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Coronavirus Update: The U.S. is rolling out Pfizer and Merck’s COVID-19 antivirals to states but ‘complex’ manufacturing process may limit launch

The U.S. has started shipping some doses of the recently authorized COVID-19 antivirals developed by Pfizer Inc. and Merck & Co. Inc. as the number of new cases in the country continues to soar.

The Food and Drug Administration authorized both treatments last week, although it put stricter rules on molnupiravir, the pill developed by Merck MRK, -0.26% and Ridgeback Biotherapeutics, saying it should only be used if there are no other treatment options available.

The pills are supposed to be prescribed to people with mild or moderate cases of COVID-19 who are also at high risk of severe diseases. They are the first treatments that someone can take at home, to lessen the risk of hospitalization and death.

Pfizer’s PFE, -3.54% Paxlovid cuts the risk by 88%, while Merck’s drug reduces that risk by 30%.

Like the monoclonal antibodies and the COVID-19 vaccines, the supply of the new antivirals is being managed by the federal government’s Office of the Assistant Secretary for Preparedness and Response, which has said it expects to provide 65,000 courses of Pfizer’s Paxlovid to states and territories by the end of this month. 

The U.S. has already purchased 10 million doses of Paxlovid and 3 million of molnupiravir.

The first doses of Paxlovid began shipping Dec. 24, within days of the FDA authorization, Pfizer CEO Albert Bourla tweeted. That said, supply of the drugs is expected to be sparse in the early days of the launch as manufacturing ramps up.

The first round of Paxlovid allocation includes 6,180 doses to California, 1,600 to Michigan, and 180 to Rhode Island; Merck’s pill allocation is slighter higher, with 28,920 doses going to California, 7,480 to Michigan, and 820 to Rhode Island “Supplies of oral antivirals will initially be extremely limited,” said New York City’s health department, which recommends clinicians prioritize the drugs for people who are immunocompromised or seniors who are not fully vaccinated and have a risk factor.

Although the treatments are standard pills, the kind anyone can pick up from a pharmacy, the manufacturing process to make them is complex, White House officials said last week. Manufacturing these drugs can take six to eight months.

“The sobering news is, unfortunately, it is really a quite complicated and complex synthetic process, which we will be working with the company to figure out how we can help alleviate the stress of the long duration that it takes to make it,” Dr. Anthony Fauci, the president’s chief medical advisor said at a press briefing last week, “and hopefully we’ll be able to shorten that process.”

News to know

• The Centers for Disease Control and Prevention moved forward with plans to shorten isolation times for people who have tested positive for the virus, saying Monday evening that people who are asymptomatic can end isolation after five days as long as they wear a mask around others for 5 more days. 

• Apple Inc. AAPL, -0.11% on Monday closed 11 retail stores in New York City for an undetermined amount of time, as reported by MarketWatch’s Jon Swartz. The tech giant has already closed stores in North America, including in Annapolis, Md., Miami, and Ottawa, Ontario, this month. 

• Moderna Inc. MRNA, -2.43% is fighting a shareholder proposal that would require the company to disclose how funding from the U.S. government for the development of its COVID-19 vaccine impacts how the shot is priced, reports the Financial Times.  

• Illinois Gov. J.B. Pritzker urged residents to “take extra care” of themselves if they attend any New Year’s Eve celebrations. “Omicron and delta are coming to your party,” he said.

What the numbers say

The U.S. on Monday reported 543,415 new cases, which boosted the 7-day average of new cases to 243,099, the most since Jan. 13, according to a New York Times tracker. There are several reasons for the huge jump in cases, including a slowdown in testing over the holiday weekend, more people testing positive after gathering for Christmas, and public-health departments catching up on a backlog of tests.

The daily average death toll on Monday was 1,205, and the daily average of hospitalizations was 71,381.

Separately, the number of fully vaccinated people in the U.S. crept up to 205.2 million, or 61.8% of the total population, according to CDC data. About 66 million Americans have received a booster dose.

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