Review Underway Into Neurological Illness Of Vaccine Trial Participant
With the AstraZeneca trial halted, scientists are now working to determine if the volunteer's serious symptoms were caused by the experimental COVID-19 vaccine.
The New York Times:
Inquiry Begins Into AstraZeneca's Coronavirus Vaccine Trial
Part of the review will include generating a timeline of the participant’s symptoms to see if they match up roughly with when the vaccine was administered. The committee will also investigate other potential causes of the symptoms, in a process of elimination. After determining whether AstraZeneca’s vaccine is the probable cause, experts will advise the company on whether to resume its trials. (Wu, 9/10)
AstraZeneca CEO Says Participant Had Neurological Symptoms, Could Be Discharged Today
The participant who triggered a global shutdown of AstraZeneca’s Phase 3 Covid-19 vaccine trials was a woman in the United Kingdom who experienced neurological symptoms consistent with a rare but serious spinal inflammatory disorder called transverse myelitis, the drug maker’s chief executive, Pascal Soriot, said during a private conference call with investors on Wednesday morning. The woman’s diagnosis has not been confirmed yet, but she is improving and will likely be discharged from the hospital as early as Wednesday, Soriot said. (Feuerstein, 9/9)
AstraZeneca Says Should Know If Vaccine Works By Year-End If Trials Resume
AstraZeneca’s chief executive Pascal Soriot said on Thursday that it should know before the end of the year whether its experimental vaccine would protect people from COVID-19, if the British drugmaker is allowed to resume trials which were paused this week. It suspended the late-stage trials after an illness in a study subject in Britain. The patient was reportedly suffering from neurological symptoms associated with a rare spinal inflammatory disorder called transverse myelitis. (Miller and Burger, 9/10)
In related news about AstraZeneca's vaccine —
Fauci: AstraZeneca Pause In Vaccine Production 'Not Uncommon'
Anthony Fauci, the nation’s top infectious diseases expert, said Wednesday that AstraZeneca’s pause in its vaccine clinical trial due to a “potentially unexplained illness” is “not uncommon.” Fauci told “CBS This Morning” that the halting of one of the leading coronavirus vaccine clinical trials is “not uncommon,” noting the documented reaction to the vaccine is why trials are conducted. (Coleman, 9/9)
The Upside Of The Vaccine Slowdown
AstraZeneca halted its coronavirus vaccine trials this week while it investigates whether a participant’s serious health problem — reportedly spinal cord inflammation — was caused by the shot. The company’s decision to pause the studies while it reviews safety data is encouraging, because it shows the system is working. But it’s a good reminder that developing safe and effective vaccines is a tricky process. And it’s rarely followed so closely by the general public as it has been during this pandemic. (Morello, 9/9)