Parents Warned as FDA Limits Emergency Use Authorization of Johnson & Johnson COVID Vaccine

Johnson & Johnson COVID vaccine US Food and Drug Administration FDA Dr. Peter Marks thrombosis with thrombocytopenia syndrome FDA limits J&J COVID vaccine

By Joel Brussels , Parent Herald May 07, 01:13 am

Photo: (Photo : TOBIAS SCHWARZ/AFP via Getty Images)

The U.S. Food and Drug Administration (FDA) announced on Thursday, May 5, that it is limiting the emergency use authorization (EUA) of the Johnson & Johnson/Janssen COVID-19 vaccine to people who are 18 and older, for whom other vaccines are not appropriate or accessible, and those who opt for J&J because they would not otherwise get vaccinated.

The FDA issued the statement, saying that the change is being made to the COVID vaccine of Johnson & Johnson because of the risk of a rare and dangerous clotting condition called thrombosis with thrombocytopenia syndrome (TTS) after receiving the jab.

Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a statement that they have been closely monitoring the Janssen COVID-19 Vaccine and the occurrence of TTS following its administration and have used updated information from their safety surveillance systems to revise the EUA.

FDA: Benefits of the J&J jab outweigh the risks for certain people

Marks clarified they still recognize the role of the Janssen COVID-19 vaccine in the current pandemic response in the United States and across the global community. He added that today's action demonstrates their safety surveillance systems' robustness and commitment to ensuring that science and data guide their actions.

The FDA confirmed to CNN that the updated emergency use authorization also applies to J&J's booster doses. The federal agency says it has determined that the benefits of the COVID vaccine of Johnson & Johnson outweigh the risks for certain people.

People who may still get J&J's COVID-19 vaccine include those who had a severe allergic reaction to an mRNA vaccine, such as those from Moderna or Pfizer/BioNTech, those with limited access to mRNA Covid-19 vaccines, and those with personal concerns about the mRNA vaccines, who would remain unvaccinated without the Johnson & Johnson vaccine.

According to the U.S. Centers for Disease Control and Prevention (CDC), more than 18.7 million doses of the J&J vaccine have been administered in the United States as of Thursday, May 5. Of those considered fully vaccinated, 7.7 percent got this particular vaccine by J&J.

CDC makes preferential recommendation for mRNA vaccines

The CDC's vaccine advisory committee issued an updated recommendation regarding Johnson & Johnson's vaccine after a meeting back in December, saying that it makes a preferential recommendation for the use of mRNA COVID-19 vaccines over the adenoviral-vectored COVID-19 vaccine of Janssen in all persons aged 18 years and above in the United States.

Like the FDA, the vaccine advisory committee of the CDC cited the same concerns over TTS for people who got the COVID jab of J&J, according to a report by Times Now. Both government agencies previously recommended a pause in the use of this J&J vaccine over reports of TTS. The pause was eventually lifted, but that decision came with a stark warning over the rare clotting events.