FDA Limits Emergency Authorization Of Johnson & Johnson COVID-19 Vaccine Citing Health Risks

On Thursday, the Food and Drug Administration restricted the use and authorization of the Johnson & Johnson COVID-19 vaccine because of various health risks associated with it.

In a statement, the FDA announced that they cannot risk potentially fatal blood clots caused by the Johnson & Johnson vaccine, which is why they are limiting the vaccine’s use. The agency released statistics that showed the rate of the risk of blood clots is 3.23 per million doses, out of which 0.48 per million die.

However, the FDA also acknowledged that those who could not get Pfizer or Moderna vaccines or refused to get any vaccine but Johnson & Johnson’s, it was in their best interests to continue receiving the doses. This is because the known benefits of the Johnson & Johnson vaccine outweigh its risks if someone is not looking to receive an mRNA vaccine, according to the FDA.

The head of the FDA’s Center for Biologics Evaluation and Research, Dr. Peter Marks, stated that the agency’s decision shows how they are committed to take safety measures guided strictly by data and science. Marks claimed that this measure also reflects the robustness of FDA’s safety and surveillance systems.

FDA’s vaccine surveillance is not only limited to Johnson and Johnson’s vaccine as the agency assured that they will keep on monitoring the safety of all Covid vaccines that have been issued in the U.S.

In December 2021, an advisory panel for the Centers for Disease Control and Prevention decided to recommend Pfizer and Moderna vaccines instead of Johnson and Johnson’s. They mentioned the risk of blood clots caused by Johnson and Johnson vaccine as the primary reason for the decision.

After considerable reports of blood clots came to light, in April 2021 both the CDC and FDA temporarily ceased the distribution of the Johnson and Johnson vaccine.

It has been discovered that the blood clots caused by the Johnson and Johnson vaccine occur due to a rare condition called thrombosis with thrombocytopenia syndrome. Up till March 2022, around 60 people have developed cases of this syndrome. Symptoms usually begin to show up within two weeks of taking the jab.

According to CDC statistics, around 126 million people in the U.S. have received the Pfizer vaccine compared to the 76 million and 17 million who opted for Moderna and Johnson and Johnson’s vaccine, respectively.