DENVER — After months of waiting, Pfizer is preparing to meet with the Food and Drug Administration (FDA) to see if its vaccine will go from "emergency use" to full approval.
“What they’re looking for is data and looking for more data that has been collected since the vaccine has been in use since the emergency use authorization,” said CSU Infectious Disease Research Center Executive Director, Dr. Raymond Goodrich.
Data shows its effectiveness and safety among the millions of individuals who are already vaccinated. The emergency use authorization process began in 2004 during an anthrax scare.
“There’s was a concern that anthrax might be weaponized and be used as a biological or bioterrorism weapon to attack the United States – to attack the United States military,” said Dr. Thomas Campbell, UC Health Chief Clinical Research Officer.
Basically, it makes it easier to quickly approve things that could conceivably help during a health crisis.
“Once a COVID vaccine, one or more COVID vaccines do have full FDA approval, they will be handled just like other vaccines as you mentioned,” Campbell said. “I think the COVID vaccines will be incorporated into our vaccine schedules and our requirements for attending school and for certain employers. Just like other vaccines already are.”
Campbell said he believes a full approval could bring several changes. The first is health care providers prescribing the vaccine.
“Health care providers who are licensed can prescribe those things both according to the wording in the label as well as what’s called off-label prescribing – which allows licensed providers to use their best judgment to determine if a device or a drug or a vaccine could be used in a particular instance in a slightly different way than the way that it’s licensed,” Campbell said.
This could potentially help those who are immunocompromised as they are more vulnerable to the virus and have a weaker immune response to the two-dose vaccine.
“Providers could recommend a third dose of the vaccine to those immunosuppressed patients that might need it,” Campbell said.
The move from authorized to fully approved might not seem like a big deal, but when it comes to the COVID-19 vaccine, it’s part of the reason why some say they're on the fence to get the shot.
Right now, 30% of eligible Americans remain unvaccinated. Campbell said he believes this approval could encourage more to get the shot. He’s also encouraging people to get the shot now while it’s free.
Full approval of the vaccine could mean Pfizer can start charging and advertising.
“The vaccine manufacturer, Pfizer in this case, could start charging for the vaccine. So right now, vaccines are free. If you are not vaccinated, now is the time to do it’s still free. We have a vaccine that’s safe, effective, and free,” Campbell said.
Experts say the FDA hopes to make a decision by Labor Day.
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