SAN FRANCISCO (KGO) -- There are four safeguards that will lead to a promising COVID-19 vaccine, but one of them is already in question. The U.S. Food and Drug Administration's vaccine monitoring system: will it be transparent enough?
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ABC7 spoke exclusively with the Food and Drug Administration's former Chief Scientist, Dr. Jesse Goodman, to weigh the strengths and weaknesses of the process.
"One thing I always say is expect the unexpected. When you're starting something new in vaccine development. Things occur," said Dr. Goodman, an infectious disease physician and professor at Georgetown University.
Goodman led the FDA's response to the H1N1 flu pandemic in 2009.
"This is a bigger challenge than we had in 2009 because we could build on proven vaccines," Goodman said. "We had pretty high confidence in manufacturing quality and in their safety and performance."
To put in perspective, it took eight years for an effective Ebola vaccine. It took six months for a safe H1N1 vaccine -- made possible with decades of prior research on influenza.
A luxury scientists don't have with COVID-19.
So what other challenges are scientists facing trying to develop a vaccine for a novel disease?
Dr. Goodman said previously scientists have struggled to produce quality antibodies to treat other strains in the coronavirus family. Some animal models showed it actually made the disease worse.
"That's an important potential safety concern," Goodman said. "That these vaccines protect but don't have this theoretical risk of making the disease worse."
"What are you most concerned about?" ABC7's Stephanie Sierra asked.
"What we don't know... could there be much rarer and more serious side effects?" said Goodman.
It's those questions that point to the vaccine monitoring process evaluated by the Centers for Disease Control and Prevention and the FDA. The public is relying on that process not only being thorough but transparent.
"You've been through this before. What exactly should be public?" Sierra asked.
"I think the data on safety and effectiveness that comes out of these phase 3 clinical trials should be public, everything we need to know about adverse events (side effects), and everything we need to know about safety," said Goodman. "Especially if there is an EUA."
If approved, an EUA or Emergency Use Authorization, authorizes the FDA to facilitate the availability of an unapproved drug or product during a state of emergency.
"If there is an EUA, it should be clear what the gaps are," Goodman said. "If we're approving this, why? What do we and don't we know?"
Data transparency will help the public confirm there are no shortcuts to compromise safety.
Once a COVID-19 vaccine is approved and in use across the country, the FDA and CDC will continue to monitor safety and potential side effects through a federal reporting system called VAERS. Anyone who has received a vaccine can file a report online.
Take a look at all of ABC7's Building a Better Bay Area stories and videos.
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