Pfizer starts process for full FDA approval of its COVID-19 vaccine
Pfizer is the first drug maker to start the process of getting full regulatory approval from the FDA for its COVID-19 vaccine.
Right now, the shot is being used under an emergency authorization.
Pfizer said they've had no safety issues, and after trials and 170 million doses administered in the U.S., no safety issues have come up.
This is a logical next step.
Pfizer will have to submit months of data to the FDA showing its COVID-19 vaccine is safe and effective.
They've requested priority unconditional approval, which speeds up the timeline.
The move comes as the supply of COVID-19 vaccines is outpacing demand.
More than 170 million doses of the 2-shot Pfizer vaccine have been administered in the U.S. under emergency use authorization.
And a filing by the pharmaceutical giant is a strong indicator the vaccine could be here to stay.
In this photo illustration, a silhouette of hands in medical gloves holds a medical syringe and a vial in front of the Pfizer logo of a US pharmaceutical industry company. (Photo Illustration by Pavlo Gonchar/SOPA Images/LightRocket via Getty Images)
"They've had a very clean clinical trial," said Dr. Katelyn Jetelina.
Dr. Jetelina is an assistant professor of epidemiology at UTHealth School of Public Health in Dallas.
She's not surprised Pfizer has requested priority, unconditional approval of its COVID-19 vaccine from the FDA.
"It really just represents the confidence of their data and the longevity of their data and the validity of this vaccine technology to work very effectively," Dr. Jetelina said.
Dr. Jetelina said Pfizer will have to submit six months of follow-up data.
She expects the FDA to approve the request.
"The vaccines continue to work," she said.
The filing comes at a time when COVID vaccine supply is outpacing demand.
Starting this week, Texas will ask the federal government only for doses that providers have ordered, as opposed to asking for as much as the state can get.
"This is where the journey of vaccination has taken us," Denton County Public Health Director Dr. Matt Richardson said.
Dr. Richardson thinks it’s the right move.
He said the county currently has enough vaccines to meet demand for the next two weeks, prompting the county to close the once widely popular hub at Texas Motor Speedway Friday, May 14.
"This is a much more flexible adaptable approach to vaccine where providers can gauge the demand for their practice," he explained.
"I think this is the next step," said Dr. John Carlo, who is CEO of Prism Health, with four clinics in Dallas.
Dr. Carlo agrees with the move.
"I think, potentially, it could really help those of us who did have a good degree of patients who need vaccines and we can go online and request," he said.
Dr. Carlo, who is also part of the Texas Medical Association’s COVID-19 Task Force, said unconditional approval of the Pfizer vaccine could build consumer confidence, even more, that this vaccine is safe and effective.
Which could, in turn, lead to more folks getting vaccinated.