FDA Plans To Attach Warning To J & J's Vaccine

 FDA PLANS TO ATTACH WARNING OF RARE NERVE SYNDROME TO JOHNSON & JOHNSON'S COVID-19 VACCINE

     " Guillain-Barre Syndrome A Rare Neurological Disorder Has Been Link To Johnson & Johnson's Covid-19 Vaccine, FDA Official Say The Risks Are Low."

July 12, 2021 By Art Fletcher & Leo Madison Reporting For: Englebrook Independent News,

WASHINGTON, DC.- The Food and Drug Administration is planning to warn that Johnson & Johnson's Coronavirus Vaccine can lead to an increased risk of a rare neurological condition known as Guillain-Barre Syndrome, another setback for a vaccine that has largely been sidelined in The United States because of manufacturing problems and a temporary pause earlier this year, according to several people familiar with the plans.

     Although regulators have found that the chances of developing the condition are low, they appear to be three to five times higher among recipients of the Johnson & Johnson vaccine than among the general population in The United States.

     Federal Officials have identified roughly one hundred suspected cases of Guillain-Barre Disease among recipients of the Johnson & Johnson shots through Federal Monitoring System that relies on patients  and health care providers to report adverse effects of vaccines. The reports are considered preliminary. Most people who develop the condition recover.

     " It's not surprising to find these types of adverse events associated with vaccines," said Dr. Luciana Borio, a former acting Chief Scientist at The FDA under President Barack Obama. The data so far by The FDA, she added suggested that the vaccines benefits "continue to vastly outweigh the risks."

     A database reports indicate that symptoms of Guillain-Barre develop within about three weeks of vaccination. One recipient, a 57-year-old man from Delaware who had suffered a Heart Attack and a Stroke within the last four years, died in early April after he was vaccinated and developed Guillain-Barre Syndrome, according to the database.

     The Biden Administration is expected to announce the new warning as early as Tuesday. The FDA has concluded that the benefits of the vaccine in preventing severe disease or death from Coronavirus still outweigh the risks, but it plans to include the provision in Fact Sheets about the drug for providers and patients. European Regulators may soon file suit. No link has been found between Guillain-Barre Syndrome and the Coronavirus vaccines developed by Phizer-BioNTech or Moderna, the other two Federally Authorized manufacturers. Those rely on different technology.

     Nearly thirteen million people in The United States have received Johnson & Johnson's shot, but 92% of Americans who have been fully vaccinated received shots developed by Phizer-BioNTech or Moderna. Even though it requires only one dose, Johnson & Johnson's vaccine has been marginalized by manufacturing delays and a ten-day pause while investigators studied whether it was linked to a rare serious blood-clot disorder in women. That investigation also resulted in a warning added to the fact sheet.

     The new safety concern comes at a precipitous moment in The Nation's fight against Covid-19. The pace of vaccinations have slowed considerably just as a new, more contagious variant called Delta is spreading fast in under-vaccinated areas. Federal Health Officials are worried that the news could make some people even more hesitant to accept the vaccines developed by Phizer-BioNTech or Moderna, even though well over hundred million people have received those vaccines, according to The Center for Disease Control and Prevention.

     Almost one-third of The Nation's adults remain unvaccinated. The Biden Administration has shifted away from relying on mass vaccination sites and is now enlisting community workers in a door-to-door campaigns, supplying doses to Primary Care Doctors and expanding mobile clinics in an attempt to convince the unvaccinated to accept shots.

FILED UNDER JULY 12, 2021: NATIONAL, HEALTH:

This Article First Appeared In The New York Times & The Chicago Tribune.