J&J Vaccine Pause – Prudence or Politics?
A Commentary by Brian C. Joondeph
The FDA and CDC this 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, not with the good seal of FDA approval but 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.
To move from FDA authorization to approval, the FDA requires six months of data, which there is now, at least for Pfizer and Moderna. The FDA then takes up to six months to review the application and data before 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.
As an EUA is technically a clinical trial, although open-label and non-randomized, the FDA is closely watching for vaccine adverse effects. Healthcare providers are required to report any and all vaccine adverse effects to the Vaccine Adverse Event Reporting System.
Several days ago, the J&J vaccine was paused “out of an abundance of caution” even though the 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? 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 that anyone who died with a positive COVID test was classified as a “COVID death,” even if they died of a gunshot wound, contributing to the nonstop death tickers running on cable news networks.
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 like with so many things COVID, the rules and goalposts shift based on the desired political narrative at the time. A CNN insider admitted that CNN hyped the COVID death toll for ratings and politics.
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. Motor vehicle traffic deaths in the US occur at a rate of 11 per 100,000, one of the highest probability causes of death, and there is no move to take a pause on driving.
The blood clots following J&J vaccine were central venous sinus thrombosis, 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 increase the risk of blood clots.
Venous thrombosis in the general population occurs annually in 1 in 1000 adults, a far higher incidence than the 1 in a million after the vaccine. Perspective is important.
Have all the blood clots been reported? What about blood clots causing heart attacks and strokes? 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.
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. Better that then having six cases turn into sixty cases a week later. One of the primary goals of FDA approval is safety, and that’s the side that the FDA will err on.
The plan now is to review more data before making a decision on 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 that aspect.
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 and only $119,768 to Trump, more than a three-fold difference. There was certainly a political preference. Did that influence Pfizer’s actions?
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.
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 COVID has been politicized and weaponized for over a year, one has to wonder what’s driving the pause.
Brian C Joondeph, MD, is a physician and writer. He is on sabbatical from social media.
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