FDA authorizes Pfizer pill Paxlovid as COVID treatment amid omicron

December 22, 2021
Omicron variant in more states; delta surge continues: COVID updates
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The Food and Drug Administration on Wednesday authorized use of a new antiviral pill that can be taken at home to help prevent people sick with COVID-19 from becoming severely ill.

Paxlovid, made by Pfizer, reduced the risk of severe disease by nearly 90% in clinical trials and appeared to be safe. Taken as a pill soon after COVID-19 symptoms start, it is intended for people at high risk for severe disease, including those over 65, people with obesity or diabetes and anyone with a weakened immune system, as well as high-risk children ages 12 and up.

The pill is easier to deliver than previous treatments, which had to be given by injection or infusion, but requires a prescription and swallowing 40 pills over 5 days. The drug works best when given within 5 days of symptom onset and not well at all after 7 days, studies show. Some hospitals and pharmacies are working to reduce the time between a positive test, receipt of a prescription and access to the pills.

 “Pfizer stands ready to begin delivery in the U.S. immediately to help get PAXLOVID into the hands of appropriate patients as quickly as possible,” Pfizer chairman and CEO Albert Bourla said in a prepared statement.

The U.S. government has pre-purchased doses to provide at no cost, but it’s not clear how quickly it can be made widely available.

The antiviral became more important in recent days as the omicron variant took over from delta. The two most used monoclonal antibodies, which also help prevent people from becoming severely ill, are not expected to be effective against omicron, though a third, sotrovimab from GlaxoSmithKline and Vir Biotechnology continues to be useful.

— Karen Weintraub, USA TODAY

Also in the news:

► The United States is once again reporting more than 1 million cases per week, Johns Hopkins University data shows. The country hadn’t been above that mark in three months, while the delta variant was ravaging some states.

► New York; New Jersey; Washington, D.C.; and Puerto Rico all set records Tuesday for their surging COVID-19 case counts. In the week ending Tuesday, cases in Washington were 9.3 times what the CDC says is a high level of community transmission. In New York they were 7.1, New Jersey, 5.7, and Puerto Rico, 2.5, a USA TODAY analysis of Johns Hopkins University data show.

In Wales, groups gathering in pubs, restaurants and movie theaters will be limited to six people beginning Dec. 26, the BBC reported.

► China on Wednesday ordered the lockdown of as many as 13 million people in neighborhoods and workplaces in the northern city of Xi’an following a spike in cases.

► CityMD, the private urgent care company that has seen long testing lines throughout New York City, said it was temporarily closing more than a dozen clinics in New York and New Jersey on Wednesday “to preserve our ability to staff our sites.”

► California will require health care workers to receive a COVID-19 booster shot, Gov. Gavin Newsom announced Tuesday, pledging to make sure hospitals are prepared as a new version of the disease begins to spread throughout the state.

► Royal Caribbean International’s Symphony of the Seas didn’t provide a COVID test to a symptomatic passenger. After disembarking, she tested positive.

📈Today’s numbers: The U.S. has recorded more than 51.2 million confirmed COVID-19 cases and more than 810,000 deaths, according to Johns Hopkins University data. Global totals: More than 276.3 million cases and 5.3 million deaths. More than 204.5 million Americans – 61.6% –  are fully vaccinated, according to the CDC

📘 What we’re reading: Alicia Carrasco, a Latina doctor, wanted to spark trust in the COVID vaccines. So, she enrolled her babies in a clinical trial.

Keep refreshing this page for the latest news. Want more? Sign up for USA TODAY’s Coronavirus Watch free newsletter to receive updates directly to your inbox and join our Facebook group.

‘Unprecedented demand’ leads to home test rationing

Heavy demand for COVID-19 home test kits, including sellouts at some stores, has led major pharmacy chains to ration individual purchases.

Increased interest in testing comes as the nation is experiencing a COVID case surge, and the omicron variant is rising quickly in its percentage of diagnoses. Tests are at a premium for holiday travelers hoping to gather safely with family and friends.

Customers are limited to four over-the-counter antigen tests at Walgreens pharmacies, while CVS is restricting buyers to six kits.

“As the nation experiences a surge in COVID-19 cases coinciding with the holidays, we are seeing unprecedented demand for related testing and vaccine services and products,” Walgreens said in a statement posted on its website Tuesday.

CVS, which carries five at-home tests, is working “around the clock” to make them available to customers, CVS Health spokesman Joe Goode said Tuesday in a statement to USA TODAY. “To ensure equitable access to tests both in-store and digitally, we’ve added a limit of six test kits per purchase.”

On Tuesday, President Joe Biden announced the purchase of 500 million at-home rapid COVID-19 tests, which are expected to be available in January.

NHL players won’t play in Olympics as COVID, game postponements surge

With COVID cases surging and games being postponed, the NHL and its players association said Wednesday that they were pulling out of the Beijing Olympics.

When the NHL reached the agreement on the 2022 Winter Games to send its players, it said it would depend on whether the COVID-19 situation would create so many postponements that the league would need to use the Feb. 6-22 Olympic break in order to reschedule games.

That happened in recent weeks as COVID-19 cases soared. On Sunday, the league postponed all cross-border games through the Christmas break (Dec. 24-26). On Monday, it decided to start its Christmas break two days early. 

– Mike Brehm, USA TODAY

Israel to begin giving out 4th COVID shot doses

An advisory panel in Israel recommended that the country begin administering additional booster doses of COVID-19 vaccines to protect against the quickly spreading omicron variant.

The campaign to administer a fourth shot of the Pfizer vaccine, which was used widely in the country, will begin with people ages 60 and over and health care workers. Prime Minister Naftali Bennett said Tuesday that he had already instructed health officials to begin preparations and the doses may be administered in the coming days.

Case drop may show South Africa’s omicron peak has passed

South Africa’s noticeable drop in new COVID-19 cases in recent days may signal that the country’s dramatic omicron-driven surge has passed its peak, medical experts say.

Daily virus case counts are notoriously unreliable, as they can be affected by uneven testing, reporting delays and other fluctuations. But they are offering one tantalizing hint – far from conclusive yet – that omicron infections may recede quickly after a ferocious spike.

After hitting a high of nearly 27,000 new cases nationwide on Thursday, the numbers dropped to about 15,424 on Tuesday. In Gauteng province – South Africa’s most populous with 16 million people, including the largest city, Johannesburg, and the capital, Pretoria – the decrease started earlier and has continued.

“The drop in new cases nationally combined with the sustained drop in new cases seen here in Gauteng province, which for weeks has been the center of this wave, indicates that we are past the peak,” said Marta Nunes, senior researcher at the Vaccines and Infectious Diseases Analytics department of the University of Witwatersrand.

– The Associated Press

Omicron doesn’t need to ruin the holidays: Here’s what you need to know about rapid tests

As millions of people seek coronavirus tests before holiday trips to see family and friends, they are encountering familiar challenges of the pandemic – long testing lines and stores often sold out of home tests.

Experts who track testing say the nation’s supply remains uneven 20 months into the pandemic, and the testing shortage comes as the fast-spreading omicron variant accounts for about 3 out of every 4 new COVID-19 cases.

“Testing, in particular, is perhaps the most critical public health tool to support our vaccine efforts to limit transmission,” said Dr. Michael Mina, an infectious disease expert and former Harvard professor. “Testing is our eyes on this virus and if we can’t see it, then we’re flying blind.”

Need to get a test before traveling? While rapid antigen tests are less sensitive – meaning they are slightly less likely to detect the virus when compared to PCR tests – advocates say they are accurate enough to detect the virus when a person is infectious and likely to pass it to others. Read more here.

– Ken Alltucker, USA TODAY

Inaccurate death certificates across the country hide the true toll of COVID-19

Nearly 1 million more Americans have died in 2020 and 2021 than in normal, pre-pandemic years, but about 800,000 deaths have been officially attributed to COVID-19, according to the CDC data. A majority of those additional 195,000 deaths are unidentified COVID-19 cases, public health experts have long suggested, pointing to the unusual increase in deaths from natural causes. 

An investigation by Documenting COVID-19, the USA TODAY Network and experts reveals why so many deaths have gone uncounted: After overwhelming the nation’s health care system, the coronavirus evaded its antiquated, decentralized system of investigating and recording deaths.

Short-staffed, undertrained and overworked coroners and medical examiners took families at their word when they called to report the death of a relative at home. Coroners and medical examiners didn’t review medical histories or order tests to look for COVID-19. They and even some physicians attributed deaths to inaccurate and nonspecific causes that are meaningless to pathologists. In some cases, stringent rules for attributing a death to COVID-19 created obstacles for relatives of the deceased and contradicted CDC guidance.

“Our death investigation system urgently needs both oversight and standardization of training and procedures,” said Andrew Stokes, a professor in the Department of Global Health at the Boston University School of Public Health. “It’s hampered our ability to respond to the COVID-19 pandemic, and leaves us unprepared for future public health emergencies.” Read more here.

– The Documenting COVID-19 project and USA TODAY Network

NHL players won’t play in Beijing Olympics as COVID cases surge

The NHL had said it would do everything possible to keep its pledge that players could return to the Olympics.

But with COVID cases surging and games being postponed, the league and players association accepted the inevitable and are opting out, according to a person with knowledge of the situation who spoke on condition of anonymity because an official announcement hasn’t been made.

When the NHL reached the agreement on the 2022 Winter Games, it said it would depend on whether the COVID-19 situation would create so many postponements that the league would need to use the Feb. 7-22 Olympic break in order to reschedule games.

That happened in recent weeks as COVID-19 cases soared. On Sunday, the league postponed all cross-border games through the Christmas break (Dec. 24-26). On Monday, it decided to start its Christmas break two days early. 

An announcement will be made on Wednesday.

– Mike Brehm, USA TODAY Sports

Contributing: Mike Stucka, USA TODAY; The Associated Press

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