The Food and Drug Administration amended its emergency use authorization for the Pfizer COVID-19 vaccine to include adolescents age 12 to 15 years old on Monday.
“The FDA’s expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic,” acting FDA Commissioner Dr. Janet Woodcock said in a statement. “Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”
The FDA amended the Pfizer emergency use authorization issued Dec. 11 to include the adolescents.
The FDA stated that safety data was collected in a study of 2,260 participants 12 through 15 years old in the United States. Around half received the vaccine, while about half received a saline placebo. More than half were tracked for at least two months following the second dose.
An analysis of those adolescents who received the vaccine and placebo found a 100 percent effectiveness rate in preventing COVID-19 among those who got the vaccine, according to the FDA.
The FDA also reported that during more than a year, from March 1, 2020, through April 30, 2021, there were 1.5 million COVID-19 cases in adolescents from 11 to 17 years old reported to the Centers for Disease Control and Prevention. Often, the youth had a milder case than adults.
The FDA stated that the Pfizer vaccine met the statutory criteria to amend the emergency use authorization, and the known and potential benefits of the vaccine in adolescents 12 to 16 outweigh the known and potential risks.
“Having a vaccine authorized for a younger population is a critical step in continuing to lessen the immense public health burden caused by the COVID-19 pandemic,” Dr. Peter Marks, M.D., director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “With science guiding our evaluation and decision-making process, the FDA can assure the public and medical community that the available data meet our rigorous standards to support the emergency use of this vaccine in the adolescent population 12 years of age and older.”
More information is at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use.
Doctors discuss vaccines
At the University of Kansas Health System news conference on Monday morning, Dr. Dana Hawkinson said getting the children vaccinated will be important, as they can then keep schools open in the fall.
Dr. Steve Stites, chief medical officer, said it appears that Pfizer will also seek full approval from the FDA for its vaccine soon, with Moderna following. It will take a few months, and he added it should give people more confidence about the vaccines.
Dr. Stites said with Israel’s vaccination rate of 60 to 70 percent, without a lot of side effects, it gives him some hope that the United States could convince the rest of the population to get vaccinated.
Dr. Hawkinson, medical director of infection prevent and control, said since there is a movement toward reducing mask-wearing a little at a time, including indoor spaces, it would be wise for people to protect themselves. People don’t know if others indoors have been vaccinated, if masks are not being worn. Protect yourself, your bubble and continue to get everyone vaccinated, he said.
Dr. Stites said he’s a little nervous because the Kansas City area is a little open now, and is not fully vaccinated.
People can get the long-haul syndrome whether they are symptomatic or asymptomatic, he said. They can get the long-haul syndrome no matter whether their COVID-19 symptoms were severe or not. The long-haul syndrome can continue for months, affecting different organs.
Dr. Hawkinson said the KU long-haul program already had around 200 patients, with 20 percent needing one or more specialists. In June, another 250 appointments are scheduled for the long-haul clinic. The long-haul syndrome affects about 30 percent of those who had COVID, he said. Patients might be seeing two to four specialists for their symptoms, he added.
“COVID-19 continues to take its toll, and it’s better to be safe than it is to be sick,” Dr. Stites said.
Defeating COVID-19 depends on vaccinations, not just here but all through the world, he said. That’s because as the number of cases rise, the numbers of variants also increase and develop, then can spread.
Dr. Hawkinson said COVID-19 also has affected the United States through world trade and supply chain disruptions.
With variants and widespread community transmission, there will be more pressure on everyone to get vaccinated, and as vaccines receive full approval, people will get more comfortable with it, Dr. Stites said. Millions have now been vaccinated, and disease transmission is down, he said. Hospital admissions and deaths have dropped significantly.
Dr. Hawkinson said they’re not seeing nursing home patients in the hospital currently for COVID-19 because there was a great program to get them vaccinated.
There is still good protection against variants in the original COVID-19 vaccines, Dr. Hawkinson said, but it can be boosted with a vaccine that includes protection against variants.
He said a question that occurred to him was should he wait and get his kids vaccinated with the booster vaccine protecting against variants, or should he get them vaccinated as soon as available. He will probably go with as soon as available because data has shown they are effective against variants.
“The more people we get vaccinated, the safer we make it for everybody,” Dr. Stites said. It keeps you safe and everybody safe, he said.
Dr. Hawkinson said people who have had transplants or have conditions involving immune systems may not have as much protection with the vaccine, and that is why everyone else needs to protect them by getting the vaccine.
The news conference also heard from Girl Scout Troop 921 at St. Elizabeth Parish in Kansas City, Missouri, where the girls earned the Girl Scout Bronze Award for working on a video project about COVID-19 safety. They also made a poster, and connected with members of their church and community through letter-writing and prayer baskets. Their video is part of the news conference and can be seen at https://www.facebook.com/kuhospital/videos/298724581861979.
Kansas revises Colorado travel quarantine list
State removed, some individual Colorado counties added
Kansas has amended its travel quarantine list to remove the state of Colorado, but has added some individual counties to the list.
Among the local Colorado areas on the Kansas quarantine list are Denver, Colorado, and more than 20 other counties.
Anyone who traveled to those listed counties on or after May 6 should quarantine for seven days with a negative test result or 10 days without testing, with release from quarantine on Day 8 and Day 11, according to the Kansas Department of Health and Environment.
“We recognize that adding Colorado to the quarantine list presented challenges to those living in the border communities,” Dr. Lee Norman, KDHE secretary, said. “As such we looked at all of the Colorado counties individually and added those core counties that were 3x higher than the rate of Kansas.”
The other Colorado counties include Adams, Arapahoe, Archuleta, Bent, Chaffee, Conejos, Crowley, Douglas, Elbert, El Paso, Fremont, Huerfano, Jefferson, Lake, Larimer, Park, Phillips, Pueblo, Rio Blanco, San Juan, Teller and Weld.
More information is at https://www.coronavirus.kdheks.gov/175/Travel-Exposure-Related-Isolation-Quaran.
Free vaccinations available Tuesday
Free walk-in COVID-19 vaccinations will be available for everyone over age 16 from 9 a.m. to 2:30 p.m. Tuesday, May 11, at the former Kmart, 7836 State Ave., Kansas City, Kansas, and at the former Best Buy, 10500 Parallel Parkway, Kansas City, Kansas.
The schedule of vaccinations is changing this week. To see the new schedule and more information about vaccinations, visit WycoVaccines.org or https://www.facebook.com/UGHealthDept.
The Health Department will be doing more mobile vaccinations, and people may request vaccines to be given at different sites in the community by going to WycoVaccines.org and clicking on “mobile vaccine request.” People also may request a ride to vaccination sites on the same page.
UG Health Department vaccinations are now open to people from other counties and states. People may walk in for vaccinations or can schedule them.
Those who wish to schedule an appointment may use the Health Department’s self-scheduling tool at WycoVaccines.org and click on a blue button that says, “Click here to schedule an appointment online.” The page is available in Spanish by clicking at the top of the page. Walk-in appointments also are welcome.
Those who don’t have an internet connection may call 3-1-1 or 913-573-5311 for assistance in scheduling their vaccination appointment time and date.
To see more information about Health Department vaccinations and next week’s schedule, visit WycoVaccines.org.
Other sites available for vaccination
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.
There are also pharmacies giving free COVID-19 vaccinations in Wyandotte County by appointment, when available. These include Price Chopper and Hen House pharmacy at 76th and State Avenue, and 81st and State Avenue (see https://www.ballsfoodspharmacy.com/), and Medicine Shoppe pharmacy at 65th and Parallel by appointment when available (see https://www.facebook.com/The-Medicine-Shoppe-Kansas-City-281548241870522).
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/.
Other pharmacies and sites giving vaccines are listed at www.vaccines.gov.
Case numbers reported
KU Health System reported a steady number of patients on Monday. There were 24 patients with the active virus being treated, no change from Friday. Nine of the patients were in the intensive care unit, a decrease of two since Friday. Five patients were on ventilators, a decrease of four from Friday. There were 10 COVID-19 patients who were out of the acute infection phase, an increase of one from Friday. There were a total of 34 patients, an increase of one since Friday.
Wyandotte County reported an increase of 36 COVID-19 cases on Monday, May 10, for a cumulative 18,588 cases, according to the Unified Government Health Department’s COVID-19 webpage. There was a cumulative total of 292 deaths reported, no change.
The Mid-America Regional Council’s COVID-19 dashboard reported 171,696 cumulative COVID-19 cases.. The daily average of new hospitalizations was 60.
The Kansas Department of Health and Environment reported 310,927 cumulative COVID-19 cases in Kansas on Monday, May 10, an increase of 345 cases since Friday, May 7. There were a total cumulative 5,016 deaths reported statewide, the same as Friday.
KDHE reported that Johnson County had 58,303 cumulative cases on Monday, an increase of 50 cases since Friday. Leavenworth County had 7,228 cumulative cases, an increase of four cases since Friday. Sedgwick County (the Wichita area) reported 56,588 cumulative cases on Monday, an increase of 113 cases since Friday.
The Johns Hopkins University COVID-19 dashboard on Monday night reported 32,744,100 cumulative COVID-19 cases in the United States, with 582,153 total deaths reported nationwide. There were 21,392 new cases nationwide and 238 new deaths nationwide.
States with the highest number of new cases were Florida, 3,231; New York, 2,373; Illinois 1,744; Pennsylvania, 1,058; and Texas, 1,024.
Countries with the highest number of new cases were India, 366,494; Brazil, 38,911; U.S., 21,392; Colombia, 17,222; and Turkey, 15,191, according to Johns Hopkins information.
Free testing available Tuesday
Free COVID-19 testing will be available from 8 a.m. to noon Tuesday, May 11, at All Saints parish, 811 Vermont Ave., Kansas City, Kansas. No appointment is needed. People can get tested regardless of symptoms or exposure.
Free COVID-19 testing will be available from 9 a.m. to 2:30 p.m. Tuesday, May 11, at the former Kmart, 7836 State Ave., Kansas City, Kansas, and at the former Best Buy, 10500 Parallel Parkway, Kansas City, Kansas. For information about UG Health Department COVID-19 testing sites and hours, visit https://wyandotte-county-covid-19-hub-unifiedgov.hub.arcgis.com/pages/what-to-do-if-you-think-you-have-covid-19. To see if there is any change to the schedule, visit https://www.facebook.com/UGHealthDept. Appointments are not needed.
One of the WellHealth sites for free COVID-19 testing is open beginning at 8 a.m. Monday, May 10,, at Lowe’s at 6920 State Ave., Kansas City, Kansas. Appointments are required. For more information, to see other testing sites and to make an appointment, visit https://www.gogettested.com/kansas.
The Health Department’s general contact page is at https://www.wycokck.org/Health/Contact.aspx. Their Facebook page is at https://www.facebook.com/UGHealthDept.
Testing sites are at https://wyandotte-county-covid-19-hub-unifiedgov.hub.arcgis.com/pages/what-to-do-if-you-think-you-have-covid-19. There are more test sites listed on this page.
Saliva testing is now offered at the UG Health Department. For more information, visit https://alpha.wycokck.org/files/assets/public/health/documents/covid/02042021-ugphd-saliva-testing-available.pdf.
The KU doctors’ news conference is online at https://www.facebook.com/kuhospital/videos/298724581861979.
The University of Kansas Health System COVID-19 update page is at https://www.facebook.com/kuhospital/videos/292961702392386.
A weekly vaccine report for the state of Kansas is at
https://www.kansasvaccine.gov/DocumentCenter/View/123/Vaccine-Historical-Document-22521?bidId=.
Information about the new mask ordinance passed April 29, which loosened restrictions in Wyandotte County, is online at https://alpha.wycokck.org/files/assets/public/health/documents/covid/updatedwycomaskorder04302021.pdf. The new mask order is online at https://alpha.wycokck.org/files/assets/public/health/documents/covid/amend-lho-may-6-2021.pdf.
The KDHE’s COVID-19 webpage is at https://www.coronavirus.kdheks.gov/.
The KC Region COVID-19 Hub dashboard is at https://marc2.org/covidhub/.
The Wyandotte County page on the Johns Hopkins COVID-19 website is at https://bao.arcgis.com/covid-19/jhu/county/20209.html.
The Johns Hopkins Data in Motion, a presentation on critical COVID-19 data in the past 24 hours, is at https://coronavirus.jhu.edu/covid-19-daily-video.