Johnson & Johnson Vaccine Paused: What Coloradans Should Know

COLORADO — Colorado paused the use of the Johnson & Johnson COVID-19 vaccine Tuesday after recommendations from the Food and Drug Administration and the Centers for Disease Control and Prevention.

Both federal agencies are reviewing data after six U.S. cases of a rare and severe type of blood clot were reported.

Our state is set to receive 9,700 doses of the Johnson & Johnson vaccine this week, but the Colorado Department of Public Health and Environment and Colorado Joint Vaccine Task Force told providers to pause use of the vaccine out of an "abundance of caution."

"These adverse events appear to be extremely rare," Colorado public health officials said in a news release. "Individuals who received the Johnson & Johnson (Janssen) vaccine more than a month ago are at very low risk of serious side effects."

Anyone who received the Johnson & Johnson vaccine within the last three weeks and develops a severe headache, abdominal pain, leg pain, or shortness of breath should contact their health care provider, Colorado public health officials said.

The news comes after hundreds of people were turned away from the COVID-19 vaccination clinic Wednesday at Dick's Sporting Goods Park. Public health officials decided to pause vaccinations at the site out of an "abundance of caution" after 11 people reported adverse reactions to the Johnson & Johnson vaccine.

The Johnson & Johnson vaccine makes up only a small portion of Colorado's weekly vaccine allocation. The state is set to receive 280,000 doses of the Pfizer and Moderna vaccines this week, compared to only 9,700 doses of the Johnson & Johnson vaccine, public health officials said.

The Johnson & Johnson vaccine is likely to be available again in Colorado in “days, not weeks,” Gov. Jared Polis said in a news conference Tuesday afternoon.

“If the situation lasts more than a few days, it will likely have an impact on Colorado’s herd immunity,” Polis said.

There are no reported cases of the rare blood clot in connection with vaccines in Colorado, public health officials said.

"Anyone scheduled to receive the Johnson & Johnson (Janssen) vaccine will either receive the Pfizer or Moderna vaccine instead, or the vaccine provider will contact them to reschedule their appointment once FDA and CDC release additional information," Colorado public health officials said in the news release.

The type of blood clot — cerebral venous sinus thrombosis — was seen in combination with low levels of blood platelets, federal public health officials said. All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination.

The FDA reported that, as of Monday, more than 6.8 million doses of the company's vaccine had been administered in the U.S.

The CDC will convene a meeting of its Advisory Committee on Immunization Practices on Wednesday to further review the six blood clot cases and assess their potential significance. The FDA will review that analysis as it also investigates these cases.

"Until that process is complete, we are recommending this pause," the FDA said. "This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot."

"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," the statement said.

Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System at CDC and FDA.

Read also: Johnson & Johnson Vaccine Pause: 6 Things To Know