AstraZeneca 3:39 Vaccine Participant Symptoms Revealed
(CNN Spanish) -
A 37-year-old volunteer suffered from “transverse myelitis” after receiving the second dose of the coronavirus vaccine during phase 3 of the clinical trials carried out by the University of Oxford and AstraZeneca.
The information comes from an internal memo from the pharmaceutical company that CNN had access to.
In this episode, Dr. Elmer Huerta tells us about the symptoms of the neurological condition, which led to the confirmation of the diagnosis and what impact this episode can have on a possible vaccine.
You can listen to this episode on Apple Podcasts, Spotify, or your favorite podcast platform, or read the transcript below.
Hello, I am Dr. Elmer Huerta and this is your daily dose of information about the new coronavirus, information that we hope will be useful to take care of your health and that of your family.
Today we will see what caused the phase 3 study of the Oxford and AstraZeneca vaccine to be stopped.
As we saw in the September 10 episode, the AstraZeneca company announced on September 8 that due to an unexplained illness of a volunteer, the phase 3 study of its vaccine candidate, developed in partnership with the University of Oxford
Quickly, on September 12, the University of Oxford announced that it was restarting the study in England and Brazil, but not in the United States.
The issue is that various media and medical specialists, including members of the National Institutes of Health in the United States, expressed concern about the lack of details about the adverse effect suffered by the volunteer.
Neither the University of Oxford nor AstraZeneca had provided accurate information on the type of complication or the characteristics of the volunteer.
The neurological complication
In this sense,
The New York Times newspaper
and the STAT portal published - on September 8 and 9 respectively - that the affected person was a woman and that she had suffered a rare disease called transverse myelitis, assertions that - in a direct communication with CNN— the lab denied on September 9.
Now, in an internal AstraZeneca report, to which CNN had access, some details of the event that stopped the study are given.
According to the report, the affected person is a 37-year-old British woman, apparently healthy and with no previous history of major illnesses.
As a study participant, she received two doses of the vaccine, the first in early June and the second in late August.
On September 2, while running, the woman "tripped, but did not fall" and felt a kind of jolt.
The next day, the report says, the woman began exhibiting symptoms that included:
Dificulty to walk,
Pain and weakness in the arms,
Decreased sensation and pain in the torso,
Headache
And difficulty using your hands.
So on September 5 she was hospitalized.
It also says that a neurologist, who saw the volunteer, suggested that the symptoms were compatible with the diagnosis of transverse myelitis, mentioning the report that the diagnosis of that disease was later confirmed.
What is transverse myelitis?
The word myelitis comes from the Greek
mielos
which means bone marrow, and
itis
, which means inflammation.
Myelitis means in this case, inflammation of the spinal cord.
Remember that the spinal cord is the continuation of the brain and is housed within the spinal column.
It is the organ that contains the nerve cables or bundles that go down from the brain to the extremities and to the organs of the trunk and abdomen.
From time to time, the nerves that provide movement and sensitivity to different regions of the body leave the spinal cord.
When the spinal cord becomes inflamed, in some segment of its extension, transverse myelitis occurs, which interrupts the passage of electricity through the corresponding nerves, causing symptoms of loss of movement and sensitivity in the affected area.
Apparently that's what happened to the volunteer, with the AstraZeneca report claiming that the volunteer had improved her symptoms in just four days.
Oxford later said in a statement that "having concluded the review process and following the recommendations of both the independent safety review committee and the UK Medicines and Healthcare Products Regulatory Agency, trials will resume in England." .
The composition of the AstraZeneca and Oxford vaccine
Recall that the AstraZeneca and Oxford vaccine uses a chimpanzee cold virus as a vector.
This virus has been manipulated to carry a gene for the new coronavirus and thus arouse immunity in the vaccinated person.
In phase 1 and 2 studies, which included 1,077 volunteers who received the vaccine and published on July 20 in
The Lancet
, the most frequent side reactions were reported to be pain, fever, chills, muscle pain, pain headache and discomfort, which, according to the report, were alleviated with the use of prophylactic paracetamol.
In the study, no serious adverse events related to the vaccine were reported.
It is also important to know that all drug and vaccine trials have an independent group of researchers called the “data and safety monitoring board”, who are constantly monitoring the side effects caused by the vaccine or placebo and are the ones that, in Ultimately, they decide - according to the severity of these side reactions - whether the studies should continue or should be suspended.
This board acts as a true safety valve to protect participants, and its independent nature allows confidence in its decisions.
It will be that board - which is independent for each country - that decides whether to restart the clinical trial in the United States.
The vaccine and safety in the population
There is no doubt that the transparency of the laboratories and academic institutions conducting these trials must be very clear.
Knowing that approximately 40% of Americans have stated in a CNN poll that they would not get the vaccine, that number may increase if there is a lack of transfer or political manipulation of the vaccines.
In any case, the episode of transverse myelitis that occurred in a volunteer who received the vaccine candidate from Oxford and AstraZeneca is a call to attention to these institutions and their data and safety monitoring boards, to take extreme measures of evaluation and communication with the audience.
Undoubtedly, a failure of transparency and communication in the development of vaccines against covid-19, could not only undermine public confidence in this type of vaccines, but could cause irreparable damage to the confidence of the population to all the other vaccines.
Do you have questions about the coronavirus?
Send me your questions on Twitter, we will try to answer them in our next episodes.
You can find me at @DrHuerta.
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Thanks for your attention.
If you have any questions you can send them to Dr. Elmer Huerta via Twitter. You can also head over to CNNE.com/coronaviruspodcast for all episodes of our “Coronavirus: Reality vs. Reality” podcast. fiction".
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