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U.K. authorities authorize new criminal charges against Kevin Spacey

Prosecutors in Britain have authorized additional charges against the actor Kevin Spacey, including three counts of sexual assault related to incidents alleged to have taken place between 2001 and 2004.

Rosemary Ainslie, head of the Crown Prosecution Service’s Special Crime Division, said in a news release Wednesday that Spacey faces seven additional charges in total, including one count of “causing a person to engage in sexual activity without consent” and three counts of indecent assault. The CPS statement said the new charges are related to alleged sexual assaults against one man.

Spacey, 63, was already facing a number of sexual assault charges in the United Kingdom. Authorities announced in May that prosecutors had authorized criminal charges against the actor, with counts stemming from alleged incidents involving three men between March 2005 and April 2013. In July, Spacey appeared in a U.K. court, where an attorney for the actor said he “strenuously denies any and all criminality in this case.” A trial has been set for June 6, 2023.

Spacey, an Oscar-winning actor, has seen a profound career downfall since he was first accused of sexual misconduct in 2017. Actor Anthony Rapp told BuzzFeed News that Spacey made a sexual advance toward him at a party when Rapp, now 51, was 14 and Spacey was 26. Following the article’s publication, Spacey said in a social media statement that he was “beyond horrified” by the allegation but did not recall the alleged incident. “If I did behave then as he describes, I owe him the sincerest apology for what would have been deeply inappropriate drunken behavior,” Spacey wrote.

Following the explosive BuzzFeed report, more than a dozen others accused Spacey of sexual misconduct, with some of the alleged incidents prompting legal action. In 2019, he pleaded not guilty to a felony charge of indecent assault and battery after he was accused of groping an 18-year-old man at a Nantucket bar in 2016. The case was later dropped, with prosecutors citing the “unavailability of the complaining witness.” A California massage therapist accused Spacey of sexual assault and battery in 2018, but the case was dismissed after the accuser died ahead of the trial. Rapp sued Spacey in civil court in 2020, accusing the actor of assault, battery and intentional infliction of emotional distress. Last month, a New York jury found Spacey not liable in the $40 million lawsuit.

Spacey’s entertainment projects have significantly dwindled since the barrage of allegations against him. He was fired in 2017 from Netflix’s “House of Cards,” for which he had received 10 Emmy nominations, ahead of the show’s sixth season. In August, a Los Angeles judge ordered the disgraced actor to pay $30 million in compensatory damages and other fees to the producers of the political drama.



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2,000 Philadelphia school district workers vote to authorize strike ahead of school year, union says

32BJ SEIU, the union, voted to strike if it does not have a new contract by August 31, the date its current contract expires, the union said.

The union is asking for higher wages and adequate training programs, calling the conditions under the current contract “unacceptable.”

John Bynum, assistant district leader of the union, said the school district has not trained its teachers to de-escalate serious situations in schools, including active shooter training.

“The Philadelphia School District needs to respect us, protect us, and pay us living wages. Bus drivers, cleaners, and those who kept our schools open during the pandemic were called essential, now it’s time for that to be reflected in a fair contract for Philadelphia School District workers,” said Bynum.

Larisa Shambaugh, chief talent officer for the School District of Philadelphia, said she is hopeful that they can reach a fair contract that “values and supports our employees.”

“We deeply value the work of our staff who are represented by 32BJ SEIU District 1201,” Shambaugh said in a statement. “We continue to actively participate in conversations and negotiations to secure a new contract as soon as possible, without disruption to in-person learning to begin the 2022-2023 school year.”

The employees included under the contract are primarily bus drivers, bus attendants, bus mechanics, building cleaners, building engineers and trades workers.

The workers agreed to pay cuts and mandatory weekly contributions from their pay to help fund the school district budget, keeping children in school and sparing thousands from unemployment due to school closures, according to the union’s press release.

“SEIU 32BJ members have shown their commitment to Philadelphia’s Public Schools through the financial crisis and a global pandemic. They are simply asking for pay and training that honors their commitment to PSD and is in line with other union workers across the City of Philadelphia,” the press release said.

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SEIU 32BJ: Philadelphia school employees vote to authorize strike

PHILADELPHIA (WPVI) — With a little more than a week from school starting in Philadelphia, the school workers union, SEIU 32BJ, has voted to strike.

“Philadelphia School District workers have just voted to strike! Enough is enough! After months of bargaining, the District is meeting the needs of workers for more training and pay that meets what those doing the same jobs in Philly make,” said SEIU 32BJ.

The district’s maintenance, custodial and transportation employees have voted to authorize a strike after a Saturday afternoon meeting.

Union members say their demands for fair pay and more training have not been met.

The current contract expires on August 31.

“We worked through COVID. Everyone considered us a hero. Currently in negotiations and no one remembers that,” said John Bynum, district leader for Local 32BJ of SEIU. “We are just negotiating for a fair contract. I can’t answer for why the district isn’t listening.”

Bynum says an estimated 2,200 workers are represented by the union and under this contract.

The jobs range from bus drivers, mechanics, cleaners, trade workers and attendants.

The lowest-paid position currently makes $14.31 an hour.

“Our scale is totally down across the board. We’re underpaid. In 2012, we gave concessions out of our paycheck when the school district was in financial distress. No one seems to remember that,” said Bynum.

In a news release, union reps said negotiations for new contracts have stalled over fair pay and standardized training programs that workers need to safely do their jobs and keep school students, teachers, and staff safe.

A Philadelphia School District spokesperson provided this statement:

“We deeply value the work of our staff who are represented by 32BJ SEIU District 1201. We continue to actively participate in conversations and negotiations to secure a new contract as soon as possible, without disruption to in-person learning to begin the 2022-2023 school year. Schools are hubs of our community. Last year, we saw firsthand the joy and excitement of our students, families, and staff as they reconnected in person and began to re-engage in the caring school communities they missed so much. Keeping this momentum going is what’s best for our young people. We remain hopeful that we will be able to agree to fair and sustainable terms of a contract that values and supports our employees.”

Copyright © 2022 WPVI-TV. All Rights Reserved.



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Moderna Asks the F.D.A. to Authorize Its Vaccine for Children Under 6

But outside experts said they would be surprised to see the F.D.A. take such a stance. “There is some discretion there, but if you have something, you’ve reviewed it and it’s meeting an unmet medical need, you’re going to want to get it out there when you can,” Dr. Jesse L. Goodman, a former chief scientist for the agency, said.

Dr. Paul Burton, Moderna’s chief medical officer, said in an interview Wednesday that “the data that we have now, that will go in today, should be sufficient for F.D.A. to begin the review.” He said he hoped that the agency would “carefully and appropriately assess the data and not hold it up,” adding: “They’ll do the right thing. They always have.”

Moderna’s clinical trial data showed that the antibody response of the youngest children compared favorably with that of adults ages 18 to 25, meeting the trial’s primary criterion for success. Although the trial was not big enough to measure vaccine effectiveness, Moderna said Thursday the vaccine appeared to be 51 percent effective against symptomatic infection among those younger than 2, and 37 percent effective among those 2 to 5.

Those results were slightly better than the ones Moderna previously released for children under 2. The company said that was because the second time, the firm excluded infections that had not been confirmed with a P.C.R. test analyzed in a laboratory. Dr. Burton said the new results came from a more rigorous analysis, but did not differ significantly from the earlier ones. He said the Omicron variant accounted for about 80 percent of infections in the study group. Side effects were at a similar level as those from previously approved pediatric vaccines, with fevers in 15 percent to 17 percent of the children, Moderna said.

Omicron has scrambled the calculus for evaluating vaccines because it has proved far more adept than previous versions of the virus at evading the vaccines’ shield against infection, although their protection remains strong against severe illness and death. Both Moderna and Pfizer found that compared with earlier trials, their vaccines’ effectiveness against infection plunged in clinical trials for young children, which were carried out largely during the winter Omicron surge. There is no agreed-upon standard for what would constitute a successful Covid vaccine for young children.

Even while it limited the vaccines’ protection, Omicron helped build up the nation’s immunity. As of February, 60 percent of Americans, including 75 percent of children, had been infected with the coronavirus at some point, according to research released this week by the Centers for Disease Control and Prevention. In December 2021, as the Omicron variant began spreading, only half as many people had antibodies indicating prior infection, the agency said.

Dr. Sean O’Leary, an infectious disease specialist at Children’s Hospital Colorado, said the C.D.C.’s findings did not lessen the need to vaccinate young children. “A lot of kids have been infected,” he said, but “there is certainly additional benefit of getting vaccinated.” He added: “I also recognize that it’s a complex situation” for the F.D.A.

The fact that the pandemic is in a relative lull may give the agency a little breathing room. For those 17 and under, the rate of new hospital admissions is one-eighth of what it was in January, when it hit a high. Daily admissions now number fewer than 120 children, out of about 73 million nationwide, according to the C.D.C.

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Covid Live Updates: Moderna Asks F.D.A. to Authorize Second Booster

Credit…Amir Cohen/Reuters

Moderna said late Thursday that it asked the Food and Drug Administration for emergency authorization of a second booster of its coronavirus vaccine for all adults, a significantly broader request than Pfizer and BioNTech filed for their shot this week.

The request is likely to intensify the latest round of an ongoing scientific debate over how long protection from the two most-used vaccines in the United States lasts in the face of new variants.

On Tuesday, Pfizer and its German partner, BioNTech, asked for emergency authorization for a second booster for those 65 and older. The firm’s request was based heavily on data from Israel, where such shots are authorized for a somewhat broader group.

Federal health officials have said they are concerned about waning potency of the booster shot that was authorized for both Moderna and Pfizer in the fall. But although there are indications that regulators could move swiftly on Pfizer’s request, it is unclear how favorably they will view Moderna’s more sweeping application.

Moderna said its request covered all adults so the Centers for Disease Control and Prevention and health care providers could determine the appropriate use of a second booster, including for those at higher risk of Covid-19 disease because of age or underlying medical conditions. About 48 percent of eligible American adults, or 93 million people, have gotten booster shots, according to the C.D.C. More than two-thirds of those 65 or older who are eligible have gotten them.

Moderna said its request was partly based on recent data on how well its vaccine protected against the Omicron variant in the United States and Israel.

Outside scientists are sharply divided over whether another dose is necessary now, and if so, for whom. In an interview on Friday, Dr. Peter J. Hotez, a vaccine expert at the Baylor College of Medicine in Houston, said, “I’m a strong proponent of giving a second booster now.”

He said the first booster shot had “made a huge difference” in bolstering protection against hospitalization and even infection from the Omicron variant.

“It’s also clear that protection is waning now pretty quickly a few months after your third dose,” he said. “So it’s short-lived. The hope is that a second booster would restore it.”

But Dr. Jesse L. Goodman, a former chief scientist for the F.D.A., said: “While protection is waning against mild infections, without more information we do not yet know to what extent, if any, protection is waning against severe disease.” Nor it is clear, he said, “to what degree and for how long another booster might help.”

Among the data the companies cited was a study released last month by the Centers for Disease Control and Prevention that found the effectiveness of Pfizer’s and Moderna’s vaccines against hospitalization dropped from 91 percent two months after a booster shot to 78 percent after four months. The study presented a broad snapshot; it did not break down hospitalizations by age, presence of underlying conditions or other factors.

Noah Weiland contributed reporting.

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Fred Meyer, QFC grocery workers authorize strike

Grocery workers at Fred Meyer and Quality Food Centers stores in Oregon have voted to authorize an unfair labor practices strike, United Food and Commercial Workers Local 555 said Saturday night.

Workers plan to go on strike beginning Friday morning if union leadership and management don’t reach an agreement on key bargaining issues.

“Fred Meyer and QFC have repeatedly violated their legal duties to negotiate in good faith with Local 555, with the most blatant example being Fred Meyer’s refusal to provide information necessary for the union to negotiate a new agreement and to process grievances,” UFCW Local 555 President Dan Clay said in a statement. “The way these employers have violated the National Labor Relations Act has left grocery workers no choice but to take action.”

Miles Eshaia, a spokesperson for the union, said workers voted to walk out after Fred Meyer and QFC stonewalled the union’s attempts to prove that certain workers uniformly are not being paid the hourly wage they’re supposed to be receiving under the current contract. The two sides have been in contract negotiations since July, according to the union.

“Our position is that [the companies] are failing to pay certain departments the correct amount,” Eshaia told The Oregonian/OregonLive Sunday. “They’re not giving us the information to prove it, which they are required to do.”

Kroger, which owns Fred Meyer and QFC, did not respond Sunday to a request for comment.

Last month, when negotiations for a new contract bogged down, Fred Meyer released a statement that said, “The company and union had been making progress and came to a tentative agreement on safety, which has been the union’s stated priority.”

“Our goal, as always, is to reach an agreement that provides a solid compensation package of wages and benefits for our associates while keeping groceries affordable,” Fred Meyer President Dennis Gibson said in the statement.

Eshaia said Sunday that 97% of the union vote backed an unfair labor practices strike. He would not provide specific numbers of votes cast or say how many workers would be involved in the potential strike.

An unfair labor practices strike is different — and often easier to resolve — than the better-known economic strike for concessions such as pay increases or benefits. Workers in an unfair labor practices strike cannot be permanently replaced, according to the National Labor Relations Board.

The union and the companies are scheduled to continue negotiations Tuesday, Wednesday and Thursday.

Eshaia said that grocery-store workers have had to endure difficult conditions throughout the pandemic and said the workers are hoping they will receive public support if they opt to strike.

“We’re hoping shoppers will not cross our line, if it goes up,” he said. “We hope the community will honor our strike. We would appreciate that.”

— Douglas Perry

dperry@oregonian.com

@douglasmperry



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FDA expected to authorize Pfizer booster for all adults this week

The Food and Drug Administration is expected to authorize Pfizer-BioNTech’s Covid-19 booster shot for all adults within days, according to a person familiar with the plans.

The FDA’s action could come as early as Thursday. The news was first reported by The New York Times.

The Centers for Disease Control and Prevention’s vaccine advisory committee is scheduled to meet Friday to discuss boosters.

Pfizer requested emergency use authorization for the booster last week, citing results from a Phase 3 clinical trial with more than 10,000 participants, which found that the third dose was safe and effective.

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Still, with case numbers once again rising in the U.S. as winter approaches, several states, including Arkansas, California, Colorado and New Mexico, along with New York City, chose not to wait for the FDA’s official signoff, moving on their own to allow boosters, including Moderna’s, for all adults in the past week.

Pfizer’s booster shot is authorized for certain subsets of adults in the U.S.: people ages 65 and up, people living in long-term care facilities and people ages 18 to 64 at high risk of Covid because of their jobs or underlying medical conditions. It is given six months after completion of the initial two-dose vaccination series.

All adults who were initially vaccinated with the Johnson & Johnson vaccine are also eligible for booster shots. Moderna has not yet asked the FDA to authorize its booster for all adults; it is limited to older adults and those at high risk.

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Pfizer Asks F.D.A. to Authorize Covid Booster Shots for All Adults

WASHINGTON — Pfizer and BioNTech asked federal regulators Tuesday to authorize their coronavirus booster shot for those 18 and older, a move that would likely make every adult in America eligible for an extra injection.

The Food and Drug Administration is expected to grant the request, perhaps before Thanksgiving and well ahead of Christmas travel and gatherings. The prospect of all 181 million fully vaccinated adults in the nation having access to extra shots is a turnaround from two months ago, when an expert advisory committee to the F.DA. overwhelmingly recommended against Pfizer-BioNTech’s request to authorize boosters for all adult recipients of that vaccine.

At the time, several committee members raised doubts about whether young, healthy people needed boosters. But the Biden administration has been eager to offer extra shots widely since August, when President Biden announced that “the best way to protect ourselves” was for every adult to get a booster.

Mr. Biden initially wanted Americans to start receiving boosters in late September, but the beginning of the campaign was delayed after regulators insisted they needed more time to review safety and efficacy data. Some global public health experts said it would be better to focus on getting initial shots to poorer countries with low vaccination rates than to distribute extra shots here so soon.

If regulators approve Pfizer’s request, President Biden will have made good on his pledge to offer every adult a booster shot — although the choice would be limited to Pfizer’s vaccine for many.

For now, only those 65 and older, and adults who are at special risk because of medical conditions or where they work or live, can get booster injections if they initially got Pfizer-BioNTech or Moderna’s vaccine. The F.D.A. authorized boosters for all Johnson & Johnson recipients because that vaccine offers less protection. People are allowed to chose which of the three vaccines they want for their extra shot.

Nearly 25 million Americans have gotten boosters so far, including people with immune deficiencies who became eligible in August. That amounts to about 14 percent of people who have been fully vaccinated, a number that could rise sharply if all other adults become eligible for a Pfizer-BioNTech booster. While the eligibility categories are quite broad, at least 30 to 40 percent of vaccinated adults are still excluded, according to estimates.

Moderna is expected to soon submit its own request for the F.D.A. to broaden eligibility for its booster. Some experts predict that the agency might authorize broader use of Moderna’s booster but exclude young men, because of concerns about a rare condition linked to the vaccine that appears to affect them disproportionately. The condition, called myocarditis, is an inflammation of the heart muscle.

Some countries in Europe have already authorized booster shots for all adults; Israel is offering them to everyone 12 and up. On Tuesday, Canadian officials authorized a booster dose of the Pfizer-BioNTech vaccine for everyone 18 and older.

In the United States, experts have been fiercely divided over whether booster shots are necessary for the entire population. Many say the vaccines continue to offer robust protection against severe disease and hospitalization, especially for younger people without underlying medical conditions.

There is virtually unanimous agreement that vaccinating the roughly 60 million Americans older than 11 who have yet to receive even their first shot should remain the government’s highest priority.

For younger, healthy people, the benefits of a booster injection will be marginal, according to Dr. Eric Rubin, a member of the F.D.A.’s advisory panel and an adjunct professor of immunology at the Harvard T. H. Chan School of Public Health.

Even so, some leading experts argue that the case for booster shots has grown stronger. Dr. Nahid Bhadelia, director of Boston University Center for Emerging Infectious Diseases Policy and Research, said that “there’s some stronger data” now than there was in September, when the F.D.A. advisory committee rejected Pfizer’s initial request.

She added, “I think that the boosters now seem to look like they may help prevent severe disease for a lot more people than we thought previously.”

Dr. Rubin said he was reassured by the fact that as Israel began vaccinating younger people, “they really weren’t seeing any significant safety signals.”

Earlier this month, Dr. Anthony S. Fauci, the federal government’s top infectious disease expert, said the most recent data from Israel shows that its aggressive booster campaign has limited the rates of severe disease, hospitalization and death there. He called the results “rather dramatic.”

Federal officials have been watching Israel’s experience closely because its vaccination campaign took off quickly and it has a nationalized health system that allows outcomes to be more easily monitored than in the United States.

An Israeli study published in the scientific journal The Lancet in late October compared about 730,000 people who had received a booster dose in August or September with individuals who had received only two doses of the Pfizer-BioNTech vaccine at least five months earlier. The study included recipients 12 and older; the median age was 52.

Compared with the two-dose recipients, the boosted recipients had a 93 percent lower risk of hospitalization, 92 percent lower risk of severe disease and 81 percent lower risk of death, the study found. The boosted recipients were evaluated between one week and nearly two months after their third dose.

Pfizer and BioNTech said their request is based on data from a clinical trial in the United States and elsewhere that included more than 10,000 volunteers. They said the third injection countered the vaccine’s waning potency over time. After the third shot, the vaccine’s efficacy rate against symptomatic disease was up to about 95 percent, they said.

The F.D.A. has the authority to modify Pfizer-BioNTech’s current emergency use authorization and is not expected to reconvene its advisory panel. Dr. Rubin said he was fine with that.

“The FDA got a good sense of what the panel was concerned about, and they’re in a good position to make a judgment themselves now,” he said.

Moderna could follow with a request much like Pfizer’s. But winning authorization may be more complicated because of concerns about rare cases of myocarditis, especially in men under the age of 30 who have received two doses of Moderna’s vaccine. Similar concerns have been raised about the Pfizer-BioNTech vaccine, but to a lesser extent.

If the regulators approve Pfizer’s request, it would to some extent just officially condone what health officials say they already see happening frequently. Many Americans appear to be getting booster shots whether or not they are officially eligible, so holding onto complicated eligibility categories may be futile, some officials said.

“A move of this sort — if it is supported by the data, which I haven’t seen — is a recognition of that reality,” said Dr. Nirav D. Shah, Maine’s top health official and the president of the Association of State and Territorial Health Officials.

“Provided the data shows that the boost is worth it, this is a good move,” he said.

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Indonesia is first country to authorize Novavax Covid-19 vaccine

JAKARTA, Indonesia — Biotechnology company Novavax said Monday that Indonesia has given the world’s first emergency use authorization for its Covid-19 vaccine, which uses a different technology than currently used shots.

The vaccine doesn’t require the extremely cold storage temperatures that some other vaccines need, which could allow it to play an important role in increasing supplies in poorer countries around the world.

The two-dose Novavax vaccine is made with lab-grown copies of the spike protein that coats the coronavirus. That’s very different from widely used mRNA vaccines such as Pfizer and Moderna that deliver genetic instructions for the body to make its own spike protein.

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The emergency authorization of the vaccine is a “very important step” for Indonesia’s Covid-19 vaccination program, Indonesian epidemiologist Dicky Budiman said.

“This vaccine will be much easier to transport, store and distribute in a place like Indonesia, where we have many islands,” he said.

Budiman said if the rollout of the vaccine is successful, it could lead to its approval and use in other developing nations.

The need for more vaccines remains critical in many countries, including Indonesia.

In June, U.S.-based Novavax announced the vaccine had proven about 90 percent effective against symptomatic Covid-19 in a study of nearly 30,000 people in the U.S. and Mexico. It also worked against variants circulating in those countries at the time, it said.

The company said side effects were mild and included tenderness at the injection site, headache, aches and pains and fatigue.

In October, it addressed concerns that production of the vaccine had been slowed due to a lack of raw materials and other issues, saying it planned to “achieve a capacity of 150 million doses per month by the end of the fourth quarter” through partnerships with Serum Institute of India, SK Bioscience in South Korea and Takeda in Japan, among others.

Novavax said it has already filed for authorization of the vaccine in the United Kingdom, European Union, Canada, Australia, India and the Philippines.

Indonesia was battered by a deadly wave of Covid-19 fueled by the delta variant and post-holiday travel from June through August. New cases have now dropped, averaging fewer than 1,000 a day since mid-October.

About 36 percent of people in Indonesia have received two doses of a vaccine, and about 58 percent have received one dose, according to the Ministry of Health.

More than 143,400 people have died from the virus in Indonesia. The number is thought to be an undercount due to low testing and tracing.

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Merck asks FDA to authorize antiviral for emergency use

The Merck logo at the Merck campus in Rahway, New Jersey.

Brendan McDermid | Reuters

Merck said Monday it has asked the Food and Drug Administration to authorize emergency use of its experimental antiviral pill to treat mild to moderate Covid-19 in adults.

The U.S. drugmaker’s request came after phase three clinical trial data released on Oct. 1 showed that the medication – known as molnupiravir – reduced the chances that patients newly diagnosed with Covid would be hospitalized by about 50%.

The drug works by inhibiting the replication of the virus inside the body. Unlike Gilead Sciences’ intravenous drug remdesivir, Merck’s molnupiravir can be taken by mouth. If approved by U.S. regulators, it would be the first pill to treat Covid, a potentially game-changing advancement in the fight against the virus, which is killing an average of more than 1,600 Americans per day.

“The extraordinary impact of this pandemic demands that we move with unprecedented
urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data,” Merck CEO Robert Davis said in a press release.

The pill could be available to Americans by late this year. Merck, which developed the drug with Ridgeback Biotherapeutics, said it is actively working with regulatory agencies worldwide to submit applications for emergency use or authorization “in the coming months.”

The company agreed earlier this year to supply the U.S. with around 1.7 million courses of molnupiravir if it receives emergency use authorization or full approval from the FDA. According to The New York Times, a five-day course of the medication will cost the federal government about $700 per patient, a third of the current cost of monoclonal antibodies.

While vaccinations remain the best form of protection against the virus, U.S. officials and health experts hope a pill like Merck’s will keep the disease from progressing in those who do get infected and prevent trips to the hospital.

Pills like Merck’s are considered a sort of “holy grail” for treatments, Dr. Mike Ryan, executive director of the World Health Organization’s Health Emergencies Program, said at a press conference last week.

Other drugmakers are also working on antiviral pills. One created by Pfizer, which developed the first authorized Covid vaccine in the U.S. with BioNTech, could be available by the end of this year, Pfizer CEO Albert Bourla told CNBC in April.

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