J&J’s COVID Vaccine Taken By 19 Million Americans Is Pulled By FDA ‘Out Of An Abundance Of Caution’ Over Blood Clot Concerns

The Food and Drug Administration (FDA) has made the decision to revoke the authorization of Johnson & Johnson’s COVID-19 vaccine following concerns about rare blood clots, a move that has led to a significant drop in demand.

This development was not unexpected, as J&J’s parent company, Janssen, had requested that federal regulators at the FDA withdraw the authorization for the vaccine. The request came after it was discovered that the last batch of doses, totaling approximately 12.5 million, had expired.

Since the onset of the COVID-19 pandemic, nearly 231 million Americans have received either one dose of the J&J vaccine or two doses of the mRNA vaccines from Pfizer or Moderna.

Vaccine fatigue has become pervasive in the United States, with millions of Americans feeling frustrated by the realization that receiving a shot does not guarantee immunity from the virus, but rather provides protection against severe illness. It is believed that those who had intended to get fully vaccinated have likely already done so.

With the likelihood of a renewed surge in demand for the J&J single-dose vaccine being extremely low, coupled with a troubled history of production issues and health concerns that have significantly eroded public trust, Johnson & Johnson has made the decision to exit the COVID-19 vaccine market.

Citing declining demand, J&J has informed the FDA that it will not be updating the formulations of its vaccine to better address emerging variants, a step that Moderna and Pfizer took last year in response to the highly contagious Omicron variant.

Dr. Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research, stated, “Because the FDA understands that Janssen Biotech, Inc. has requested that FDA withdraw the EUA for the Janssen COVID-19 Vaccine, FDA has determined that it is appropriate to protect public health or safety to revoke this authorization.”

In comparison to other vaccines approved for use in the US, only a fraction of Americans have received the J&J vaccine. Approximately 367 million Americans have received a Pfizer shot, while over 232 million have received a dose of Moderna’s vaccine. J&J accounts for a small portion of the total shots administered in the US since early 2021, with just over 19 million doses.

Johnson & Johnson’s vaccine has faced controversy since its introduction in February 2021. By that time, more than 2.1 million mRNA shots had already been administered, establishing the vaccines from Pfizer and Moderna as the gold standard.

The FDA had announced restrictions on the use of the Janssen COVID-19 vaccine for individuals aged 18 and older after an investigation revealed a risk of blood clots among those who received the jab.

Less than a month after the J&J vaccine received emergency use authorization from the FDA, concerns emerged about a small but growing number of severe blood clotting disorders known as thrombosis with thrombocytopenia syndrome (TTS) in individuals who had received the vaccine.

TTS is a serious condition characterized by the formation of blood clots along with a low platelet count, which impairs the body’s ability to stop bleeding from wounds.

Symptoms of TTS, also referred to as Vaccine-induced Prothrombotic Immune Thrombocytopenia (VIPIT) or Vaccine-induced Immune Thrombotic Thrombocytopenia (VITT), typically manifest between four and 42 days after vaccination.

In April 2021, the FDA and the Centers for Disease Control and Prevention (CDC) issued a widespread pause on administering the J&J vaccine following reports of six cases of this rare clotting disorder.

{Matzav.com}