COVID-19: FDA approves experimental treatment; U.S. reports 195,500 new cases

Nov. 21 (UPI) — The United States Food and Drug Administration on Saturday approved use of monoclonal antibodies for treatment of COVID-19 reported the highest number of new infections and the highest number of hospitalizations.

On Saturday the FDA issued a press release saying it has issued an emergency use authorization (EUA) for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients over age 12.

“The emergency authorization of these monoclonal antibodies administered together offers health care providers another tool in combating the pandemic,” Patrizia Cavazzoni, M.D., acting director of the FDA’s Center for Drug Evaluation and Research, said in the release.

President Donald Trump received an infusion of Regeneron’s investigational cocktail Oct. 2 after he was diagnosed with the virus, but the drug is expected to be in short supply initially.

The approval comes nearly every state reporting rapid surges in cases, and as public health officials continue to unearth evidence that South Dakota’s Sturgis motorcycle rally in August caused outbreaks elsewhere in the country.

On Friday more than 195,500 new infections were recorded nationwide and 82,178 people were hospitalized with the illness.

Both of those numbers set new records in the United States, and the number of new cases is more than double the new number recorded in July — 77,100 — during the summer surge.

In the month of November alone, the U.S. has recorded 2.7 million new infections, and in the past week more than 10,000 COVID-19 deaths have been reported in the country.

The country has now recorded nearly 12 million cases and 255,098 deaths since the pandemic began, according to Johns Hopkins University’s COVID-19 tracker.

The number of new daily cases has increased in recent weeks in nearly all states and U.S. territories, but in many states, elected officials are reluctant to impose the sort of sweeping stay-at-home orders jurisdictions implemented this spring as the virus took hold in the country.

The Centers for Disease Control and Prevention published a report this week that pinpointed the 10-day Sturgis rally — which was attended by 460,000 people without any restrictions or business closures — as the cause of an outbreak in Minnesota, which had tighter measures in place to control the spread of the virus.

Minnesota’s public health department found at least 51 Minnesota residents attended the rally and became sick, then infected an additional 35 people — household, social and workplace contacts — who did not attend the event.

Of the 86 people who became ill, four were hospitalized and one died.

The CDC noted that the report’s findings provide a snapshot on the rally’s impact on other states and are likely an underestimate of its impact on Minnesota, where one-third of the state’s counties had at least one case associated with the rally.

The report comes as Americans contemplate holiday travel and shopping, and as public health experts reiterate the importance of mask wearing and social distancing.

The CDC has strenuously recommended avoiding Thanksgiving travel and Black Friday crowds, and this week published a brief Friday on the efficacy of cloth masks for preventing the spread of the virus.

“Masks are primarily intended to reduce the emission of virus-laden droplets (‘source control’), which is especially relevant for asymptomatic or presymptomatic infected wearers who feel well and may be unaware of their infectiousness to others, and who are estimated to account for more than 50% of transmissions,” the brief said.

While local elected officials in both parties have been reluctant to reinstitute the types of sweeping closures they instituted in the spring, the rhetoric is slowly shifting in some areas.

Republican Gov. Kim Reynolds of Iowa announced a statewide mask mandate this week after insisting such measures were unenforceable and did not help.

“If Iowans don’t buy into this, we lose,” said Reynolds, whose state has the sixth-highest rate of new cases in the country. “The cost in human life will be high.”

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