DENVER -- Colorado on Tuesday paused its use of the Johnson & Johnson vaccine following guidance from the Centers for Disease Control Prevention (CDC), which reported six cases of rare blood clots tied to the vaccine.
None of the blood-clot cases were reported in Colorado as of Tuesday. But providers, out of an abundance of caution, put the J&J vaccine on hold as health officials investigate the vaccine's side effects.
Still, the Johnson & Johnson vaccine has made up only a small portion of the vaccines administered in Colorado.
Here's an overview of the J&J vaccine and its distribution in Colorado:
• Through Monday, 122,280 J&J doses have been administered in Colorado. That's compared to 1,645,357 Pfizer vaccines and 1,529,767 Moderna vaccines.
• On Monday, 358 people were vaccinated with the J&J in Colorado, compared to 4,497 with the Moderna vaccine and 9,477 with the Pfizer vaccine.
• Officials have expected for weeks to scale up usage of the one-dose J&J vaccine in Colorado, but those operations were limited even before Tuesday's news.
The J&J vaccine was put on hold at the Dick's Sporting Goods Park vaccination site on Wednesday after 11 people experienced adverse reactions to the shot. Two people were taken to the hospital.
The vaccine provider, Centura Health, later in the week said it was stopping J&J distribution at all of its drive-thru clinics in Colorado due to a national shortage and the adverse reactions. Those reactions ranged from nausea to dizziness after receiving the J&J vaccine.
How does the Johnson & Johnson vaccine differ from the others?
Johnson & Johnson’s Janssen COVID-19 vaccine is a viral vector vaccine, which means it uses a modified version of a different virus (the vector) to deliver instructions to cells to produce the COVID-19 spike protein, according to the Center For Disease Control and Prevention.
The body’s immune system will then produce antibodies as it attacks the harmless spiked protein cells, building an immunity to the actual COVID-19 virus.
Viral vector vaccines were created in the 1970s, and have been studied for gene therapy, to treat cancer, and for molecular biology research, according to the CDC.
The Moderna and Pfizer vaccines are mRNA vaccines, which are a new type of vaccines. These type of vaccines give instructions to cells to make a harmless piece of the spike protein that is found on the surface of the COVID-19 virus, according to the CDC.
None of the three vaccines use the live virus that causes COVID-19.
Federal, state health officials react to pause of Johnson & Johnson vaccine in the US
During a news conference Tuesday after the CDC and the FDA recommended pausing the use of the vaccine, Jeff Zients, the White House COVID-19 response coordinator on the Johnson & Johnson vaccine, as well as Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said that despite the pause, the announcement would have no significant impact on the nation’s vaccination program, as the J&J vaccine makes up “less than 5% of the more than 190 million recorded shots in arms in the United States to date.”
Fauci, speaking to reporters from the White House, said the pause will give health officials time to study how to treat these rare cases of cerebral venous sinus thrombosis (CVST), which is normally treated with heparin, a blood thinner that prevents the formation of blood clots.
“That would be a mistake in this situation because it could be dangerous and make the situation much worse. So, there's a clinically relevant reason why you want to make this known to people,” Fauci said during the briefing. “The pause not only allows us to take a look at the cases and learn more, but it is also a signal out there to help the physicians.”
Fauci also said pausing the J&J vaccine would help health officials determine if there are any common denominators among the six women who suffered these adverse reactions, which could help health officials determine whether to rule out giving the vaccine to a certain group of people based on certain criteria.
Still, Fauci reiterated the six adverse reactions reported by the FDA and the CDC from the J&J vaccine are very rare, saying the Moderna and Pfizer vaccines — which use a different technology than the J&J vaccine — have shown no red flags that would cause federal health officials to stop their use.
“The FDA acting the way they did today shows that they are indeed the gold standard, and I think that should reassure the American public that they will be very diligent and conservative in how they approach the vaccines,” Zients said during the news conference. “The fact that a pause was done, I think, just serves as a testimony to how seriously we take safety.”
Zients said toward the end of the news conference he hoped to have the pause of the J&J vaccine resolved “pretty soon, within days, two weeks,” but that will largely be determined by what health officials learn about those six severe cases, according to acting FDA commissioner Dr. Janet Woodcock, who said the review could extend longer depending on "what we learn."
In Tuesday’s announcement of the pause of the J&J vaccine, Dr. Anne Schuchat, the principal director of CDC, added that anyone who received the J&J vaccine over a month ago likely won't experience the clotting issues moving forward.
She also said that anyone who has taken the J&J vaccine within the last month and experienced "severe headaches, abdominal pain or leg pain" should contact their doctor, noting that the pain would be different than the typical aches and pains associated with the flu.
Fauci further recommended that people who recently got the J&J vaccine and who may be concerned to “not get anxiety reaction.”
“Remember, it’s less than one in a million. However, having said that, pay attention,” he said, noting that the main warning sign for potential clotting issues is headaches. Additionally, he said people should pay attention to anything that resembles a neurological symptom within three weeks after vaccination.
In Colorado, Dr. Eric France, the chief medical officer for the Colorado Department of Public Health and Environment (CDPHE), said during a news conference Tuesday afternoon that the pause on the J&J vaccine "is a strong reflection of the national oversight of vaccine safety,” and added that he expects other severe cases to pop up over the next day or two across our state.
“Hospitals across the nation may have cases today they’ll report to CDC as well,” France said. “That should give us better sense and ability to determine is this just coincidence or something more associated with the vaccine.”
Dr. Michelle Barron, the senior medical director of infection prevention at UCHealth, told Denver7 reiterated what Fauci said earlier Tuesday, that CVST is extremely rare, even for people who haven't been vaccinated.
"This occurs on average, about five out of a million people," Barron said. "And there's probably some genetic predisposition in the blood where you are more likely to clot."
Barron said the severe symptoms experienced by six women between 18 and 48 years old, and which were reported to the CDC and the FDA, appeared a week to 10 days after they got the vaccine. If you were inoculated more than 10 days ago, Barron said you shouldn't worry.
"I'd be more worried about potentially contracting COVID, actually," she said. "It's going to be much more common."
Denver Health's Chief Medical Officer, Dr. Connie Savor Price, echoed Barron's words, saying, "it’s unusual, but we do see it occur in cases outside of the vaccine."
"We’ll know more this afternoon from the CDC and we may expect guidance from the CDC as well," Price said, adding she hopes Tuesday’s news does not create more vaccine hesitancy.
“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.”
Still, it's possible Colorado could see more of these severe cases. On Tuesday, the CEO Centura Health, Peter Banko, confirmed with Denver7 its hospital system is treating at least one patient who is under investigation for "blood clotting issues" after receiving the J&J vaccine.
Banko could not share how recently the patient sought treatment or whether the patient is located in Colorado or Kansas (Centura Health operates in both states), but Centura's chief clinic officer said the patient did not receive the vaccine from Centura Health's drive-up clinics.
Gov. Polis, from his part, hailed the decision from the FDA and the CDC to pause the use of the J&J vaccine as a move designed to increase confidence in public health officials, while at the same time, urging Coloradans who were scheduled to receive the J&J vaccine to reschedule with their provider to receive a different shot. When asked about how the announcement from the FDA and the CDC would hurt vaccination efforts, Polis responded with some perspective.
“We have 2.1 million Coloradans who’ve gotten at least one vaccine, that’s roughly ⅓ of state. … There will be people with blood clots because we have a third of the population that has been vaccinated. The key question here is: Is there any statistical difference between the people who have been vaccinated and the people who haven’t been vaccinated with regard to any of these side effects?” Polis said. “We know that one thing is sure: COVID-19 is several orders of magnitude more dangerous than any reported incidences of side effects of these vaccines.”
The FDA and CDC said Advisory Committee on Immunization Practices (ACIP) will meet Wednesday to review all data available from the U.S. as well as other countries to review the rates of these rare adverse reactions and assess their potential significance.
Denver7's Pattrik Perez contributed to this report.