COLORADO SPRINGS — A lot of questions still remain after the Colorado Department of Public Health and Environment notified patients vaccinated at a Colorado Springs clinic they’ll need to get vaccinated all over again due to improper vaccine storage.
News 5 wanted to know, how did the clinic get vetted by the state in the first place, and how can people be assured this won’t happen elsewhere?
The state health replied late Wednesday:
Each provider goes through a formal enrollment process that is laid out by the CDC and CDPHE and the provider must demonstrate capacity to meet all COVID-19 Vaccine Program requirements prior to becoming an approved vaccine provider. Providers must certify by signature that they understand and will comply with the requirements laid out in the application"
The clinic is the Dr. Moma clinic, located inside the Satellite Hotel building off Academy and Airport.
Friday evening, the owner/CEO of the clinic issued a statement and said a news conference will be held Monday, April, 19 that will "detail all facts pertaining to the allegations and findings." The statement was posted in a Facebook group about the clinic and can be found here.
It all started on April 9 when the Colorado Department of Public Health and Environment notified people it was temporarily pausing vaccinations at the Dr. Moma Clinic “as a result of irregularities in vaccine storage.”
The department said inspectors “observed failure to comply with storage protocols.”
Then, on Tuesday, the state health department sent out another message, advising patients “the provider failed to provide proper documentation of temperature storage,” and anyone who got a vaccine there would need to get it again.
What’s not clear, is why Dr. Moma, who according to her clinic's website is a nurse practitioner, was permitted to administer vaccines at her clinic in the first place.
News 5 reached out to both the Colorado Department of Health and Environment and El Paso County Public Health to find these answers.
El Paso County Public Health promptly responded, telling us it was a state issue, and our questions would need to be directed to CDPHE.
On Friday, CDPHE wrote to clarify the mention of inspections for all vaccine providers.
We've received numerous questions about the mention of on-site inspections on our website, and we realized the language was not clear. From the beginning, our plan was to regularly conduct compliance visits, informal observations, or investigations, in conjunction with local public health agencies. With over 1,300 approved providers, rarely does a compliance visit happen prior to enrollment. We rely on the information providers submit in the formal enrollment process including certifying by signature that they understand and will comply with the requirements laid out in the application.
Friday morning News 5 also noticed a change had been made on CDPHE's website. A line was removed in a section titled "Requirements to enroll as a COVID-19 vaccine provider." The line stated that any interested provider must "participate in a compliance site visit conducted by CDPHE."
News 5 anchor Elizabeth Watts asked Gov. Polis about the Dr. Moma Clinic. Polis said state health inspectors work full-time but they can’t be everywhere at once.
“They, like others (other clinics), self-certified they were doing the techniques,” Polis said, “saying ‘we are doing proper storage’ and everything else. It turned out they weren’t and thankfully we caught that.”
He also said he's encouraging Coloradans to come forward if they notice something unusual at a vaccine clinic.
“2 million Coloradans have gotten their vaccine already, which is amazing. With an operation that large there’s bound to be issues. I’m glad the inspectors with CDPHE caught the issue,” Polis said.
NBC’s Senior Medical Correspondent and Monument-based doctor, Dr. John Torres, told News 5 this isn’t a reason to lose confidence in the vaccination system as a whole.
“I fully understand that it can be disconcerting to hear about these vaccines that should not have been used,” Torres said. “Sure some things are gonna slip through the cracks, but they get on those very quickly to keep the rest of us safe, and that should give people, I think a lot of confidence.”
And there are some steps you can take to make sure your clinic is reputable. “The best thing you can do is simply observe and ask,” Torres said. “Look around when you go into a place. Is it well run? Is it well organized, is it clean.”
And it’s important to keep things in perspective. “The thing you have to remember, is these things are happening in very rare circumstances, in very rare instances,” he said.
After consulting with the CDC, CDPHE released the following recommendations for patients who were vaccinated at a Dr. Moma vaccination clinic:
If you received one dose of Pfizer vaccine at a Dr. Moma vaccination clinic, that dose is considered invalid and you should receive two additional doses of Pfizer vaccine according to the time frames below:
- Additional dose of Pfizer 21 days after initial invalid Pfizer dose was received at Dr. Moma, and
- Final dose of Pfizer 21 days after repeated valid dose
If you received one dose of Moderna vaccine at a Dr. Moma vaccination clinic, that dose is considered invalid and you should receive two additional doses of Moderna vaccine according to the time frames below:
- Additional dose of Moderna 28 days after your initial invalid Moderna dose was received at Dr. Moma, and
- Final dose of Moderna 28 days after your repeated valid dose)
If you do not know which vaccine you received at a Dr. Moma vaccination clinic, you should receive two additional doses of either Moderna or Pfizer vaccine according to the time frames below:
- Additional dose of Moderna or Pfizer 28 days after your initial invalid mRNA dose was received at Dr. Moma, and
- Final dose of Moderna or Pfizer 28 days later (e.g., 28 days after your repeated valid dose)
Records show that most patients only received one dose at the site, but for people who received two doses at the Dr. Moma Health and Wellness Clinic the CDC and CDPHE recommends:
- If you received two doses of Pfizer vaccine at a Dr. Moma vaccination clinic, those doses are considered invalid and you should receive one additional dose of Pfizer vaccine at least 21 days after your last COVID-19 dose.
- If you received two doses of Moderna vaccine at a Dr. Moma vaccination clinic, those doses are considered invalid and you should receive one additional dose of Moderna vaccine at least 28 days after your last COVID-19 dose.
- If you do not know which vaccine you received at a Dr. Moma vaccination clinic, you should receive one additional dose of either Moderna or Pfizer vaccine at least 28 days after your last COVID-19 dose.
Because of lack of clinical data, the CDC does not recommend people get more than three doses of any COVID-19 vaccine, regardless of validity.