The U.S. Medicines Agency warned Monday of a “Increased risk” to develop Guillain-Barré syndrome, a rare neurological disorder, associated with the Covid-19 vaccine from Johnson & Johnson.
US health authorities have identified 100 reported cases of people having developed Guillain-Barré syndrome, out of nearly 12.5 million doses of this vaccine administered. Of these 100 cases, 95 were serious and required hospitalization. One person died.
“The chances of this happening are very low and the rate of reported cases only exceeds the base rate in the general population by a small margin.”, nevertheless affirmed Monday evening the pharmaceutical company Johnson & Johnson in a press release.
The benefits “clearly” outweigh the risks
Guillain-Barré syndrome is an attack on the peripheral nerves characterized by weakness or even progressive paralysis, most often starting in the legs and sometimes going up to the breathing muscles then the nerves of the head and neck. . This disease affects between 3,000 and 6,000 people each year in the United States.
In its warning, the US Medicines Agency (FDA) states that in most people, symptoms begin within 42 days of receiving the vaccine. People who have received this serum must consult a doctor urgently in case of difficulty in walking, swallowing or chewing as well as in case of speech problems, double vision, inability to move the eyes in particular.
However, the FDA has assured that it “Continued to find that the benefits [du vaccin] clearly outweighed the potential risks ”.
The announcement is a further blow to Johnson & Johnson (J&J) serum, urgently approved in the United States last February, which was suspended for ten days in April after reports of women having developed severe cases of blood clots in association with low levels of platelets, following their vaccination. In this case, too, the health authorities ultimately ruled that the benefits of the vaccine outweighed the risks.
J & J’s vaccine also experienced a problem in June at one of its production plants in Baltimore that had to be shut down for three months. Several million doses had to be thrown away as tests revealed that components of the British vaccine AstraZeneca, made at the same factory, had been mistakenly mixed into the Johnson & Johnson formula.
This new setback for Johnson & Johnson also comes as the United States is experiencing a decline in demand for vaccination, with only 430,000 doses administered per day, when the seven-day average was 3.5 million in April. The country is experiencing an increase in cases of contamination with the virus in the southern and midwestern states where the population is less vaccinated than in other regions, the highly contagious Delta variant being now the dominant strain in the territory.