The Johnson & Johnson Vaccine 'Pause' Is a Demonstration of Scientists Calling The Shots. The Media Should Stop Turning It Into A Win For Anti-Vaxxers.
In a call with the media (video above), Acting FDA Commissioner Janet Woodcock said she expects the pause to last only days.
Some have reacted to the development by pointing to concerns that this level of attention given to what appears to be an extraordinarily rare phenomenon - just six cases were found in the US among 6.8 million people who were vaccinated through the J&J vaccine - could deliver a public relations boost to anti-vaxxers. While their concerns are not unfounded as anti-vaxxers are already having a field day on social media, as President Biden has made clear from day one, these decisions correctly belong in the hands of scientists, regardless of where the chips may fall.
However, precisely because the way the media is dramatizing reporting on this action - by acting like the vaccine supply has been poisoned somehow - it is absolutely critical that people understand what is actually happening here. I will try to provide some context.
YOU ARE LITERALLY TWICE AS LIKELY TO BE STRUCK BY LIGHTNING THAN GET A BLOOD CLOT FROM A VACCINE
First and foremost, as has been already mentioned, the occurrence of the blood clot associated with vaccine administration is exceedingly rare, literally less than one in a million. Six cases have been reported out of 6.8 million vaccinated. Compare that to the risk of actually contracting COVID, which presents a better than one-in-five chance of developing a blood clot.
Heck, according to the same CDC that has recommended a pause, the chances of getting struck by lightning in a given year is literally twice as high: 1 in 500,000.
Second, no medical data has yet established that the blood clots and the vaccination are causally related, i.e. that the vaccine is actually causing the blood clots. A myriad of medical conditions are associated with blood clots, including pregnancy, obesity, and certain medications, according to the Mayo Clinic. All six reported cases have been among women of childbearing age.
The fact that the risk is exceedingly rare (and may or may not be associated with the vaccine at all) is also accentuated by the fact that the FDA did not revoke the emergency use authorization - even temporarily - that makes this and other vaccines available in the market.
THE PAUSE IS TO GIVE MEDICAL PROVIDERS THE RIGHT TOOLS AND TIME TO PREPARE FOR PROPER TREATMENT
In fact, the FDA-CDC statement is much more about providing guidance to individuals and healthcare providers about what symptoms to look for, and in case the one-in-a-million side effect does develop from the vaccine, how to treat it. The pause, the joint statement says, is necessary so that health care providers can fully prepare to deal with this type of blood clot, which is similar to blood clots that have been observed with the yet-to-be-FDA-approved AstraZeneca vaccine and requires treatment different from standard blood clot medication, not because the safety and efficacy of the vaccine has been called into serious question (at the present moment, it has not).
The joint statement reads:
The bottom line is this: vaccines in general remain safe and effective, approved COVID vaccines specifically remain safe and extremely effective, and in every likelihood, the J&J vaccine remains greatly safe and highly effective.
The bottom line also is this: the FDA and CDC’s relentless focus on safety - to the point of even what some would call an overcautious approach - should improve public confidence in vaccines that scientists back. It tells us that scientists working for this administration are completely free to call the shots as they see fit with no political interference. It tells us that those scientists are on the game 24/7 and are hyper-focused on safety.
Turning this extraordinary story of government scientists doing their jobs and public health experts investigating even a whiff of a possibility of adverse reaction into a reason why vaccines are to be doubted - as much of the coverage today has done - is nothing short of promoting crazy anti-vaxxer propaganda.
Don’t fall for it.
Some have reacted to the development by pointing to concerns that this level of attention given to what appears to be an extraordinarily rare phenomenon - just six cases were found in the US among 6.8 million people who were vaccinated through the J&J vaccine - could deliver a public relations boost to anti-vaxxers. While their concerns are not unfounded as anti-vaxxers are already having a field day on social media, as President Biden has made clear from day one, these decisions correctly belong in the hands of scientists, regardless of where the chips may fall.
However, precisely because the way the media is dramatizing reporting on this action - by acting like the vaccine supply has been poisoned somehow - it is absolutely critical that people understand what is actually happening here. I will try to provide some context.
YOU ARE LITERALLY TWICE AS LIKELY TO BE STRUCK BY LIGHTNING THAN GET A BLOOD CLOT FROM A VACCINE
First and foremost, as has been already mentioned, the occurrence of the blood clot associated with vaccine administration is exceedingly rare, literally less than one in a million. Six cases have been reported out of 6.8 million vaccinated. Compare that to the risk of actually contracting COVID, which presents a better than one-in-five chance of developing a blood clot.
Heck, according to the same CDC that has recommended a pause, the chances of getting struck by lightning in a given year is literally twice as high: 1 in 500,000.
Second, no medical data has yet established that the blood clots and the vaccination are causally related, i.e. that the vaccine is actually causing the blood clots. A myriad of medical conditions are associated with blood clots, including pregnancy, obesity, and certain medications, according to the Mayo Clinic. All six reported cases have been among women of childbearing age.
The fact that the risk is exceedingly rare (and may or may not be associated with the vaccine at all) is also accentuated by the fact that the FDA did not revoke the emergency use authorization - even temporarily - that makes this and other vaccines available in the market.
THE PAUSE IS TO GIVE MEDICAL PROVIDERS THE RIGHT TOOLS AND TIME TO PREPARE FOR PROPER TREATMENT
In fact, the FDA-CDC statement is much more about providing guidance to individuals and healthcare providers about what symptoms to look for, and in case the one-in-a-million side effect does develop from the vaccine, how to treat it. The pause, the joint statement says, is necessary so that health care providers can fully prepare to deal with this type of blood clot, which is similar to blood clots that have been observed with the yet-to-be-FDA-approved AstraZeneca vaccine and requires treatment different from standard blood clot medication, not because the safety and efficacy of the vaccine has been called into serious question (at the present moment, it has not).
The joint statement reads:
"Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.Treatment and diagnostic options was also the primary focus of the joint briefing that the FDA and CDC provided today on the subject.
"[...] This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot."
The bottom line is this: vaccines in general remain safe and effective, approved COVID vaccines specifically remain safe and extremely effective, and in every likelihood, the J&J vaccine remains greatly safe and highly effective.
The bottom line also is this: the FDA and CDC’s relentless focus on safety - to the point of even what some would call an overcautious approach - should improve public confidence in vaccines that scientists back. It tells us that scientists working for this administration are completely free to call the shots as they see fit with no political interference. It tells us that those scientists are on the game 24/7 and are hyper-focused on safety.
Turning this extraordinary story of government scientists doing their jobs and public health experts investigating even a whiff of a possibility of adverse reaction into a reason why vaccines are to be doubted - as much of the coverage today has done - is nothing short of promoting crazy anti-vaxxer propaganda.
Don’t fall for it.