Washington (AP) — US regulators added a new warning to Johnson & Johnson’s COVID-19 vaccine on Monday about its association with rare and potentially dangerous neural reactions, but shots are a problem. Said that it was not completely clear that it caused.
The Food and Drug Administration has issued a new warning, flagging reports of Guillain-Barré syndrome, an immune system disorder that can cause weakness and occasional paralysis. Health officials have described it as a “small possible risk” for those who have been shot with side effects.
This action will take place after the FDA and the US Centers for Disease Control and Prevention have reviewed reports of approximately 100 people who developed the syndrome after receiving a single vaccination. Almost all of them required hospitalization and one died, the FDA said.
Guillain-Barré syndrome occurs when the body’s immune system mistakenly attacks some of the nerve cells, causing weakness and usually temporary paralysis. According to the CDC, an estimated 3,000 to 6,000 people develop this syndrome each year.
The number of cases reported in connection with the J & J vaccine is only a small percentage of the approximately 13 million Americans who received a single vaccination. Most cases have been reported in men (mostly over 50 years of age), usually about 2 weeks after vaccination.
J & J said in a statement that it was discussing the report with the FDA and other health regulators around the world.
The CDC said it would ask a committee of external vaccine experts to consider the issue at the next meeting.
The government said the most used vaccine in the United States, manufactured by Pfizer and Moderna, shows no risk of injury after more than 320 million doses.
The new warning will be included in the pamphlet distributed to those who take J & J shots. According to the FDA, you should see a doctor if you experience symptoms such as tingling, difficulty walking, or diplopia.
Vaccines have historically provided a wide range of protection with little risk, but like other drugs and medical treatments, they have occasional side effects. The three COVID-19 vaccines used in the United States have each been tested in tens of thousands of people, but even such a large study cannot rule out very rare side effects.
The CDC and FDA monitor side effect reports submitted by doctors, pharmaceutical companies, and patients to the Federal Vaccine Safety Database.
Guillain-Barré syndrome can be caused by many infectious diseases such as influenza, cytomegalovirus, and Zika virus. However, there are rare cases where the disorder develops days or weeks after receiving a particular vaccine.
J & J’s vaccine was highly anticipated due to its one-time prescription and easy-to-ship refrigeration. But early on, it was associated with another rare risk of blood clots, and due to problems at the Baltimore factory that helped make shots, the company was unable to produce as much as expected. ..
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