CDC recommends Janssen suspension after 6 people out of 6.8 million got rare blood clots
Guam and the CNMI have put the brakes on the administration of Johnson& Johnson's Covid-19 vaccine, following the Center for Disease Control and Prevention's recommendation.
The CDC called for a pause on the J&J vaccine, also known as Janssen, pending review of six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the shot.
"In these cases, a type of blood clot called cerebral venous sinus thrombosis was seen in combination with low levels of blood platelets (thrombocytopenia)," Dr. Anne Schuchat, principal deputy director of the CDC and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research said in a joint statement.
As of April 12, more than 6.8 million doses of the Janssen vaccine have been administered in the U.S.
Schuchat and Marks said all six cases occurred among women between the ages of 18 and 48, and symptoms occurred six to 13 days after vaccination.
"Treatment of this specific type of blood clot is different from the treatment that might typically be administered," the health officials said. "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."
On Guam, a total of 306 doses of J&J/Janssen have been administered as of April 12.
Guam and CNMI health officials said people who received the vaccine more than a month ago are at low risk at this time. Those who recently got the vaccine— within the last few weeks— are advised to be aware of any symptoms.
"If you have received the vaccine and develop a severe headache, abdominal pain, leg pain, or shortness of breath, individuals should contact their healthcare provider and seek medical treatment," states a press release from the Joint Information Center.
Last Friday, the Guam Department of Public Health and Social Services’ (DPHSS) Immunization Program placed an order of 8,500 doses of J&J/Janssen, which were expected to arrive this week.
Guam first received an allocation of 1,300 doses of J&J Janssen on March 2 shortly after the FDA issued an Emergency Use Authorization for this brand.
DPHSS earlier said the April allocation for the J&J/Janssen vaccine expanded from 1,300 doses, which arrived earlier this month, to 18,200 doses. The remaining 8,400 doses will be ordered later this month.
The U.S. Naval Hospital Guam announced the suspension of Janssen administration effective April 14.
"USNH Guam recently began administering the Janssen vaccine and paused administration out of an abundance of caution recommended by CDC and FDA," the Navy hospital said in a press release. "The vaccination clinic is continuing to administer the Moderna version of the Covid-19 vaccine to beneficiaries who are due for their second dose at Top O’ the Mar on Nimitz Hill, Asan." USNH Guam urged those who have received the Janssen vaccine to immediately contact their healthcare provider if they experience severe headache, abdominal pain, leg pain, or shortness of breath, within three weeks after receiving the vaccine.
"The health and safety of service members, beneficiaries and hospital staff remain USNH Guam’s priority. The Department of Defense is communicating this pause with military healthcare facilities and USNH Guam will provide updates as they develop," the Navy hospital said.
On Saipan, health officials said a small number of CNMI residents have received the J&J/Janssen vaccine and have not reported any adverse side effects.
“While no cases of blood clots have been reported here in the CNMI, we will continue to trust in our federal and local public health officials throughout our vaccine rollout as they remain an important tool in protecting our community from a serious illness," CNMI Gov. Ralph Torres said. "We continue to encourage everyone to get vaccinated through the Pfizer and Moderna vaccines, which remain available here in the CNMI.” The CHCC said until Janssen is cleared again, the CNMI will only offer Pfizer-BioNTech and Moderna vaccines at the Covid-19 vaccination sites.
“The CDC and FDA, acting quickly and decisively, is delivering on their commitment to safety as a priority. We share that commitment and that is why we immediately paused the use of the Johnson & Johnson/Janssen vaccines,” said CHCC CEO Esther Muna. “We are in constant communication with the CDC and FDA to get the most updated information in regard to this and all other vaccines.”
CDC is scheduled to convene a meeting of the Advisory Committee on Immunization Practices on Wednesday to further review the six 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," CDC said in a statement.
"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."
CDC said the adverse events currently 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," CDC said.
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