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Home / Health / The vaccine side effects of shingles are mostly mild, says CDC

The vaccine side effects of shingles are mostly mild, says CDC



Shingrix, which was manufactured by GlaxoSmithKline and approved by the US Food and Drug Administration in October 2017, is recommended for adults over the age of 50 to prevent shingles, a painful rash that affects every third American in his life is affected. It is a non-live vaccine, shot in the humerus and given in two doses every two to six months.
Received a total of 4,381 adverse event reports during the first eight months following the launch of Shingrix, the Vaccine Adverse Event Reporting System or VAERS; 130 of them were serious.

For every 100,000 dose distributed, the CDC found 136 complaints submitted to the system. During the eight-month reporting period analyzed by the CDC, approximately 3.2 million doses were distributed by GlaxoSmithKline.

  CDC recommends a new shingles vaccine to replace the older

Fever, chills and pain and swelling and redness in the arm that received the shot were common side effects.

Seven more patients died within six hours to six weeks after receiving Shingrix, the CDC said. The cause of four of these deaths was cardiovascular disease (three of the individuals had multiple cardiac risk factors). Two were immunosuppressed patients who died of sepsis. And an 86-year-old woman died after falling. v A fourth death after using Shingrix has also been reported to VAERS, although this has not been confirmed by the CDC.

Dr. Elisabeth M. Hesse, lead author of the report and doctor at the CDC Office of Immunization Safety, wrote in an e-mail that "no information in medical records [any of] has been made that the reported deaths are related to the vaccine."

Another 196 patients (4.5% of the system reports) reported developing shingles after the shot, although CDC showed that 14 of these patients had the pre-vaccination rash. And just over 1% or 49 people had burning pain as a result of the shot. According to CDC, six cases already existed.

In total, 230 vaccine errors occurred, mostly when the healthcare provider shot the vaccine under the skin and not into the muscle as stated by the manufacturer. Shingrix is ​​also supplied in two vials that need to be combined, and in some cases the vendor could not mix the content before the shot was administered.

Overall, the CDC found that none of the side effects reported for Shingrix were "disproportionate to the occurrence of other adverse events in other vaccines" in the VAERS system. "Healthcare providers and patients can be reassured," as results from early safety surveillance CDC authors wrote, "Serious adverse events were rare and no unexpected patterns were found."

However, in a CDC analysis of clinical trial data, Dr. Kathleen Dooling of the Department of Viral Diseases stated that approximately 1 in 6 patients receiving Shingrix reported reactions severe enough to prevent normal activity, while three out of four patients experienced at least some pain, and Dooling also noted that the vaccine protects more than 90% against shingles. [19659003] Hesse said manufacturers are committed to VAER S "Report all adverse events reported to you for each vaccine." Similarly, after the vaccine, healthcare providers must report some adverse reactions and, in addition, be prompted to report "clinically important or unexpected events (even though they are not sure whether the vaccine has triggered the event), "she said.

It noted that the Rotashield vaccine for infants had been withdrawn following reports to VAERS of bowel obstruction and an investigation confirming these allegations.

Administrative disorders in addition to side effects

Dr. Carla Perissinotto, associate professor and deputy clinical director of the Department of Geriatrics at the University of California, San Francisco, wrote in an e-mail that few patients received the vaccine because of the complexity of Medicare's reimbursement.

"You must bill the patient and then submit Medicare," said Perissinotto, who was not involved in the new CDC report. For clinics it is "administratively" difficult to keep Shingrix and then settle Medicare.

Following discussions with "the few of my colleagues" who have experience with the Shingles vaccine, she believes that Shingrix has not caused any serious or numerous side effects: "So far, it seemed well tolerated."

"We would use more if the payment structure was simpler, which means that many of our patients who would benefit from it will not get what they need."

Dr. Alison Moore, head of geriatrics and gerontology at UC San Diego Health, said in an email to CNN that she regularly recommends the vaccine for its efficacy and "superiority over the earlier version of the [shingles] Zostavax vaccine," a CDC live recommendation vaccine for adults over 60 years.

Because Shingrix is ​​not a live vaccine, "more people can have it," added Moore, who was not involved in the CDC report.

"I've found that patients can not have a reaction, a mild reaction that can include redness and warmth and mild pain at the site of injection, as well as more severe reactions such as fever, chills, and discomfort, a type of flu-like illness lasts one day," said Moore. She has seen reactions occur at either the first or second shot. Despite the side effects, she still recommends the vaccine, she said, though she warns patients and recommends that they take an acetaminophen or ibuprofen drug to reduce their effects.

Sean Clements, a spokesman for GlaxoSmithKline, wrote in an e-mail that "as is usual with all vaccines," his company, along with the CDC and the FDA, will continue to monitor safety.

"About seven million doses of Shingrix were distributed by September 2018, and preliminary data show that approximately 76 percent of people have completed the double-dose series," Clements wrote.


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