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Tissue vaccine side effects are generally mild, says CDC

Shingrix, produced by GlaxoSmithKline and approved by the US Food and Drug Administration in October 2017, is recommended for adults aged 50 and over to prevent shingles, a painful rash that affects 1 to 3 Americans during their lifetime. It is a non-living vaccine that is inserted into the muscle of the upper arm and is given in two doses in the interval of two to six months.
During the first eight months of Shingrix's post-marketing use, the vaccine reporting system, or VAERS, received a total of 4,381 reports of harmful events; of these 130 were serious.

For every 100,000 distributed doses, CDC has found 136 submissions submitted in the system. Approximately 3.2 million doses were distributed by GlaxoSmithKline during the eight-month reporting period analyzed by CDC.

CDC recommends a new shingle vaccine to replace the older

Common side effects were elevated temperature, colds and pain in the body, swelling and redness in the hand that received the bullet.

However, seven patients died within six to six weeks after receiving Shingrix, CDC said. The cause of four of these deaths was cardiovascular disease (three people had multiple cardiovascular risk factors). There are two immunosuppressive patients who have died of anemia. One 86-year-old woman died after the fall. v The eighth death sentence after the administration of Shingrix was also reported to VAERS, although the CDC did not confirm it.

Dr. Elisabeth M. Hesse, the lead author of the report and a physician at the CDC Vaccine Security Office, wrote in an email saying "no information is included in the medical records [any of] reported deaths are associated with vaccination. "

Additional 196 patients (4.5% system reports) reported that they developed shingles after receiving the bullet, although 14 of these patients had rash before vaccination, according to CDC. And slightly more than 1%, or 49 people, experienced burning pain as a result of the shooting; Here are six cases already existing, CDC said.

Overall, 230 bleeding events occurred, most when the physician fired the skin vaccine instead of the muscle, according to the manufacturer's instructions. Also, Shingrix comes in two bottles that need to be combined, and in some cases, the service provider fails to mix the content before it fired.

In all, the CDC found that none of the reported side effects for Shingrix was "disproportionate to the reporting of harmful events for other vaccines" in the VAERS system. "Healthcare Providers and Patients Can Be Sure," as Early Security Surveillance Results Comply with Clinical Trials Data, CDC authors wrote. "Serious adverse events were rare and no unexpected patterns were detected."

However, in the CDC clinical data analysis, Dr. Kathleen Dooling of the Department of Viral Disease reported that about 1 out of 6 patients who received Shingrix reported on reactions that were serious enough to prevent normal activity, while three out of four patients experienced at least some pain. Dooling also noted that the vaccine was more than 90% shielded.

Hesse said that manufacturers are obliged to report VAERS on "all the undesirable events known to them in the vaccine". Likewise, healthcare professionals are being asked to report some side effects, apart from being "strongly encouraged to report any clinically important or unexpected events (even if they are not sure the vaccine caused the incident) after any vaccine," she said.

He pointed out that the newborn Rotashield vaccine was withdrawn from the market after reporting to VAERS about bowel obstruction and investigation that confirmed these allegations.

Administrative problems with side effects

Dr. Carla Perissinotto, Associate Professor and Head of Geriatrics Clinic at the University of California in San Francisco, wrote in an e-mail that she saw only a few patients who received the vaccine for the severity of the reimbursement through Medicare.

"You have to charge the patient and then hand it over to Medicare," Perissinotto said, who did not participate in the new CDC report. The clinic is difficult to administratively store Shingrix, and then charge Medicare.

Based on the discussion among "a few of my colleagues" who have experience with a shingle vaccine, she believes Shingrix has not caused serious or numerous side effects: "So far it seemed to be well tolerated."

"We would use more to make the payment structure easier, which means that many of our patients, who would benefit, do not get what they need."

Dr. Alison Moore, head of geriatrics and gerontology at San Diego Health University, told CNN in an email to regularly recommend the vaccine with regard to its effectiveness and "superiority over the previous version". [shingles] vaccine, Zostavax, "a vaccine that is recommended for CDCs for adults aged 60 and over."

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

"I've found that patients can not have any reaction, a mild reaction that may include redness and heat, and mild pain around the injection site and more serious reactions, including fever, colds and malaise, like a flu-like illness that lasts," Moore said. despite the side effects, she still recommends the vaccine, she said, though she warns patients and advises them to take acetaminophen or ibuprofen medication to reduce the effect.

Sean Clements, a spokeswoman for GlaxoSmithKline, wrote in an e-mail that "as is the standard practice for all vaccines" his company will continue to monitor security alongside CDC and FDA.

"Approximately seven million doses of Shingrix have been distributed until September 2018, and preliminary data show that approximately 76 percent of people have completed a two-dose series," Clements wrote.

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