Officials with the state Department of Health and Social Services tackled more COVID-19 misinformation during a press briefing Thursday.
The discussion came in the wake of local and national interest in alternative treatments for the disease and distrust among some in the public of federally recognized public health agencies.
Last month, the Pfizer-BioNTech COVID vaccine received full approval by the Food and Drug Administration for use in those 16 and older and was rebranded under the name Comirnaty. Previously — along with the Moderna and Johnson & Johnson/Janssen vaccines for those 18 and older — the Pfizer shot was approved by the FDA for emergency use authorization.
Dr. Coleman Cutchins, a clinical pharmacist PhD with the state, explained the differences between the two FDA authorization categories.
“Emergency use is FDA approval,” he said Thursday. “What emergency use does is it allows you to skip the line. … It’s like if you go to a theme park and you get a fast pass, you still go to the same place, you still get the same experience, you just skip the line.”
Cutchins said the EUA process has been around since the late 1980s and has been used over 40 times for drugs since — usually in the midst of a public health emergency like an epidemic.
“The other thing that it really allows is for a smaller portion of people to get approved before everybody else,” he said.
For full FDA approval without an EUA, Cutchins said, the data from the clinical trials in different age groups would take longer to gather and present for federal health officials.
“It would wait until the last trial on the last 6-month-old was done, and then all of it would get submitted to the FDA at the same time,” he said. “Outside of the EUA if you have ongoing trials, you can’t submit to the FDA, even if part of your study population is done.”
Officials made clear Thursday that the Pfizer/Comirnaty COVID vaccine are exactly the same formulation.
“So when Pfizer went from being EUA to (full) FDA approval, the product that was manufactured before that time period is no different than the product that’s manufactured after that,” Cutchins said.
Matthew Bobo, the state immunization program manager, said during the briefing that there are differences in legal options in terms of injury compensation programs with an EUA-approved drug in comparison to a full-FDA approved product.
“Under an emergency use authorization, you would fall under the Counter Measure Injury Compensation Program,” he said. “Under full authorization or for licensure, you would be under the National Vaccine Injury Compensation Program.” For example, a person is covered for serious physical injuries and death after taking a EUA vaccine. This is slightly different from coverage after taking a fully FDA approved vaccine, in which a person is entitled to coverage in the event of death, inpatient hospitalization and surgery, or injuries with effects lasting more than six months after the vaccine was given.
Full comparisons for vaccine injury compensation with an EUA and fully approved vaccine are available at the Health Resources and Services Administration website at hrsa.gov/cicp/cicp-vicp.
Officials also reiterated that current research does not support the use of ivermectin or hydroxychloroquine to treat COVID-19.
Cutchins said there’s a lot of misinformation circulating about alternative drugs and their effectiveness at preventing serious illness due to COVID.
“There’s three or four websites that do a pretty convincing job of presenting articles,” he said Thursday. “They fill a lot of holes. They’ll choose a study to show that ivermectin is safe, but that study doesn’t show that it’s effective.”
The use of ivermectin as an alternative treatment for COVID-19 has become a hot topic locally. It was brought up multiple times during public comment at this week’s Kenai Peninsula Borough Assembly meeting and was recently promoted by Borough Mayor Charlie Pierce in several public forums.
According to the FDA, current data does not show ivermectin is effective against COVID-19, although studies are still ongoing. The agency specifies not to use the medication in excessive doses, or if it’s prescribed illegitimately.
Ivermectin, which is approved for human use to treat certain parasites and skin conditions, is also used to prevent worms in livestock animals, the FDA states. Health officials continue to caution against self-medicating with ivermectin — both the veterinary grade kind for animals and the human-approved drug.
Additionally, Cutchins said Thursday that taking more than the recommended ivermectin dose can result in health consequences.
“What a lot of the regimens that people are recommending, with no data to support it, with ivermectin are at two, three, five times higher than that once dose,” he said. “So what it really leads to is a lot more drug in the body. … So it’s a concerning topic in terms of liability.”
Cutchins said medical providers can “be held liable if things go wrong, especially if it’s something that’s not based by evidence and guidelines.”
Officials Thursday reiterated that the three FDA-approved vaccines are the best way to prevent and minimize symptoms of the virus, while the use of monoclonal antibodies as a COVID treatment have the most encouraging supporting data among other drugs.
“I think one of the big points is we’re in so much of a better place right now, in terms of protocols and understanding treatment options,” Cutchins said Thursday. “A year ago, we didn’t have vaccine, we didn’t have monoclonals. … So I kind of turn these around into hope. Let’s not focus on the ones that are not proven, and focus on the fact that we have really good evidence-based treatment options.”
Getting a vaccine
COVID-19 vaccines do not cost money.
Many different organizations on the central peninsula, including pharmacies in Walmart, Walgreens, and the Kenai Fire Department offer vaccines. They are also available for both residents and visitors at airports in Anchorage, Juneau and Fairbanks.
Additionally, Soldotna Professional Pharmacy hosts a walk-in clinic in its strip mall storefront at the “Y” intersection of the Sterling and Kenai Spur highways Monday through Friday from 4 p.m. to 8 p.m.
Vaccination appointments can also be scheduled through the online portal PrepMod, which can be accessed at myhealth.alaska.gov.
A map of vaccine providers can be found on DHSS’ COVID-19 vaccine website at covidvax.alaska.gov.
People who would like assistance with scheduling a vaccination appointment can call the Kenai Peninsula Borough Office of Emergency Management call center. The center operates Monday through Friday from 9 a.m. to noon. The central peninsula call center can be reached at 907-262-4636. The Homer call center can be reached at 907-235-4636. The Seward call center can be reached at 907-224-4636.
Officials encourage anyone with symptoms to test for COVID-19, despite vaccination status.
In Kenai, testing is available at the Chignik Lagoon Clinic, Odyssey Family Practice, Kenai Public Health Center and Capstone Clinic.
In Soldotna, testing is available at the Peninsula Community Health Center, Urgent Care of Soldotna, Walgreens and Soldotna Professional Pharmacy.
In Seward, testing is available at Providence Medical Center, Chugachmiut-North Star Health Clinic, Glacier Family Medicine, Seward Community Health Center and the Safeway pharmacy. Starting August 17, the Seward Community Health Center is offering drive-through testing Tuesdays and Thursdays from 2 p.m. to 3 p.m.
In Homer, testing is available at South Peninsula Hospital, or through other area health care providers at Seldovia Village Tribe Health and Wellness, Kachemak Medical Group and Homer Medical Center.
Reach reporter Camille Botello at email@example.com.