The U.S. Food and Drug Administration on Saturday issued an emergency use authorization for the Johnson and Johnson COVID-19 vaccine.
Johnson and Johnson’s Janssen vaccine is the third one that received an EUA from the FDA. The other two are the Pfizer and Moderna COVID-19 vaccines. The main differences between the new vaccine and the others are that the new vaccine requires only one shot, and it is an adenovirus-based vaccine, not an MRNA vaccine.
The EUA will allow the new vaccine to be distributed in the United States to individuals 18 years old and older, according to the FDA.
“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” said Dr. Janet Woodcock, acting FDA commissioner, said in a news release. “The FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency called for during this pandemic, using the agency’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.”
According to the FDA, the available data shows evidence that the new vaccine may be effective in preventing COVID-19. According to the FDA, the vaccine’s benefits outweigh its known and potential risks.
“In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information,” the FDA stated in the news release.
The Janssen COVID-19 vaccine uses the adenovirus type 26 to deliver a piece of the DNA that is used to make the distinctive spike protein of the SARS-CoV-2 virus, according to the FDA.
While adenoviruses are a group of viruses that are relatively common, Ad26, which can cause cold symptoms and pink eye, was modified for the vaccine so that it cannot replicate in the body to cause illness, the FDA stated.
The body temporarily makes the spike protein after receiving the vaccine, but it doesn’t cause disease, the FDA stated. Instead, the vaccine triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2, according to the FDA.
“After a thorough analysis of the data, the FDA’s scientists and physicians have determined that the vaccine meets the FDA’s expectations for safety and effectiveness appropriate for the authorization of a vaccine for emergency use,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said. “With today’s authorization, we are adding another vaccine in our medical toolbox to fight this virus. At the same time, the American people can be assured of the FDA’s unwavering commitment to public health through our comprehensive and rigorous evaluation of the data submitted for vaccines to prevent COVID-19.”
In a randomized study, the vaccine was found to be about 67 percent effective in preventing moderate to severe – critical COVID-19 occurring at least 14 days after vaccination, and 66 percent effective in preventing moderate to severe – critical COVID-19 at least 28 days after vaccination, according to the FDA.
The vaccine also was about 77 percent effective in preventing severe – critical COVID-19 occurring at least 14 days after vaccination, and 85 percent effective in preventing severe – critical COVID-19 occurring at least 28 days after vaccination, the FDA stated.
The study participants included 39,321 participants in the United States, South Africa, South America and Mexico. Receiving the vaccine in the study were 19,630 persons, while the other 19,691 persons received a saline placebo, according to the FDA.
Side effects of the new vaccine most commonly were mild to moderate, and included pain at the injection side, headache, fatigue, muscle aches and nausea, according to the FDA. Most side effects lasted one to two days.
Gov. Laura Kelly said in a conference call Friday that she expected the new vaccine doses to be shipped to Kansas soon, possibly even a few days after the EUA approval.
New sports order issued in Wyandotte County
The Unified Government Health Department has issued a new health order on school sports.
The order rescinds a Sept. 4 order prohibiting contact athletic activity and replaces it with a new order. The new order applies to school sports, including school and college sports, as well as club and league sports.
According to the new order, the June 26 and Nov. 20 orders will remain in full effect. They will require strict masking and 6-foot social distancing at sports for all players, coaches, staff and spectators while on the sidelines, in locker rooms, in the gym, in the stands, while practicing and when not in actual competition.
Players can take off their masks to engage in sports competition or practice, according to the health order. However, they must wear the mask at all other times, including on the sidelines, in the locker room, in meetings and any time when they’re not on the field or court.
Coaches, trainers, scorekeepers, referees, fans and all others watching the sports are not exempt from the June 27 order and must wear masks at all times, according to the order.
The health order also says it is highly recommended that everyone participating in sporting events wear a high-quality mask in accordance with CDC recommendations.
There are some more requirements, however, if players take off their masks during competition and practices. College and high school players, their coaches and staffs ust test negative on PCR tests once a week and provide results to their team coach or sponsor. The coaches or sponsors must maintain the information and provide it to the Health Department staff or organizational leadership if requested.
The testing rule does not apply to club, recreational and informal sports, but it is highly recommended, according to the health order.
Players who have COVID-19 symptoms must notify their coach immediately and are not permitted to attend practice or play. They should isolate for the duration of their symptoms and shoud be tested for OVID-19 immediately, according to the order. If they are positive, they must follow standard county isolation requiremetns.
If a player tests positive for COVID-19, the program must notify the UG Health Department immediately. Then the team would have to quarantine all team members and others with close contact for 14 days from the first day the positive player would have been considered contagious, according to the health order. All of the persons quarantining would have to be tested for COVID-19 from seven to nine days after the first day of potential exposure. The team’s coach or organizer must cooperate with contact tracing by the UG Health Department.
The new health order also stated it is highly recommended that players and coaches and staff traveling to Wyandotte County for college or high school sports competitions or practices have a negative PCR COVID-19 test 72 hours before the game or practice, the health order stated.
Anyone on the other teams who has symptoms are not permitted to travel to Wyandotte County with their team, according to the order. Also, players traveling to Wyandotte County for competition should not have any contact with the Wyandotte County team when not actively engaging in the competition, according to the health order.
In addition, the new health order amends the Jan. 4 order on singing, choir or band activity.
The order stated that it is strongly recommended that all indoor singing, chir or band activity involving brass or woodwind instruments remain suspended at this time. However, these activities will be permitted if certain rules are followed.
High school students, college students, teachers and conductors who participate in a school-sanctioned singing, choir or band practice or performance are required to have a negative PCR COVID-19 test weekly.
Those in outdoor singing with any organization or school are required to wear masks at all times.
Masks must be worn while playing all instruments that allow for masking, such as drums or string instruments.
Eight feet of social distancing is required between all participants at all times.
It’s recommended that all instrument covers that reduce risk of salivary aerosolization should be used at all times.
Participants in these activities from all other grade levels and organizations are recommended to have a negative PCR COVID-19 test weekly.
If a band or choir member tests positive for COVID-19, the director or organizer must cooperate with contact tracing efforts of the UG Health Department, according to the order.
The order went into effect on Feb. 26. According to the health order, the penalties for violation of the order are the same as the other health orders, a misdemeanor with a $500 maximum fine and potentially 30 days in jail.
The new sports order for Wyandotte County is at https://alpha.wycokck.org/files/assets/public/health/documents/covid/localhealthofficersportsorder2.26.21.pdf.
Vaccine procedures explained
UG Health Department staff are explaining the various rules around who can get a vaccine and when they can get it. Most of the information contained in the video has already been previously reported, but there are some tips in it for those who want to get their vaccinations.
To see the UG Health Department video on vaccine procedures and details, visit https://www.facebook.com/UGHealthDept/videos/936562330215630.
COVID-19 case numbers reported
Wyandotte County reported an increase of 1 COVID-19 case on Saturday, Feb. 27, for a cumulative 17,659 cases. There was a cumulative total of 269 deaths reported, no change since Friday.
The Mid-America Regional Council’s COVID-19 dashboard reported 154,537 cumulative COVID-19 cases on Saturday. The daily average of new hospitalizations was 95.
The Johns Hopkins University COVID-19 dashboard on Saturday night reported 28,554,452 cases in the United States, with 511,994 total deaths nationwide.
COVID-19 tests scheduled Monday
The Pierson Community Center COVID-19 testing site at 831 S. 55th is open from 9 a.m. to 5:30 p.m. Monday, March 1. Tests are through WellHealth. Appointments are required, check with the website, www.gogettested.com/Kansas, for available appointment times.
Unified Government COVID-19 testing and vaccine sites are scheduled to be open on Monday. Those seeking vaccinations need to have an appointment, while those seeking COVID-19 testing may walk in and get a test kit.
The Unified Government Health Department’s COVID-19 test site at the former Kmart building at 78th and State will be open Monday, March 1, from 9 a.m. to 3 p.m. Appointments are not needed for COVID-19 tests there on Monday. There is also another UG Health Department location for COVID-19 testing at the former Best Buy store, 10500 Parallel Parkway. More information is at 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.
The Health Department is offering saliva COVID-19 tests to the public. Tests from the Health Department are free for those who live or work in Wyandotte County.
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.
Wyandotte County residents who are interested in getting a COVID-19 vaccine may fill out a survey form at the UG Health Department at https://us.openforms.com/Form/2f2bcc68-3b6a-450b-9007-d39819db6572. Residents will be contacted to make an appointment when vaccine becomes available. The Health Department currently is vaccinating high-contact critical workers, as well as residents over 65.
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.
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/2931897000469224.
The University of Kansas Health System COVID-19 update page is at https://www.facebook.com/kuhospital/videos/806512689941175.
For more information about how Wyandotte County residents over 85 can get a vaccine at the Health Department site, visit https://alpha.wycokck.org/files/assets/public/health/documents/covid/02032021_wycovaccinationsage85.pdf.
A weekly vaccine report for the state of Kansas is at
https://www.kansasvaccine.gov/DocumentCenter/View/123/Vaccine-Historical-Document-22521?bidId=.
Cards and letters of encouragement for caregivers at KU Health System may be sent to Share Joy, care of Patient Relations, 4000 Cambridge St., Mailstop 1021, Kansas City, Kansas, 66160. Emails can be sent to [email protected].
Wyandotte County is under a mandatory mask and social distancing order.
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.