Johnson and Johnson COVID Vaccine: Here's Why the FDA Issues Limit on the Use of the Jab
The U.S. Food and Drug Administration (FDA) announced on Thursday that they are limiting the use of the Johnson and Johnson COVID vaccine among American adults.
The limit announced by the FDA would allow Americans 18 years old and above for whom other vaccines are not appropriate or accessible, or to those who opt for the said vaccine brand because they would not get inoculated otherwise, according to a CNN news report.
The FDA also emphasized that the examples of adults who may still receive the Johnson and Johnson COVID vaccine include those who experience an anaphylactic reaction after receipt of the mRNA COVID-19 jab and those who have a particular concern about the mRNA COVID-19 vaccine.
The FDA underscored that their decision to limit the coverage of the vaccine's emergency use authorization came after they conducted an updated analysis and investigation of the reported cases of thrombosis with thrombocytopenia syndrome (TTS), a condition of life-threatening blood clots. The said condition reportedly occurred among those who received Johnson and Johnson vaccines.
"Today's action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions," FDA's Center for Biologics Evaluation and Research Director Peter Marks, M.D., Ph.D., said.
Confirmed Cases of Blood Clots Among Johnson and Johnson COVID Vaccine Takers
The FDA and the CDC have identified at least 60 confirmed cases, including nine fatalities through March 18.
"The FDA has determined that the reporting rate of TTS is 3.23 per million doses of vaccine administered and the reporting rate of TTS deaths is 0.48 per million doses of vaccine administered," the agency noted in a statement.
The Daily Mail pointed out that the blood clot symptoms appear in the individual about one to two weeks following the inoculation of the Johnson and Johnson COVID vaccine.
In their statement, the FDA reiterated that the known potential benefits of the Johnson and Johnson COVID vaccine still outweigh the known and potential risks for people.
Marks underscored that their department is closely monitoring the TTS occurrence that is observed after the said vaccine brand is administered.
"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," Marks added.
However, the agency pointed out that the factors that put an individual at risk for having TTS after being inoculated with the J&J vaccine are still unknown.
Johnson and Johnson COVID-19 Vaccine
The Johnson and Johnson COVID vaccine was authorized for emergency use on February 27 last year.
However, the Centers for Disease Control and Prevention (CDC) and the FDA issued a recommended pause for the said vaccine brand on April 13. This was done to give way to the investigation regarding six reported cases of TTS and make sure that healthcare providers were made aware of the potential for TTS.
The CDC pointed out that more than 18.7 million doses of Johnson and Johnson vaccines have been administered in the United States as of Thursday. Furthermore, at least 7.7 percent of those fully vaccinated got the J&J vaccine.
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This article is owned by Latin Post.
Written By: Joshua Summers
WATCH: Johnson & Johnson COVID-19 Vaccine: What You Should Know - From mnhealth
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