On Monday, the Food and Drug Administration took a long-awaited and important step in the nation's fight against the coronavirus pandemic, giving full approval to Pfizer-BioNTech's vaccine for Covid-19.
The Pfizer-BioNTech vaccine, which has been branded with the name "Comirnaty," now has full approval for those ages 16 and older and emergency-use authorization for those ages 12-15. The FDA has also given emergency-use authorization for a third dose of the Pfizer and Moderna vaccines for immunocompromised individuals.
The FDA granted full approval for the Pfizer vaccine after reviewing updated data from the original clinical trial of individuals ages 16 and older. The agency analyzed effectiveness data from over 20,00 vaccine recipients and over 20,000 people given a placebo, according to an FDA news release. To review long-term safety outcomes, more than half of the trial participants in the clinical study were followed for at least four months after receiving their second dose, with about 12,000 being followed for at least six months.
"The public can be confident that this vaccine meets the FDA gold standard for safety, effectiveness and manufacturing quality that we require for an approved product," said Dr. Janet Woodcock, acting FDA commissioner, at a press conference. "While we continue to battle against the Covid-19 pandemic, we're acutely aware that vaccines are one of our greatest weapons against the virus, and we know that vaccine approval holds the promise of altering the course of the pandemic in the United States and that, for some, an FDA-approved Covid vaccine may instill in them the confidence to go and get vaccinated."
The FDA review hundreds of thousands of pages of data and information about the vaccine's safety, effectiveness and manufacturing quality, according to Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.
Officials at East Alabama Health, which administered the Pfizer vaccine at its Community Vaccine Clinic and continues to do so at its East Alabama Apothecary locations, welcomed the move by the FDA to grant full approval.
"We're very thankful to finally hear this great news. The FDA is the gold standard for ensuring safe and effective drugs for all Americans," said Chuck Beams, executive director of Pharmacy Services, in a news release. "There's been a lot of back and forth regarding vaccination, but that does not interest us at all. Our goal is simple, and that is to limit the spread of Covid-19 in our community, which will assuredly limit the number of Covid hospitalizations and deaths. And the best way to reach that goal is through vaccination. We ask for the help of people throughout this region in trusting our physicians as well as national healthcare leaders as we try to navigate through the rest of this pandemic. We only want a healthy, prosperous community."
According to data released by East Alabama Health on Monday, of the 74 patients hospitalized at EAMC and EAMC-Lanier, 59 are unvaccinated, 13 are fully vaccinated and two are partially vaccinated. Twenty of the 22 patients in the ICU are unvaccinated, as well as 15 of 16 patients on ventilators.
"The vaccine is clearly effective in preventing hospitalization and death, but may not always prevent infection, symptoms, or transmission of the virus from person to person," said Marks, of the Pfizer vaccine, which requires two doses and uses mRNA technology, like the Moderna vaccine, which has not yet received full approval. "We have not lost sight that the Covid-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S."
If you have not yet received a Covid-19 vaccine, health experts recommend discussing the issue with your doctor.
The FDA also weighed in on booster shots on Monday, saying that more information and data are needed before recommending an additional dose of the vaccine beyond the current approval of an emergency authorized third dose for immunocompromised people.
"We need to look at both safety and efficacy data, or immunogenicity data, and make a decision about that," said Woodcock.
The Biden Administration recently stated its support for giving booster shots to those who are eight months removed from receiving their second dose, although that position is not yet supported by the FDA or the CDC.
The CDC released the study results on Tuesday that indicated that vaccines are less effective at preventing infection against the Delta variant than other strains of the virus.
The study looked at more than 4,200 essential workers, 83 percent of whom where vaccinated — with the Pfizer (65 percent), Moderna (33 percent) or Johnson & Johnson (2 percent). The study looked at vaccine efficacy among participants during weeks dominated by the Delta variant as well as the preceding months, which were dominated by different strains. The study indicated that vaccine efficacy dropped from 91 percent to 66 percent when the Delta variant became dominant.
At the FDA's press conference on Monday, Marks provided an update on vaccine trials for children ages 5-11, saying that the trials were still ongoing.
"The agency has to wait for the company to submit the data for those trials so that we have a good safety data set because we certainly want to make sure that we get it right in the children ages 5 through 11, and then even in younger children after that," he said.
That update comes as the nation, including Auburn, has seen an increase in the number of children testing positive for Covid-19. The Pediatric Clinic in Opelika reported that from Aug. 16-22 219 pediatric patients tested positive, an increase of 103 over the previous week, which was the highest one-week total there since the pandemic began. The positivity rate was 17.3 percent in Opelika. At the Pediatric Associates in Auburn, the positivity rate was 20.6 percent.
On Sunday, Auburn City Schools released its numbers from Aug. 16-20, with ACS reporting 79 confirmed cases of Covid-19 to the Alabama Department of Public Health.