CDC hits pause on J&J vaccine over possible blood clots

Vermont Business Magazine The CDC has issued a pause in the distribution of the Johnson & Johnson/Janssen vaccine for COVID-19 "out of an abundance of caution" related to possible but rare blood clots.

Vermont also is pausing its use of the J&J and the VDH will contact those who already have a scheduled shot to offer them either to get the Pfizer/Moderna vaccines or wait until the Johnson & Johnson vaccine is once again cleared for use.

Governor Scott said that the CDC announcement was "a recommendation not a mandate," but that Vermont is following that recommendation.

Human Services Secretary Mike Smith said today that about 2,000 Vermonters a day were scheduled to get the J&J vaccine and beyond this week there are another 1,800 scheduled.

The White House informed Governor Scott that the total number of vaccine doses will remain the same at least for this week as the Pfizer and Moderna doses are increased.

Smith said that he does not know at this point whether the overall vaccine schedule will change. Nor does he know whether the governor's reopening schedule, targeted as normalization by the Fourth of July, will be altered.

Vermont officials expect to hear more from the CDC and FDA by the end of this week.

Health Commissioner Dr Mark Levine noted that the blood clotting incidence is less than one in a million cases, as only six people in 6.8 million doses have reported these rare blood clots. Levine said there have been no such cases in Vermont.

He said they are showing up only in women between 16 and 48 and presented symptoms six to 13 days after the shot. The clots are occurring in the brain or digestive system. They have resulted in severe headaches and stomach aches.

Levine said that if you got the J&J shot more than a month ago then you should be safe.

Governor Scott and Vermont health officials received the information during a conference call with White House officials today at 11 am and have delayed their usual Tuesday press briefing until noon. Scott and Health Commissioner Mark Levine are expected in the coming days to present next steps in the state's vaccine rollout and information to those who have either received a dose of the J&J vaccine or are scheduled to receive it.

"I have complete confidence in what we're doing," Scott said.

The CDC and FDA are looking at treatments for these rare J&J-related blood clots. The other two vaccines are not showing these blood clots.

Dr Levine said the J&J blood clots "should not alarm us" as they are so rare.

He said he expects this to be a "relatively brief pause." It's reasonable to put safety first and "be cautious but not fearful."

Governor Scott said he expects to "be back on track by the weekend."

He said J&J is still manufacturing and there is inventory being built up, which presumably will be then distributed.

As a reminder, when the 16-plus age band begins on Monday April 19, that only the Pfizer vaccine is available for those 16-18 in any case.

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. Tuesday, April 13, 2021.

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 today at a media briefing. A recording of that media call will be available on the FDA’s YouTube channel.

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

CDC works 24/7 protecting America’s health, safety and security. Whether disease start at home or abroad, are curable or preventable, chronic or acute, or from human activity or deliberate attack, CDC responds to America’s most pressing health threats. CDC is headquartered in Atlanta and has experts located throughout the United States and the world.

Source: CDC 4.13.2021