Shingrix® Vaccine 2023
GlaxoSmithKline plc (GSK) 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 is up to 90% effective in various clinical trials, says GSK. On February 25, 2021, U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) Herpes Zoster Work Group presented the results of a comprehensive risk-benefit analysis of Shingrix that included a review of post-marketing data. The analysis of clinical trials and observational studies confirm the considerable benefits of Shingrix vaccination in preventing HZ, severe disease, and complications.
GSK announced on July 26, 2021, that the U.S. Food and Drug Administration (FDA) had approved Shingrix to prevent shingles in adults (18 years) at increased risk of shingles due to immunodeficiency or immunosuppression caused by known disease or therapy. The UK Health Security Agency confirmed in September 2021 that seniors with weakened immune systems would be offered the Shingrix vaccine to help protect them against shingles.
On October 20, 2017, the U.S. FDA authorized STN: 125614. The EMA issued EMEA/H/C/004336 on March 21, 2018. On August 18, 2021, Public Health England announced that 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. On April 24, 2023, GSL confirmed Shingrix was approved in India for adults aged 50 years and above.
The U.S. cumulative immunization rate grew from 30% at year-end 2022 to 32% at Q1 2023. Beginning September 1, 2023, about 900,000 adults in the United Kingdom became eligible for Shingrix vaccinations.
London, England-based GlaxoSmithKline is the producer of Shingrix. GSK's top priority is patient safety.
Shingrix Shingles Protection
GSK announced on October 19, 2022, interim data from a phase 3 clinical trial demonstrated overall efficacy of greater than 80% over the follow-up period of approximately six to 10 years after the initial vaccination. On January 21, 2022, the CDC's Morbidity and Mortality Weekly Report confirmed the Advisory Committee on Immunization Practices previously recommended two doses (0.5 mL each) for the prevention of herpes zoster and related complications in immunodeficient or immunosuppressed adults aged ≥19 years. In addition, the U.S. CDC published updated Shingrix vaccination schedules for 2022.
Shingrix Vaccine Price
In July 2023, the company announced Shingrix produced about $1.1 billion in sales during the second quarter of 2023, representing a 20% increase at constant exchange rates. In the U.S., sales declined 10%. Medicare covers the cost of Shingrix for eligible people. However, most commercial patients pay less than $50 per dose, says GSK. The U.S. CDC Vaccine Price List - $171 - was last updated in August 2022. Vaccine prices and discount information are posted at InstantRx™.
Shingrix Availability 2023
Shingrix is available in 33 countries in 2023, including India, Japan, and the U.K.
Shingrix Indication
Shingrix is a non-live vaccine for preventing shingles (herpes zoster). Shingrix is not used to avoid primary varicella infection (chickenpox). The U.S. FDA approved Shingrix on July 26, 2021, to prevent shingles at increased risk in adults 18 years and older 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 would benefit from a shorter vaccination schedule, the second dose can be administered 1 to 2 months after the first dose. 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.' In addition, the American Academy of Dermatology Journal reported that among people who had a first-time shingles attack, approximately 4% had another outbreak.
Shingrix Immunocompromised People
The recombinant zoster vaccine guidelines were updated on September 15, 2022. The re-administration dose of RZV should be administered 6-12 months after hematopoietic stem cell transplant (HSCT) if the transplant was allogeneic and 3-12 months after HSCT if the transplant was autologous. In addition, the CDC stated on Feb. 17, 2022, that the Shingrix vaccine is recommended for persons 19 years old and with altered immunocompetence. Vaccination of Contacts of Persons with Altered Immunocompetence Household contacts and other close contacts of persons with altered immunocompetence should receive all age- and exposure-appropriate vaccines, except for the smallpox vaccine.
During the U.S. CDC's 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 recommends two doses of recombinant zoster vaccine for adults aged ≥19 years who are immunodeficient or immunosuppressed due to disease or therapy to prevent herpes zoster and its complications.
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.'
GSK says people should not receive Shingrix if they are allergic to its ingredients or have had an allergic reaction to a previous dose of Shingrix.
Shingrix and COPD
The peer-reviewed Journal of the COPD Foundation® published Herpes Zoster Awareness and Vaccine Recommendations for Patients with COPD. Conclusions: Significant educational opportunities exist for HCPs related to HZ and its vaccine prevention among patients with COPD, which may be responsive to targeted interventions.
Shingrix Dosage
Shingrix 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 between 2 and 6 months. The Shingrix vaccine series is administered as an injection into the upper arm's muscle. Therefore, it is essential 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 Side Effects
The U.S. FDA Safety Communication issued a notice on March 24, 2021, to inform the public and healthcare providers that the 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. In addition, 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 seniors: about three excess GBS cases per million vaccinations. Therefore, 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.
In addition, the National Institute on Aging says, 'the shingles vaccine is safe and easy, and it may keep people from getting shingles and ongoing pain called postherpetic neuralgia.
Shingles and COVID-19
The Journal of Infectious Diseases published research on June 1, 2022, that concluded RZV vaccination was associated with a 16% lower risk of COVID-19 diagnosis and a 32% lower risk of hospitalization.
The journal Open Forum Infectious Diseases published a study on March 9, 2022, which found a COVID-19 diagnosis in 50-year-old people (+) was associated with a significantly increased risk (15% higher) of developing HZ. A previous peer-reviewed study using relative rates estimated that there had been an excess of approximately 5 and 7 cases of hospitalization due to herpes zoster after every 1 million doses of CoronaVac and BNT162b2 vaccination, respectively. A nested case-control analysis showed similar results. Finally, on February 16, 2022, a study found that mild and infrequent HZ reactions may occur shortly after mRNA COVID-19 vaccination, at a higher frequency than reported with influenza vaccination, especially in patients over 40.
Shingrix Billing Codes
SHINGRIX has broad insurance coverage for patients. The CPT Code (Product) is 90750. Additional codes are found at this GSK link. In addition, 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.
Shingles Herpes Zoster
Shingles, also known as herpes zoster (HZ), is a painful skin rash caused by reactivation of the varicella-zoster virus, which causes chickenpox, says the U.S. CDC. If you've had chickenpox, you are at risk for shingles. And
Shingrix News 2023
April 24, 2023 - GlaxoSmithKline Pharmaceuticals Ltd announced the launch of Shingrix in India.
November 26, 2022 - BMC Infectious Diseases published: Willingness to accept herpes zoster vaccines and the influencing factors in China. Vaccine hesitancy is multifaceted and might require multisectoral and multidisciplinary strategies to engage in conversations addressing public concerns.
October 19, 2022 - Sabine Luik, Chief Medical Officer & SVP of Global Medical Regulatory & Quality, GSK, said in a press release: "The findings from ZOE-LTFU demonstrate that (Shingrix) can provide a decade of protection against the pain, debilitating impact and potentially severe complications that shingles can cause in people aged 50 and over."
April 13, 2022 - The global shingles vaccine market is expected to reach USD 6.35 billion by 2028 and expand at a CAGR of 9.9% from 2021 to 2028.
March 14, 2022 - Australia's version of Shingrix became available on the private market to prevent shingles and postherpetic neuralgia in adults at increased risk of shingles.
November 25, 2021 - GlaxoSmithKline Inc. announced that the SHINGRIX vaccine had been approved in Canada to prevent shingles in adults aged 18 years and older who are or 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 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 an increased risk of developing GBS following vaccination with RZV.
October 20, 2021 - GlaxoSmithKline plc announced that the US CDC Advisory Committee on Immunization Practices voted unanimously to recommend two doses of Shingripreventingion 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 Workgroup Recommendation.
September 2, 2021 - Shingrix has been licensed in the UK to prevent shingles in adults aged 50 years and older and in adults 18 or older at increased risk of shingles.
July 26, 2021 - GSK announced that Shingrix is now U.S. FDA-approved to prevent shingles in immunocompromised adults.
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 Zvaccinesaccine in Immunocompromised Populations.
February 25, 2021 - U.S. CDC ACIP Meeting presentation: Summary of the Herpes Zoster Work Group's Interpretation of Recombinant Zoster Vaccine Safety Data.
May 22, 2019 - China's National Medical Product Administration (NMPA) announced the 'conditional approval' for Shingrix.
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.
January 26, 2018 - Recommendations of the CDC's Advisory Committee on Immunization Practices for the Use of Herpes Zoster Vaccines.
Shingrix Clinical Trials
ZOSTER-049 is an open-label, long-term follow-up study from two pivotal phase III randomized clinical trials (ZOE-50, ZOE-70). The evaluation evaluates the efficacy, safety, and immunogenicity for six additional years after completing the ZOE-50 and ZOE-70 studies. In the interim analysis conducted over four>4 years of long-term follow-up, representing up to 10 years since immunization (mean: from 5.6 (±0.3) to 9.6 (±0.3) years post-vaccination), vaccine efficacy was 81.6%. From 1 month post-second dose in those initial studies up to ten or ten post-vaccination (mean: 9.6 (±0.3) years post-vaccination), vaccine efficacy was 89.0%. The safety profile observed in this extension study is consistent with the established safety profile of the vaccine. No new safety concerns were identified. The incidence of serious adverse events was consistent with the age of the study population. No deaths or other Safety Adverse Events related to vaccination were reported. Five HZ-related complications (PHN - 3 cases and HZ disseminated disease - 2 cases) were reported.
A total of 7,413 participants were enrolled in the study's Safety cohort. The participants were 60.7% female. Participants were 76% White-Caucasian/European heritage, 18.7% Asian, and 5.3% Other.
ZOSTER-049 is being conducted in 18 countries/regions, including Australia, Brazil, Canada, Czech Republic, Estonia, Finland, France, Germany, Hong Kong, Italy, Japan, Republic of Korea, Mexico, Spain, Sweden, Taiwan, the United Kin,gdom and the U.S.
