Doubts continue in the United States about the security of the Single-dose COVID-19 vaccine developed by Johnson & Johnson affiliate Janssen. The Food and Drug Administration (FDA) plans to issue a warning about a possible link between the drug and the Guillain-Barré syndrome (GBS), a rare disorder of the immune system It causes inflammation of the nerves and can lead to pain, numbness, muscle weakness and even difficulty walking. A few days ago, the European Medicines Agency (EMA) also warned about the appearance of this syndrome in vaccinated people, although referring to the AstraZeneca vaccine.
Although health regulators ensure that possibilities to develop the disease are low, appear to increase three to five times among vaccine recipients compared to the general population of the United States, as reported to the media The New York Times sources related to the FDA decision. It is expected that the detected cases of this syndrome will be analyzed in the next meeting of the committee of external experts who advise the Centers for Disease Control and Prevention (CDC).
So far, a few 100 suspected cases of GBS disease among Janssen vaccine recipients thanks to a federal monitoring system, noting that the majority managed to recover. “It is not surprising to find this type of adverse event associated with vaccination”, says Luciana Borio, former acting scientific director of the FDA under the presidency of Barack Obama. In addition, he adds that the data collected so far suggests that the benefits of the vaccine “continue to far outweigh the risks.”
America’s low confidence in Janssen
About 13 million Americans have received the Johnson & Johnson vaccine, but 92% of those who have completed the vaccination schedule have received that of Pfizer / BioNTech or Modern. Studies have shown that the drug provides immunity of at least eight months to prevent severe COVID-19, hospitalizations, and death. It was also observed that it was effective in protecting people against the most contagious variants, including Delta. However, his relationship with the United States has been most controversial.
Among the numerous problems, the manufacturing delays dose and a 10 day break because the drug relationship with a blood clotting disorder, rare but serious, detected especially in women. That research also ended up being listed as a warning on the vaccine fact sheet. Nor did the inoculation of this vaccine help the fact that the Baltimore plant that supposedly would supply the majority of the doses to the United States were closed for three months because regulatory violations. The factory, operated by Emergent BioSolutions, had to throw away about 77 million doses that could be contaminated.