FDA limiting Johnson & Johnson COVID shot due to safety concerns

For years, Americans who expressed concerns over the safety of COVID-19 vaccines were accused of spreading disinformation.

However, a new announcement from the Biden administration suggests that at least some of them were right. 

According to the Daily Caller, the Food and Drug Administration (FDA) revealed on Thursday that it is now limiting the use of Johnson & Johnson’s COVID-19 vaccine.

Potential for rare blood clot cited

Going forward, Johnson & Johnson’s single-shot vaccine will only be used in those instances where vaccines from Pfizer and Moderna are unavailable or an individual will only accept Johnson & Johnson’s product.

An FDA statement explained the policy change is due to a risk that Johnson & Johnson’s vaccine may bring about rare but severe blood clots.

After conducting an updated analysis, evaluation and investigation of reported cases, the FDA has determined that the risk of thrombosis with thrombocytopenia syndrome (TTS), a syndrome of rare and potentially life-threatening blood clots in combination with low levels of blood platelets with onset of symptoms approximately one to two weeks following administration of the Janssen COVID-19 Vaccine, warrants limiting the authorized use of the vaccine.

Dr. Peter Marks serves as director of the FDA’s Center for Biologics Evaluation and Research, and he said that Johnson & Johnson’s vaccine “still has a role in the current pandemic response in the United States and across the global community.”

“Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions,” Marks continued.

“The agency will continue to monitor the safety of the Janssen COVID-19 Vaccine and all other vaccines, and as has been the case throughout the pandemic, will thoroughly evaluate new safety information,” he concluded.

Nine of 60 cases resulted in death

The Daily Caller noted despite the apparent rarity of TTS, the FDA has changed its policy on the Johnson & Johnson vaccine due to its severity.

Politico reported that although just 60 cases have been reported out of more than 18 million Johnson & Johnson doses, nine of those cases ended in death.

What’s more, the Daily Caller pointed out how “[n]either the FDA nor the Centers for Disease Control and Prevention (CDC) have determined what the risk factors for TTS after a Johnson & Johnson shot may be.”

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