The United States Centers for Disease Control and Prevention issued a statement regarding the Johnson & Johnson/Janssen Covid-19 vaccine, sharing that approximately 100 individuals suffered from a rare neurologic disorder called Guillain-Barre Syndrome (GBS) after receiving this vaccine. Close to 13 million Johnson & Johnson vaccines have been administered to date in the U.S. The CDC’s statement sent to Insider was as follows:
“Reports of GBS after receipt of the J&J/Janssen COVID-19 Vaccine in the Vaccine Adverse Event Reporting System (VAERS) are rare, but do likely indicate a small possible risk of this side effect following this vaccine. These cases have largely been reported about two weeks after vaccination and mostly in males, many aged 50 years and older.”
This is the second major blow to this single-dose vaccine. On April 12, 2021, the CDC and Food and Drug Administration (FDA) issued a joint statement to pause the use of this vaccine after several cases of a rare form of life-threatening blood clot, known as CVST, or cerebral venous sinus thrombosis, afflicted several individuals, primarily women between the ages and 18 and 48. Three of these women died. After reviewing the data on these adverse events, both agencies lifted this pause on April 23rd and encouraged people to receive this vaccine. At that time, nearly 7 million doses of this vaccine had been administered in the U.S.
The new findings of Guillain-Barre Syndrome (GBS) developing approximately two weeks after receipt of the vaccine has predominantly been seen in men over age 50.
Guillain-Barre is a rare syndrome whereby an autoimmune reaction occurs in the nervous system, leading to muscle weakness and even paralysis. Symptoms may begin as vague tingling, unsteady gait, vision changes, or cramping. If it progresses, it can lead to full body paralysis, including paralyzing the muscles of respiration. This would necessitate intubation and mechanical ventilation in an ICU setting. It is often seen following viral infections, most notably Zika virus or gastrointestinal bacterial infections. While most patients recover from Guillain-Barre, it can result in long term weakness or muscle disorders. There are approximately 3,000-6,000 new cases of GBS each year in the U.S.
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In 1976, there were several reported cases of GBS in individuals after receiving the swine flu vaccine. This entity was reviewed by what was then the National Institute of Medicine (now known as the National Academy of Medicine) and this risk was found to be one additional case of GBS per 100,000 swine flu vaccines. This issue has been an area of continued study with regard to annual flu vaccines, and is now found to be in the range of one to two additional cases of GBS per one million flu vaccines. During this past flu season, nearly 190 million flu vaccines were administered in the U.S., up from under 180 million vaccines in the prior season.
While the FDA and CDC are not issuing a statement to pause the administration of the Johnson & Johnson vaccine, reports of 100 cases of GBS will not help encourage the vaccine-hesitant to receiving this vaccine. It is important to appreciate that sharing information regarding severe, albeit extraordinarily rare, side effects is critical in better understanding these vaccines, but also in putting these rare events into perspective.
To date, over 600,000 Americans have died due to complications of Covid-19 infections. Over 334 million vaccines, including 13 million Johnson & Johnson vaccines have been administered in the U.S. since December 16, 2020. As the majority of vaccines administered have been the two-dose Pfizer/BioNTech and Moderna vaccines, nearly half of this country remains un-vaccinated. As the Delta variant, and variants-to-be are poking their spike proteins into now thousands of immune systems each day, we are far from a point of seeing an end in sight to this vaccine-preventable illness. Loss of confidence in vaccine safety will only make things worse. On the other hand, transparency of reporting adverse events should be a positive indicator of how closely these vaccine events are being monitored.