EL PASO COUNTY, Colo. — After halting COVID-19 vaccinations on Friday in Colorado Springs due to "irregularities" in the storage and handling, the Colorado Department of Public Health and Environment (CDPHE) said Tuesday it had confirmed substandard vaccine storage and handling at the clinic
Now, CDPHE wants anyone who received a COVID-19 vaccine at the Dr. Moma vaccination clinic to be "offered revaccination."
"Through an investigation with the Centers for Disease Control and Prevention (CDC), we identified substandard vaccine storage and handling, vaccine preparation, mass clinic operations and poor recordkeeping practices," CDPHE said in an email to those who received a vaccination at the site.
CDPHE said El Paso County Public Health alerted the Joint Vaccine Task Force after observing a failure to comply with storage protocols at Dr. Moma Health and Wellness Clinic. According to CDPHE, El Paso County Public Health (EPCPH) was on-site Friday.
Health officials last week said they were particularly concerned about possible temperature excursions and lack of regular temperature monitoring as required for participation in the COVID-19 vaccination program.
The EPCPH said in the week leading up to April 9, it began receiving emails and phone calls from members of the public expressing concerns about the COVID-19 vaccinations taking place at the clinic The concerns identified difficulties with contacting the clinic by phone and inquired whether the clinic was in fact a valid vaccine provider.
EPCPH then reviewed the clinic’s publicly available appointment schedule in PrepMod, the same system used by Public Health’s vaccine clinics (as well as many clinics statewide), and noticed 1,472 individual appointments scheduled for that day, the health department said. Because it seemed unlikely that the size of the facility could support that many appointments, EPCPH visited the facility that afternoon where "concerning conditions and activities" were observed and reported to CDPHE. The concerns included:
- Lack of COVID-19 prevention measures in place, such as masking and social distancing.
- Unlabeled, pre-drawn syringes were observed, with no indication of how long they had been at room temperature.
- Concerns for improper cold storage were observed in the vaccine draw room. Lack of appropriate observation post-vaccination.
- Concerns regarding documentation of vaccine administration.
The Dr. Moma clinic had administered 3,933 when it was stopped by the state. CDPHE said more than 3,000 doses were then confiscated from the site.
Just over 1,000 appointments were canceled at that location for April 10 and another 6,000 appointments were scheduled through May 8, CDPHE said.
9NEWS has reached out to the owner of the Dr. Moma clinic. A statement is expected soon.
9NEWS Legal Analyst Whitney Traylor said the Dr. Moma clinic could avoid liability because of a 2005 law called the Public Readiness and Emergency Preparedness Act, or PREP Act.
"It does say distribution and handling of the vaccine is what you will be shielded, you will be protected from liability," he said. "Really the issue is who can be liable and there are only a few different players. There is the government, the manufacturer, the distributor and there is potentially the employer."
Traylor said lawsuits could be possible if someone gets seriously ill while waiting for another dose.
"There would be some tough hurdles in terms of the burden of proof but that would be the argument a plaintiff would make," he said. "Look, I would have had the vaccine, I would have been protected but yours is the dud."
A woman named Sylvienash Moma appears to run this Colorado Springs clinic. Colorado Department of Regulatory Agencies (DORA) said licenses held by Moma are currently in good standing with the State Board of Nursing. She has a license to be a nurse practitioner. A DORA spokesperson said it is within the scope of practice for Advanced Practice Nurses with prescriptive authority (RXNs) to possess and administer vaccines.
What to do if you received a vaccine at the site
CDPHE said for those who received one dose of Pfizer vaccine at the Dr. Moma vaccination clinic, that dose is considered invalid and they should receive two additional doses of Pfizer vaccine according to the time frames below:
- An additional dose of Pfizer 21 days after your initial invalid Pfizer dose was received at Dr. Moma, and
- Final dose of Pfizer 21 days later (e.g., 21 days after your repeated valid dose)
For those who received one dose of Moderna vaccine at the Dr. Moma vaccination clinic, that dose is considered invalid and they should receive two additional doses of Moderna vaccine according to the time frames below:
- An additional dose of Moderna 28 days after your initial invalid Moderna dose was received at Dr. Moma, and
- Final dose of Moderna 28 days later (e.g., 28 days after your repeated valid dose)
For those who do not know which vaccine they received at the Dr. Moma vaccination clinic, they should receive two additional doses of either Moderna or Pfizer vaccine according to the time frames below:
- An 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)
Because of the lack of clinical data, the CDC does not recommend that people get more than three doses of any COVID-19 vaccine, regardless of validity.
CDPHE said the provider uses PrepMod scheduling software, which allows the state to contact people with future appointments at that location to reschedule them and direct them to another clinic.
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