In-Depth: Omicron made some COVID drugs obsolete. Why won’t the U.S. share them?

Monoclonal antibodies
Posted at 5:47 PM, Feb 15, 2022
and last updated 2022-02-15 23:53:28-05

SAN DIEGO (KGTV) – Clinics and hospitals across California are storing COVID-19 antivirals that are ineffective against omicron and are no longer authorized for use anywhere in the U.S.

These life-saving monoclonal antibodies would be welcome relief in the corners of the world still contending with variants other than omicron, but U.S. health providers are barred from sharing them.

“Right now, we’re just kind of sitting on them,” said Dr. Christian Ramers, who oversees the monoclonal antibody clinic at Family Health Centers of San Diego.

He estimates his clinic has enough of these restricted treatments for a few hundred patients that are now just “taking up fridge space.”

One country that could use these drugs is the Solomon Islands, located about 1,200 miles northwest of Australia. The island nation, which had been virtually untouched by COVID-19 until last month, is in the middle of a surge fueled by that delta variant that is threatening to overrun the burial grounds in the capital city of Honiara.

“There are not enough spaces. And now with the death toll increasing, there will be no spaces to bury the dead,” said Esther Nuria, a journalist for Solomon Star News.

The government recently posted instructions on social media, explaining how citizens should handle the corpses of COVID-19 victims.

The Solomon Islands is one of the last countries on earth where omicron hasn’t taken over, and their hospital system has few tools to treat the sick.

“Hospitalized patients who are short of breath, we’re giving [them] oxygen support when needed. But when it comes to any antibodies to treat patients with COVID, there is nothing like that on the ground here,” Nuria said.

In January, when omicron became ubiquitous throughout the United States, the Food and Drug Administration (FDA) restricted the use of monoclonal antibody treatments that were ineffective against the variant and urged providers to use other drugs instead, such as the antiviral pills from Pfizer and Merck.

The Department of Health and Human Services (HHS) encouraged clinics to store doses of Regeneron’s REGEN-COV and Eli Lilly’s bamlanivimab/etesevimab antibody cocktails in case they become useful in the future.

HHS did not respond to repeated requests for comment from ABC 10News last week.

It’s not clear how many doses of these obsolete antibodies remain stored throughout San Diego County. The county does not track the doses of the Regeneron or Eli Lilly monoclonal antibodies in stock at local hospitals, clinics, or its own MARC treatment centers, said San Diego County Health and Human Services spokeswoman Sarah Sweeney.

The California Department of Public Health (CDPH) said it also does not keep a county-by-county inventory of these drugs. Federal records show California received 27,748 doses in the three weeks before the FDA pause.

“We follow CDPH guidance and are recommending unused supplies of the medicine be retained in the event of a future variant against which they may be effective,” Sweeney said via email.

Scripps Health confirmed it also has supplies of these restricted drugs, but declined to say how many.

“We are in regular communication with HHS officials and were informed [last month] that there is no mechanism in place to return our unused supplies. We are held to regulatory standards that, without government intervention, would not allow us to ship supplies out of the country,” said Scripps Health spokesman Steve Carpowich.

Like the COVID-19 vaccines, all of the monoclonal antibody therapies available in the U.S. were purchased by the federal government. The emergency regulations that allow their use specify that the federal government controls their distribution.

“Unfortunately, we can’t donate these drugs to other countries or even send them to our other University of California members,” said Desi Kotis, chief pharmacy executive at UC San Francisco Health.

Last year, UCSF and other providers tried to convince federal officials to allow hospitals to donate unused vaccines at risk of expiring to other countries. Federal officials turned down the request.

However, Kotis said the situation with these antibodies is different. With the vaccines, tens of thousands of doses were at risk of expiring within weeks. “With the Lilly/Regeneron antiviral products, those expirations are much longer, so you don’t have to worry about something expiring,” she said.

The antibody drugs can be kept in a refrigerator for up to 18 months, according to FDA documents.

These monoclonal antibodies, which can reduce hospitalizations and death by up to 87 percent, are also far more expensive than vaccines. The U.S. government paid $2,100 per course of REGEN-COV.

“Things change and it may be that a couple months from now, there’s another variant that it works for,” Ramers said. “They are not about to expire tomorrow or next week or next month, so right now, we’re just kind of holding on to them.”

UCSF Health has enough Eli Lilly and Regeneron antibodies for 60 patients, Kotis said. It plans to send 40 doses back to the manufacturer in hopes someone else can use them.

“These drugs do show promise and could be helping others, versus you know, a small amount of them sitting on the shelf,” Kotis said.

In a small country like the Solomon Islands, even a few treatments could make an outsized impact. For now, they’re not coming.

“Frustrating. It’s very frustrating,” said Nuria.