Supervisor Elham AbolFateh
Editor in Chief Mohamed Wadie

FDA Restricts Using J N' J COVID-19 Vaccine


Fri 06 May 2022 | 08:04 PM
Rana Atef

The US Food and Drug Administration announced on Thursday that it is restricting the emergency use approval of Janssen's COVID-19 vaccine, Johnson & Johnson (J&J), to 18 years old people or older who are not able to receive other kind of vaccines.

Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research said: "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."

Marks added: "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. ... Today's action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our actions."

In the same context, the US Centers for Disease Control and Prevention responded to the FDA's decision, saying: It is a "preferential recommendation for the use of mRNA COVID-19 vaccines over the Janssen adenoviral-vectored COVID-19 vaccine in all persons aged ≥18 years in the United States."

According to the data of the FDA cited by the CNN, more than 18 million doses of J&J vaccine have been given in the US, and those are considered as fully vaccinated persons.