The “pause” on the Johnson and Johnson COVID-19 vaccine has been lifted, according to a CDC and FDA news release on Friday night.
Immunizations of this vaccine can now resume in the United States, according to the announcement from the CDC.
A safety review was conducted by the Advisory Committee on Immunization Practices, the FDA and the CDC.
Six cases of a rare and severe type of blood clot in women resulted in the pause of the Johnson and Johnson (also called Janssen) vaccine. There were a total of 6.8 million doses given. FDA and CDC medical and scientific teams examined data to assess the risk of thrombosis involving the cerebral venous sinuses, as well as large blood vessels of the abdomen and veins of the legs, and low blood platelet counts. They also reached out to providers and clinicians to make sure they were aware of the potential for adverse events and could manage and recognize these events.
The investigation found a total of 15 cases of thrombosis reported to the Vaccine Adverse Effect Reporting System, including the original six. All the cases were in women from 18 to 59 years old. Symptom onset was between six and 15 days after vaccination.
The FDA and CDC’s determination:
• Use of the Janssen COVID-19 vaccine should be resumed in the United States.
• The FDA and CDC have confidence that this vaccine is safe and effective in preventing COVID-19.
• The FDA has determined that the available data show that the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older.
• At this time, the available data suggest that the chance of TTS occurring is very low, but the FDA and CDC will remain vigilant in continuing to investigate this risk.
• Health care providers administering the vaccine and vaccine recipients or caregivers should review the Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Fact Sheet for Recipients and Caregivers, which have been revised to include information about the risk of this syndrome, which has occurred in a very small number of people who have received the Janssen COVID-19 Vaccine.
“Safety is our top priority,” Dr. Janet Woodcock, acting FDA commissioner, said in the news release. “This pause was an example of our extensive safety monitoring working as they were designed to work—identifying even these small number of cases. We’ve lifted the pause based on the FDA and CDC’s review of all available data and in consultation with medical experts and based on recommendations from the CDC’s Advisory Committee on Immunization Practices. We have concluded that the known and potential benefits of the Janssen COVID-19 Vaccine outweigh its known and potential risks in individuals 18 years of age and older. We are confident that this vaccine continues to meet our standards for safety, effectiveness and quality. We recommend people with questions about which vaccine is right for them have those discussions with their health care provider.”
“Above all else, health and safety are at the forefront of our decisions,” said CDC director, Dr. Rochelle P. Walensky. “Our vaccine safety systems are working. We identified exceptionally rare events – out of millions of doses of the Janssen COVID-19 administered – and we paused to examine them more carefully. As we always do, we will continue to watch all signals closely as more Americans are vaccinated. I continue to be encouraged by the growing body of real-world evidence that the authorized COVID-19 vaccines are safe and effective, and they protect people from disease, hospitalization, and death. I urge anyone with questions about the COVID-19 vaccines to speak with their healthcare provider or local public health department.”
Walk-in vaccinations available Monday
Walk-in vaccinations will be available for Wyandotte County residents from 9 a.m. to 2:30 p.m. Monday, April 26, at two Unified Government Health Department locations: the former Kmart store at 78th and State, and the Kansas National Guard Armory at 18th and Ridge, Kansas City, Kansas. The former Best Buy location will be closed on Monday, April 26.
Wyandotte County residents 18 and older and those who work in Wyandotte County may walk in for a COVID-19 vaccination during open hours. Appointments also are being scheduled for the Health Department vaccine sites.
All Kansas residents can make an appointment to be vaccinated at any of the Health Department’s vaccination facilities on Tuesdays, Wednesdays and Thursdays.
Kansas residents who wish to schedule an appointment or any Wyandotte County resident 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.
Wyandotte County residents 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.
People coming in for an appointment may be asked to show they live in Kansas, such as showing a driver’s license, a piece of mail addressed to them, or similar paperwork.
To see more information about Health Department vaccinations and next week’s schedule, visit WycoVaccines.org.
Other sites available for vaccinations
KU Health System offers vaccinations seven days a week at different locations. Appointments are required. Current patients may use MyChart to make an appointment. Others may call 913-588-1227 or visit kansashealthsystem.com/vaccine to see if vaccines are available.
The University of Kansas Health System also has vaccinations for Wyandotte and Johnson county residents. Any residents of Kansas can call to get an appointment whether they are patients or not at the health system.
There are also pharmacies giving 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 pharmacy also has announced that it will offer COVID-19 vaccines at one of its stores in Kansas City, Kansas. Registration is at CVS.com.
Case numbers reported
Wyandotte County reported an increase of 14 COVID-19 cases on Friday, April 23, for a cumulative 18,357 cases, according to the Unified Government Health Department’s COVID-19 webpage. There was a cumulative total of 290 deaths reported, an increase of one since Thursday. The numbers are not updated on Saturday.
The Mid-America Regional Council’s COVID-19 dashboard reported 169,156 cumulative COVID-19 cases on Saturday. The daily average of new hospitalizations was 66. The number of cumulative deaths was 2,377.
The state of Kansas reported 307,372 cumulative COVID-19 cases on Friday, April 23, an increase of 489 cases since Wednesday. There were a total cumulative 4,968 deaths reported statewide, an increase of seven. The numbers will not be updated until Monday.
The Johns Hopkins University COVID-19 dashboard on Saturday night reported 32,044,974 cumulative cases in the United States, with 571,920 total deaths reported nationwide. There were 62,399 new cases in the United States and 852 new deaths reported in the United States.
According to the Johns Hopkins data, states with the highest number of new cases included Michigan, 5,640 new cases; Florida, 5,464; New York, 4,847; Pennsylvania, 4,029; and Illinois, 3,363. Countries with the highest number of new cases included India, 346,786 new cases; Brazil, 69,105; U.S., 62,399; Turkey, 49,438; and France, 32,340.
Free testing available Monday
Free COVID-19 testing will be held from 8 a.m. to noon Monday, April 26, at Oak Ridge Baptist Church, 9301 Parallel Parkway, Kansas City, Kansas. The test is in conjunction with the Wyandotte County Health Equity Task Force.
Unified Government Health Department COVID-19 will have two free COVID-19 testing sites open from 9 a.m. to 3 p.m. Monday, April 26. For more information on which ones are open, 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.
Tests from the Health Department are free for those who live or work in Wyandotte County. They are saliva tests.
The tests are open to asymptomatic people as well as those who have symptoms or have been exposed to COVID-19. Check with the UG Health Department’s Facebook page to see if there have been any changes in the schedule. Bring something that shows that you live or work in Wyandotte County, such as a utility bill.
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 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=.
Wyandotte County has a local mask and social distancing ordinance approved by the UG Commission. The UG COVID-19 webpage is at https://alpha.wycokck.org/Coronavirus-COVID-19-Information.
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.