FDA fully approves vaccine
Officials OK Pfizer shot after receiving emergency use approval
The Food and Drug Administration Monday gave full approval to the Pfizer vaccine for COVID-19, an action that could nudge some hesitant people to get their shots, experts said.
The testing that preceded the FDA’s emergency use authorization for Pfizer and the performance of its vaccine since then has shown the drug to be safe and effective, according to Don Yealy, UPMC chief medical officer, in a news conference Monday.
The lack of full FDA approval seemed to be “one of the reasons people were holding off,” said Mark Taylor, Blair County’s emergency management director.
Now, “there’s some sort of hope we can get more people vaccinated,” Taylor said.
Forty-nine percent of the Blair County residents eligible for COVID-19 vaccinations — those 12 and up — have received shots so far, according to the Centers for Disease Control and Prevention.
It’s not known how many might be persuaded by Monday’s announcement.
“I hope today’s news reaches a lot of people” and that it helps them at least consider a shot, said Graham Snyder, UPMC medical director for infection prevention.
Getting more people vaccinated is currently the “biggest challenge” of the pandemic, Yealy said.
Some who’ve hesitated claim the vaccines were developed and authorized in too much of a hurry.
It’s true the process moved at “an incredible pace,” Yealy said.
“But it has not been rushed,” because the FDA considered “reams of data,” he said. The process has been one of the most thorough of its kind he’s ever witnessed.
The FDA’s emergency use approval review included an analysis of “effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose,” the FDA stated in a news release Monday on its website. It also included safety evaluations for 22,000 people 16 and up who got the vaccine and 22,000 who got the placebo.
More than half the clinical trial patients were followed for four months to evaluate safety and 12,000 were followed for six months, according to the FDA.
The vaccine, now being marketed as Comirnaty, was 91 percent effective in preventing COVID-19 disease, the FDA said.
“The public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Dr. Janet Woodcock, a 1966 graduate of Hollidaysburg High School, the FDA website stated.
“Full approval by the FDA solidifies the overall safety and efficacy of the Pfizer BioNTech COVID-19 vaccine,” Gov. Tom Wolf said in a news release.
The full approval applies to people 16 and up, while the EUA continues to apply to those between 12 and 15.
Side effects of the Pfizer vaccine are most commonly pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills and fever, according to the FDA.
The full approval does not change UPMC’s position on whether to mandate its employees to be vaccinated, according to Yealy.
The organization has been urging vaccinations and educating employees so that they would get their shots, but it has not required vaccinations.
Yealy expects that the vaccines from Moderna and Johnson & Johnson, both of which are being used under an EUA, will get full approval.
The Wolf administration is “supportive” of employers’ mandating vaccination, according to Department of Health spokeswoman Maggi Barton.
The administration also strongly encourages all commonwealth employees to get vaccinated, Barton wrote in an email.
The administration started a vaccine or test requirement for employees in state health care facilities, and beginning Sept. 7, all new external hires for those facilities must be vaccinated before starting work, Barton wrote.
Mirror Staff Writer William Kibler is at 814-949-7038.