The Pfizer COVID-19 vaccine received full approval on Monday morning from the Food and Drug Administration.
The Pfizer COVID-19 vaccine now can be marketed to consumers for persons 16 and older, according to the FDA. It will be under the name Comirnaty.
The Pfizer vaccine will continue to be available under emergency use authorization for persons who are 12 through 15 years old, the FDA stated in a news release, and for a third dose in some immunocompromised persons.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, 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,” acting FDA Commissioner Janet Woodcock said. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
The Pfizer vaccine has been available under emergency use authorization since last Dec. 11.
The FDA stated today that it reviewed data, and the analysis showed the Pfizer vaccine was 91 percent in preventing COVID-19.
The full FDA news release is online at https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine.
Doctors at the University of Kansas Health System briefly discussed the FDA full approval of the Pfizer vaccine during a morning news conference Monday, and said it was wonderful news.
The full approval is expected to lead to more employers or organizations requiring vaccines of their employees or customers. Earlier, some organizations said they were waiting for full FDA approval before requiring employees to be vaccinated.
According to Dr. Angela Myers, division director of infectious diseases at Children’s Mercy Hospital, the data have shown the vaccines are safe. While some of the vaccine-hesitant have said the vaccine was rush and there wasn’t enough data, Dr. Myer said there has been more data available on them than any other vaccines. There have been billions of doses of COVID-19 vaccine given worldwide.
Dr. Dana Hawkinson, medical director of infection prevention and control at KU Health System, said while he hoped the full approval would result in more people deciding to get vaccinated, he thought that some of them would come up with another excuse to avoid doing so.
The full FDA authorization also is what many companies were waiting for before making vaccines mandatory for their employees, he said.
In another announcement Monday, the Kauffman Center for the Performing Arts said that effective Sept. 6, all persons who enter the building to attend a public performance must provide proof of full COVID-19 vaccination. Masks also will be required. The policy applies to patrons, event staff and volunteers. Included are the performances of the Kansas City Ballet, Lyric Opera of Kansas City, the Kansas City Symphony, the Harriman Jewell Series and the Kansas City Jazz Orchestra.
At the doctors’ news conference, discussing a question on Monday about doctors prescribing the Pfizer vaccine “off-label” to kids, Dr. Myers said her hope is that data for children’s vaccine is not far behind, and that there wouldn’t likely be a lot of physicians giving the vaccine to those who are 6 years old without seeing the data first.
Dr. Hawkinson said he isn’t sure many physicians would give the vaccine “off-label.” The vaccine is not yet approved for children under 12, and they hope data and analysis on it will be coming out soon for young children.
Dr. Hawkinson reported Monday morning that the total number of COVID-19 patients at KU Health System was 90, with 62 active COVID patients, 22 in the intensive care unit, 15 on the ventilator and 28 recovering. The number of active COVID cases increased by six. There were two COVID-19 deaths on Sunday, and there have been nine COVID deaths in the last week at the health system, he said.
He said the deaths are a consequence of the spread of the Delta variant, particularly through unvaccinated people. Of the 62 active COVID patients in the hospital, only four are vaccinated, he said. That is in line with national statistics stating just 6 percent of hospital COVID patients are fully vaccinated, he added.
Children’s Mercy Hospital reported 15 positive COVID-19 cases, Dr. Myers said.
Dr. Myers urged people to follow guidelines at school, washing hands, wearing masks, and those who are eligible should get a COVID vaccine.
Dr. Hawkinson urged people to get a COVID vaccine today, and not rely on having previously had COVID-19. Vaccines are available by appointment at the KU Health System, by calling 913-588-1227.
“Anytime you get infected, you are rolling the dice,” he said.
The vaccine protects against severe disease, hospitalization and death, he said. People need to be thoughtful, wear masks and get their vaccines, he said.
In a news release, the governor and the Kansas health department urged people to get vaccinated.
“Today’s announcement from the FDA is good news. I urge all Kansans to get vaccinated as soon as possible to protect themselves, their neighbors, our frontline workers, and our economy,” Gov. Laura Kelly stated in a news release Monday. “The vaccine is safe, effective against severe illness and death, and our best tool to beat this virus.”
Moderna began the application for full FDA approval in June, nearly a month after Pfizer/BioNTech. Full approval of Moderna is anticipated in several weeks. Johnson and Johnson has stated they will begin the approval process later this year.
Kansas reported that 51.4 percent of residents had received at least one dose of COVID-19 vaccine by Aug. 23.
“Millions of people have already received the COVID-19 vaccine and this approval should instill a high-level of confidence in all Kansans that the vaccine has met the high standards for safety, effectiveness and manufacturing set by the FDA,” said Dr. Lee Norman, secretary of the Kansas Department of Health and Environment. “Our state is seeing high numbers of people diagnosed with the Delta variant. The best way to fight this disease, especially the variant, is to receive the COVID-19 vaccine. For those that were waiting on full approval and more data, it’s happened today. Everyone who is eligible should schedule their appointment today to get the vaccine.”
The vast majority of new COVID-19 cases in the state of Kansas are the Delta variant, according to the KDHE. This variant continues to cause the number of cases to rise at the level that was seen in November 2020.
According to state health officials, the Delta variant is highly contagious, more than twice as contagious as previous variants. The greatest concern is for those who are unvaccinated. Data shows that this variant causes more severe illness in people who are unvaccinated. The COVID-19 vaccines reduce a person’s risk of contracting the virus, including this variant. Additionally, it has been shown to prevent severe disease and death.
KDHE urged all eligible Kansans to receive the COVID-19 vaccine., according to the spokesman. Free COVID-19 vaccine locations are at Vaccines.gov.
Free vaccines available
Free COVID-19 vaccines will be available from 10 a.m. to 6 p.m. Wednesday through Friday at the Kmart vaccination site, 7836 State Ave., Kansas City, Kansas. Vaccines are free for people ages 12 and older. There are gifts available, and a “Spin to Win” promotion is ongoing for Wyandotte County residents, as supplies last.
The Health Department announced it would increase the Spin to Win prizes, starting Aug. 18, for first vaccines given at the Kmart site, according to a Health Department spokesman. Previously prizes were as high as $50, and now they will go up to $100.
Currently, the incentives and prizes are only at the Kmart site, and only available for people who live in Wyandotte County and come in for their first dose. There have been other prizes at some of the community events that the mobile vaccine team has attended.
For more information on the Unified Government Health Department’s vaccine schedule, see WycoVaccines.org.
The Health Department has announced it will give a third vaccine shot to moderately to severe immunocompromised patients. For more information, visit https://wyandotteonline.com/health-department-to-provide-third-vaccine-doses-for-immunocompromised-people/.
Back-to-school childhood immunizations will be available from noon to 6 p.m. Wednesday, Aug. 25, at the Kmart vaccination site, 7836 State Ave., Kansas City, Kansas. These free immunizations are for children without health insurance or for children who are insured through KanCare (Medicaid). Parents should bring children’s vaccination records.
A free vaccine and testing event will be held from 9 a.m. to 1 p.m. Thursday, Aug. 26, at Cross-Lines Community Outreach, 736 Shawnee Ave. These events are being held in conjunction with the Kansas Department of Health and Environment.
Mobile vaccines can still be requested online at WycoVaccines.org or by calling 3-1-1 (913-573-5311).
Other sites available for vaccinations
Some doctors’ offices offer COVID-19 vaccinations. If you haven’t received your vaccination yet, call your doctor’s office to see if it is available now.
Free vaccinations at KU Health System are open to the public. Current patients may use MyChart to make an appointment. Others may call 913-588-1227 or visit kansashealthsystem.com/vaccine to make an appointment to get vaccinated. KU Health System currently is vaccinating residents of Kansas and Missouri who are 12 or older, by appointment only. Those under 18 must be accompanied by a parent or guardian throughout the appointment.
There are also pharmacies giving free COVID-19 vaccinations in Wyandotte County by appointment, when available. These include Price Chopper and Hen House pharmacies, which are now also accepting walk-in vaccinations or appointments, and are starting vaccinations for age 12 and up at those pharmacies that are giving Pfizer vaccine (see https://www.ballsfoodspharmacy.com/).
CVS has announced walk-in appointments for COVID-19 vaccine at some of its stores. Those interested in getting a vaccination at a CVS pharmacy are asked to visit a CVS website in order to make sure there is vaccine available. The website is at www.cvs.com/. Walgreens and Walmart also were listed on www.vaccines.gov as giving vaccinations.
Other pharmacies and sites giving vaccines are listed at www.vaccines.gov. The website also tells whether vaccines are in stock at the locations.
Case numbers reported
On Monday morning, KU Health System reported 62 active COVID patients, an increase of six from Friday, according to Dr. Dana Hawkinson, medical director of infection prevention and control at KU Health System. Twenty-two patients were in the ICU, an increase of two from Friday. Fifteen were on ventilators, an increase of two from Friday. Twenty-eight other patients were still hospitalized because of COVID, but were out of the acute infection phase, a decrease of eight from Friday. There were a total of 90 patients, a decrease of two from Friday. There were two COVID deaths on Sunday, and nine total COVID deaths during the past week at KU Health. Children’s Mercy Hospital reported 15 positive COVID patients, a decrease of three since Friday.
Wyandotte County reported a cumulative 21,912 cases on Monday, an increase of 190 since Friday, according to the Unified Government Health Department’s COVID-19 webpage. There was a cumulative total of 320 deaths reported, no change from Friday.
On Wednesday, Aug. 18, the Unified Government Health Department reported that 44.87 percent of Wyandotte County residents had received at least one dose of vaccine. Those completing their vaccinations totaled about 37.7 percent.
The percentage of Wyandotte County residents who were age 12 and older who had received at least one dose was 55.2 percent.
The Mid-America Regional Council on Sunday reported 191,434 cases in Greater Kansas City, a nine-county area. There were a total of 2,580 deaths. The daily average of new hospitalizations was 165.
The Kansas Department of Health and Environment reported 358,843 cumulative COVID-19 cases in Kansas on Monday, Aug. 23, an increase of 2,778 since Friday, Aug. 20.
The KDHE reported 67,064 cumulative COVID-19 cases in Johnson County on Aug. 20, an increase of 474 since Aug. 20. Leavenworth County had 8,817 cases, an increase of 88 since Aug. 20. Sedgwick County (the Wichita area) reported 64,293 cases, an increase of 423 since Aug. 20.
Douglas County (the Lawrence area) had 10,159 cumulative COVID-19 cases on Aug. 20, an increase of 77 since Aug. 20, according to KDHE. Shawnee County (the Topeka area) had 20,947 COVID-19 cases, an increase of 352 since Aug. 20. Riley County (the Manhattan area) had 7,012 cases, an increase of 27 cases since Aug. 20.
On Monday afternoon, there were a cumulative 37,813,616 COVID-19 cases in the United States, with cumulative 628,984 deaths, according to the Johns Hopkins Coronavirus Resource Center.
Free testing available
Free COVID-19 testing is available from 9 a.m. to 3 p.m. Monday to Friday at the UG Health Department’s central location, the former Kmart, 7836 State Ave., Kansas City, Kansas. Free gift cards are available to those who get a test, while supplies last.
Free COVID-19 testing also is available from 8:30 a.m. to 6 p.m. Mondays through Wednesdays at the Vibrant Health Cordell D. Meeks Jr. Clinic, 4313 State Ave., Kansas City, Kansas.
Free COVID tests also are being held at the Kansas National Guard Armory, including tests from 8 a.m. to 8 p.m. Friday at 100 S. 20th St., Kansas City, Kansas. There also are tests at the Armory from 9 a.m. to 3 p.m. Saturdays and Sundays. Appointments can be made at gogettested.com/Kansas.
For more information, visit www.facebook.com/UGHealthDept.
COVID-19 testing is available at several locations in Wyandotte County.
Visit gogettested.com/Kansas and https://wyandotte-county-covid-19-hub-unifiedgov.hub.arcgis.com/pages/what-to-do-if-you-think-you-have-covid-19 for more sites.
Wyandotte County residents may contact the Health Department at wycohelp.org to sign up for a test to be delivered to their home.
For more details about free COVID-19 testing offered by the UG Health Department, visit https://wyandotte-county-covid-19-hub-unifiedgov.hub.arcgis.com/pages/what-to-do-if-you-think-you-have-covid-19, https://www.facebook.com/UGHealthDept or call 3-1-1.
To view the mask order in Kansas City, Kansas, visit https://www.wycokck.org/files/assets/public/health/documents/covid/mask-mandate-resolution-r-47-21-effective-august-6-through-september-16-2021.pdf and https://www.wycokck.org/files/assets/public/health/documents/covid/ug-issues-mask-order-for-kck-and-other-portions-of-wyco.pdf.