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The Centers for Disease Control and Prevention (CDC) Vaccine Advisory Committee said Thursday that the benefits of Johnson & Johnson’s COVID-19 vaccine still outweigh the risk of a serious, but rare, neurological disorder after the vaccination.
The Immunization Practices Advisory Committee met to discuss the incidence of Guillain-Barré syndrome (GBS) following an injection of J&J and agreed that the vaccine should continue to be used in people. 18 years of age and over under the Emergency Use Clearance of the Food and Drug Administration (FDA). , claiming that the benefits of the vaccine far outweigh the risks.
GBS is a disease in which an individual’s immune system attacks nerve cells in the body, causing numbness, pain, and muscle weakness. In severe cases, it can progress to paralysis. An estimated 3,000 to 6,000 cases of GBS are reported each year in the United States, with most people making a full recovery, “but some have permanent nerve damage,” according to Dr Mathew Daley of the Vaccine Task Force. COVID-19 advisory committee.
However, GBS cases after a J&J vaccine were higher than expected in the general population with 8.1 cases per million doses. This figure was also higher than the reported cases of GBS after receiving the messenger RNA vaccines: 1.21 cases per million for the Moderna vaccine and 1.05 cases per million for the Pfizer vaccine.
Approximately 100 cases of GBS have been reported within 42 days of vaccination with a J&J vaccine on the Vaccine Adverse Event Reporting System (VAERS) as of June 30. About 12.6 million doses of the vaccine have been administered.
Of the 100 cases, 95 were severe and required hospitalization, with 10 patients needing a ventilator and one dying 25 days after vaccination of a 57-year-old man with a medical history of stroke, heart failure, high blood pressure and diabetes. .
According to a presentation by Dr. Meghna Alimchandani of the FDA, 83 percent of cases have occurred in patients between the ages of 18 and 64, with the risk of GBS being highest in men and a median time to onset of 13 days.
While 84 percent of cases occurred within the 21-day risk window used for the assessment, “the majority of cases, 98 percent, occurred within this 42-day risk window,” Alimchandani said. . Two cases were not included in the period because one occurred outside the 42-day window and the other did not specify the onset of the disease.
Alimchandani said the FDA is still trying to collect the medical records of the 100 reported cases and more follow-up information is still to come. So far, only seven cases have been verified.
The federal health regulator updated the emergency use authorization fact sheet for the J&J vaccine on July 12, warning vaccine suppliers and recipients that the vaccine is linked to the neurological disorder.
The European Medicines Agency (EMA) announced on Thursday that Guillain-Barré syndrome would be listed as a “very rare side effect” of the Johnson & Johnson COVID-19 vaccine, and “a warning will be included in the product information to educate health professionals and people who get vaccinated.
The EMA’s safety committee said a causal relationship between the J&J vaccine and GBS was possible after reviewing the available evidence.
“People who have been vaccinated are advised to seek immediate medical attention if they develop signs and symptoms suggestive of GBS, such as weakness in the extremities, double vision or difficulty moving their eyes,” the EMA said in a statement.
Despite the additional warning from GBS, the European regulator has said the benefits of the Johnson & Johnson COVID-19 vaccine continue to outweigh the risks of the vaccine.
Guillain-Barré syndrome has been reported following other vaccines, including the annual influenza vaccine, the 1976 swine flu vaccine, and the shingles vaccine. Although no causal relationship has been established between the shingles vaccine and GBS, a warning has been added to the “Package Leaflet due to approximately three to six cases of excess GBS per patient. million doses administered to people. [65 and older] within six weeks of vaccination.
Johnson & Johnson did not respond to a request for comment.
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