ORLANDO, Fla. — A COVID-19 vaccine trial in Orlando now has added safety guidelines.
The U.S. research by drugmaker AstraZeneca was paused for more than a month after safety concerns abroad.
Those trials are back on, cleared by a Food and Drug Administration review.
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“We have not observed any major significant events,” said Dr. Edwin DeJesus with Orlando Immunology Center.
In September, thousands were on the waiting list for the COVID-19 vaccine study at Orlando Immunology Center when all US clinical trials by its drug maker AstraZeneca hit the brakes after two people became sick in other countries.
After finding no evidence the vaccine was related to those illnesses, the FDA cleared those concerns after six weeks.
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At Orlando Immunology Center, the first round of volunteers who had already received the first dose before the pause will now have an option to take the second dose late, and is normally given within 30 days.
AstraZeneca released a statement saying patients who take the late dose will “continue to be followed up and contribute to analyses.”
All participants must also sign new research “consent forms.”
Building on early positive results from July, AstraZeneca said the vaccine appears to be effective in protecting older as well as younger adults.
The vaccine will now need to pass Phase 3 trials.
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Cox Media Group
