FDA officially approves Pfizer vaccine

Tuesday, August 24, 2021
Photo courtesy of U.S. Food and Drug Administration

The COVID-19 vaccine developed by pharmaceutical company Pfizer received official approval from the U.S. Food and Drug Administration on Monday, and it is now expected to be marketed as Comirnaty. The vaccine and others like it have been available under an emergency use order from the FDA since Dec. 11. This week's approval applies to vaccination of individuals age 16 and older, but the FDA's emergency use authorization still applies to vaccination of individuals as young as 12. More than 3 million doses of the vaccine have been administered in Iowa, according to the Iowa Department of Public Health, and about 1.5 million Iowans have completed the two-dose course to become fully vaccinated against the respiratory virus.

Dickinson County Public Health has for the most part been allocated vaccines developed by pharmaceutical company Moderna, but other area providers or programs may offer the Pfizer vaccine. Dickinson County Public Health Director Katy Burke said more than 4,500 people have been fully vaccinated through her office alone. The office continues to offer immunization clinics each week, and individuals with compromised immune systems will have the chance to receive a vaccine booster shot from 1-4 p.m. Aug. 25 or from 9 a.m. to noon Aug. 26 at the local public health office.

Burke went on to say local COVID-19 activity is slowly increasing. Case counts are now between one and three per day, according to Burke, compared to zero to two earlier this summer. A total of six people haven been hospitalized with COVID-19 at Lakes Regional Healthcare since May 1, she said.

"Last year the number of positive COVID cases was lowest in August and then increased in September with the spike in November," Burke said. "So far it appears like we may be trending that same way again this year. We will see what happens this fall and winter now that many people are vaccinated."

Burke also said local health officials reported two deaths related to the respiratory virus in recent months one in June and one in July. She hopes more people will choose to be vaccinated in light of the FDA's recent announcement.

"Now that the Pfizer vaccine is FDA approved, we believe people can have more confidence in the vaccine," Katy Burke, director of Dickinson County Public Health, said. "The approval demonstrates the Pfizer vaccine has met the FDAs high standards for safety, effectiveness, and manufacturing quality. We dont know how many people locally have postponed getting the vaccine due to FDA approval, but according to national polls, about 30 percent of people were waiting until the vaccines received FDA approval."

Photo courtesy of U.S. Food and Drug Administration

Dr. Pat Winokur, executive dean of the medicine at the University of Iowa which aided in some of the COVID-19 vaccine trials, said during an April press conference with Iowa Gov. Kim Reynolds that each vaccine the FDA made available for emergency use was tested on 30,000 to 40,000 people.

"That's ten-fold higher than we typically include in our drug trials," Winokur said at the time.

Similarly, Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation Research, said the study of the vaccine's safety and effectiveness was both thorough and thoughtful. He said experts not only examined the vaccine and related information but also went so far as to inspect the manufacturing facilities where the vaccines were being produced.

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," Marks said. "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."

The FDA said Monday's green-lighting of the Pfizer vaccine came after reviewing updated data from the clinical trials that took place ahead of its emergency approval the FDA noted it increased the duration and the population of its follow up data in reviewing the Pfizer vaccine. Specifically, the FDA looked at data from 20,000 recipients of the vaccine as well as 20,000 individuals who received a placebo during the trial. About 12,000 recipients of the vaccine were followed for review for at least six months, according to the FDA.

Results of the clinical trial showed the vaccine to be about 91-percent effective at preventing COVID-19 disease, the FDA said. Commonly recorded side effects of the vaccine included redness and swelling at the injection site as well as fatigue, headache, chills, fever and muscle or joint pain. The FDA also looked into some concerns regarding inflammation of structures in and around the heart muscles after vaccination, and found there was an increased risk of the condition particularly among younger males. The FDA said its findings indicate the condition resolved itself in most cases, but some individuals required intensive care support.

The FDA has put measures in place to continue identifying and evaluating future safety concerns related to the vaccine. It is also requiring Pfizer to conduct post-market studies of the vaccine, especially as it relates to inflammation of heart muscles.

The FDA's full approval of the Pfizer COVID-19 vaccine offers Iowans and Americans who've not yet been vaccinated the assurance they need to do so now," Gov. Kim Reynolds said. "The vaccine is the best defense against the virus, and it's been proven highly effective at preventing serious illness, hospitalization and death, even against variants. Vaccine is widely available in the state, and I encourage all eligible Iowans to get vaccinated as soon as possible."

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