FDA added a rare reaction risk warning for Johnson & Johnson Covid-19 vaccine

WASHINGTON: US Regulator on Monday added a new warning to Johnson & Johnson’s Covid-19 vaccines about relations with rare neurological reactions and potentially dangerous, but said it was not fully clear a shot that caused the problem.
Food and Medicine Administration (FDA) announced a new warnings, reported Guillain-Barre’s syndrome, immune system disorders that could cause muscle weakness and occasional paralysis.
Health officials describe side effects as “possible small risks” for those who get shots.
Actions arise after the FDA and disease control centers and reports that review around 100 people develop syndrome after receiving a one-dose vaccine.
Almost all of them need hospitalization and one person died, FDA said.
Guillain-Barre Syndrome occurs when the immune system mistakenly attacks several of its nerve cells, causing muscle weakness and sometimes paralysis that is usually temporary.
It is estimated that 3,000 people develop syndrome every year, according to the CDC.
The number of cases reported in connection with the J & J vaccine is a small faction of nearly 13 million Americans who have received a one-dose shot.
Most cases are reported in men, many 50 years old and rise, and usually about two weeks after vaccination.
J & J said in a statement discussed reports with the FDA and other health regulators Arou and the world.
CDC said he would request an outside vaccine panel to review the problem at the upcoming meeting.
The government said the most widely used vaccine in the US, was made by Pfizer and Moderna, did not show the risk of disruption after more than 320 million doses had been given.
The new warning will be included in the pamphlets given to people who get J & J shots.
They must seek medical attention if they experience symptoms, which include tingling sensation, the difficulty of walking and multiple vision, FDA said.
Historically vaccine provides extensive protection with little risk but comes with occasional side effects such as other drugs and medical therapy.
Three Covid-19 vaccines used in the US each were tested on tens of thousands of people, but even such large studies could not override side effects that were very rare.
The CDC and FDA have monitored the side effects report delivered by doctors, drug makers and patients to the federal vaccine security database.
Guillain-Barre can be triggered by a number of infections, including flu, cytomegalovirus and Zika virus.
But there are rare cases where people develop day or week disorders after receiving certain vaccines.
The J & J vaccine is strongly anticipated due to formulations of one-and done and cooling easily paid.
But early, it was associated with other rare risks, from blood clotting, and the company has not been able to produce as much as expected because of the problem at the Baltimore factory that helps make shots.