Options. The ACIP's Recommendation is: Two doses of recombinant zoster vaccine are recommended for adults aged ≥19 years who are or will be immunodeficient or immunosuppressed due to disease or therapy to prevent herpes zoster and its complications. Additionally, Camille Nelson Kotton, M.D., presented an ACIP herpes zoster overview.
Previously, Camille Nelson Kotton, M.D., Chair, ACIP Herpes Zoster Work Group, presented the Introduction Zoster Vaccines Session on September 29, 2021; Ismael R. Ortega-Sanchez, Ph.D. presented 'Economics of vaccinating immunocompromised 19–49-years-old adults against herpes zoster in the USA; Tara Anderson, DVM, MPH, Ph.D. presented 'Preliminary Evidence to Recommendations Framework Regarding Use of Recombinant Zoster Vaccine in Immunocompromised Adults and Next Steps.'
Shingrix Shingles Vaccine Dosage
Shingrix (Herpes Zoster) is a suspension for intramuscular injection only. It is supplied in 2 vials (0.5 mL each) that must be combined before 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. The Shingrix vaccine series is administered as an injection into the upper arm's muscle. Therefore, it is important to complete the 2‑dose series to help prevent shingles. The CDC has stated: If more than six 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 Side Effects and Warning
COVID-19 vaccines may be administered without regard to the timing of other vaccines, stated the CDC on September 15, 2021. This includes simultaneous administration of the COVID-19 vaccine and other vaccines on the same day. However, it is not known if the reactogenicity of COVID-19 vaccines increased with coadministration, including with other vaccines known to be more reactogenic, such as adjuvanted vaccines, including certain flu shots.
Previously, the CDC stated 'You should wait a minimum of 14 days after administering the mRNA COVID-19 vaccine series to give a patient Shingrix. Alternatively, if a patient just received Shingrix, you should wait a minimum of 14 days before giving them the mRNA COVID-19 vaccine series.'
Healthcare providers should defer vaccination for patients with suspected or confirmed COVID-19, regardless of symptoms, until the patient has met the criteria for discontinuing isolation, says the CDC.
The U.S. FDA Safety Communication issued a notice on March 24, 2021, to inform the public and healthcare providers that FDA has required and approved safety labeling changes to the Prescribing Information for Shingrix (Zoster Vaccine Recombinant, Adjuvanted) based on post-marketing experience. The revised label includes Guillain-Barré Syndrome (GBS) in the "Warnings and precautions" section.
On February 25, 2021, meeting of the US Centers for Disease Control and Prevention Advisory Committee on Immunization Practices, the Herpes Zoster Work Group presented results of a comprehensive risk-benefit analysis of SHINGRIX that included a review of post-marketing data. The analysis concluded that GBS is rare, and data on GBS risk following HZ (herpes zoster or "shingles") and vaccination are limited. However, clinical trials, observational studies, and risk-benefit analysis confirm the considerable benefits of RZV (SHINGRIX) vaccination in preventing HZ, severe disease, and complications.
A case series cohort study published by the JAMA Internal Medicine on November 1, 2021, found an increased risk of Guillain-Barré syndrome during the 42 days following RZV vaccination in the seniors: about three excess GBS cases per million vaccinations. Clinicians and patients should be aware of this risk while considering the benefit of decreasing the risk of herpes zoster and its complications through an efficacious vaccine, as a risk-benefit balance remains in favor of vaccination.
Shingrix Shingles Vaccine Billing Codes
SHINGRIX has broad insurance coverage for patients. The CPT Code (Product): 90750. Additional codes are found at this GSK link. The GSK Vaccines Reimbursement Support Center is a resource for physicians, physician office staff, and pharmacists to address billing, coding, and reimbursement for GSK vaccines.
Shingrix Shingles Vaccine News
December 28, 2021 - The Swiss Medical Weekly published an ORIGINAL ARTICLE - Complications and cost estimations in herpes zoster – a retrospective analysis at a Swiss tertiary dermatology clinic. CONCLUSION: In this herpes zoster population at a university hospital, one in three patients was affected by herpes zoster-related complications. Age and cancer were independently associated with a high complication rate, suggesting a need to vaccinate cancer patients. Herpes zoster-related complications and the need for inpatient treatment escalated the costs per case.
December 9, 2021 - AARP published: Common but Misunderstood: 6 Myths About Shingles.
December 1, 2021 - Harvard Health reported unvaccinated people who get shingles for the first time should still receive Shungrix to reduce their risk of future attacks, says a study published Sept. 1, 2021, in the Journal of the American Academy of Dermatology.
November 25, 2021 - GlaxoSmithKline Inc. announced that the SHINGRIX vaccine had been approved in Canada for the prevention of shingles in adults aged 18 years and older who are or who will be at increased risk of shingles due to immunodeficiency or immunosuppression caused by known disease or therapy. Immunocompromised individuals are at greater risk of shingles and associated complications than immunocompetent individuals.
November 24, 2021 - Local media in Canada reported the Shingrix vaccine will be available to Prince Edward Islanders who are 65 and older for free beginning in January 2022.
November 1, 2021 - The JAMA Network published an Original Research: Risk of Guillain-Barré Syndrome Following Recombinant Zoster Vaccine in Medicare Beneficiaries. In an observational study of Medicare beneficiaries, a medical record-based, self-controlled analysis of GBS cases after RZV vaccination identified a rate ratio of 2.84 between the risk and control windows, resulting in an attributable risk of 3 cases per million RZV (Shingrix) doses. This means these findings suggest that there is an increased risk of developing GBS following vaccination with RZV.
October 27, 2021 - GSK announced Shingrix revenues reached £502 million, representing a +41% CER.
October 20, 2021 - GlaxoSmithKline plc announced that the US CDC Advisory Committee on Immunization Practices voted unanimously to recommend two doses of Shingrix for the prevention of shingles and its complications in adults 19 years of age and older who are or will be immunodeficient or immunosuppressed due to disease or therapy.
October 20, 2021 - The U.S. CDC vaccine committee presented a Herpes Zoster Introduction and its Workgroup Recommendation.
September 29, 2021 - The U.S. CDC ACIP committee presented various overview slides during its meeting.
September 2, 2021 - Shingrix has been licensed in the UK to prevent shingles in adults aged 50 years and older, as well as in adults 18 years of age or older who are at increased risk of shingles. The vaccine will be available for eligible adults to purchase via pharmacy chains, private GP clinics, and other healthcare settings in the UK. In addition, GPs should offer the non-live shingles vaccine Shingrix to all those who are eligible for shingles vaccination but who are clinically contraindicated to receive the live vaccine Zostavax due to their immunocompromised status.
September 1, 2021 - Karen Mullen, Medical Director UK & Ireland, GSK, stated: "The risk of shingles increases with age as the immune system gradually becomes less effective in mounting a strong response to infection. Shingrix was developed specifically to overcome this decline in immune function and help protect people as they get older. We are pleased that people in the UK will now have access to this vaccine to help reduce the burden of this painful disease."
July 28, 2021 - GSK reported its financial results. Shingrix declined by 9% AER but grew 1% CER to £295 million. Growth from launches in the UK and China was mostly offset by a decline in Germany, where COVID-19 related restrictions and prioritization of COVID-19 mass vaccination limited Shingrix uptake. In the US, increased market demand in the current quarter was offset by favorable prior period returns and rebates movements and channel stocking in the comparator quarter.
July 26, 2021 - GSK announced Shingrix is now FDA approved in the USA to prevent shingles in immunocompromised adults. Thomas Breuer, Chief Medical Officer, GSK Vaccines, stated in a press statement, "Older age and being immunocompromised are the most common risk factors for shingles disease. GSK is committed to this important patient population at increased risk for shingles disease and its complications by bringing them a vaccine option that can help prevent this painful condition."
June 25, 2021 - Grace Lee, M.D., MPH, led the ACIP Herpes Zoster Work Group overview presentation; Zoster Vaccines Session: Burden of Herpes Zoster in Immunocompromised Adults: Policy question: "Should vaccination with RZV be recommended for immunocompromised adults 19 years of age and older?" Then, Robyn Widenmaier, GSK's Global Medical Portfolio Lead, Zoster Vaccine, led this discussion regarding the Use of Recombinant Zoster Vaccine in Immunocompromised Populations.
April 28, 2021 - GSK reported quarterly sales of Shinrix decreased by about 47%.
March 24, 2021 - The FDA required GlaxoSmithKline, the manufacturer of Shingrix, to revise the Prescribing Information to include the following language in the Warnings and Precautions section: In a post-marketing observational study, an increased risk of Guillain-Barré syndrome was observed during the 42 days following vaccination with Shingrix. In addition, the association between vaccination with Shingrix and GBS was evaluated among Medicare beneficiaries aged 65 years or older.
February 25, 2021 - U.S. CDC ACIP Meeting presentation: Summary of the Herpes Zoster Work Group's Interpretation of Recombinant Zoster Vaccine Safety Data.
February 9, 2021 - WebMD reported searches for the term "covid shingles" were recently searched. "There is no scientific evidence of this [association]," says Aaron Glatt, MD, chief of infectious diseases at Mount Sinai South Nassau in Oceanside, NY, and a spokesperson for the Infectious Diseases Society of America.
February 4, 2021 - GlaxoSmithKline plc reported fourth-quarter 2020 sales from the Vaccines segment were up 16% at CER, driven by the strong recovery in demand for Shingrix: sales rose 23% reported quarter, driven by strong demand in Europe.
January 13, 2021 - The UK's Public Health England update stated: People aged 70 years of age are eligible for the vaccine. By having the vaccination, you will significantly reduce your chance of developing shingles. In fact, in the first three years since the vaccine was introduced, there were about 17,000 fewer GP consultations for shingles. And, if you do go on to have shingles, the symptoms are likely to be milder and the illness shorter than if you had not had the vaccination. Like all licensed vaccines, the shingles vaccine has been thoroughly tested and meets the UK and European safety and licensing requirements. It has been used extensively in several countries, including the United States of America and Canada. In the first four years of the shingles vaccination program, more than 2.3 million people were vaccinated in England.
December 14, 2020 - Most Medicare beneficiaries who received an initial dose of the Shingrix vaccine received the second dose within six months. Still, follow-up rates were lower among beneficiaries in communities of color, those who are younger than age 65 with long-term disabilities, and low-income beneficiaries. Most (74%) Medicare beneficiaries who received an initial dose of Shingrix between January and June 2018 received the second dose within six months. Conversely, 1 in 4 beneficiaries (26%) who received an initial dose of Shingrix between January and June 2018 did not receive the second dose within the recommended timeframe. An additional 6% of beneficiaries received the second dose after the 6-month timeframe but no later than the end of 2018. This analysis is based on 2018 Medicare Part D prescription drug event claims data from a 20% sample of Medicare beneficiaries from the Centers for Medicare & Medicaid Services Chronic Conditions Data Warehouse. Our analysis includes 0.8 million Part D enrollees enrolled for the entire 2018 calendar year and received an initial shot of Shingrix between January and June of 2018.
January 4, 2021 - The U.S. CDC updated its Shingrix frequently asked questions webpage for health care providers with guidance on shingles vaccination during the COVID-19 pandemic. Shingles vaccination is an essential preventive care service for older adults that should not be delayed or discontinued because of the COVID-19 pandemic unless a patient is suspected or confirmed to have COVID-19.
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 its message around a straightforward statement: "Shingles Doesn't Care." They tell 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 publicly funds a shingles vaccine for Yukoners between the ages of 65 and 70, the vaccine's age 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. Brought to You By Vaccines, the campaign will educate adults ages 50 and older about vaccines' value 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+) vaccinated rose from 6.7% in 2008 to 34.5% 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.
April 16, 2020 - The National Advisory Committee on Immunization has recommended LZV as a standard vaccine for HZ prevention in adults ≥ 50 years of age. Still, no studies directly comparing the safety and efficacy of RZV and LZV vaccines have been conducted. This article reviews the brief history, efficacy, and safety of the two vaccines and discusses the advantage of RZV over LZV based on the available literature.
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 new shingles vaccine's availability is improving across the Military Health System. 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 the Use of Herpes Zoster Vaccines.
Shingrix Shingles Vaccine Clinical Trials
Since October 20, 2017, the U.S. FDA Approved zoster vaccine recombinant, adjuvanted (Shingrix, GlaxoSmithKline Biologicals) to prevent herpes zoster in adults aged ≥ 50 years. 'GSK remains confident in the favorable benefit-risk profile of SHINGRIX for the prevention of shingles. We will continue to communicate with FDA and CDC on post-marketing safety monitoring for SHINGRIX.'