Anti-Covid drug allocated for Guam, other US territories, FAS

GRMC opens infusion clinic to distribute anti-Covid drug

Marion Whicker, a member of the Senior Executive Service, explains the components of ancillary vaccine COVID-19 kits while making a promotional video at Operation Warp Speed headquarters in Washington D.C., Nov. 13, 2020. Operation Warp Speed is an effort by several U.S. government components and public partnerships to facilitate the development, manufacturing and distribution of Covid-19 vaccines, therapeutics and diagnostics. DoD photo by EJ Hersom

(Updated)

Some 1,310 doses of Covid-19 antibody treatment have been allocated for U.S. territories and freely associated states, according to the U.S. Department of Health and Human Services' distribution list.

Guam has received 200 vials of the treatment called bamlanivimab, which has also been distributed to Puerto Rico, American Samoa, Virgin Islands, CNMI, Palau, Federated States of Micronesia and Republic of Marshall Islands.

On Guam, the Guam Regional Medical City has opened a new Covid Outpatient Infusion Clinic to distribute bamlanivimab, which reportedly has shown positive results for Covid patients with mild to moderate symptoms.

According to Dr. Felix Cabrera, a limited number of doses have been made available to Guam through the

U.S. Department of Health and Human Services. The Outpatient Infusion Clinic to safely administer the medication to patients with a doctor’s referral. It is currently located within one of the negative-pressure BLU-MED tents erected outside GRMC’s Emergency Department.

HHS said the weekly distribution across the nation began Nov. 10 after the Food and Drug Administration issued an emergency use authorization for the yet-to-be approved therapy drug manufactured by Eli Lilly.

According to the federal health department, bamlanivimab, an intravenous drug, is for treatment of mild-to-moderate Covid-19. It is applicable for patients who are 12 years old and older, weighing at least 40 kg, and who are at high risk for progressing to severe infection or hospitalization.

The health agency said bamlanivimab should be administered “as soon as possible” after a positive test and within 10 days of symptom onset. The treatment is not for patients who are already hospitalized.

The department said it has allocated more than 100,000 treatment vials of bamlanivimab across the nation.

Of the 1,310 doses allocated for U.S. territories and FAS, Puerto Rico gets the lion’s share of 1,020. The CNMI has been allocated 20; American Samoa, 10; U.S. Virgin Islands, 30; Palau, 10; the Federated States of Micronesia, 10; and Marshall Islands, 10.

According to the Department of Defense, which spearheads the Operation Warp Speed, a state or territory’s percentage of the country’s total number of confirmed Covid19 patients and the total number of confirmed hospitalized patients during a seven-day reporting period will equal that jurisdiction’s percentage of available bamlanivimab for a given distribution week.

“State/territorial health departments, not the federal government, then determine how much bamlanivimab each health care facility within their respective jurisdictions can receive based on the state/territory’s total allocation,” the DOD said.

The Guam Regional Medical City said it has teamed up with the federal health department and the Guam Memorial Hospital for the creation of a dedicated Covid19 outpatient infusion clinic in order to help streamline the safe administration of the therapy. The clinic is currently located within one of the negative-pressure BLU-MED tents erected outside GRMC’s Emergency Department.

With bamlanivimab distribution now in the third week, Health and Human Services Secretary Alex Azar said Operation Warp Speed plans to begin distribution of the new drug cocktail where it's needed most around the country.

To start with, Azar said, about 30,000 doses will be available for distribution initially, with more becoming available in the coming weeks.

Dr. John Redd, the chief medical officer for the federal health department, said distribution of the casirivimab and imdevimab cocktail will be similar to the distribution of bamlanivimab.

“In so doing we've taken into account both ethical and clinical considerations as part of the allocation methodology," Redd said. "We will continue to use this methodology for allocation of the Regeneron therapeutic as well."

Redd said allocations to state and territory health departments are proportionally based on confirmed Covid-19 cases in each state and territory over the previous seven days, he said.

"It is a remarkable tribute to the Operation Warp Speed approach that we now have significant supplies of two FDA-authorized antibody products, designed to treat a novel virus, just 11 months after the virus was identified," Azar said.

Gen. Gus Perna, chief operating officer of Operation Warp Speed, said agencies are working constantly on the distribution plans.

"We work rehearsals of different scenarios to make sure we are capturing all the nuances of the delivery. Each and every week we get stronger," he said. "Each week we are one week closer to distributing the vaccine. We are one week closer to refining to the exactness that we need to have to do this - and I'm very confident in that process."

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