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Shingles vaccine side effects are mostly mild, CDC says

Shingrix, manufactured by GlaxoSmithKline and approved by the US Food and Drug Administration in October 2017, is recommended for use in adults 50 and older to prevent shingles, a painful rash that affects one in three Americans during their lifetime. It is a live vaccine taken in the upper arm muscle and administered over two to six months.
In the first eight months of using Shingrix, the Vaccine Adverse Event Reporting System (VAERS) received 4,381 reports of adverse events; 130 of these were serious.

For every 100,000 doses given, the CDC found complaints in 136 systems. Approximately 3.2 million doses of GlaxoSmithKline were distributed over an eight-month reporting period analyzed by CDC.

CDC recommends the new shingles vaccine to replace the parent

Fever, chills and body pain, pain, swelling and redness in the hands of the shotgun were common side effects.

However, six patients died within six hours of six weeks after receiving Shingrix, CDC said. Four of these causes were cardiovascular disease (three of them had multiple heart risk factors). Two were immunosuppressed patients who died of sepsis. And after the fall, one 86-year-old woman died. v VAERS has also been reported to be eighth after using Shingrix, although not confirmed by CDC.

Dr Elisabeth M. Hesse, author of the report and medical officer at the CDC Immunization Security Bureau, wrote in an e-mail that "there is no information in the medical records [any of] reported deaths were related to vaccination. "

A further 196 patients (4.5% of system reports) reported that they had developed shingles after receiving a shot, although 14 of these patients had a rash prior to vaccination, according to the CDC. And just over 1% or 49 people shot the pain of burning; here, six of these cases were previously, CDC said.

In total, 230 vaccination errors occurred, mostly when the health care provider indicated from the manufacturer that the vaccine was under the skin rather than the muscle. Shingrix also comes in two vials to be combined, and in some cases the service provider was unable to confuse the content before injecting.

Overall, the CDC found that none of the reported side effects of Shingrix were "disproportionate to the adverse event reporting patterns observed with other vaccines" in the VAERS system. "Healthcare providers and patients can be confident," as early safety observations are consistent with clinical trial data, CDC authors wrote it. "Serious side effects were rare and no unexpected patterns were found."

However, in the CDC analysis of clinical trial data, Dr. Dooling of the Kathleen Virus Disease Division reported that about 1 in 6 patients receiving Shingrix reported reactions that were severe enough to prevent normal activity, while three out of four patients had at least some pain. Dooling also noted that the vaccine is more than 90% protected against shingles.

Hesse said that manufacturers are obliged to report to VAERS "any adverse reactions known to them about any vaccine." Similarly, healthcare providers are obliged to report some side effects in addition to "strongly advising" to report any clinically significant or unexpected events (even if the vaccine has not occurred), "she said.

She pointed out that the Rotashield Infant Vaccine was withdrawn from the market following reports of VAERS on bowel disorders and an investigation confirming these claims.

Administrative problems in addition to side effects

Carla Perissinotto, Associate Professor at the Department of Geriatrics at the University of California, and Associate Clinic, wrote in an e-mail that she had seen few patients receiving the vaccine thanks to the complexity of Medicare's compensation.

"You have to pay the patient and submit to Medicare," said Perissinotto, who was not involved in the new CDC report. It's "administratively" difficult in clinics to store Shingrix and then bill Medicare.

Based on discussions between "some of my colleagues" who have experience with shingles vaccine, she believes that Shingrix has not caused serious or many side effects: "it seems to be well tolerated so far."

"We could use more if the payment structure was easier. This means that many of our patients who benefit would not get what they need."

Dr. Alison Moore, Head of Health Sanitation and Gerontology at UC San Diego, CNN sent an e-mail that she regularly recommended the vaccine, considering its effectiveness and "superiority to the previous version. [shingles] vaccine, Zostavax, is a live CDC recommended vaccine for adults aged 60 years and over.

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

"I found that patients had no response, a mild reaction that could include redness and heat and mild pain at the injection site and more severe reactions, including fever, chills and weakness, like a flu-like illness lasting one day," Moore said. Despite the side effects, she still recommends the vaccine, she said, although she warns patients and advises them to take acetaminophen or ibuprofen-type drugs to reduce the effects.

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

"About seven million doses of Shingrix were distributed in September 2018, and preliminary data indicate that about 76 percent of people have completed a two-dose series," Clements wrote.

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