Colo. finds “no cause for concern” with J&J vaccine

State health officials announced Thursday they found no sign of a problem after unexpected reactions to Johnson & Johnson’s COVID-19 vaccine at a mass-inoculation site in Commerce City led to its early closure this week.

The site at Dick’s Sporting Goods Park shut down Wednesday afternoon after 11 people experienced reactions such as dizziness and nausea. None of them became seriously ill, but it was an unusual number in less than four hours. Only 10 people had suffered adverse reactions at all previous mass-vaccination events in Colorado.

“After reviewing each patient’s symptoms, analyzing other vaccinations from the same lot of the vaccine and speaking with the (Centers for Disease Control and Prevention) to confirm our findings, we are confident in saying that there is no reason for concern,” said Dr. Eric France, the Colorado Department of Public Health and Environment’s chief medical officer.

“We are committed to making sure every community clinic is well-staffed with medical professionals who take patient safety with the utmost seriousness, just as they did at yesterday’s clinic.”

The Food and Drug Administration checked with other locations that used vaccines from the same Johnson & Johnson lot, and didn’t find any unusual reactions, according to the state health department. The agency determined the site followed protocols, but will also do an “after-action” analysis to learn anything that might help with similar incidents in the future.

Dr. Shauna Gulley, chief clinical officer for Centura Health, which runs that site and two others, said earlier Thursday that the unused doses from Dick’s Sporting Goods Park on Wednesday were being “sequestered” while the state investigated. About 640 more people were scheduled to be inoculated that afternoon before the closure.

All 11 people had a reaction within 15 minutes, so people who were vaccinated Wednesday and felt fine don’t need to monitor

their health more closely than usual, Gulley said. Sites ask everyone getting vaccinated to wait 15 to 30 minutes, in case of rare, but potentially serious, allergic reactions.

Nine of the people felt nauseous or light-headed, and recovered after drinking some water or juice, according to the state health department. Two people had low blood pressure and went to an emergency room as a precaution but felt better after resting and went home without specific treatment, Gulley said.

State epidemiologist Dr. Rachel Herlihy said it’s not uncommon to feel anxious or faint after vaccinations or other procedures, such as getting blood drawn.

“When you go to your vaccine appointment, bring a beverage and a snack, or a friend or family member to help offer some reassurance,” she said.

Mass vaccination sites in Colorado had given more than 6,000 Johnson & Johnson shots since Monday, including 1,700 at Dick’s Sporting Goods Park on Wednesday before the site shut down, Centura CEO Peter Banko said. No one reported any adverse reactions Monday or Tuesday, he said.

To date, more than 1.2 million people have been fully vaccinated in Colorado, with either two doses of Pfizer or Moderna or one dose of the single-shot Johnson & Johnson vaccine. Nearly 86,000 people in Colorado have received Johnson & Johnson vaccinations since the company received its emergency use authorization from the federal government.

The site at Dick’s Sporting Goods Park is normally closed Thursday through Saturday and will give shots as usual starting Sunday, Banko said. The 640 people who didn’t get their shots Wednesday because the site shut down were rescheduled to Sunday, when the site will get a shipment of the Pfizer shot.

Sunday already was scheduled as a “Pfizer day” before Wednesday’s reactions, Gulley said.

Any adverse reactions are reported to a site’s medical director, Gulley said, but she wasn’t sure if a specific number triggered the decision to shut down.

“Any deviation from what we normally see gets our attention,” she said.