Outcome Definitions And Follow
Our primary outcome was community HZ, defined by a claim in the OP or PB setting with an International Classification of Diseases, Tenth Revision, Clinical Modification diagnosis code for HZ in any position with a claim for HZ-specific antiviral , identified using NDCs, within 7 days of diagnosis. As a sensitivity analysis, we used this same clinical definition without requiring a prescription for antivirals. As secondary outcomes, we evaluated community ophthalmic zoster and PHN. We defined community OZ by a claim in the institutional OP or PB setting with an ICD-10 diagnosis code for OZ in any position , combined with a claim for a prescription for HZ-specific antivirals within 7 days of diagnosis. We defined PHN in the 90180 days after HZ onset using a modified version of the PHN algorithms from Klompas et al and Klein .
Follow-up continued until occurrence of any of the following: a subsequent claim for a third dose of RZV death termination of Medicare Parts A/B or D coverage or enrollment into Part C admission to a nursing home, skilled nursing facility or hospice occurrence of either HZ, OZ, or PHN or end of the study period.
Shingles Vaccine Lawsuit Update
Our law firm is handling Zostavax and Shingrix vaccine lawsuits. These vaccines were intended for the prevention of herpes zoster which is more commonly known as the shingles virus.
These herpes lawsuits allege that the shingles vaccine was unsafe for patients. The key injury, incredibly, is that the Zostavax shingles vaccine causes shingles and zoster-related injuries. So the very thing meant to protect them against shingles actually caused shingles.
The Zostavax shingles suits make a lot of allegations against Merck. Many of the extraneous claims have already been dismissed. Lawyers make a lot of claims when they file lawsuits like this, sometimes too many. But the core of it is plaintiffs attorneys allege that Merck knew or should have known of the risks and reactions associated with their product.
Because Merck knew of the risks, it had a legal obligation to provide warnings. These should have fairly and accurately depicted the severity of the risks associated with the Zostavax. This is particularly true because there were better options available than Zostavax on the market.
- Speculation about Zostavax claims settlement value based on the value of similar types of cases and injuries
- Shingrix recall
The Shingles Virus The New Jersey Lawsuit
This lawsuit filed in New Jersey alleges that nearly 1,000 victims took Zostavax vaccine to avoid shingles, but instead developed a recurring strain of herpes zoster, which is more difficult to treat than usual.
Zostavax MDL Update
How Cdc Monitors Vaccine Safety
CDC and FDA monitor the safety of vaccines after they are approved or authorized. If a problem is found with a vaccine, CDC and FDA will inform health officials, health care providers, and the public.
CDC uses 3 systems to monitor vaccine safety:
- The Vaccine Adverse Event Reporting System : an early warning system, co-managed by CDC and FDA, to monitor for potential vaccine safety problems. Anyone can report possible vaccine side effects to VAERS.
- The Vaccine Safety Datalink : a collaboration between CDC and 9 health care organizations that conducts vaccine safety monitoring and research.
- The Clinical Immunization Safety Assessment Project: a partnership between CDC and several medical research centers that provides expert consultation and conducts clinical research on vaccine-associated health risks.
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How Is The Shingles Vaccine Made
The shingles vaccine available in the U.S., Shingrix®, contains a single protein from the surface of herpes zoster virus as well as two adjuvants: QS21 and monophosphoryl lipid A. QS21 is a soap-based molecule isolated from the bark of the Quillaja saponaria tree. Monophosphoryl lipid A is a detoxified form of lipopolysaccharide, a potent adjuvant taken from the surface of common bacteria.
The first shingles vaccine, called Zostavax®, is no longer available in the U.S. However, this version contained a more concentrated version of the same live, weakened virus as the current chickenpox vaccine. It contained about 14 times the amount of weakened chickenpox virus than the vaccine for children. This amount of virus was necessary to obtain a protective response in the aging immune systems of older adults. The introduction of Shingrix vaccine was important because adjuvants in the vaccine improved immune responses in older adults and decreased the need to use large quantities of the live, weakened virus also necessary to make chickenpox vaccine. For these two reasons Zostavax is no longer available in the U.S.
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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Are There Any Side Effects Of Taking The Shingles Vaccine
As with any medication or vaccine, the shingles vaccine has possible side effects. The shot helps your body develop an immune defense against shingles. Any side effects you might have are temporary and usually resolve within two to three days.
You might have side effects from the first shot, the second shot, or both shots. You can take an over-the-counter pain reliever like Advil or Tylenol .
Common side effects can include:
- Redness and swelling at the shot site
- Sore arm and mild to moderate pain
Guillain-Barré syndrome , a nervous system disorder, is a condition that has reported as developing, although rarely, after Shingrix. However, the risk of developing GBS also is slightly elevated if you get shingles.
Talk with a healthcare provider about the shingles vaccines possible risks and side effects and what to do if you experience any.
New Shingles Vaccine Over 90% Effective
Shingles is a painful rash on the skin that comes from the same virus that causes chickenpox.
Recently, shingles has made headlines because of a new vaccine that was approved in 2017: the recombinant zoster vaccine, or Shingrix.
According to the Centers for Disease Control and Prevention , two doses of the new vaccine are more than 90 percent effective at preventing shingles and its side effects.
Shingles is a painful, often debilitating rash that affects roughly 1 million people each year. Luckily, getting vaccinated can help you prevent it and stop shingles from spreading.
To help explain more about how shingles spreads and what it is, weve gathered key information from MedlinePlus and the National Institute of Neurological Disorders and Stroke.
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What Are The Risk Factors For Shingles
Anyone who has had chickenpox can get shingles. In the U.S., most adults had chickenpox when they were children, before the Food and Drug Administration approved the nations first chickenpox vaccine in 1995.
- Age. Shingles is most common in people older than 50.
- Having a weak immune system. Diseases such as HIV/AIDS can increase your risk of shingles.
- Undergoing cancer treatments. Radiation or chemotherapy may trigger shingles.
- Certain medications. Prolonged use of steroids, such as prednisone, and drugs that prevent the rejection of organ transplants can increase your risk of shingles.
How Does The Shingles Vaccine Work
The vaccine recommended for most people is a live vaccine called Zostavax. It contains a weakened chickenpox virus . It’s similar, but not identical, to the chickenpox vaccine.
People with a weakened immune system cannot have live vaccines. They will be offered a non-live vaccine called Shingrix. It activates the immune system but also contains an ingredient called an adjuvant, which helps to boost the response to the vaccine.
Very occasionally, people develop chickenpox following shingles vaccination . Talk to a GP if this happens to you.
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Allergic Reaction To Shingles Vaccination
There is a very small chance of a severe allergic reaction to the shingles vaccine, as there is with other vaccines.
Anaphylaxis is very serious and potentially life-threatening, but it can be treated. All healthcare staff that deliver vaccinations are trained in this. With prompt treatment, people fully recover from anaphylaxis.
Risk Of Bias Assessment
Pairs of reviewers independently appraised risk of bias in each study using the Cochrane risk of bias tool33 for randomised controlled trials and quasi-randomised controlled trials, the Newcastle Ottawa Scale34 for observational studies, and the Cochrane Effective Practice and Organisation of Care Risk-of-Bias Tool35 for non-randomised trials and quasi-experimental studies. Only reviewers experienced in using the tools were involved at this step. A third reviewer consistently resolved discrepancies.
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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.
What If There Is A Serious Problem
An allergic reaction could occur after the vaccinated person leaves the clinic. If you see signs of a severe allergic reaction , call 9-1-1 and get the person to the nearest hospital.
For other signs that concern you, call your health care provider.
Adverse reactions should be reported to the Vaccine Adverse Event Reporting System . Your health care provider will usually file this report, or you can do it yourself. Visit the VAERS website at www.vaers.hhs.gov or call 1-800-822-7967.VAERS is only for reporting reactions, and VAERS staff do not give medical advice.
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What Are The Possible Side Effects Of Shingles Immunisation
All medicines and vaccines can have side effects. Sometimes they are serious, most of the time theyre not.
For most people, the chance of having a serious side effect from a vaccine is much lower than the chance of serious harm if you caught the disease.
Talk to your doctor about possible side effects of shingles vaccines, or if you have possible side effects that worry you.
Common side effects of shingles vaccines include:
- pain, redness, swelling or itching where the needle went in
Serious reactions to immunisation are rare. With Zostavax® vaccination, very rarely a generalised chickenpox-like rash may occur around 24 weeks after vaccination. This may be associated with fever and feeling unwell. This rash may be a sign of a serious reaction to the virus in the vaccine. Seek medical attention and inform of recent Zostavax vaccination if you experience this reaction.
New Shingles Vaccine: What You Need To Know
Nov. 13, 2019 — Unlike some vaccines, thereâs been so much demand for the new shingles vaccineShingrix that itâs not always easy to find. It was approved in 2017, and the CDC recommends the vaccine for adults 50 and older to prevent this painful, blistering illness. It is being used in place of the previous vaccine, Zostavax.
More than a year later, doctors say they are learning more about how it works, its safety risks, and how it compares to Zostavax.
How effective is Shingrix?
âIt’s just remarkable,” says Wilbur Chen, MD, an associate professor of medicine at the Center for Vaccine Development and Global Health, University of Maryland School of Medicine. “It has performed better than I expected.”
In studies, Shingrix was more than 97% effective at preventing shingles in people 50 and older. It works just as well in older adults, who are at greater risk for a painful shingles complication called postherpetic neuralgia . “When 70- and 80-year-olds get shingles, it can be extremely debilitating,” Chen says.
By contrast, Zostavax cuts the risk of shingles by only 51% and PHN by 67%. It’s only about 38% effective in people over age 70.
How safe is Shingrix?
“So far so good,” Schaffner says. The main side effect is soreness in the arm where you get the shot.
Other side effects are mild and usually last for 2 to 3 days, including:
Who shouldn’t get Shingrix?
Can I get the Shingrix vaccine now?
What do doctors still need to learn about Shingrix?
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Reasons To Get The Shingles Vaccine
Once a person develops chickenpox after contracting the varicella-zoster virus, the virus never leaves the body. It remains dormant in the nerve roots and can reappear as shingles later in life.
The primary symptom of shingles is a painful rash on one side of the body, most often on the torso or face. People initially have pain or a burning sensation on the skin without a rash, and then painful blisters develop. The rash lasts approximately seven to 10 days and fully clears within two to four weeks.
The likelihood of developing shingles increases dramatically after age 50. Therefore, the Centers for Disease Control and Prevention recommends that all adults age 50 and over receive two doses of Shingrix to prevent shingles. The vaccine is recommended even if a person is unsure if they have ever had chickenpox.
People with weakened immune systems are at higher risk for shingles. Therefore, the Food and Drug Administration also recently approved Shingrix vaccination for adults age 18 and older who are at risk for shingles due to immunodeficiency or immunosuppression caused by an underlying disease or medication.
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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What Should Immunocompromised Patients Know
Immunocompromised means that a persons body has:
Zostavax is a live virus, which means a weakened form of the shingles virus is injected into a patients body. Since an immunocompromised patient has difficulty combatting weakened forms of a virus, these patients may actually develop shingles.
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Know Your Risk Of Getting Shingles And Complications
About 1 out of every 3 people in the United States will develop shingles during their lifetime.
If youve had chickenpox, you are at risk for shingles. More than 99% of Americans born before 1980 have had chickenpox, even if they dont remember it.
Your risk of getting shingles and having serious complications increases as you get older.
About 1 in 10 people who get shingles develop nerve pain that lasts for months or years after the rash goes away. This is called postherpetic neuralgia and is the most common complication of shingles.
Shingles may lead to other serious complications involving the eye, including blindness. Very rarely, it can also lead to pneumonia, hearing problems, brain inflammation or death.
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Vaccination Can Prevent A Painful Shingles Infection
Shingrix, the newest shingles vaccine, is more than 90 percent effective in preventing shingles, post herpetic neuralgia and other associated complications. It has proven to be more effective than the previously used single-dose vaccine which was only 51 percent effective. A physician order is required but the vaccine itself can be administered at most retail pharmacies.
The vaccine is a two-shot series, with the second shot being given two to six months after the first. Doctors recommend that all adults 50 years and older, without contraindications, receive the vaccine, even if they have had shingles and/or received the previous one-dose vaccine.
Those who are immunocompromised or expect to be immunocompromised for example, those starting long-term steroid treatment or cancer treatment or preparing for organ transplant should be vaccinated earlier ideally 19 years of age or older.
Shingles Vaccine And Insurance
Private health insurance plans often cover vaccination costs. Still, a patient might have a charge depending on the specific insurance plan.
Medicaid may or may not cover the vaccine cost.Medicare Part D plans cover the shingles vaccine, but there may be a cost to the patient depending on the plan. Usually, the fees are less than $50 per dose.
Medicare Part B does not cover the shingles vaccine.
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Who Is At Risk From Chickenpox
Chickenpox is a common childhood infection. Usually, it’s mild and complications are rare.
Almost all children develop immunity to chickenpox after infection, so most only catch it once. It can be more severe in adults.
But some people have a higher chance of developing serious complications from chickenpox.
These include:
- people who have weakened immune systems through illnesses such as HIV or treatments like chemotherapy
Who Should Have The Chickenpox Vaccine
The vaccine is recommended for people who are not immune to chickenpox and are in close contact with people at risk of becoming seriously ill if they catch it.
For example, if you’re having chemotherapy, any children you’re in close contact with who are not immune to chickenpox should be given the chickenpox vaccine. This can reduce the risk of them getting the infection and spreading it to you.
The vaccine is also given to people who are not immune to chickenpox whose job puts them at risk of catching it.
This includes:
- healthcare workers who are not immune to chickenpox and are in contact with patients
- laboratory staff who are not immune to chickenpox and who may be exposed to chickenpox through their work
The vaccine is not given to people with a weakened immune system as it contains a small amount of the live virus that causes chickenpox.
The virus in the vaccine is weakened so it’s safe for most people, but it could make you ill if you have a weakened immune system.
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