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'This is the standard process': Doctors say emergency approval of COVID-19 vaccines in paused Phase 3 trials shouldn't be delayed, if safe

Virologists estimate the soonest we could see an Emergency Use Authorization from the FDA is early 2021.

As the search for a COVID-19 vaccine continues across the world, four vaccines have risen to the top in the U.S. 

Johnson & Johnson, Moderna, Pfizer, and AstraZeneca's vaccines are all in Phase 3 trials with thousands of volunteers enrolled.

"It's gone very quickly. Johnson & Johnson is on hold after some illnesses, and AstraZeneca today had what appeared to be a reportable event in Brazil. But the latest news is that the individual who died was not a recipient of the vaccine," Dr. Jay Wolfson with USF Health said.

The public health expert says Brazil's trial was stopped after a volunteer died. While the death is shocking, Wolfson says adverse reactions in a trial this big are common and there's no reason to be concerned. 

"This is the standard process. We shouldn't be surprised. We shouldn't be disappointed. We should be pleased that they are monitoring this and measuring it," Wolfson said.

Brazil's health department says the clinical trial will resume. Scientists say AstraZeneca's trial in the U.S. should do the same in a few weeks. It was put on hold after a volunteer in the U.K. got sick.

"The AstraZeneca one should go back into recruiting phase," Dr. Michael Teng with USF Health said.

The virologist suggests finding the efficacy of each vaccine will depend on how quickly people get infected with the virus

"There certainly will not be any approvals before November because one of the requirements that the FDA has put in their guidance is that they require a two month follow up after the last vaccination," Teng said.

Teng expects the soonest we could see an Emergency Use Authorization from the FDA is early 2021.

"They'll be able to file for Emergency Use Authorization by the end of the year. I think this is an optimistic timetable, but it's not unreasonable. We may have a vaccine that's widely available by summer next year. maybe summer, fall next year," Teng said.

The FDA will hold its first data safety monitoring board meeting on COVID-19 vaccines tomorrow. This independent board is made up of experts who review the progress of vaccine trials. They'll plan how to authorize and license any vaccine that gets emergency approval. 

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