April 14, 2021
On Tuesday morning, federal officials said they expected the recommended pause in administration of the Johnson & Johnson COVID-19 vaccine to last only a few day—and said it should not impact the United States’ vaccination goals, Roll Call reports.
The Food and Drug Administration and the Centers for Disease Control and Prevention announced early on March 13 that the they were recommending a pause in Johnson & Johnson COVID-19 vaccinations after six female patients out of the 6.8 million Americans who had received the vaccine to date reported the development of a rare type of blood clot six to 13 days after vaccination. The women were between the ages of 18 and 48.
The Director of the FDA’s Center for Biologics Evaluation and Research, Peter Marks, told reporters on a call that the pause is necessary to educate providers about the type of blood clot caused by the Johnson & Johnson vaccine, called a cerebral venous sinus thrombosis.
Standard blood clot treatment does not work for this type of clot, which, according to Johns Hopkins Medicine, occurs in the brain’s venous sinuses. Such a clot prevents blood from draining out of the brain. As a result, blood cells may break and leak blood into the brain tissues, forming a hemorrhage—and leading tio a life-threatening stroke.
The experts warn that, if the standard course of treatment is followed for a cerebral venous sinus thrombosis, it could cause further harm or even be fatal, Roll Call reports.
Marks said there is no known link to birth control or contraceptives. The only hypothesis health officials mentioned is that the adenovirus vaccine creates an extreme immune reaction in some people that causes platelet clots.
The CDC’s Vaccine Advisory Committee on Immunization Practices is set to meet on Wednesday, March 14, to review these cases and discuss the potential significance.
CDC Principal Deputy Director Anne Schuchat told reporters that anyone who was vaccinated with this one-shot vaccine a month ago or more should not worry. But anyone who received the Johnson & Johnson coronavirus vaccine in the past few weeks should watch for symptoms including severe headaches, leg pain, or abdominal pain that differs from typical post-vaccination symptoms.
Acting FDA Commissioner Janet Woodcock said these reactions are extremely rare and should not deter Americans from getting vaccinated for COVID-19. The pause is due to regular safety monitoring, she said.
“The message to patients who haven’t been vaccinated is to continue to get vaccines that may still be available to them,” Woodcock said.
White House COVID-19 Response Coordinator Jeff Zients told reporters the delay would not have a significant impact on the U.S. vaccination plan. The one-shot vaccines from Johnson & Johnson make up less than 5% of recorded shots in arms to date.
The U.S. has secured enough doses of the COVID-19 vaccines from Moderna and Pfizer to continue vaccinating 3 million people per day, Zients said. States and the federal government plan to work quickly to get anyone scheduled for a Johnson & Johnson vaccine rescheduled for a two-dose shot by Moderna or Pfizer.
The pause will immediately impact the places that receive vaccines directly from the federal government: retail pharmacies, community vaccination clinics, mobile vaccinations units and FEMA-run sites.
The move could shutter some mass vaccination sites. The Federal Emergency Management Agency said it is working with states to find other vaccines.
“FEMA is committed to helping the President’s goal to ensure everyone who wants to be vaccinated can be. In alignment with the Centers for Disease Control and Prevention and Food and Drug Administration’s recommendation to pause the use of the Johnson & Johnson vaccine, effective immediately FEMA will stop administering this vaccine at our pilot Community Vaccination Clinics, as well as via our Mobile Vaccine Units,” said Acting Administrator Bob Fenton in an emailed statement. “We are working with our state partners to determine the path forward and find alternative vaccine options for these sites.”
Georgia, North Carolina, and Colorado have reportedly shut vaccination sites because of adverse events experienced by people receiving the Johnson & Johnson vaccine.
Several states—including Maryland, New York, and Ohio—confirmed Tuesday morning that they would pause administering the vaccine.
Research contact: @rollcall