Other Claims Made In The Zostavax Lawsuits
Patients and physicians have alleged many issues associated with the production and distribution of Zostavax. Specific violations named in the 191-page complaint include:
- Breach of express and implied warranty
- Conscious and negligent misrepresentation involving risk of physical harm
- Defective product design
- Unjust enrichment
- Strict liability.
The plaintiffs attorneys also filed for punitive damages claiming that the defendants had intentionally avoided FDA recommendations and have been repeatedly reprimanded by the FDA regarding marketing tactics.
Administering And Storing Shingrix
- Adults 50 years and older should receive 2 doses of Shingrix. Give the second dose 2 to 6 months after the first.
- Administer Shingrix intramuscularly in the deltoid region of the upper arm with a 1- to 1.5-inch needle.
- Both vials of Shingrix must be refrigerated at a temperature of 36-46° F. Do not use if exposed to temperatures below 36° F.
Related: Gsks New Shingles Vaccine May Win Nod Over Mercks Zostavax
We are absolutely thrilled to get to this point because the science behind this vaccine offers tremendous potential for helping patients, protecting them against getting shingles and its complications, said Dr. Leonard Friedland, vice president for scientific affairs and public health for GSKs North American vaccines unit.
Shingles is a delayed complication of chickenpox, a highly infectious disease most children suffered through in the era before the chickenpox vaccine was developed.
People who have had chickenpox harbor the varicella zoster virus the bug that causes the disease in their bodies after infection.
Healthy immune systems keep the virus in a dormant state. But people who have weakened immune systems, either because of an illness or because the immune system declines with age, can develop shingles.
The condition typically manifests as a painful, itchy rash, either on one side of the torso or one side of the face. The blisters can lead to ulcers and scars.
Theres nothing good about shingles, said Dr. Anne Louise Oaklander, a shingles expert who is director of the nerve unit at Massachusetts General Hospital.
And it can be quite bad. In the worst cases, people may not be able to put their clothing on. And it can leave ulcers and scars.
Shingles can also lead to strokes, vision and hearing loss, and other complications, Oaklander said.
Read Also: What Is Shingles Vaccine Called
Can It Cause Side Effects
Like every vaccine, Shingrix has the potential for side effects, although so far, none seem particularly worrisome. The new shingles vaccine does appear to be more likely to cause pain during injection and at the site of injection for up to three days afterward than Zostavax does.
In clinical trials, the side effects also included injection site redness and swelling, muscle pain, and immune system responses such as headache, shivering, fever, and upset stomach. Most, according to GlaxoSmithKline, its manufacturer, lasted less than three days.
Though Shingrix was tested on some 16,600 adults in clinical trials, its real-world use has been limited. The company will be conducting additional safety and efficacy studies over the next few years, and the CDC will be monitoring any adverse events that are reported.
As with any drug thats approved on the basis of studies in only thousands, in contrast to millions after approval, strict post-marketing surveillance studies have to be agreed upon, with severe penalties for irregularities, says CRs Lipman.
When Should I See A Doctor Because Of The Side Effects I Experience From Shingrix
Shingrix causes a strong response in your immune system, so it may produce short-term side effects. These side effects can be uncomfortable, but they are expected and usually go away on their own in 2 or 3 days. You may choose to take over-the-counter pain medicine such as ibuprofen or acetaminophen. Contact your healthcare provider if the symptoms are not improving or if they are getting worse.
In clinical trials, Shingrix was not associated with serious adverse events. In fact, serious side effects from vaccines are extremely rare. For example, for every 1 million doses of a vaccine given, only one or two people might have a severe allergic reaction. Signs of an allergic reaction happen within minutes or hours after vaccination and include hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness, or weakness. If you experience these or any other life-threatening symptoms, see a doctor right away.
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Research Into Mrna Vaccines For Shingles
Several companies are researching the potential use of mRNA vaccines for shingles. Pfizer and BioNTech are partnering on an mRNA shingles vaccine just as they did with vaccines for the flu and COVID-19.
A major advantage to the technology is the ability to develop new vaccines quickly. The fact that mRNA vaccines are synthetic and dont rely on actual virus particles also means they can be quickly produced in large numbers.
While the Shingrix vaccination is considered safe, the FDA has confirmed a link between Shingrix and Guillain-Barre Syndrome. Phasing out the old vaccine with the introduction of a new one, as the FDA did when Shingrix replaced Zostavax, might eliminate this potential issue.
Pfizer and BioNTech hope to begin clinical trials later this year.
Obstacles To Getting Vaccinated
Despite the fact that the small, but vocal, group of individuals who oppose vaccinations remains strong, Jain says she hasnt encountered much opposition to getting vaccinated among her patients.
A lot of patients will actually come to me asking how they can get the shingles vaccination, so I actually have experienced the opposite, she said. Theres a very small percentage of patients, Id say under 10 percent, that are very averse to getting vaccinations, though.
Jain said that with these patients, their concerns often center around possible adverse effects from the vaccination, fears that theyll contract shingles by getting the vaccination, or the belief that since theyve never had the illness, they dont need the vaccine.
Another big concern that patients have is cost, Jain told Healthline in March 2018. Zostavax cost $213, and Shingrix costs about $280 out of pocket.
Prices have fluctuated slightly in 2019, with Shingrix at $185 per injection (.
She explained that even insurance or Medicare coverage doesnt solve the problem.
The issue is that Medicare Part B is not covering it, Medicare Part D is covering part of it, and Medicaid may or may not cover it it really depends on the insurer and the insurance plan, she said. So, I think cost is also a big barrier for patients as well.
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For Media And Investors Only
Issued: Philadelphia, London
GlaxoSmithKline plc today announced that the US Food and Drug Administration has approved Shingrix 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.
Shingrix, a non-live, recombinant sub-unit adjuvanted vaccine, given intramuscularly in two doses, was initially approved by FDA in 2017 for the prevention of shingles in adults 50 years of age or older. Shingrix is not indicated for prevention of primary varicella infection . The approval for this new population expands the number of people who can be protected against shingles by Shingrix.
Were proud to offer Shingrix in the US for the prevention of shingles in those who are immunocompromised, with FDA granting a broad indication for use in adults at increased risk of this disease, said Thomas Breuer, Chief Medical Officer, GSK Vaccines. 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.
Vaccine Safety And Side Effects
Vaccines are very safe, and they can help keep you from getting serious or life-threatening diseases. The most common side effects for all these vaccines are mild and may include pain, swelling, or redness where the vaccine was given.
Before getting any vaccine, talk with a doctor or pharmacist about your health history, including past illnesses and treatments, as well as any allergies. A health care provider can address any concerns you have.
Its a good idea to keep your own vaccination record, listing the types and dates of your shots, along with any side effects or problems.
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Can You Get Shingles After Youve Been Vaccinated
While the shingles vaccine is highly effective, some people can still get shingles. However, people who do get shingles after getting the shingles vaccine usually have milder symptoms and a shorter illness. Youll also be less likely to have complications from shingles, including postherpetic neuralgia.
Also Check: Can You Get The Shingles Vaccine Before Age 50
Does The Shingles Vaccine Contain Thimerosal
You may be concerned about additives to the shingles vaccine, like thimerosal.
Thimerosal is a preservative that contains mercury. Its added to some vaccines to prevent bacteria and other germs from growing in them. The shingles vaccine contains thimerosal.
The worry about thimerosal arose when early research linked it to autism. This connection has since been found to be untrue.
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More Information On Side Effects
Reactions listed under possible side effects or adverse events on vaccine product information sheets may not all be directly linked to the vaccine. See Vaccine side effects and adverse reactions for more information on why this is the case.
If you are concerned about any reactions that occur after vaccination, consult your doctor. In the UK you can report suspected vaccine side effects to the Medicines and Healthcare products Regulatory Agency through the Yellow Card Scheme . See more information on the Yellow Card scheme and monitoring of vaccine safety.
How Well Does Shingrix Work
Two doses of Shingrix provide strong protection against shingles and postherpetic neuralgia , the most common complication of shingles.
- In adults 50 to 69 years old with healthy immune systems, Shingrix was 97% effective in preventing shingles in adults 70 years and older, Shingrix was 91% effective.
- In adults 50 years and older, Shingrix was 91% effective in preventing PHN in adults 70 years and older, Shingrix was 89% effective.
- In adults with weakened immune systems, Shingrix was between 68% and 91% effective in preventing shingles, depending on their underlying immunocompromising condition.
In people 70 years and older who had healthy immune systems, Shingrix immunity remained high throughout 7 years following vaccination.
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Who Should Get Shingles Vaccine
Shingrix is a recommended vaccine for all adults age 50 years and older. In addition, everyone 19 years and older who have a weak immune system are now recommended to get Shingrix. Please talk with your primary care provider to see if you are eligible to get Shingrix. You can get this vaccine even if you have had shingles, previously received varicella vaccine or if you don’t know if you have had chickenpox in the past.
You can get a shingles vaccine if you have a minor illness, such as a cold. But if you are severely ill or have a temperature above 101.3 degrees, wait until you recover before getting shingles vaccine.
Considerations For Patients Who Previously Received Zostavax
Studies have not examined the safety and immunogenicity of Shingrix administered less than 5 years following Zostavax vaccination. However, there are no data or theoretical concerns to indicate that Shingrix would be less safe or less effective when given at an interval shorter than 5 years following Zostavax. Since the risk of herpes zoster increases with age, providers should weigh a patients risk of herpes zoster with the age-specific protection expected from Zostavax to determine when to vaccinate with Shingrix.
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Us Committee Recommends Gsk Shingles Vaccine Over Merck Rival
2 Min Read
LONDON – The committee responsible for U.S. vaccination schedules has given a preferential recommendation to GlaxoSmithKlines newly approved shingles vaccine Shingrix over Merck & Cos established product Zostavax.
The endorsement, by a 8-7 vote, promises to boost Shingrix sales and confirm its potential as a product with multibillion-dollar sales potential.
The backing from the Centers for Disease Control and Preventions Advisory Committee on Immunization Practices follows evidence from clinical trials that Shingrix is significantly more effective than Zostavax, the only currently available shingles prevention vaccine.
ACIP members also recommended that Shingrix should be given routinely to Americans aged over 50 years, compared with 60 years for Zostavax, and they supported revaccination of people who previously received Zostavax.
The new recommendations mean up to 62 million more adults in the United States should be immunized, approximately 42 million aged 50-59 years old and 20 million who have previously been vaccinated against shingles, according to GSK.
Analysts currently forecast Shingrixs annual sales will reach 1.03 billion pounds in 2023, a figure that could rise in light of the positive U.S. recommendations.
However, the British drugmaker, which also reported quarterly results on Wednesday, cautioned it would take time to build up prescription coverage.
GSKs vaccine is given in two doses, while Zostavax needs only a single dose.
Shingrix Shingles Vaccine For 2022
GlaxoSmithKline plc Shingrix is a non-live, adjuvanted recombinant shingles vaccine 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. Shingrix has been commercially available since 2017.
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 human immune systems as people age, which increases the risk for shingles.
On February 25, 2021, U.S. CDC Advisory Committee on Immunization Practices 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, observational studies, and risk-benefit analysis confirm the considerable benefits of RZV vaccination in preventing HZ, severe disease, and complications. And 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.
London, England-based GlaxoSmithKline is the producer of Shingrix. GSK’s top priority is patient safety.
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What Else To Know About The Shingles Vaccine
Ready to get vaccinated? This is the essential info on how the shots are given, what to expect with side effects, and more.
You need two doses of Shingrix to get full protection from shingles. You should get your second dose 2 to 6 months after the first. Your doctor or pharmacist will inject the vaccine into the muscle of your upper arm, so wear clothes that give easy access to that area.
If it has been more than 6 months since you got your first dose, go ahead and get your second dose. You donât need to start over, Dooling says.
Because Shingrix is so new, experts arenât sure whether youâll eventually need another shot, or a booster, years down the road.
âThe CDC is actively following how protected people remain after the two-dose series,â she says. We know that after 4 years, protection remains above 85%. Only time will tell how durable that protection is.â
You do not have to wait between Shingrix and COVID-19 vaccination. The CDC has determined its safe to get the COVID-19 vaccine at the same time as Shingrex, but recommends they be given in different arms. You should not get eithe vaccine if you have COVID.
Side effects are fairly common. You may have heard that people sometimes have unpleasant side effects soon after they get the shingles vaccine.
âShingrix tends to have has more side effects than some vaccines, like those for the seasonal flu,â says Kistler. The shingles vaccine may cause:
Before Taking This Medicine
You should not receive Shingrix if you have ever had a life-threatening allergic reaction to inactivated zoster virus vaccine.
Tell your doctor if:
-
you have ever had an allergic reaction to any vaccine or
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you have fainted after receiving an injection.
Tell your doctor if you are pregnant or breastfeeding.
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What Everyone Should Know About The Shingles Vaccine
Shingles vaccination is the only way to protect against shingles and postherpetic neuralgia , the most common complication from shingles.
CDC recommends that adults 50 years and older get two doses of the shingles vaccine called Shingrix to prevent shingles and the complications from the disease. Adults 19 years and older who have weakened immune systems because of disease or therapy should also get two doses of Shingrix, as they have a higher risk of getting shingles and related complications.
Your doctor or pharmacist can give you Shingrix as a shot in your upper arm.
Shingrix provides strong protection against shingles and PHN. In adults 50 years and older who have healthy immune systems, Shingrix is more than 90% effective at preventing shingles and PHN. Immunity stays strong for at least the first 7 years after vaccination. In adults with weakened immune systems, studies show that Shingrix is 68%-91% effective in preventing shingles, depending on the condition that affects the immune system.
Why A New Shingles Vaccine
Did we need a new shingles vaccine? To answer that question, it helps to have a bit of background on this infection.
Shingles, which is also called herpes zoster, occurs when the chickenpox virus , which is dormant in those whove had the illness, reawakens later in life. Almost all adults older than 40 carry the chickenpox virusand the older we get, the more the risk of getting shingles climbs. According to the CDC, the infection strikes about 1 million people in the U.S. each year and nearly one in three adults will experience a bout of shingles in their lifetime.
The two to four weeks of shingles, marked by symptoms such as a blistery and painful rash on one side of the body, can be difficult enough. But about one in five people with shingles go on to develop postherpetic neuralgia, or PHN, which is nerve pain that can linger for months or even years.
Since 2006, weve had Zostavaxapproved for those between 50 and 59 but recommended by the CDC for adults 60 and olderas the sole bulwark against shingles. Zostavax offers 70 percent protection against shingles for people between 50 and 59 but only 18 percent in people 80 and older, according to the Pink Sheet, which reports on the pharmaceutical industry.
When all ages are taken into consideration, Zostavax cuts the chance of shingles by only 51 percent and the risk of PHN by 67 percent.
Shingles is a big problem with immunocompromised people, Schaffner says.
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