Tuesday, April 20, 2021

Johnson & Johnson Suspension: “Out of an Abundance of Caution?”

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By Jack Gerson

Last week, regulators from the US Federal Drug Agency (FDA) and Centers for Disease Control (CDC) indefinitely suspended use of Johnson & Johnson’s coronavirus vaccine pending investigation into its possible connection with increased risk of cerebral venous thrombosis (CVT -- potentially fatal blood clots in veins that drain blood from the brain). The government regulators said, repeatedly, that this was done “out of an abundance of caution”. Last month, several European governments, and for a time the EU, had suspended use of a coronavirus vaccine from Oxford U. and AstraZeneca, and that too was for suspected connection with CVT and “out of an abundance of caution”.

Was this really necessary? Was it really exhibiting “an abundance of caution”

An Oxford University study, just concluded but not yet peer reviewed, seems to suggest otherwise. This study found that the risk of CVT clotting is roughly ten times as great following COVID-19 infection than it is following coronavirus vaccination. And brain clots are only one of the many deadly outcomes from COVID-19 infection. Since vaccination is highly protective against serious COVID infection, the risk from vaccination pales in comparison to the risk of remaining unvaccinated. These results really just confirm and begin to quantify what was already pretty well known -- it’s much more dangerous to not get vaccinated than to get vaccinated. The study also found evidence that suggests that the risk of CVT from vaccination with mRNA vaccines (Pfizer and Moderna) is about the same as vaccination from the adenovirus viral vector vaccines (AstraZeneca and Johnson and Johnson)! More on this a few paragraphs down.

Suspending the use of the J & J vaccine won’t have much effect on the U.S. vaccination program. The Biden administration has already announced that it has acquired enough of the mRNA vaccines from Moderna and Pfizer/BioNTech to vaccinate everyone over the age of 18 in the U.S., and will soon have enough to vaccinate those aged 12 to 18. The U.S. had hoped to speed vaccination with the J & J vaccine, because it only requires a single shot. But a few weeks ago, 15 million doses of that vaccine had to be destroyed because of contamination in their manufacturing process. Another 62 million doses, nearly all of the remaining available J & J supply in the U.S., were put on indefinite hold pending inspection for possible contamination. And production at the Baltimore plant that’s the main facility for manufacturing the J & J vaccine has been suspended indefinitely. In other words, several days before the U.S. suspended use of the J & J vaccine “out of an abundance of caution”, there was virtually no J & J vaccine available to use, nor could there be for at least several weeks. So suspending use of the J & J vaccine not only didn’t hurt the U.S. vaccination rollout, it was inevitable -- there was no J & J vaccine around to ship and to use.

But unlike the U.S., low and middle income countries have been depending on the Johnson & Johnson and AstraZeneca vaccines. They are much cheaper ($10 for full vaccination with J & J; $4 to $10 for full vaccination with AZ -- compare this to about $40 to $60 for full vaccination with Pfizer of Moderna. And the J & J and AZ vaccines are far more suitable for shipping to rural and low income areas -- they can be stored for months using ordinary refrigeration, where the mRNA vaccines require freezing and have much shorter shelf lives.

Pfizer and Moderna each project profits of over $20 billion in 2021 alone from sales of their coronavirus vaccines. AstraZeneca has pledged to forego profit from its vaccine until the pandemic is ended, and Johnson & Johnson has set low profit margins. Perhaps huge profits vs their absence might help explain why there’s been no notice of the CVT (brain) blood clotting from the Pfizer and Moderna vaccines, despite their occurring at about the same frequency as those from the J & J and AZ vaccines. (We will leave for another time evidence that the mRNA vaccines are associated with a higher rate of serious abdominal blood clots [PVT] than the J & J and AZ vaccines.)

So it’s especially poor and working people in Africa and many Asian and Latin American countries who are most dependent on the Johnson & Johnson and AstraZeneca vaccines. The U.S. suspension of the J & J vaccine (AstraZeneca’s, although widely used in the UK, hasn’t even been approved yet in the U.S.) has only increased vaccine hesitancy and fear around the world. And unlike the U.S., these countries don’t have the luxury of vaccinating their entire populations with Pfizer and / or Moderna vaccines. Indeed, in the 92 lowest income countries, well under 5% of the population has even been partially vaccinated.

Here’s what really would and should be done “out of an abundance of caution”.

The US would share available vaccines with other countries, even if only out of self-interest -- since “no one is safe until everyone is safe” because coronavirus variants don’t respect borders and develop most rapidly where the infection rate is highest (that is, where vaccination rates are lowest).

The US would take initiative in ending patent protection for COVID vaccines, making their production and distribution available to and affordable by low income countries. Peoples’ health should not be sacrificed for the sake of maximizing profitability.

The US would help those countries to create locally based facilities to manufacture the vaccines, providing urgently needed financial and technical assistance.


Expert reaction to preprint looking at incidence of rare cerebral venous thrombosis (CVT) following Covid-19 infection compared to incidence after vaccination or influenza:
expert reaction to preprint looking at incidence of rare cerebral venous thrombosis (CVT) following COVID-19 infection compared to incidence after vaccination or influenza

Summary of the preprint in the British Medical Journal:


The preprint itself:



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