On Wednesday night, the Food and Drug Administration announced that it would no longer allow the Johnson & Johnson Covid-19 vaccination to be given to individuals under 18 due to risk of blood clotting.
ABC News reports:
Use of the Johnson & Johnson vaccine will now be limited to people ages 18 and older for whom other authorized or approved COVID-19 vaccines are not "accessible or clinically appropriate," and to adults who choose to receive the vaccine or else they would not get vaccinated, the FDA wrote in a press release.
The decision was made after conducting an updated analysis into reports of the rare blood clot condition called thrombosis with thrombocytopenia syndrome, or TTS, the FDA said.
Yes, the very rare blood clots are SO rare that the FDA is pulling the plug completely on the J&J vaccine for minors.
It's totally safe, but also DO NOT give it to kids. It's too dangerous.
"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. Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, wrote in a statement.
The FDA's action demonstrates the FDA's strong safety surveillance systems, Marks said, adding that the agency is committed to making scientific and data-driven decisions.
"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. 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 said.
Yeah, remember when they canceled the J&J vax really early on and decided they were wrong to do it?
Well, now they were right. At least when it came to kids.
The Johnson & Johnson vaccine was first authorized for emergency use by the FDA in February 2021. Just two months later, the FDA and the CDC, announced a recommended pause in the administration of the vaccine to investigate a handful of cases of TTS that had been discovered in patients across the country.
The pause was lifted just 10 days later. However, in December, after reviewing additional safety and efficacy data, the CDC's vaccine advisory recommended that people use the mRNA vaccines from vaccine companies Pfizer and Moderna, instead of Johnson & Johnson, in most situations.
Through March 18, the FDA and CDC have identified 60 confirmed cases of TTS, including nine fatal cases, which illustrates that blood clots are a rare but real adverse event associated with the Johnson & Johnson shot.
At least nine people have died from clots associated with the J&J shot.
I have an idea: Maybe the CDC shouldn't be so aggressive in pushing experimental drugs on kids for diseases that statistically aren't a threat to them!
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