Coronavirus vaccine volunteer in Brazil’s AstraZeneca trial dies — but authorities say trial to continue | CNN.com | October 21, 2020
In addition to the reported October incident in Brazil, in July, AstraZeneca put its vaccine trial on pause while they investigated a volunteer’s illness.
In an email to CNN, the company claimed that the patient had “an undiagnosed case of multiple sclerosis” but that an independent investigation decided it was “unrelated to the vaccine.”
Then in September, there was another illness in a volunteer. This was AstraZeneca’s phase 3 US trial which started on August 31 with the trial pause announced on September 8.
CNN was sent an “internal safety report.”
The report explained that
the volunteer, a previously health 37-year-old woman, “experienced confirmed transverse myelitis” — an inflammation of the spinal cord — after receiving her second dose of the vaccine and was hospitalized on September 5.
CNN says the trial started up again in the UK but remained on pause in the US.
Information on the September and earlier July incidents:
AstraZeneca confirms Covid-19 vaccine trial was also paused in July
CNN.com | September 10, 2020
Info on September 2020 incident
Internal AstraZeneca safety report sheds light on neurological condition suffered by vaccine trial participant | CNN.com | September 17, 2020
Fourteen days after receiving her second dose of the vaccine, the woman, who lives in the UK, “experienced confirmed transverse myelitis,” with symptoms including trouble walking and pain and weakness, the safety report said. Researchers were sufficiently concerned that they filed a SUSAR, or Suspected or Unexpected Serious Adverse Reaction report.”
Here is an official document for volunteers:
PARTICIPANT INFORMATION SHEET: COV002 Investigating a Vaccine Against COVID-19 “A phase 2/3 study to assess the efficacy and safety of a recombinant adenovirus-based vaccine against Coronavirus Disease (COVID-19)” | September 11, 2020
This document discusses possible side effects of the two vaccines used in the trials, one as a “placebo” from what I have heard:
“2.Vaccination Side Effects: ChAdOx1 nCoV-19 and MenACWY”
“The MenACWY vaccines are licensed vaccines, meaning they have been approved for use in the general population. They have been given to many hundreds of thousands of people, with no safety concerns.”
The last part of that statement is dubious, and the October incident relates to this “placebo.”
In any case, the statement I would focus on is on page 12:
With any vaccination there is a risk of rare serious adverse events, such as an allergic reaction.These may be related to the immune system or to the nervous system. Severe allergic reactions to vaccines (anaphylaxis) are rare, but can be fatal. . . .Reactions in the nervous system are also extremely rare [“rare’ is very subjective], but can include an illness called Guillain-Barré syndrome, a condition in which people can develop severe weakness and can be fatal. These adverse events have not previously been seen following administration of similar vaccines using ChAdOx1 as a viral vector. In the current trial we have undertaken safety reviews when volunteers in the trials of ChAdOx1 nCoV-19 [what they are testing] developed unexplained neurological symptoms including changed sensation or limb weakness, and have paused the study while a safety review took place. After independent review, these illnesses were either considered unlikely to be associated with the vaccine or there was insufficient evidence to say for certain that the illnesses were or were not related to the vaccine. In each of these cases, after considering the information,the independent reviewers recommended that vaccinations should continue.
The vaccine ChAdOx1 nCoV-19 was first given to 500 healthy adults in Oxford in April 2020 as part of a separate safety trial (COV001).