Right now, U.S. health officials are banking on six vaccine candidates, all looking for a way to prevent the virus that causes COVID-19.
Over two days, the Vaccine and Related Biological Products Advisory Committee, made up of medical experts across specialties, are hashing out many of the painstaking details, then giving recommendations to the FDA, who will then determine licensing and distribution of the vaccine.
Logistical concerns around manufacturing and quality control are high on the priority list.
The head of BARDA, the government department that takes care of getting and making vaccines, said the plan is to use multiple manufacturing facilities to make the vaccine concoctions. He wouldn't say how many.
This raises another concern: vaccine quality. FDA guidelines do not require inspection of facilities manufacturing under an emergency authorization.
"Quality is always paramount," Robert Johnson said. "And so this is something we are focused on heavily and spend a lot of time and effort on, you know, regardless of of, you know, when the regulatory authorities may come for an audit."
Experts also talked about vaccine distribution. Many worry that Black and Indigenous communities, some of the hardest-hit by COVID-19, will avoid getting the vaccine once it is available.
All but one of the six vaccine candidates require two doses. So in order to track a patient's vaccine dosage, the panel suggested a monitoring system, including using cellphone texting and a backup card.
"We are asking that they keep and return that card when they come back for their second dose," Janell Routh, the CDC's COVID-19 Vaccine Implementation Planning Unit deputy, said. "That card will contain information about the vaccine that they did receive and the timing in order to ensure that they get that appropriate second dose."
Many of the recommendations that come up in these meetings are just suggestions. Historically, the FDA has taken about 80% of what this panel brings to them.
Lindsey Theis, Newsy, Denver.
