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FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals

By on May 6, 2022 0 156Views

On Thursday, U.S. Food and Drug Administration announced plans on who can receive Johnson & Johnson’s COVID-19 vaccine due to the ongoing risk of rare but serious blood clots.

The FDA will now limit the authorized use of the Janssen COVID-19 Vaccine to individuals 18 years of age and older who cannot receive a different brand of vaccine or specifically request the Johnson & Johnson’s vaccine. This comes after the U.S. authorities for months have recommended that Americans get Pfizer or Moderna shots instead of the Johnson & Johnson vaccine.

Under the new FDA instructions, Johnson & Johnson’s vaccine can still be administered to people who have experience a severe allergic reaction to one of the other COVID-19 brand vaccines and are not able to receive an additional dose. The Johnson & Johnson shot may still remain an option for people who refuse to receive the mRNA vaccines from Pfizer and Moderna.

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.

The FDA has determined that the known and potential benefits of the vaccine for the prevention of COVID-19 outweigh the known and potential risks for individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and for individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.

The Fact Sheet for Healthcare Providers Administering Vaccine  now reflects the revision of the authorized use of the Janssen COVID-19 Vaccine and includes a warning statement at the beginning of the fact sheet for prominence which summarizes information on the risk for TTS. Additionally, information on the revision to the authorized use of the vaccine and updated information on this risk of blood clots with low levels of blood platelets has been added to the Fact Sheet for Recipients and Caregivers.

The FDA formally authorized Johnson & Johnson’s shot in February 2021 for adults 18 and up.

Director of the FDA’s Center for Biologics Evaluation and Research Dr. Peter Marks said the problem occurs in the first two weeks after vaccination, “So if you had the vaccine six months ago you can sleep soundly tonight knowing this isn’t an issue.”

Experts say the Johnson & Johnson vaccine was initially considered a great option in the pandemic fight because it only required one shot. But the single-dose option proved to be less effective than two doses of the Pfizer and Moderna vaccines.

In December of 2021, the Centers for Disease Control and Prevention recommended Moderna and Pfizer shots over the Johnson & Johnson vaccine because of the safety concerns.

“We recognize that the Janssen COVID-19 Vaccine still has a role in the current pandemic response in the United States and across the global community. Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals,” said Marks.

“Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions. We’ve been closely monitoring the Janssen COVID-19 Vaccine and occurrence of TTS following its administration and have used updated information from our safety surveillance systems to revise the EUA. 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.”

Federal scientists have identified 60 cases with the side effects of the vaccine, nine of which were fatal. That equates to 3.23 blood clot cases per 1 million Johnson & Johnson vaccine. The problem presents more of a problem in women under 50, where the death rate was roughly 1 per million shots.

Pfizer and Moderna have reportedly been the provider of the majority of COVID-19 vaccines in the U.S. It is estimated that 200 million Americans have been fully vaccinated with the companies’ two-dose shots. Less than 17 million Americans got the Johnson & Johnson shot.