April 19, 2021
The FDA and CDC last week recommended a pause in COVID vaccinations of the Johnson & Johnson single shot vaccine due to a small number of reports of blood clots in individuals receiving the vaccine.
This vaccine is the third FDA “allowed” vaccine, along with Pfizer and Moderna. Note the difference between “allowed” and “approved.” None of the vaccines have seal of FDA approval but are being administered under Emergency Use Authorization (EUA). Such authorization allows the Secretary of HHS to declare that emergency use is appropriate when necessary, for public health and national security when no adequate approved alternatives exist.
One could argue about therapeutics as an alternative to vaccination, but the medical and political establishment refuses to even consider such options as hydroxychloroquine and ivermectin.
To move from FDA authorization to approval, the FDA requires six months of data, which Pfizer and Moderna now have. The FDA then reviews the application and data for up to another six months before potentially granting approval. Once a fully approved vaccine is available, the opportunity for an EUA vaccine goes away as there would be an approved alternative at this point and new vaccines would need to go through standard clinical trials, hence the current vaccine races.
An EUA is technically a clinical trial, although open-label and non-randomized, and the FDA is closely watching for vaccine adverse effects. Healthcare providers are required to report any vaccine adverse effects to the Vaccine Adverse Event Reporting System.
Last week, the J&J vaccine was paused “out of an abundance of caution” even though the dangerous blood clots appeared to be “extremely rare,” six reported cases out of 7 million doses, less than one in a million odds.
All six cases were in women ages 18 to 48; one woman died, and one was hospitalized in critical condition. Is one in a million enough to cause a pause? Motor vehicle traffic deaths in the US occur at a rate of 10.7 per 100,000, one of the highest probability causes of death, and there is no move to take a pause on driving.
There are reports of people dying after the other vaccines. In fact, as of early March, over 900 persons died after COVID vaccination. Note I did not say “due to,” only “after,” raising the issue of association versus causation.
Remember last year when anyone who died with a positive COVID test was classified as a “COVID death,” even if they died of a gunshot wound or alcohol poisoning, contributing to the nonstop death tickers running on cable news.
Under those rules, anyone who died within a few weeks of vaccination should be called a “vaccine death,” regardless of actual cause of death. But as with so many things COVID, the rules and goalposts shift based on the desired political narrative at the time. A a CNN insider admitted as much to an undercover journalist, how CNN hyped the COVID death toll for ratings and politics.
A recent example is a University of Cincinnati premed student who died 24 hours after receiving the J&J vaccine. As some universities, like Cornell, are mandating vaccination for on-campus students; how many other students may die who otherwise have a 99.99 plus percent chance of surviving the Chinese coronavirus?
For perspective, the odds of a blood clot after the J&J vaccine, one in a million, are smaller than the odds of being struck by lightning in a given year, 1 in 700,000, and far smaller than the lifetime risk of 1 in 3000. The odds of getting hit by a meteorite are also 1 in 3000.
The blood clots following J&J vaccine were “central venous sinus thrombosis” (CVST), a rare but potentially fatal condition, occurring in 2-14 per million, more common than what was reported post vaccine and more common in women. Systemic inflammation, induced via vaccination, also increases the risk. Oral contraceptives, common in the age group of the women having blood clots post vaccine, also raise the risk of blood clots.
Interestingly, in a large European registry, the risk of central venous thrombosis was 8-10 times higher after COVID infection than after the vaccine, but both are still significantly higher than in the general population.
Blood clots of all types in the general population occur annually in 1 in 1000 adults, a far higher incidence than the 1 in a million CVST after the vaccine. It’s all data and definitions and depending on how it’s sliced and analyzed, the results can be all over the map.
The vaccine induced clots are more complicated, now being called “vaccine-induced immune thrombotic thrombocytopenia” which combines the seemingly contradictory state of low platelets and blood clots, forming clots and hemorrhaging at the same time.
Have all the blood clots been reported? What about blood clots causing heart attacks and strokes? Are busy doctors and hospitals reporting everything they should? What if the patient does not mention their vaccination a few weeks ago? Do we have complete data? Are government agencies playing it straight with the public?
Remember these are the same agencies that recommended no masks, then one, then two, then one mask and an arbitrarily selected six feet for social distancing without any scientific rationale besides the whims of the basketball player and scarf queen, famous for their press briefings a year ago.
It’s likely that the FDA is watching vaccine data closely, given the emergency use status, with a low threshold for taking a pause if any safety signals arise, even if faint. One of the primary goals of FDA approval is safety and that’s the side that the FDA will err on. Better that then having six cases turn into sixty cases a week later, which may be happening.
Is the safety cat out of the bag already? These adverse effects are on the rise with the European regulatory agencies noting over 220 blood abnormalities following the AstraZeneca vaccine. The world is close to the one billion mark of administered vaccines. Will Operation Warp Speed become Operation Death Trap?
The plan now is to review more data before making a decision if or when to resume the J&J vaccinations. Perhaps this is the prudent move, but given how everything is political these days, one has to consider alternative explanations.
Recall that Pfizer did “not seek an emergency authorization for its coronavirus vaccine until after the election.” They cited a need for additional safety data. President Trump claimed this was deliberate to hurt his reelection bid.
Last year Pfizer employees contributed $381,930 to Biden compared to only $119,768 to Trump, more than a three-fold difference. There was certainly a political preference. Did that influence Pfizer’s actions, dragging their feet until after the election?
If the J&J vaccine is sidelined, that means more business for Pfizer and Moderna, and an excuse to continue the COVID mandates, including masks, distancing, and business/school closures favored by Democrat governors and elected officials. How convenient.
Dr Fauci has no idea when masks and distancing might end, as he was unable to answer simple questions posed by Rep Jim Jordan about actual metrics or endpoints. Dr Fauci may have been a good basketball player in his youth, but he missed his true calling, on the gridiron moving the goalposts.
Of course, vaccines are political, like everything else. Rasmussen Reports found 45 percent of Democrats very confident that the COVID vaccines are safe and effective, compared to only 32 percent of Republicans, and 24 percent of independents.
How the J&J vaccine pause plays out is anyone’s guess. Was the pause premature? Was it based on an abundance of caution? Or is politics at play? Judging from how much COVID has been politicized and weaponized for over a year, one must wonder what’s driving the pause. And how many will needlessly suffer or die as the ruling class flexes its newfound tyrannical muscles.
Brian C Joondeph, MD, is a physician and writer. He is on sabbatical from social media.