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Pfizer says trial shows its pill is highly effective at preventing severe illness from COVID

Pfizer announced Friday that its pill to treat COVID-19 had been found in a key clinical trial to be highly effective at preventing severe illness among at-risk people who received the drug soon after they exhibited symptoms.

The antiviral pill is the second of its kind to demonstrate efficacy against COVID. It appears to be more effective than a similar offering from Merck, which is awaiting federal authorization.

President Biden said Friday that the United States has already secured millions of doses of Pfizer’s experimental pill.

“If authorized by the FDA, we may soon have pills that may treat the virus in those who become infected,” Biden said at a news conference. “The therapy would be another tool in our toolbox to protect people from the worst outcomes of COVID.”

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Molnupiravir, produced by Merck and Ridgeback Biotherapeutics, has been proved in clinical trials to reduce by half the risk of hospitalization or death in adults with mild to moderate COVID-19.

Pfizer’s pill, which will be sold under the brand name Paxlovid, cut the risk of hospitalization or death by 89 percent when given within three days after the start of symptoms.

Pfizer said an independent board of experts monitoring its clinical trial recommended that the study be stopped early because the drug’s benefit to patients had proved so convincing. The company said it planned to submit the data as soon as possible to the Food and Drug Administration to seek authorization for the pill to be used in the United States.

“The results are really beyond our wildest dreams,” said Annaliesa Anderson, a Pfizer executive who led the drug’s development. She expressed hope that Paxlovid “can have a big impact on helping all our lives go back to normal again and seeing the end of the pandemic.”

The treatment could become available in the next few months, though supplies are likely to be limited at first. The Pfizer and Merck pills are both geared toward patients regarded as high-risk, such as those older than 60 or with conditions like obesity that make them more susceptible to severe consequences from COVID.

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NEW YORK TIMES and WASHINGTON POST

AGs sue Biden administration over vaccine mandate

JEFFERSON CITY, Mo. — Attorneys general in 11 states filed suit Friday against President Biden’s administration, challenging a new vaccine requirement for workers at companies with more than 100 employees.

The lawsuit filed in the St. Louis-based US Court of Appeals for the 8th Circuit argues that the authority to compel vaccinations rests with the states, not the federal government.

“This mandate is unconstitutional, unlawful, and unwise,” said the court filing by Missouri Attorney General Eric Schmitt, one of several Republicans vying for the state’s open US Senate seat next year.

New regulations by the Occupational Safety and Health Administration mandate that companies with more than 100 employees require their workers to be vaccinated against COVID-19 or be tested for the virus weekly and wear masks on the job. The requirement is to kick in Jan. 4. Failure to comply could result in penalties of nearly $14,000 per violation.

Schmitt said Missouri has 3,443 private employers who could be covered by the vaccine requirement, with nearly 1.3 million employees.

He said he sued ‘’to protect personal freedoms, preserve Missouri businesses, and push back on bureaucratic tyrants who simply want power and control.”

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The Biden administration has been encouraging widespread vaccinations as the quickest way out of the pandemic. A White House spokeswoman said Thursday that the mandate was intended to halt the spread of a disease that has claimed more than 750,000 lives in the United States.

Missouri was joined in the lawsuit by the Republican attorneys general of Alaska, Arizona, Arkansas, Montana, Nebraska, New Hampshire, North Dakota, South Dakota, and Wyoming. The office of Iowa Attorney General Tom Miller, a Democrat, also joined in the suit, along with several private, nonprofit and religious employers.

The Daily Wire, a conservative media company, filed a challenge in federal court on Thursday. So did companies in Michigan and Ohio represented by a conservative advocacy law firm, as well as two Wisconsin manufacturers represented by a conservative law firm.

ASSOCIATED PRESS

Ariz. uses COVID relief money for schools without mask mandates

PHOENIX — Arizona Governor Doug Ducey is defying a demand that he stop using federal coronavirus relief money to fund an education grant program that can only go to schools without mask mandates.

The Republican governor also is continuing a program that gives private school vouchers to parents upset that their children’s schools require masks or quarantines after being exposed to COVID-19.

In a letter sent to the US Treasury Department on Thursday, Ducey’s federal grant team manager ignored the department’s demand that he stop using the money. Instead, Jason Mistlebauer said the money was appropriately being used to help students who were harmed by school mask mandates.

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“In Arizona, disadvantaged communities bear the brunt of overbearing measures and the state wants to ensure that low-income students are not disproportionately affected by mask mandates rules and school closures,” Mistlebauer wrote.

Despite the rationale Mistlebauer laid out, a $163 million grant program Ducey created goes to schools in high-income areas, but only if they do not require masks. And a much smaller program that gives private school vouchers to parents whose children’s public schools have mask mandates or require isolation after COVID-19 exposures doesn’t only target low-income children.

ASSOCIATED PRESS

Croatia sets limits as COVID infections reach new highs

ZAGREB, Croatia — Croatian authorities will limit gatherings and widen the use of COVID-19 passes to curb soaring infections after the numbers of infected people hit new records again on Friday.

The country’s crisis team said after a meeting that the new rules for gatherings will apply starting Saturday while the use of COVID passes will take more time to prepare.

Prime Minister Andrej Plenkovic complained that vaccination is going “at snail’s pace” after reaching some 50 percent of the population of 4.2 million.

“That is not normal,” Plenkovic said, according to the state HRT television. “We have had a pandemic for nearly two years, more than 5 million people have died, and we have a situation where some of our citizens still do not realize the danger COVID-19 poses.”

Like much of Central and Eastern Europe, Croatia has seen a huge rise in infections and hospitalizations in the past weeks because of low vaccination rates and relaxed virus rules.

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Most countries in the region have vaccination rates of about 50 percent or less, which is lower than the European Union average of about 75 percent.

ASSOCIATED PRESS

Japan to open borders to vaccinated travelers on business or studying

TOKYO (AP) — Japan announced it will ease border controls beginning Monday for fully vaccinated travelers, excluding tourists, responding to requests from the business community following a rapid decline in infections.

Everyone entering Japan must be fully inoculated with COVID-19 vaccines that are recognized by the Japanese authorities.

Those eligible include travelers on short-term business visits of less than three months, as well as longer-term visitors including foreign students and workers on so-called technical internship programs, with a 14-day quarantine requirement.

Schools and companies sponsoring them are required to submit documents detailing their activities and how they will be monitored.

The 10-day self-isolation for Japanese citizens and foreign nationals with reentry permits will be shortened to three days.

Japan shut its borders to virtually all foreign visitors in January, except for those with special permits and for humanitarian purposes.

Daily cases have sharply fallen since September, in a trend generally attributed to vaccinations and extensive mask-wearing.

About 73 percent of the population have been fully vaccinated.

ASSOCIATED PRESS

Germany sets daily record for new COVID infections

BERLIN — Germany recorded its second consecutive daily record for new coronavirus cases on Friday as infections pickup across Europe, and its disease control center said unvaccinated people now face a “very high” risk of infection.

The country saw 37,120 reported new infections over the past 24 hours, according to the disease control center, the Robert Koch Institute. That compared with Thursday’s figure of 33,949 — which in turn topped the previous record of 33,777 set on Dec. 18 of last year.

While it’s possible that the figures were pushed up by delayed testing and reporting following a regional holiday Monday in some of the worst-affected areas, they underlined a steady rise in infections over recent weeks. Another 154 deaths linked to COVID-19 brought Germany’s total to 96,346 on Friday.

The country’s infection rate has now exceeded its peak during a spike of cases in the spring, though it’s still short of the worst-ever showing in December, according to Friday’s figures. There have been 169.9 reported cases per 100,000 residents over the past seven days, up from 139.2 a week ago.

That’s still a lower rate than in several other European countries, but it is ringing alarm bells. Officials point to a large number of unvaccinated people and to often-lax enforcement of regional rules, which restrict access to some indoor activities and venues to people who have been vaccinated, have recently recovered or been tested.

ASSOCIATED PRESS