Tuesday, 13 April 2021

Johnson and Johnson COVID Vaccine on ‘Pause’ After FDA, CDC Report Rare Blood Clot Issues

 The Biden administration called for a ‘pause’ in administering the Johnson and Johnson COVID-19 China coronavirus vaccine Tuesday morning. The FDA and CDC, citing six reports of blood clots in women aged 18-48–including one fatality–out of about seven million administered vaccines, called on states to ‘pause’ the J&J vaccine while the problem is studied. The similar AstraZeneca vaccine deployed in Europe has faced similar rare clotting issues. The New York Times was first to report on the ‘pause’.

FDA and CDC statement:

Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine

The following statement is attributed to 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.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.

The White House issued a statement after the Times report claiming the pause would not “significant impact” vaccinations:

Statement from Jeff Zients, White House COVID-19 Response Coordinator on Johnson & Johnson Vaccine

As FDA and CDC announced earlier today, out of an abundance of caution, they have recommended a pause in the use of the Johnson & Johnson vaccine as they review data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the Johnson & Johnson vaccine. The FDA and CDC will be providing details at their briefing later this morning.

This announcement will not have a significant impact on our vaccination plan: Johnson & Johnson vaccine makes up less than 5 percent of the recorded shots in arms in the United States to date. Based on actions taken by the President earlier this year, the United States has secured enough Pfizer and Moderna doses for 300 million Americans. Over the last few weeks, we have made available more than 25 million doses of Pfizer and Moderna each week, and in fact this week we will make available 28 million doses of these vaccines. This is more than enough supply to continue the current pace of vaccinations of 3 million shots per day, and meet the President’s goal of 200 million shots by his 100th day in office—and continue on to reach every adult who wants to be vaccinated. We are working now with our state and federal partners to get anyone scheduled for a J&J vaccine quickly rescheduled for a Pfizer or Moderna vaccine.

States around the country have since announced they are pausing administering the Johnson and Johnson vaccine.

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