The Colorado Department of Public Health and Environment is pausing the use of Johnson & Johnson's COVID-19 vaccine, a move that comes in response to the FDA and CDC announcing a recommendation to temporarily halt the company's vaccines in the United States.
The FDA and DC said Tuesday that the pause is "out of an abundance of caution" after receiving reports that six people developed "rare and severe" blood clots after receiving the vaccine. The clots were only present in people who had thrombocytopenia (low levels of blood platelets) and those who had histories of blood clotting issues, officials said in a joint-press conference with the FDA and CDC Tuesday morning. The six cases all occurred in women between 18 and 48 years old, with symptoms popping up six to 13 days after the vaccination. Almost 7 million Americans have received the single-dose Johnson & Johnson COVID-19 vaccine.
The federal government is leaving it up to the states on whether they want to pause the vaccine use or not. The CDPHE chose to require all providers to stop administering the Johnson & Johnson vaccine.
The CDPHE said people who received the vaccines over a month ago are at "very low risk" of serious side effects, and those who received it in the last three weeks should monitor themselves for severe headaches, abdominal pain, leg pain or shortness of breath. If you feel these symptoms, call your health care provider.
“We know very little at this time. We’ll know more this afternoon from the CDC and we may expect for the guidance from the CDC as well. What we do know is that this is a very rare type of blood clot,” said Connie Savor Price, MD, the chief medical officer at Denver Health. “It’s unusual, but we do see it occur in cases outside of the vaccine. … These clots are occurring in very unusual places, meaning in the brain.”
Price added that she hopes Tuesday’s news does not create more vaccine hesitancy.
“The Pfizer and Moderna is still in use and still available. And in terms of preventing that vaccine hesitancy, it’s incredibly important that we be transparent and investigate these issues if we do hear about them.”
Of the three vaccines currently approved and used in Colorado — Pfizer, Moderna and Johnson & Johnson (Janssen) — the Johnson & Johnson vaccine makes up the smallest portion of the state's weekly vaccine allocation.
The CDPHE said it received 9,700 doses this week, compared to the nearly 280,000 doses of Pfizer and Moderna it expects to receive in the same time frame.
"Most vaccine clinics will not be significantly affected," the CDPHE said.
Providers should keep the Johnson & Johnson vaccine supply in storage, the CDPHE said. Colorado’s vaccine dashboard showed that 122,280 Johnson & Johnson doses have been administered so far in Colorado.
Anybody with an immediate appointment for a Johnson & Johnson vaccine will either receive the Pfizer or Moderna vaccine, or will have the chance to reschedule their appointment after the FDA and CDC release more information on their findings, officials said. Colorado's mobile vaccination buses, which have been administering this vaccine, are canceled Tuesday and Wednesday.
Governor, CDPHE officials discuss ramifications
Dr. Eric France, the chief medical officer at CDPHE, said during a news conference Tuesday afternoon that he believed the pause at the federal level “is a strong reflection of the national oversight of vaccine safety.”
He explained the next steps, in which the ACIP will review data to see if there are any signs of blood clotting within 1 or 2 weeks of people receiving the Johnson & Johnson vaccine.
France said he expected there will be more cases that will be identified over the next 48 hours or so because hospitals across the nation have to report such instances to the CDC. France said that data should give federal officials “the ability to determine if this is just a coincidence or something more associated with the vaccine.”
After ACIP meets on Wednesday, they would make decisions on recommendations to states on how to proceed with the Johnson & Johnson vaccine – guidance which France said could come as soon as Wednesday.
France added that as of the 1 p.m. news conference, there were no confirmed cases of the clotting disorder, CVST, confirmed in Colorado. He said that the state have asked health care providers in Colorado to provide them information, along with the standard reporting process to the federal government, if they find any potential cases of CVST here.
Gov. Jared Polis said that people should keep the numbers – 6 confirmed cases of blood clotting versus nearly 7 million people who have received the J&J vaccine – in perspective.
“The virus has killed over 550,000 Americans, more than 1 in every 600. That’s a startling figure. So while it’s very important to know any minor-risk parameters of any vaccine, there are none that even approach two or three orders of this magnitude,” the governor said.
Polis and officials from the CDPHE, including Executive Director Jill Hunsaker Ryan, said the state was working with clinics to get them Moderna or Pfizer vaccine that had been scheduled to administer Johnson & Johnson. They said that some providers had to reschedule those appointments. For people who still want to get the Johnson & Johnson vaccine should the pause be lifted, they will likely have to reschedule their appointments.
How vaccine clinics responded Tuesday
All City and County of Denver's vaccination centers will use the Pfizer and Moderna vaccines, and the sites "do not anticipate it will impact operations," the city said in a press release Tuesday.
Several health departments and vaccine clinics that had been scheduled to administer the Johnson & Johnson vaccine this week said they were rescheduling people’s appointments or keeping the appointments and administering either Pfizer or Moderna vaccines instead.
Centura Health said Tuesday it is pausing use of the Johnson & Johnson vaccine in all of Colorado and western Kansas. Centura also paused use of the vaccine at three drive-up clinics last Friday after 11 people experienced immediate light headedness, dizziness, nausea and more last Wednesday at the mass vaccination clinic at Dick’s Sporting Goods Park in Commerce City.
After an investigation, CDPHE officials said they found “no cause for concern” with the J&J vaccine after that episode.
However, Centura Health said it has not administered any Johnson & Johnson vaccine since April 7. The health care organization said all of its Johnson & Johnson vaccines are being stored in freezers while it awaits the CDC’s guidance for next steps. Thus far, Centura has administered about 13,500 doses of Johnson & Johnson vaccine at the sites in Commerce City and Colorado Springs.
“If anyone has concerns or experiences any side effects, including severe headache, abdominal pain, leg pain and/or shortness of breath within three weeks after receiving the Johnson & Johnson vaccine, they should contact their personal doctor or call 911 immediately,” Centura said in a news release.
Peter Banko, the CEO of Centura Health, said in an interview Tuesday that the hospital has one person under investigation for clotting issues and that the state and CDC had been alerted.
That person was not vaccinated by Centura but is being treated by the group. It was unclear if that person was from Colorado or Kansas.
Centura Health Chief Clinical Officer Dr. Shauana Gulley said Centura had not seen any of the clotting issues related to CVST at its mass vaccination events.
“We haven’t seen any of the more severe reactions that have been reported by the CDC and the FDA coming through our drive-through events,” Gulley said.
France stressed during Tuesday’s news conference that the incidents seen at Dick’s Sporting Goods Park were not directly comparable to the blood-clotting issues and “not really related to each other.”
“As an internist and pediatrician, I continue to emphasize the importance of signing up to receive your vaccine. One of the best ways to protect yourself, your loved ones, and help end this pandemic is to get your COVID-19 vaccine,” said Shauna Gulley, MD, the senior vice president and chief clinical officer for Centura Health.
The Northeast Colorado Health Department suspended a clinic that had been scheduled for Wednesday in Sterling and said people who had been signed up to get the J&J vaccine there will be contacted by email or phone to instead register for a Moderna vaccine.
The STRIDE Community Health Center said it would not be canceling any clinics but offering Moderna for the time being.
The Thornton Fire Department said it will be offering Moderna vaccines to people signed up to receive Johnson & Johnson vaccines at the Margaret Carpenter Recreation Center site.
“We had to pivot pretty quickly to reappoint about 900 people who were scheduled to get Johnson & Johnson today, to get them into Pfizer or Moderna,” said Theo Gonzales, an EMS captain with the Thornton Fire Department who is overseeing the clinic.
Gonzales said that many people who had been set to get a J&J shot Tuesday “are willing to just wait” for those vaccines to be allowed for use again and chose not to receive a Pfizer or Moderna vaccine.
“It’s been about 50-50. Most people have either offered to schedule the Pfizer, take the Moderna or some people have just said they’re going to wait it out,” Gonzales said, adding that the Broomfield County Health Department helped transfer vaccine so the site could honor all of its appointments.
He said that at the site, which has been operational since January, crews have not seen an adverse effects not seen on a typical day. The site also administers Moderna and Pfizer vaccine.
Catherine Luevano was one of the people set to get the J&J vaccine on Tuesday in Thornton. She said she heard on the news Tuesday morning about the Johnson & Johnson jab being halted.
“I decided even though I knew they were going to halt, I was going to show up here anyway to see what was going to happen. So, I was willing to take Johnson & Johnson, however, Moderna is better. So, I’m quite happy with the outcome,” she said. “I have a 5 1/2-month old grandson that I do child care for, and if I’m not vaccinated, he is of high risk. I also have a 13-year-old grandson who is not vaccinated, and he has a high risk. So, I think the vaccination is worth taking the risk for my family. It was worth it.”
Anna Alarcon also took the Moderna vaccine Tuesday at the site when the Johnson & Johnson vaccine was paused.
“I was kind of happy because me and my friends were talking about it, that the Johnson & Johnson was giving people symptoms,” she said. “…I’m feeling good. It was a quick and easy shot, but after a while, you feel it. My arm’s a little sore, but other than that, I’m OK.”
Eagle County Public Health will administer the Moderna vaccine at the clinic Tuesday at the Westin Riverfront Resort and at the upcoming Thursday clinic in El Jebel. The county said that more than 8,300 doses had been provided since March 4.
"We understand that this change is inconvenient and possibly not the vaccine the you were hoping for," ECPH said. "With the level of disease transmission still high in our community we believe that for most people, the best vaccine to get is the one you can get the soonest."
Routt County had a J&J clinic scheduled for Wednesday at the Steamboat Christian Center. The county has not yet said what it plans to do with respect to that clinic after the CDPHE’s announcement.
According to the Ouray County Plaindealer, Ouray County Public Health canceled its Johnson & Johnson clinic Tuesday at the 4-H Center.
Bent County Public Health said it will continue to administer Moderna at vaccine clinics moving forward and that it had availability for this week for people in the county. People who wish to sign up to get vaccinated by BCPH can call 719-456-0517.
A spokesperson for a clinic that was supposed to administer Johnson & Johnson vaccine to more than 170 residents of Holiday Hills Village, a community in Federal Heights for people ages 55 and up, said residents would be getting the Pfizer vaccine instead.
The CDC's Advisory Committee on Immunization Practices will hold an emergency meeting on Wednesday to review the cases as the FDA continues to investigate.
Denver7's Stephanie Butzer, Blair Miller, Pattrik Perez and Gary Brode contributed to this story.