NEW YORK (CBSNewYork) — A setback in the race to produce a COVID-19 vaccine was announced Wednesday by AztraZeneca. A volunteer who received the experimental vaccine has developed a serious complication.
As CBS2’s Dr. Max Gomez reported Wednesday, a so-called adverse event is not entirely unexpected. In very large vaccine clinical trials involving tens of thousands of people, there will often be volunteers who get sick for reasons unrelated to the vaccine. But, it might be due to the vaccine and that’s why the trial has been paused.
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The AstraZeneca-Oxford trial was one of the furthest along, recruiting volunteers in England, India, Brazil, South Africa and the U.S. One volunteer in the U.K. developed a serious spinal cord inflammation, according to Dr. Anthony Fauci, triggering a safety review and trial pause.
“You alert the other sites to see if they see anything similar to this, or related to that. And then you proceed cautiously as you go forward, making sure you’re on the alert for this type of an adverse event,” Fauci said.
Neither Dr. Fauci or AstraZeneca would predict how long the trial pause would last while the independent data safety monitoring board evaluates the case, but it clearly will slow the testing process.
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Meanwhile, at a Senate hearing, two of the government’s top doctors sought to reassure the country that no vaccine will be approved until it is fully tested for safety and efficacy.
“Science and science alone will be the way in which this decision is made. Otherwise, I will have no part of it,” said NIH Director Dr. Francis Collins.
As to when a vaccine might be available, the government doctors said while it’s conceivable that it could be by Election Day, the most likely timetable is not until at least the end of the year.
A spokesperson for AstraZeneca released a statement about the ill patient, saying in part, ” … there is no final diagnosis, and that there will not be one until more tests are carried out.”
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