BA.5 and BA.4.6 continue US rises, kids' illnesses increase

Two Omicron SARS-CoV-2 subvariants—BA.5 and BA.4.6—increased their predominance last week, the Centers for Disease Control and Prevention (CDC) said today in its latest update. It estimated that BA.5 makes up 88.7% of sequenced samples, up slightly from 88.2% the week before, and BA.4.6 accounted for 7.5% of samples, up from 6.7% the previous week.

The southern Midwestern region that includes Iowa, Kansas, Missouri, and Nebraska continue to have the highest proportion of BA.4.6, averaging 17.2%. Eastern states are also seeing increasing proportions.

In other developments, pediatric COVID cases increased last week after declining for 2 weeks in a row, the American Academy of Pediatrics (AAP) said in its latest weekly update. About 86,600 cases were reported for the week ending Aug 25. Levels have fluctuated over the summer, and school has already resumed in some parts of the country.

In international developments, COVID-19 is still circulating widely in Europe and hospitalized about 3,000 people last week, the head of the World Health Organization (WHO) European regional office said today at a briefing. Hans Henri Kluge, MD, MPH, said that, with autumn and winter approaching, officials expect a surge in COVID activity, with or without a resurgence in seasonal flu. He urged countries to administer flu shots alongside COVID-19 vaccine whenever possible and for health officials to focus on community-level surveillance.

Elsewhere, China continues to battle COVID-19 flare-ups in some of its biggest cities, prompting strict measures in locations including Shenzhen, a technology hub in the south, and Dailan, a major port in the northeast, according to Reuters.
CDC Nowcast variant proportion estimates
Aug 30 AAP weekly COVID update
Aug 30 WHO European office Kluge speech
Aug 30 Reuters story on COVID curbs in China

Hospitals still used 2 COVID monoclonals after FDA deauthorization  

US health systems administered more than 158,000 doses of two monoclonal antibodies (mAbs) to COVID-19 patients at a cost likely exceeding $71 million after the Food and Drug Administration (FDA) deauthorized their use because they didn't work against the Omicron variant.

The findings were published yesterday in JAMA Network Open by a team led by Beth Israel Deaconess Medical Center researchers. The investigators analyzed data on the use of Lilly's bamlanivimab-etesevimab and Regeneron's casirivimab-imdevimab reported to the US Department of Health and Human Services from Oct 27, 2021, to Jun 29, 2022.

The FDA granted emergency use authorizations to the mAbs to treat mild to moderate COVID-19 in high-risk outpatients in 2021 but revoked them on Jan 24, 2022, because they were ineffective against Omicron, the dominant variant.

The use of bamlanivimab-etesevimab and casirivimab-imdevimab peaked the week of December 22, 2021, with 91,036 doses administered, but then gradually declined. After deauthorization, 158,395 mAb doses were administered. Administration varied widely, with Florida and New York accounting for 24% and 20%, respectively. Fourteen states administered less than 10% of their mAb stores, while 11 states administered more than 50%.

The authors estimate that, with Medicare payments for mAbs of $450 to $750 per dose, the deauthorized medications probably cost more than $71 million. "Whether deauthorized treatments will be covered by payers and whether the FDA will take regulatory action against entities violating its guidance remains unknown," they wrote.

The team said that conflicting state government guidance or lack of hospital awareness may have contributed to the continued use of mAbs.

"Although the FDA announcements clearly stated that these mAbs were no longer authorized for use, the agency did not fully revoke their emergency use authorizations because of the possibility that future COVID-19 variants could retain susceptibility, which could have led to misinterpretation," they wrote. "Efforts to improve transparency, equity, and value in the COVID-19 response should include public release of facility-level reporting for all therapeutics."
Aug 29 JAMA Netw Open research letter

Full-dose anticoagulation drugs best for preventing COVID-19 blood clots

Full-dose anticoagulation medication was better at preventing COVID-19–related blood clots in hospitalized patients than standard prophylactic dosing, according to a new study in Circulation.

The randomized trial, called COVID-PACT, was conducted on 390 hospitalized US patients at risk for developing blood clots in 34 intensive care units. A total of 40% required invasive ventilation during hospitalization. Outcomes were measured through hospital discharge or 28 days after drug administration.

The risk of developing venous or arterial clotting complications was 44% lower among patients who received full-dose anticoagulation medication than among standard-dose recipients. Just 9.9% of patients with full-dose medication experienced a venous or arterial thrombotic event, compared with 15.2% in the standard-dose group.

Though there was no difference in all-cause mortality, patients receiving full-dose medication had more severe bleeding events (2.1% vs 0.5% in the standard-dose group). None of the bleeding events were fatal.

"Until now, the optimal strategy for preventing blood clots among patients who are critically ill with COVID-19 has remained uncertain," said lead researcher David Berg, MD, MPH, of Brigham and Women's Hospital. "COVID-PACT shows that, compared with standard-dose prophylaxis, full-dose anticoagulation more effectively prevents the clotting complications of COVID-19."
Aug 29 Circulation study
Aug 29 Brigham and Women's Hospital press release