For several months the Food and Drug Administration has advised Americans to receive either the Pfizer or Moderna series of COVID vaccines as opposed to the Johnson & Johnson single-shot vaccine, but that guidance has now been strengthened as the agency is now strictly limiting the usage of the drug.
On Thursday, the FDA announced that it would impose strict limits on who can receive the Johnson & Johnson vaccine amid ongoing concerns about a rare but serious side effect that could cause life-threatening blood clots in patients who receive the shot.
Here is the latest on what we know about the FDA’s change of guidance.
How Did FDA Guidance Change?
As of Thursday, United States regulators have said that patients should only receive the Johnson & Johnson vaccine if they are warned of the risks of doing so, and if they meet other specific criteria.
Federal officials recommend that patients needing initial COVID vaccine doses or boosters should receive the Pfizer or Moderna vaccine.
Why Did the FDA Make the Changes?
The FDA has warned of the small risk of a potentially life-threatening condition associated with the Johnson & Johnson vaccine, but continued research into those findings has led the department to make the change to its recommendations.
During investigation and analysis, the FDA says that there is a risk of a condition called thrombosis with thrombocytopenia syndrome, or TTS, associated with receiving the Johnson & Johnson vaccine.
The condition, while rare, can cause life-threatening blood clots, along with low levels of blood platelets. Several instances have been reported to federal regulators, which they say warrants “limiting the authorized use of the vaccine.”
Just How Rare is TTS?
Even though the FDA has advised patients to receive other COVID vaccines, the incidence of TTS in patients who received the Johnson & Johnson vaccine is still extremely rare.
Federal officials say that 3.23 cases of the illness have occurred per million doses of the vaccine administered. Deaths related to TTS have occurred at a rate of 0.48 per million doses of vaccine administered.
According to the FDA, TTS can lead to long-term and debilitating health consequences, and that the syndrome has a high death rate.
Can Americans Still Receive the Johnson & Johnson Vaccine?
Specific Americans can still receive the Johnson & Johnson vaccine, although they are required to be warned about the risk of TTS.
According to the FDA, these groups can still receive the single-dose shot series:
-Individuals who experienced an anaphylactic reaction after receiving the Pfizer or Moderna COVID vaccine.
-Individuals who have personal or religious concerns about receiving mRNA vaccines.
-Individuals who would remain unvaccinated for COVID-19 due to limited access to mRNA vaccines.