The U.S. Food and Drug Administration is planning to warn that Johnson & Johnson’s one-dose COVID-19 vaccine can lead to an increased risk of a rare neurological condition known as Guillain-Barré syndrome. The warning does not involve the Moderna or Pfizer vaccines, which are much more widely used in the United States.
This will not help calm nerves or quiet vaccine doubters, though it could send a signal that the FDA is serious about ensuring the public knows about even small risks.
People familiar with the FDA’s plans tell The New York Times that even though the chances of developing the condition are low, recipients of the Johnson & Johnson vaccine are between three and five times more likely to develop the condition compared to the general population.
The FDA is looking at about 100 cases of Guillain-Barré that were reported to the federal monitoring system, which is based on reports from patients and doctors. Keep in mind, that is 100 reported cases out of nearly 13 million doses given. The Washington Post reports, “The cases have largely been reported about two weeks after vaccination and mostly in men, many aged 50 and older. Most people fully recover from Guillain-Barré.”
Anybody can report the problems and, until they are investigated and confirmed as directly related to the vaccine, the reports are considered to be preliminary. That is hugely important to keep in mind. Reports of adverse reactions to vaccines are often coincidental.
For example, the Vaccine Adverse Reporting System contains records of thousands of posts from people who claimed COVID-19 vaccines caused deaths. Careless journalists and hyperventilating scaremongers have pointed to the VAERS reports as proof that the government knows of vaccine-caused deaths. And it is not true. It actually means that people have reported the death of a person who also was vaccinated. After such reports, an investigation begins into whether there is any proof of a link. Anti-vaccine advocates have erroneously used the unvetted database for decades.
Guillain-Barré syndrome is one of those conditions that occurs generally after a viral infection, including the seasonal flu. The Centers for Disease Control and Prevention says about 3,000 to 6,000 people get the condition each year, meaning about 100 cases occur per week across the country. In general, Guillain-Barré is estimated to affect about one person in 100,000 each year.
So, you can see, because cases occur regardless of the vaccine, it will be hard to directly link the vaccine to the syndrome. And the suspected cases fit the normal pattern of syndrome cases since people who are age 50 or older are more at risk. Most people who develop the syndrome show symptoms of diarrhea combined with lung or sinus problems. Most people recover.
The FDA put the Johnson & Johnson vaccine on a brief hiatus once before in order to investigate concerns about whether it is linked to blood clots. It eventually said the drug was safe, but that was the second stumble for the vaccine. The first happened when the drug company had to throw away millions of doses that had been improperly produced. The company said none of those doses made it into the public, but it all happened at just the time that conspiracy rumors raised unfounded doubts about vaccine safety.
What is Guillain-Barré?
What, exactly is this disease? The Mayor Clinic explains:
Guillain-Barre (gee-YAH-buh-RAY) syndrome is a rare disorder in which your body's immune system attacks your nerves. Weakness and tingling in your extremities are usually the first symptoms.
These sensations can quickly spread, eventually paralyzing your whole body. In its most severe form Guillain-Barre syndrome is a medical emergency. Most people with the condition must be hospitalized to receive treatment.
The exact cause of Guillain-Barre syndrome is unknown. But two-thirds of patients report symptoms of an infection in the six weeks preceding. These include respiratory or a gastrointestinal infection or Zika virus.
There’s no known cure for Guillain-Barre syndrome, but several treatments can ease symptoms and reduce the duration of the illness. Although most people recover from Guillain-Barre syndrome, the mortality rate is 4% to 7%. Between 60-80% of people are able to walk at six months. Patients may experience lingering effects from it, such as weakness, numbness or fatigue.
The National Institutes of Health adds:
Normally the immune system uses antibodies (molecules produced in an immune response) and special white blood cells to protect us by attacking infecting microorganisms (bacteria and viruses). In Guillain-Barré syndrome, however, the immune system mistakenly attacks the healthy nerves.
Most cases usually start a few days or weeks following a respiratory or gastrointestinal viral infection. Occasionally surgery will trigger the syndrome. In rare cases vaccinations may increase the risk of GBS. Recently, some countries worldwide reported an increased incidence of GBS following infection with the Zika virus.
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