MIAMI – The FDA is limiting the use of two brands of monoclonal antibody treatments it says data shows are not effective against the dominant omicron variant of COVID-19.
Regeneron confirmed to Local 10 News that its treatment does not currently work against omicron. The manufacturer of the other, Eli Lilly and Company, said it agrees with the FDA that it is “not medically appropriate” to treat mild to moderate COVID, given the current formulation is not effective against omicron.
“You have to give the right drug to the right problem,” said Dr. Aileen Marty, infectious disease expert at Florida International University.
The FDA does list other therapies that are expected to work against the variant, though.
.@BrowardHealth tells me they have received an allocation of the #monoclonal #sotrovimab - but that it is “reserved for in-patients and those who meet very strict FDA guidelines, primarily individuals who are transplant recipients or immunocompromised.” 2/2 pic.twitter.com/xlpSFysbsh
— Christina Boomer Vazquez (@CBoomerVazquez) January 26, 2022
Broward County Mayor Michael Udine says “some small amount are now starting to come down to Broward County.” Broward Health says they have received an allocation of sotrovimab but that it is “reserved for inpatients and those who meet very strict FDA guidelines, primarily individuals who are transplant recipients or immunocompromised.”
In Miami-Dade County, Jackson Health says they have remdesivir and sotrovimab, which is reserved “for patients that meet the criteria.”
“We’ve been eagerly waiting and we are ready to deliver on the range of treatments that are effective against omicron,” Miami-Dade Mayor Daniella Levine Cava said. “We got everything in place with our test sites, our vaccination sites and our treatment sites. We are fully ready to roll it out the minute those treatments arrive.”
When it comes to Pfizer’s COVID antiviral pills, Marty said they are “very efficacious.”
“It has 88-89% reduction in hospitalizations and that’s phenomenal,” she said. “Early is better, after you have tested positive.”
Publix, CVS, Walgreens and Walmart say they are now offering the pills. A prescription is required and supplies remain limited.
Also on the FDA’s list of treatments expected to work against omicron is the monoclonal sotrovimab, which Marty said has to be given to give almost three times as much with omicron.
“Which is part of the reason that we have had short supply,” Marty said.
CDR Health, which manages this now-closed site at Tropical Park in Miami-Dade, says they are ready and willing to provide sotrovimab once there is enough allocation to support demand, adding: “We have heard the federal government will be making 300,000 doses of sotrivimab available nationwide soon. When that happens, and if CDR receives an allocation, we can reopen the sites within 24 to 48 hours.”
Information on antiviral pills
More details from Publix:
There are five Publix Pharmacies in the state of Florida that were selected by the Florida Department of Health to offer the oral antiviral treatment. A prescription from a physician is required in order to obtain the medication. The stores are:
MIAMI-DADE COUNTY: River Landing Publix #1561, 1420 Nw North River Dr., Miami, 33125-2888
BROWARD COUNTY: Harbor Shops Publix #1097, 1940 Cordova Rd., Fort Lauderdale, 33316-2156
PALM BEACH COUNTY: Crosstown Plaza Publix #0371, 2895 N Military Trl., West Palm Beach, 33409
HIGHLANDS COUNTY: Fairmont Plaza Publix #1347, 3610 US Highway 27 N., Sebring, 33870-1691
CHARLOTTE COUNTY: Port Charlotte Crossing #0755, 4265 Tamiami Trl., Port Charlotte 33980-2152
More details from Walgreens:
As part of the Federal Retail Pharmacy Partnership (FRPP) Oral Antiviral Program, Walgreens is dispensing Paxlovid to eligible individuals at select Walgreens locations across more than 25 states and local jurisdictions, including Florida. States and jurisdictions are still fluctuating. Walgreens has shared with primary care providers participating store locations, as well as a provider only toll-free number and HHS website to locate inventory in their area.
Walgreens dispenses COVID-19 oral antiviral medications to eligible patients with a valid prescription from a prescribing healthcare provider, including telehealth providers. Healthcare providers are responsible for determining patient eligibility for treatment with COVID-19 oral antivirals and therapy must be started within 5 days of symptom onset.
Per the two FDA emergency use authorizations, the following additional eligibility requirements apply:
1. Eligible populations for Pfizer’s antiviral include patients 12 years of age and older (weighing at least 40 kilograms) with positive results of direct SARS-CoV-2 viral testing, and who are at high-risk for progression to severe COVID-19, including hospitalization or death.
2. Eligible populations for Merck’s antiviral include patients over age 18 with positive results of a direct SARS-CoV-2 viral testing, and who are at high-risk for progression to severe COVID-19, including hospitalization or death.
More details from CVS:
CVS Pharmacy has started to receive our initial and limited allocated supply of the Pfizer and Merck oral antiviral COVID-19 therapies as determined by the federal government, subject to each State’s selection of CVS Pharmacy as a participating provider. Currently we are able to dispense prescriptions for these therapies at select CVS Pharmacy locations in 11 states (AZ, CA, CT, FL, IN, LA, NV, NY, RI, UT, VT) that have selected CVS Pharmacy as an access point for this medication and only once allocation is provided to CVS.
The health care provider who prescribes the medication has access to information provided by the federal government about participating pharmacies in the patient’s area that have allocated supply of the medications. When they prescribe this medication to a patient, the provider will let the patient know which pharmacy to go to in order to pick up their prescription. At this time, not every pharmacy in your area may have supply of this medication allocated to them for dispensing.
For the protection of patients, customers, and our colleagues, we encourage any COVID-19 positive patient prescribed this medication to utilize one of our drive-thru windows to pick up their prescription or have a caregiver pick up the medication for them. If the pharmacy does not have a drive-thru, or a caregiver is not available, patients can contact their Pharmacist to discuss pick-up options. Same-day delivery is also offered for a small fee at many of our locations, or free with a CarePass subscription.
More details from Walmart can be found by clicking here.