Trump Says FDA Made a Terrible Decision on J&J Vaccine
Julio Gonzalez, M.D., J.D.
The Office of Donald J. Trump, via Telegram, released a statement bashing the decision by the FDA to recommend pausingthe use of the Johnson & Johnson (Janssen) vaccine. Here is Former President Trump's statement in its entirety:
The Biden Administration did a terrible disservice to people throughout the world by allowing the FDA and CDC to call a “pause” in the use of the Johnson & Johnson COVID-19 vaccine. The results of this vaccine have been extraordinary but now it’s reputation will be permanently challenged. The people who have already taken the vaccine will be up in arms, and perhaps all of this was done for politics or perhaps it’s the FDA’s love for Pfizer. The FDA, especially with long time bureaucrats within, has to be controlled. They should not be able to do such damage for possibly political reasons, or maybe because their friends at Pfizer have suggested it. They’ll do things like this to make themselves look important. Remember, it was the FDA working with Pfizer, who announced the vaccine approval two days after the 2020 Presidential Election. They didn’t like me very much because I pushed them extremely hard. But if I didn’t, you wouldn’t have a vaccine for 3-5 years, or maybe not at all. It takes them years to act! Do your testing, clean up the record, and get the Johnson & Johnson vaccine back online quickly. The only way we defeat the China Virus is with our great vaccines!
According to the FDA, there have been more than 6.8 million doses of J&J's COVID-19 vaccine administered in the United States. Of these, six have resulted in blood clot formation within the cerebral venous sinuses, a condition called cerebral venous sinus thrombosis (CSVT). Six out of six million seems to be astronomically rare indeed. Interestingly, according to the CDC, all cases occurred in women between the ages of 18 and 48, about 6-13 days following the vaccine's administration. Apparently, the clots are associated with low levels of platelets. Additionally, heparin, a go-to blood thinner used in the treatment of blood clots, is dangerous in this setting, although the release by the CDC does not describe why.
CSVT is a condition occurring when a blood clot forms within the brain inside one of its capacious, exiting veins. The clot can back up the blood flow out of the brain causing damage through pressure and intense inflammation. The most common symptom is a severe headache, although a seizure may also be the presenting event. These unusual clots may be associated with clotting disorders and are usually identified via a CT scan or MRI. Normally, the majority of patients experience a full recovery. Treatment may include the use of an anticoagulant (blood thinner) or even shunt placement.
Although many have accused President Trump of politicizing the issue, the most intriguing point related to his accusations is the European experience with similar issues related to the AstraZeneca vaccine. There, 18 cases of CSVT were identified in 20 million people having received the vaccine. As the European Medicines Agency (EMA) evaluated the situation, Norway, Denmark, France, Germany, and Italy temporarily pausedthe roll out of the vaccine causing an unnecessary slowdown in the measure's distribution. In the end, the EMA found no clear association and allowed the vaccination process to continue,statingthat the benefits outweighed the risks.
It is very likely that the American pause will similarly result no benefits and no changes to the vaccine that will prevent these incredibly rare, untoward effects. The fact remains that the J&J vaccine has demonstrated a 66.3% chance at preventing COVID-19 positivity and a near 100% chance of preventing hospitalizations and death. It is difficult to conceive how pausing this most important national effort will help in light of the exorbitantly greater odds of benefitting from it compared to those of suffering from its side effects.
As to the CDC's politicization of the issue, any denial by the CDC is obviate by its demonstrated willingness to engage in racial politics as it did last week when it called Americans racist.
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Dr. Julio Gonzalez is an orthopaedic surgeon and lawyer living in Venice, Florida. He served in the Florida House of Representatives. He is the author of numerous books including The Federalist Pages, The Case for Free Market Healthcare, and Coronalessons. He is available for appearances and book signings, and can be reached through www.thefederalistpages.com.