Colorado resumes use of single-dose Johnson & Johnson COVID-19 vaccine after US lifts pause on shot

CDC panel adds warning label, says benefits outweigh the risks of rare blood clots
johnson & johnson vaccine janssen
Posted at 8:57 PM, Apr 23, 2021
and last updated 2021-04-24 00:41:51-04

DENVER – State health officials say providers can resume use of the single-dose Johnson & Johnson COVID-19 vaccine in Colorado after the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) lifted a ten-day pause on the vaccine as they investigated rare but severe blood clots in people who had taken the shot.

The announcement by the Colorado Department of Public Health and Environment (CDPHE) early Friday evening came a few hours after a vote by the Advisory Committee on Immunization Practices (ACIP), which recommended lifting the pause on the vaccine after hearing more about the rare instances of dangerous blood clots from scientists both at the CDC and from Johnson & Johnson.

“We are happy to have this highly effective, one-dose vaccine back as an option for Coloradans,” said Dr. Eric France, the chief medical officer for the CDPHE. “We appreciate the caution the CDC and FDA took to evaluate the Johnson & Johnson vaccine and are ready to ramp back up distribution as quickly as possible.”

Use of the Janssen COVID-19 vaccine was halted on April 13 after the FDA and the CDC received reports that six people in the U.S. developed "rare and severe" blood clots after receiving the vaccine, none of which were reported in Colorado.

Nearly 7 million people in the U.S. had safely received the vaccine prior to its pause.

As of Friday, there were 15 cases, mostly among women younger than 50, of dangerous – but very rare – blood clots (now called thrombosis with thrombocytopenia syndrome, or TTS) out of nearly 8 million shots administered so far. Three of these cases were fatal, the CDC said.

The CDPHE noted in its release that it will include the FDA’s warning to patients about the increased risk for the rare blood clot syndrome for women under 50. Additionally, the state department of public health said they have also sent information to health care providers to help them identify and treat this potentially severe blood clot disorder, “in the very rare case it were to occur.”

Furthermore, vaccine providers are required to report any adverse side effects from any of the three approved COVID-19 vaccines in the U.S. to the Vaccine Adverse Event Reporting System (VAERS), the CDPHE said.

MORE: Fact sheet for recipients and caregivers using the Johnson & Johnson COVID-19 vaccine

Dr. Michelle Barron, the senior medical director of infection at UCHealth, told Denver7 she was excited about the outcome because it could help end the pandemic.

“The potential risks for this is not zero but it’s incredibly rare,” Dr. Barron said. “The risk of you having this complication versus the potential risk of getting COVID right now certainly is on the side of getting COVID because variants are present and more infectious, resulting in more hospitalizations.”

She added that it’s vital to make an informed decision based on your health and access to the vaccines available.

“Given the rise of COVID cases you are still probably better off getting the vaccine than getting no vaccine at all,” Dr. Barron said.

There are approximately 73,000 doses of the Johnson & Johnson vaccine at 129 locations across the state, according to the CDPHE. Prior to the pause, Centura Health had already administered 13,500 Johnson & Johnson shots into the arms of Coloradans.

“We have received the information regarding the CDC advisory panel’s stance on the Janssen (Johnson & Johnson) vaccine and are in the process of reviewing it," reads a statement from Centura Health. "We will continue to offer appointments to our communities for Pfizer and Moderna vaccines at our drive-up events and community vaccine clinics by visiting"

At this time, it’s unclear when the hospital will resume the use of the vaccine, which is is approved for people 18 years and older.

Dr. Barron said vaccines have side effects, but added that people who opt for the Johnson & Johnson vaccine and experience a severe headache, visual changes, stomach pain, slurred speech, nausea or vomiting should seek medical help and inform doctors if they received the vaccine.

"They may want to treat you with a different type of blood thinner than the standard one that they would use,"Dr. Barron said. She encourages people with health concerns to seek out alternative vaccines like Pfizer or Moderna.

During Friday’s meeting, the ACIP said the benefits of the single-dose COVID-19 vaccine outweighed the risks of dangerous blood clots, but stressed there needs to be an awareness campaign among doctors and those giving the vaccine to make sure people, and especially women, understand the risks and what their vaccination options are.

“I’m glad to hear that after carefully reviewing data and proceeding with appropriate caution, the FDA is recommending that we resume using the Johnson & Johnson COVID-19 vaccine in our efforts to vaccinate people against this deadly virus. The vaccine, which requires just one shot, is especially helpful in our efforts to protect those who may be transient, lack a medical home, or have transportation challenges, and Colorado will be resuming use of the Johnson & Johnson vaccine,” said Gov. Jared Polis in a statement Friday night. “While this vaccine is approved for those 18 and up, all Coloradans 16 and up are eligible for a vaccine and I urge everyone to get it, so that together we can power the Colorado comeback.”