Johnson & Johnson vaccine on hold
ommunity Health Center of Southeast Kansas (CHC/SEK) is following guidance from the Food and Drug Administration and the Centers for Disease Control to temporarily pause the distribution of Johnson & Johnson’s (Janssen) single-dose coronavirus vaccine, according to Dr. Linda Bean, Chief Clinical Officer for the health center.
More than 6.8 million doses of the Johnson & Johnson vaccine have been administered in the U.S.
CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine.
According to a KDHE press release, there are no known cases in Kansas.
CDC will meet with the Advisory Committee on Immunization Practices (ACIP) today to further review these cases and assess their potential significance.
People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider.
“CHC/SEK has administered more than 800 doses of Johnson and Johnson to date without any significant side effects” Dr. Bean. said. “However out of an abundance of caution, CHC/SEK will follow the recommendations of the CDC and FDA and pause further administration of this vaccine until more information is available.”
There are still COVID-19 vaccination options available. The Moderna COVID-19 vaccine is 90 percent effective after full immunization of the second dose. Even after one dose the vaccine is over 80 percent effective, according to the FDA.
CHC/SEK recommends unvaccinated individuals to continue to seek vaccinations. CHC/SEK also expects to begin distribution of the Pfizer vaccine, approved for individuals 16 years and older for vaccinating school-age children, however this will be available for adults if needed.
Individuals can request a vaccine appointments on the CHC/SEK website chcsek.org. Click on COVID-19 Vaccination Request Form. CHC/SEK representatives will contact the recipients to schedule a date for the vaccine.
For those without web access, the health center has a toll-free number, 866-888-8650 and a second number for Spanish-speakers 620-240-8940 to make vaccination appointments.
The KDHE announced Tuesday that Kansas will pause administration of the Johnson & Johnson (Janssen) COVID-19 vaccine following an announcement from the Centers for Disease Control and Prevention and the Food and Drug Administration Tuesday morning.
“Just as important as getting vaccines into arms – is making sure those vaccines are safe,” Governor Laura Kelly said. “While this appears to have affected six people in the nearly seven million doses administered, out of an abundance of caution, Kansas will suspend Johnson and Johnson until the CDC and FDA clear it for use again.”
“In the meantime, we anticipate our shipments of Pfizer and Moderna to continue and we will build on the one-third of Kansans who have already received their first dose of the COVID-19 vaccine.”
Rebecca Johnson, administrator for the SEK Multi-County Health Departments and Bourbon County Public Health Officer, said in light of this development, the SEKMCHD will pause administration of the Johnson and Johnson vaccine “until further notice.”
“If residents have received this vaccine and have concerns, they may call their local health department,” Johnson said.
The federal government will further study links between the vaccine and the rare blood clotting disorder. An emergency meeting of the CDC’s advisory committee has been scheduled for Wednesday, the release said.
KDHE asks providers with Johnson & Johnson vaccine to pause administration of the vaccine immediately and to place the supply into storage while material is reviewed. After KDHE has reviewed the findings from the federal government, further guidance will be given to providers on next steps.
Those who have received the Johnson & Johnson vaccine should contact their health care provider if they have any symptoms and report any illness to the VAERS Reporting System, https://vaers.hhs.gov.
The week of April 19, Kansas is anticipated to receive the following doses:
• 39,780 Pfizer Prime
• 38,610 Pfizer Boost
• 29,000 Moderna Prime
• 27,800 Moderna Boost
Joint CDC and FDA Statement
As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the U.S. CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine. In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination. Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.
CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.
Right now, these adverse events appear to be extremely rare. COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously. People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider. Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System at https://vaers.hhs.gov/reportevent.htmlexternal icon.
CDC and FDA will provide additional information and answer questions later today at a media briefing. A recording of that media call will be available on the FDA’s YouTube channel.