Federal regulators said Tuesday they are calling for suspension of the administration and distribution of the Johnson and Johnson coronavirus vaccine, after reports of blood clots forming in a handful of recipients around the United States.
Local health departments had planned to use the J&J single-shot this week at their clinics, but have decided to instead offer just the other two vaccines that require a pair of doses.
ABC News reports a certain severe blood clot occured in just six women, but it has to be treated in a special way so the Centers for Disease Control and Prevention and the Food and Drug Administration want to temporarily halt the use of the Johnson and Johnson vaccine so doctors can learn about it.
The patients between the ages of 18 and 48 developed the blood clot about a week after receiving their dose. Nearly 7 million doses have been administered so far.
Johnson and Johnson said they have found no causal relationship between these rare blood clots and its vaccine.
The following statement is from Dr. Anne Schuchat, Principal Deputy Director of the CDC and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research:
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.html.
“(The) 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,” said Beth Lovette, N.C. Department of Health and Human Services Deputy Director/Section Chief, Local and Community Support for the Division of Public Health.
“Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” Lovette said in an email to county health departments.
“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,” Lovette said.
Sheila Davies, director of the Dare DHHS, said Tuesday they will make changes for the clinic they have scheduled for this coming weekend.
“We will be making alternative plans for Saturday by offering a different option for folks who wish to be vaccinated on Saturday, either Moderna or Pfizer,” Davies said.
“To date, Albemarle Regional Health and Services has not given any J&J vaccine,” said ARHS director R. Battle Betts, Jr. “All ARHS J&J clinics for this week have been cancelled.”
“We encourage people to utilize one of the other two vaccines and move ahead with their vaccination efforts,” Betts said. “Moderna is available at any ARHS facility for any and all that want to be vaccinated.”
Several pharmacies in northeastern North Carolina have also suspended administration of the Johnson and Johnson shot following Tuesday’s announcement.
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