Hello, welcome to Medicine with Dr. Moran. I'm Dr. Keith Moran. This week a lot of information has
come out from the approximate 10-day pause in the Johnson and Johnson-Jansen Covid-19 vaccination.
The FDA and CDC have now resumed vaccinations with this product. I wanted to review this
information. Some of the slides that I will put up are directly from the CDC and I have a link below
in the description to the full slide set presentation if you wish to look at that.
As this vaccine was being rolled out in the USA reports of blood clots were noted just
like what has been seen for the AstraZeneca vaccine. This was not seen in any patient in
the Phase 3 Johnson & Johnson trial but obviously we're getting into much larger numbers of people
receiving the vaccine compared to what we saw in the Phase 3 trial. About 8 million people in
the U.S. have received the vaccination now. It is the one-shot vaccine. Now what's being described
in very small numbers of vaccinated people is a syndrome of blood clots which we call Thrombosis
and it's associated with a low platelet count which medically we call Thrombocytopenia. They're
calling this Thrombosis and Thrombocytopenia syndrome. There are other terms to describe it
that you may have heard of such as vaccine-induced immune Thrombosis with Thrombocytopenia.
Here is some background information on Thrombosis. Thrombosis can occur in veins as well as arteries
and it can cause heart attacks, strokes, and other problems. There are additional risk factors for
blood clots and there are hosts of symptoms that people can get depending upon which artery or vein
is blocked. We diagnose blood clots mainly through imaging tests where we can see the blood clot
on either ultrasound CT or MRI blood tests can often tell the extent of the damage. This slide
explains what low platelets mean. The platelets of the blood cells in our circulation which
stop bleeding by clumping together and form a plug in a blood vessel injury for example
when you cut yourself and you're bleeding. The platelet plug is what occurs first.
Now dangerously low platelet counts can lead to serious spontaneous internal bleeding.
In Europe as well as other countries they have found a link with the AstraZeneca vaccine to
this particular syndrome. This slide is a release from the European Medicines Agency acknowledging
this fact. They found 62 cases of blood clots in the veins of the brain and 24 cases of blood
clots in the veins draining the intestines. 18 of these cases unfortunately were fatal.
About 25 million people had received the vaccine which gives an overall risk of 1 in 300,000.
Obviously this is a rare condition and as I've highlighted at the bottom of this slide the
overall benefits of the vaccine and preventing Covid-19 outweigh the risks of side effects.
It is though something for the individual person to consider
if they're going to receive the AstraZeneca vaccine. As far as the Johnson & Johnson
vaccine goes there were reports of blood clots involving the veins which drained the brain
and a decision was made to put the vaccine on hold April 14 to get more information. This slide
shows how blood is actually drained from your brain through veins which we call sinuses
the blood ultimately drains into both the left and right internal jugular veins which then drain back
into the heart. Blood clots in these veins of the brain are termed Cerebral Venous Sinus Thrombosis.
These types of blood clots are quite rare but they're quite significant and they can cause
significant symptoms and illness and sometimes even death. They're very uncommon. I can tell
you I've only seen two cases in my 30-year career as a consultant in internal medicine.
These types of blood clots are not associated with low platelets. usually.
What we're seeing now though with Johnson and Johnson vaccination
are not only blood clots in the cerebral veins but the presence of low platelet counts as well.
What was being found April 14th when the vaccine was put on pause is summarized on this slide from
the CDC. At that time they noted six reports of women in the 18 to 48 years of age all with
low platelets at the time this was six cases out of 6.8 million vaccinations. The rates of these
venous blood clots in the brain appear to be about threefold greater than what you might expect as
background rates in the general population. I make note that no reported cases of this clotting had
been seen in 182 million vaccinations with Moderna or Pfizer. Now the clinical features were similar
to the features observed with the AstraZeneca vaccinations in Europe that I just talked about
the thing in common of course is that both vaccines use an incompetent adenoviral vector
to deliver vaccine into the cells whereas the Pfizer and Moderna vaccines are different they
have a lipid layer or if you like a coating of fat around their vaccine which allows the vaccine to
be delivered directly into cells. I will review how the vaccines work in this particular video.
Subsequently additional cases were noted after the Johnson and Johnson pause
and this slides details them. They're predominantly noted in the female population with
the vast majority in the 18 to 49 years of age range. This slide shows the age groups and rates.
This next slide gives you a better idea of the ages. The patients had an average age of 37 and
typically developed this syndrome six to fifteen days after the vaccination. Twelve cases were
of clots inside the brain with three cases having blood clots not within the brain but in different
blood vessels. Some of the twelve cases with clots inside the brain also had blood clots elsewhere.
Now how do you know if you have a blood clot? Well this slide shows the typical symptoms as well as
medical signs that someone might have this if they have a clot. A lot of the symptoms as you can see
are quite non-specific such as a headache, chills, fever, nausea, fatigue, vomiting, and abdominal
pain. Later on there can be more specific symptoms such as neck discomfort or stiffness,
weakness on one side of the body, trouble with speech, difficulty with vision, or double vision,
seizures and loss of consciousness can also occur. I wanted to show the locations of blood clots in
these 15 people because they may not just be in the veins of the brain. As I mentioned three cases
were not in that location but were in other veins or arteries of the body. Many people had blood
clots in more than one location in fact 11 of the 15 people had blood clots outside of the brain.
This means as physicians we need to consider other locations for these clots.
This slide shows treatments as well as outcomes of the 15 patients. Three unfortunately died
seven were still hospitalized at this time with four in the ICU and five were discharged
from the hospital. I will go into diagnosis and treatment of this condition in another video. Now
in total approximately 8 million Johnson & Johnson vaccinations were given and we see 15 events where
their blood clots associated with low platelets which gives an overall risk of 1 in 500,000
or one and a half a million. We now understand more about this condition and its frequency
in a nutshell both the AstraZeneca and Johnson and Johnson vaccines do induce an immune response
which causes an antibody to be produced against platelets ultimately leading to platelets to
coming together and clump to cause blood clots and because they're all clumping they get consumed and
you have left less platelets in the rest of your body giving you a low platelet count.
now people are using different words to describe the syndrome as I presented. The CDC is using the
term Thrombotic Thrombocytopedic syndrome but you'll hear other terms such as vaccine-induced
immune Pro-Thrombotic Thrombocytopenia to describe what's happening. It is important for doctors to
consider blood clots in patients who present after vaccination and carry out the appropriate
diagnostic tests and treatment and of course report these cases. There will continue to be
safety surveillance and research on this condition as we go forward. Ultimately it's a rare condition
with the current rate estimated of one in five hundred thousand with respect to the J and J
vaccine. The frequency of course may change slightly with time but it will still be rare.
It is on the order of someone getting struck by lightning and other infrequent risks.
Risks of course using over-the-counter medications like Aspirin, Ibuprofen, even acetaminophen are
going to be higher than this. Now it's obviously not rare if you happen to be the person who
gets it. It's something that people will want to consider when they're getting their vaccinations.
Putting it in perspective this is a tiny risk in comparison to the benefit of the vaccination
in people at risk of an adverse event from Covid-19. Remember that blood clots are quite
common in Covid-19 illness with about 15% of people in the hospital getting a blood clot.
We don't know the exact percentage of people who have Covid who are not hospitalized who get blood
clots but for sure it's almost certainly to be much higher than one in five hundred thousand.
I'm just trying to put things in perspective for you. Despite this this remains a good vaccine.
I have more information on the vaccine itself in this video.
In that video I review the results of the Phase 3 trial and the effectiveness of the vaccine.
Overall I'm pleased to see resumption of vaccinations as the approximate 10-day pause
meant that many people did not get vaccinated which would have led to more Covid-19 infections
that would not have happened if they had not had a pause. The pause and this risk unfortunately is
going to make people think twice about receiving the Johnson & Johnson vaccine. It of course is a
personal decision which I know some of you are interested in and so I've tried to present the
best information we have so that people can make an informed decision and choose for themselves.
Thanks for joining me today on Medicine with Dr. Moran.
I'm Dr. Keith Moran. Thanks for watching my channel. Remember get healthy and stay healthy.