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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study, just concluded but not yet peer reviewed, seems to suggest otherwise.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.
References:
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:
https://www.bmj.com/content/373/bmj.n1005
The preprint itself:
https://osf.io/a9jdq/
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