FDA Changes Stance on Janssen Vaccination Suspension Just Four Days Later

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[Asia Economy Reporter Cho Hyun-ui] The U.S. Food and Drug Administration (FDA) has suffered a blow to its credibility after temporarily suspending Johnson & Johnson subsidiary Janssen's COVID-19 vaccine due to blood clot issues.

On the 13th (local time), the FDA issued a joint statement with the Centers for Disease Control and Prevention (CDC), saying, "Six cases of rare blood clots such as cerebral venous sinus thrombosis (CVST) have been reported among recipients of the Janssen vaccine in the U.S.," and recommended "temporarily suspending use until the investigation is complete."

This marks a reversal for the FDA just four days after its previous stance. The possibility of a link between the Janssen vaccine and blood clots was first raised in Europe. When the European Medicines Agency (EMA) announced on the 9th (local time) that it was reviewing blood clot issues related to the Janssen vaccine, the FDA drew a line, stating, "At this point, no association has been found."

At that time, there were multiple reports in the U.S. of side effects such as dizziness and headaches following Janssen vaccination. Some states, including Colorado, North Carolina, and Georgia, independently suspended Janssen vaccinations. U.S. health authorities acknowledged "some cases" showing blood clot reactions and low platelet counts after receiving the Janssen vaccine but stated, "Currently, we do not recommend suspending vaccination with any manufacturing lot of COVID-19 vaccines."

However, after six cases of "rare but serious" thrombosis appeared, the FDA ultimately decided to suspend use. All six individuals who experienced blood clot side effects were women aged 18 to 48; among them, one died and one is in critical condition. The thrombosis observed after Janssen vaccination is cerebral venous sinus thrombosis accompanied by low platelet counts, a side effect also very rarely seen after AstraZeneca vaccine administration.

If the Janssen vaccine, which had raised expectations as a single-dose vaccine, is suspended, it is expected to disrupt vaccination plans worldwide. The Janssen vaccine has been approved in the U.S., European Union (EU), Canada, South Africa, the World Health Organization (WHO), and South Korea. BBC reported that South Africa, which was the first in the world to approve the Janssen vaccine, also halted vaccinations following the FDA's recommendation. Europe has also decided to delay the introduction of the Janssen vaccine.

However, the U.S. maintains that there is sufficient vaccine supply even if Janssen vaccinations are suspended. President Joe Biden emphasized on the same day, "We have clearly stated that we have 600 million doses of messenger RNA (mRNA; Pfizer, Moderna) vaccines," adding, "There is unquestionably enough supply for 100% of Americans to be vaccinated."

This content was produced with the assistance of AI translation services.