U.S. government to buy $1 billion more worth of Merck’s COVID-19 pill

By Manas Mishra

(Reuters) – The U.S. government will buy another $1 billion worth of the COVID-19 pill made by Merck & Co Inc and partner Ridgeback Biotherapeutics, the companies said on Tuesday.

The government in June agreed to buy 1.7 million courses of molnupiravir for $1.2 billion and is now exercising options to buy 1.4 million more.

That brings the total secured courses to 3.1 million and worth $2.2 billion. Merck said the government has the right to buy 2 million more courses as part of the contract.

The drug has been closely watched since data last month showed that when given early in the illness it could halve the chances of dying or being hospitalized for those most at risk of developing severe COVID-19.

“Molnupiravir, if authorized, will be among the vaccines and medicines available to fight COVID-19 as part of our collective efforts to bring this pandemic to an end,” said Frank Clyburn, president of Merck’s human health business.

President Joe Biden said on Friday that the United States had also secured millions of doses of Pfizer Inc’s rival antiviral drug, which was shown to cut by 89% the chance of hospitalization or death for adults at risk of severe disease.

The Pfizer negotiations were for a deal similar to the one with Merck – 1.7 million courses of the treatment upfront with an additional option for 3.3 million, a senior U.S. health official said on Tuesday, confirming a New York Times report.

Pfizer Chief Executive Officer Alfred Bourla said on Friday that the company plans to sell its treatment for around the same price for high-income countries as Merck, at roughly $700 for a course of therapy.

Merck expects to produce 10 million courses of the treatment by the end of this year, with at least 20 million set to be manufactured in 2022.

(Reporting by Manas Mishra and Leroy Leo in Bengaluru; Additional reporting by Jeff Mason in Washington; Editing by Anil D’Silva, Arun Koyyur and Sriraj Kalluvila)

U.S. Supreme Court wrestles with Puerto Rico’s exclusion from benefits program

By Lawrence Hurley

WASHINGTON (Reuters) – The U.S. Supreme Court on Tuesday tackled the question of whether a decision by Congress five decades ago to exclude Puerto Rico from a federal program that provides benefits to low-income elderly, blind and disabled people was unlawful.

Some of the nine justices posed tough questions during arguments in the case to the lawyer for the U.S. government, which has appealed a lower court ruling that Puerto Rico’s Supplemental Security Income (SSI) program exclusion violated a U.S. Constitution mandate that laws apply equally to everyone.

But it remained unclear whether the Supreme Court, which has a 6-3 conservative majority, ultimately will rule in favor of Puerto Rican resident Jose Luis Vaello-Madero, who received SSI benefits when he lived in New York but lost eligibility when he moved to Puerto Rico in 2013.

Many Puerto Ricans have long complained that the Caribbean island’s residents are treated worse than other Americans despite being U.S. citizens. Puerto Rico, which is not a state, is the most-populous of the U.S. territories, with about 3 million people.

SSI benefits are available to American citizens living in any of the 50 states, Washington, D.C., and the Northern Mariana Islands, but not the territories of Puerto Rico, the U.S. Virgin Islands and Guam.

If Vaello-Madero wins, more than 300,000 Puerto Rico residents could become eligible for the benefit at a cost that the U.S. government has estimated at $2 billion annually.

The Supreme Court has been instrumental in defining the legal status of Puerto Ricans dating to a series of rulings starting more than a century ago called the Insular Cases, some suffused with racist language. The rulings endorsed the notion that the people of newly acquired U.S. territories could receive different treatment than citizens living in U.S. states.

Vaello-Madero’s case gives the justices an opportunity to revisit those rulings. Conservative Justice Neil Gorsuch seemed interested in doing so.

“Why shouldn’t we just admit that the Insular Cases were incorrectly decided?” Gorsuch asked.

Liberal Justice Sonia Sotomayor, whose parents were from Puerto Rico, mentioned the history of Puerto Ricans being treated as second-class U.S. citizens.

“Puerto Ricans are citizens and the Constitution applies to them. Their needy people are being treated different than the needy people in the 50 states,” Sotomayor said.

The federal government’s central argument is that the congressional decision to exclude Puerto Rico was rational based on the fact that Puerto Ricans do not pay many federal taxes, including income tax.

Conservative justices wondered about the repercussions of a ruling favoring Vaello-Madero including whether other benefits would have to be extended to residents of U.S. territories.

Justice Amy Coney Barrett noted that if there was “equal treatment across the board” then questions would be raised over whether Puerto Ricans should pay federal income taxes. Justice Brett Kavanaugh said Vaello-Madero’s lawyer made “compelling policy arguments” but noted that a clause of the Constitution specifically allows Congress to treat territories differently than states.

Kavanaugh said it is a part of the Constitution that “people would want to change” but that it is not the court’s role to do that.

Vaello-Madero is 67 years old and disabled. The government sued him in federal court in Washington in 2017 seeking more than $28,000 for SSI payments he received after moving to Puerto Rico.

Congress decided not to include Puerto Rico when it enacted the program in 1972. Puerto Ricans are eligible for a different government program, called Aid to the Aged, Blind and Disabled, that allows for more local control but not as much federal funding.

The appeal originally was filed by Republican former President Donald Trump’s administration. His Democratic successor Joe Biden has continued the appeal while at the same time urging Congress to extend SSI to Puerto Rico.

A provision extending SSI benefits to Puerto Rico is being considered as part of Democratic-backed social spending legislation being crafted in Congress. Enactment of the provision would limit the importance of the Supreme Court’s eventual ruling, due by the end of June.

(Reporting by Lawrence Hurley; Editing by Will Dunham)

Oklahoma court overturns $465 million opioid award against Johnson & Johnson

By Nate Raymond

(Reuters) – The Oklahoma Supreme Court on Tuesday overturned a $465 million judgment against Johnson & Johnson in a lawsuit by the state alleging the drugmaker fueled the opioid epidemic through the deceptive marketing of painkillers.

The court on a 5-1 vote ruled that the state’s public nuisance law does not extend to the manufacturing, marketing and sales of prescription opioids and that a trial judge went too far in holding that it did.

J&J had no immediate comment. A spokesperson for Oklahoma Attorney General John O’Connor did not immediately respond to a request for comment.

The decision marked the latest setback for states and local governments pursuing lawsuits seeking to hold drug companies responsible for a drug abuse crisis the U.S. government says led to nearly 500,000 opioid overdose deaths over two decades.

The case against J&J by Oklahoma’s attorney general was the first to go to trial nationally of more than 3,000 similar cases against pharmaceutical manufacturers, drug distributors and pharmacies.

A similar trial in California pitting several large counties against J&J and three other drugmakers resulted in a judge on Nov. 1 ruling in the companies’ favor and concluding the epidemic could not be considered a public nuisance.

(Reporting by Nate Raymond in Boston,; Editing by Franklin Paul and Bernadette Baum)

U.S. credit card use returning to pre-pandemic patterns, NY Fed report finds

By Jonnelle Marte

(Reuters) – U.S. consumers are spending more and ramping up credit card balances, reversing a shift during the COVID-19 crisis, when they scaled back spending and substantially paid down debt, a Federal Reserve Bank of New York report showed on Tuesday.

After rising by $17 billion in both the second and third quarters, credit card use appears to be returning to pre-pandemic patterns, the researchers said. However, balances were still $123 billion lower than at the end of 2019, according to the quarterly report on household debt and credit.

“As pandemic relief efforts wind down, we are beginning to see the reversal of some of the credit card balance trends seen during the pandemic, namely reduced consumption and the paying down of balances,” Donghoon Lee, a research officer at the New York Fed, said in a statement. “At the same time, as pandemic restrictions are lifted and consumption normalizes, credit card usage and balances are resuming their pre-pandemic trends, although from lower levels.”

Credit cards typically follow a seasonal pattern, in which balances show “modest” increases in the second and third quarters, followed by a more substantial increase in the fourth quarter, researchers said. Consumers then usually reduce those balances in the first quarter as they pay off holiday spending, the report said.

During the pandemic, however, households supported by direct cash payments and forbearance programs that paused payments on mortgages and student loans largely reduced their credit card debt.

With forbearance programs winding down, some of those consumers may be able to use some of their available credit to make ends meet, the Fed researchers said.

The report also found that total household debt increased by $286 billion in the third quarter to $15.24 trillion, driven mostly by a $230 billion increase in mortgage balances. Total debt balances are now $1.1 trillion above where they were at the end of 2019, the report showed.

Auto debt increased by $28 billion in the third quarter and student loan balances grew by $14 billion.

Originations of new mortgage loans, at $1.1 trillion, and auto loans, at $199 billion, both remained near series highs. Rising car prices contributed to the high volume for new auto loans by leading to a higher origination amount per loan, researchers said. The authors did not do a similar breakdown for mortgages but said rising home prices could be having a similar effect on mortgage debt.

Lenders may be offering more credit to borrowers with lower credit scores after clamping down at the start of the pandemic, the report showed. For example, credit card issuance for lower credit score borrowers is back to pre-pandemic levels after declining at the start of the crisis. The median credit score for new mortgages and auto loans declined slightly in the third quarter, but was still high by historic standards, researchers said.

The findings showed that consumer debt delinquencies remain low, thanks in part to forbearance programs and other federal aid.

(Reporting by Jonnelle Marte; Editing by Andrea Ricci and Dan Grebler)

White House looks to move quickly on $17 billion revamp of U.S. ports

By David Shepardson and Trevor Hunnicutt

WASHINGTON (Reuters) – The White House plans to move quickly on a $17 billion revamp of U.S. ports approved by Congress as part of President Joe Biden’s $1 trillion infrastructure bill.

Biden is due to visit the Port Of Baltimore on Wednesday to tout funding for revamping U.S. ports facing huge backlogs.

The $17 billion will “improve infrastructure at coastal ports, inland ports and waterways, and land ports of entry along the border,” the White House said.

Many U.S. ports have bridge or depth limitations that restrict their ability to receive larger vessels, while a surge of cargo is straining land operations at some ports.

The project aims:

* To identify projects for U.S. Army Corps of Engineers construction at coastal ports and inland waterways within the next 60 days.

* To provide a roadmap for more than $4 billion in funding to repair outdated infrastructure and to deepen harbors for larger cargo ships.

* To prioritize key ports of entry for modernization and expansion within the next 90 days.

* To identify $3.4 billion in investments to upgrade obsolete inspection facilities and allow more efficient international trade through the northern and southern borders.

The Biden administration aims to alleviate congestion at the Port of Savannah by funding a project by the Georgia Port Authority.

That will allow the state to reallocate more than $8 million to convert existing inland facilities into five pop-up container yards in Georgia and North Carolina.

The Port of Savannah will transfer containers further inland so that they can be closer to final destinations, a move that will free more dock space.

(Reporting by David Shepardson and Trevor Hunnicutt; Editing by Howard Goller)

U.S. borders reopen, but not for asylum seekers stuck in Mexico

By Kristina Cooke, Mica Rosenberg and Caitlin O’Hara

NOGALES, Mexico (Reuters) – Leo fled his hometown in southern Mexico after his uncle was murdered by gang members and he received death threats. Earlier this year, he, his wife and their two children headed to the U.S.-Mexico border hoping to claim asylum.

After months of waiting, he hoped he would finally get his chance on Monday. But even as U.S. borders opened for travelers vaccinated against COVID-19, they remained closed to asylum seekers.

When Leo, 23, and his family approached the port of entry in Nogales, Mexico with his and his wife’s vaccination cards in hand, they were told by a border official they could not enter and seek asylum.

“I feel dispirited and sad,” said Leo, who asked his last name not be published for fear of reprisals from the gang he fled. President Joe Biden “is just continuing the same policies of Donald Trump.”

Biden has kept in place a controversial U.S. Centers for Disease Control and Prevention (CDC) order, first implemented by his Republican predecessor Trump in March 2020, that allows migrants to be immediately expelled without an opportunity to seek asylum.

The Biden administration has said the CDC’s order, known as Title 42, remains necessary to prevent the spread of COVID-19, as asylum seekers are processed in crowded settings at the border.

Any foreign national attempting to enter the United States without proper documentation will be subject to expulsion regardless of vaccination status, according to the Department of Homeland Security.

Advocates have criticized the Biden administration’s continuation of the expulsion policy as borders reopen.

The idea that a vaccinated asylum seeker is more of a risk than a vaccinated tourist is laughable, said Noah Gottschalk, global policy lead with Oxfam America, one of the advocacy groups suing the Biden administration to overturn the Title 42 order. Gottschalk said the exclusion of vaccinated asylum seekers strengthens the group’s argument that the policy isn’t about public health.

In September, a federal judge ordered the Biden administration to stop expelling family units – parents or legal guardians arriving with their children – under the Title 42 order. The administration appealed, and a higher court put the judge’s ruling on hold as the case moves forward.

Last month, more than 1,300 medical professionals signed letters to the CDC urging it to end the border expulsions order, saying it lacked epidemiological evidence to justify it and put migrants at risk.

New York-based nonprofit Human Rights First has documented more than 7,600 kidnappings and other attacks on migrants stuck in Mexico who were blocked from entering the United States since Biden took office in January.

Leo has been working in construction to pay rent in Nogales, but he says his earnings are not enough to support his family. “They abuse you because they know you are not from here, they pay you what they want,” he said.

He is also worried about his children getting hit by a stray bullet when gunshots ring out at night. The U.S. State Department recommends Americans reconsider travel to the Mexican state of Sonora, where Nogales is located, due to crime and kidnapping.

“We were fleeing a place that was dangerous,” said Leo. “And here it is the same.”

(Reporting by Kristina Cooke in San Francisco, Mica Rosenberg in New York and Caitlin O’Hara in Nogales, Mexico; Editing by Mary Milliken and Karishma Singh)

Gasoline, auto retailing boost U.S. producer prices

By Lucia Mutikani

WASHINGTON (Reuters) – U.S. producer prices increased solidly in October, driven by surging costs for gasoline and motor vehicle retailing, suggesting that high inflation could persist for a while amid tight global supply chains related to the pandemic.

The Federal Reserve last week restated its belief that current high inflation is “expected to be transitory.” A tightening labor market as millions remain at home is adding to price pressures, which together with shortages of goods sharply restrained economic growth in the third quarter.

The Fed this month started reducing the amount of money it is injecting into the economy through monthly bond purchases.

“The acceleration in inflation may not fade as quickly as previously thought, particularly for businesses because of the global supply-chain issues,” said Ryan Sweet, a senior economist at Moody’s Analytics in West Chester, Pennsylvania. “Elevated inflation is turning up the heat on the Fed but they haven’t shown signs of buckling as they will stomach higher inflation to get the labor market back to full employment quickly.”

The producer price index for final demand rose 0.6% last month after climbing 0.5% in September, the Labor Department said on Tuesday. That reversed the slowing trend in the monthly PPI since spring. In the 12 months through October, the PPI increased 8.6% after a similar gain in September.

Economists polled by Reuters had forecast the PPI advancing 0.6% on a monthly basis and rising 8.7% year-on-year.

More than 60% of the increase in the PPI last month was due to a 1.2% rise in the prices of goods, which followed a 1.3% jump in September. A 6.7% surge in gasoline prices accounted for a third of the rise in goods prices. There were increases in the prices of diesel, gas and jet fuel as well as plastic resins.

Wholesale food prices dipped 0.1% as the cost of beef and veal tumbled 10.3%. Prices for light motor trucks fell as the government introduced new-model-year passenger cars and light motor trucks into the PPI.

Exorbitant motor vehicle prices have accounted for much of the surge in inflation as a global semiconductor shortage linked to the nearly two-year long COVID-19 pandemic has forced manufactures to cut production, leaving virtually no inventory.

Services gained 0.2% last month after a similar rise in September. An 8.9% jump in margins for automobiles and parts retailing accounted for more than 80% of the increase in services. The cost of transportation and warehousing services jumped 1.7%, also reflecting snarled supply chains.

Surveys from the Institute for Supply Management this month showed measures of prices paid by manufacturers and services industries accelerating in October. Manufacturers complained about “record-long raw materials lead times, continued shortages of critical materials, rising commodities prices and difficulties in transporting products.”

Data on Wednesday is expected to showed strong gains in consumer prices in October, according to a Reuters survey of economists. Stocks on Wall Street retreated from record highs. The dollar was steady against a basket of currencies. U.S. Treasury prices rose.

PORT CONGESTION

There is congestion at ports and widespread shortages of workers at docks and warehouses. There were 10.4 million job openings as of the end of August. The workforce is down 3 million from its pre-pandemic level.

Worker shortages were underscored by a report from the NFIB on Tuesday showing almost 50% of small businesses reported job openings they could not fill in October.

Also on Tuesday, Fed Chair Jerome Powell emphasized the U.S. central bank’s commitment to maximum employment, telling a virtual conference on diversity and inclusion in economics, finance and central banking that “an economy is healthier and stronger when as many people as possible are able to work.”

Wholesale prices of apparel, footwear and truck transportation of freight also rose last month as did the costs of food and alcohol retailing, hospital outpatient care as well as machinery, equipment parts and supplies.

Excluding the volatile food, energy and trade services components, producer prices shot up 0.4%. The so-called core PPI gained 0.1% in September. In the 12 months through October, the core PPI rose 6.2%. That followed a 5.9% advance in September.

Construction prices surged 6.6%, the largest gain since the series was incorporated into the PPI data in 2009.

“As companies feel the squeeze from higher energy and labor costs, as well as persistent logistics issues, producer price increases should be robust in the coming months,” said Will Compernolle, a senior economist at FHN Financial in New York.

Details of the PPI components, which feed into the personal consumption expenditures (PCE) price index, excluding the volatile food and energy component, were mixed. The core PCE price index is the Fed’s preferred measure for its flexible 2% target. Healthcare costs increased 0.4%. Airline tickets rebounded 0.3%, but portfolio management fees dropped 2.2%.

Though the October CPI data is still pending, economists believed that the core PCE price index moved higher last month after increasing 3.6% year-on-year in September.

“For now, we think the core PCE price index will be up 3.8% year-on-year in October,” said Daniel Silver, an economist at JPMorgan in New York.

(Reporting by Lucia Mutikani; Editing by Andrea Ricci)

U.S.-Mexico border reopens after 20 months of COVID disruption

By Lizbeth Diaz and Jose Luis Gonzalez

TIJUANA/CIUDAD JUAREZ, Mexico (Reuters) -There were fewer crossings at the Mexico-United States border than expected on Monday as it reopened to non-essential travel following a 20-month closure due to the COVID-19 pandemic, with many residents staying home to avoid potential chaos.

Officials in the Mexican border city of Tijuana said people did not make the most of restrictions being lifted along the 2,000-mile (3,200-km) border lest they get caught in traffic.

“In the morning, there was no line,” Tijuana resident Claudia Hernandez said as she prepared to enter the United States to go shopping ahead of the Thanksgiving holiday next week.

“Next week we’ll see the massive lines that always form.”

Javier Delgado, a Tijuana transport official, said there were was about 35% less traffic than expected on the city’s border with San Diego, one of the busiest in the world.

On Sunday, hundreds of cars had formed lines stretching back kilometers from Tijuana, fueling fears the reopening could become a problem. But traffic advanced steadily.

In the Mexican city of Ciudad Juarez opposite El Paso, Texas, about 20 people lined up early on Monday before crossing and embracing family on the other side of the border.

“We thought they were going to tell us again they had decided not to open it,” said Lorena Hernandez, stroking her grown-up daughter’s hair and smiling broadly after they were reunited in El Paso for the first time since March 2020. “I said: If they don’t reopen, I’m going to take a plane.”

Still, differing rules over coronavirus vaccines threaten to hold up other family reunions, while the prospect of some curbs easing has also encouraged migrants to try their luck seeking U.S. asylum, posing a new test for the Biden administration.

Some inoculated Mexicans will not be able to enter the United States immediately if they received vaccines in Mexico that have not been approved by the World Health Organization, such as China’s CanSino and Russia’s Sputnik V.

“I never imagined that because I got the CanSino vaccine I wouldn’t be able to cross,” lamented Donato Suarez, a driver at a private university in Tijuana who had hoped to visit relatives in the United States he has not seen for nearly two years.

“We even had plans to do something when the border reopened,” he added, noting around 300 people where he works are in the same predicament. “We’ll have to wait.”

(Reporting by Lizbeth Diaz; Editing by Michael Perry and Jonathan Oatis)

Investigators probe Houston concert where 8 fans died, hundreds injured

By Nathan Frandino and Joseph Ax

HOUSTON (Reuters) – Authorities on Monday were investigating the events leading to the deaths of eight people, including two teens, when the audience at rap star Travis Scott’s performance at a Houston-area music festival last week surged toward the stage, crushing or trampling the victims.

Scott, a hometown star who was the headline act at the Astroworld festival, will offer refunds to all attendees, according to a source familiar with his plans. He has canceled a scheduled performance this weekend at Day N Vegas in Las Vegas, a similar outdoor festival, the source said.

The victims were crushed in a chaotic surge of concertgoers near the stage, with some unable to breathe and others trampled underfoot. Hundreds of others were injured during Friday’s performance.

Though he paused the music multiple times after spotting fans who needed medical attention, Scott completed his set. He later released a statement saying he did not realize how out of control events had become in the crowd and was “devastated” by the tragedy.

More than a half dozen lawsuits from victims and their families have already been filed against several defendants, including Scott and concert promoters Live Nation and ScoreMore. Houston-based Buzbee Law Firm scheduled a news conference on Monday to announce a lawsuit on behalf of Axel Acosta, 21, who died at the festival, as well as other victims.

Police have opened a criminal investigation, in part based on reports that someone in the audience may have injected a security guard with drugs.

Officials have also said they intend to examine whether security plans were flawed or followed improperly.

Details about the victims, who ranged in age from 14 to 27, have begun to emerge, as friends and family shared remembrances.

HIGH SCHOOL FRESHMAN

The youngest, John Hilgert, was a freshman at the Houston-area Memorial High School. Over the weekend, members of the community put up green ribbons around campus in honor of Hilgert, whose favorite color was green, according to local television station KHOU.

Hilgert was an avid baseball player, according to posts on social media from those who knew him.

“He wanted to be the best he could be every day, every game, every pitch,” Jordan Venable, the director of a travel baseball club that Hilgert had played for since he was 12, wrote on Facebook, adding that Hilgert had an “unforgettable smile.”

Brianna Rodriguez, 16, was a member of the band at Heights High School in Houston who loved to dance.

“Brianna was someone who performed with the band and was someone who could always make anyone smile,” the band’s Twitter account wrote.

Her family set up an online fundraiser to help pay for funeral expenses.

Two college students originally from Naperville, Illinois – Franco Patino, 21, who attended the University of Dayton, and Jacob Jurinek, 20, who attended Southern Illinois University – also died at the concert, according to their schools.

Patino, a mechanical engineering technology major, was a member of several campus organizations, including Alpha Psi Lambda, a Hispanic interest fraternity and the Society of Hispanic Professional Engineers.

“Jacob was a creative, intelligent young man, with a promising career in journalism and advertising,” Austin Lane, the chancellor at Southern Illinois, said in a statement confirming Jurinek’s death.

(Reporting by Erwin Seba and Joseph Ax; Additional reporting by Barbara Goldberg, Nathan Frandino, Brendan O’Brien, Daniel Trotta, Shivam Patel and Tim Reid; Editing by Steve Orlofsky)

Analysis – COVID-19 pills are coming, but no substitute for vaccines, disease experts say

By Julie Steenhuysen

CHICAGO (Reuters) – Oral antiviral pills from Merck & Co and Pfizer Inc/BioNTech SE have been shown to significantly blunt the worst outcomes of COVID-19 if taken early enough, but doctors warn vaccine hesitant people not to confuse the benefit of the treatments with prevention afforded by vaccines.

While 72% of American adults have gotten a first shot of the vaccine, according to a Kaiser Family Foundation poll, the pace of vaccination has slowed, as political partisanship in the United States divides views on the value and safety of vaccines against the coronavirus.

Vaccine mandates by employers, states and the administration of U.S. President Joe Biden have helped increase vaccinations but also fueled that controversy.

Some disease experts fear the arrival of oral COVID-19 treatments may further impede vaccination campaigns. Preliminary results of a survey of 3,000 U.S. citizens by the City University of New York (CUNY) School of Public Health suggest the drugs could “hamper the effort to get people vaccinated,” said Scott Ratzan, an expert in health communication at CUNY, who led the research.

Ratzan said one out of every eight of those surveyed said they would rather get treated with a pill than be vaccinated. “That is a high number,” Ratzan said.

The concern follows news on Friday from Pfizer, maker of a leading COVID-19 vaccine, that its experimental antiviral pill Paxlovid cut the risk of hospitalization and death from the disease by 89% in high-risk adults.

Pfizer’s results followed news from Merck and partner Ridgeback Biotherapeutics on Oct. 1 that their oral antiviral drug cut hospitalization and death by half. That drug, known as molnupiravir, won conditional approval in the UK on Thursday. Both need clearance from U.S. health regulators but could be on the market in December.

“By relying exclusively on an antiviral drug, it’s a bit of a roll of the dice in terms of how you will do. Clearly, it’s going to be better than nothing, but it’s a high-stakes game to play,” said Dr. Peter Hotez, a vaccine expert and professor of molecular virology and microbiology at Baylor College of Medicine.

Six infectious disease experts interviewed by Reuters were equally enthusiastic about the prospect of effective new treatments for COVID-19 and agreed they were no substitute for vaccines.

Even in the face of the highly transmissible Delta variant of the virus, the vaccines from Pfizer/BioNTech remain effective, cutting the risk of hospitalization by a combined 86.8%, according to a government study of U.S. veterans.

They said some unvaccinated people have already relied on monoclonal antibodies – drugs that need to be delivered through intravenous IV infusions or injections – as a backstop in case they become infected. “I think the Pfizer news is terrific news. It goes hand in hand with vaccination. It doesn’t replace it,” said Dr. Leana Wen, an emergency physician and public health professor at George Washington University and Baltimore’s former health commissioner.

Choosing not to get vaccinated “would be a tragic mistake,” said Albert Bourla, chief executive officer of Pfizer Inc. “These are treatments. This is for the unfortunate who will get sick,” Bourla told Reuters in an interview on Friday. “This should not be a reason not to protect yourself and to put yourself, your household and society in danger.”

ANTIVIRAL CHALLENGES

One main reason not to rely on the new pills, the experts said, is that antiviral medications, which stop the virus from replicating in the body, must be given in a narrow window early in the disease because COVID-19 has different phases.

In the first phase, the virus rapidly replicates in the body. A lot of the worst effects of COVID-19, however, occur in the second phase, arising from a defective immune response that gets triggered by the replicating virus, said Dr. Celine Gounder, an infectious disease expert and the CEO and founder of Just Human Productions, a non-profit multimedia organization.

“Once you develop shortness of breath or other symptoms that would lead you to be hospitalized, you are in that dysfunctional immune phase where the antivirals are really not going to provide much benefit,” she said. Hotez agreed. He said getting treated early enough could be challenging because the window when the virus transitions from the replication phase to the inflammatory phase is fluid. “For some people, that will happen earlier; for some, later,” Hotez said. Hotez said many people in the early phase of the illness feel surprisingly well and may be unaware that their oxygen levels are dropping, one of the first signs that the inflammatory phase of the disease has started. “Oftentimes, you’re not going to realize that you’re getting sick until it’s too late,” he said.

(Reporting by Julie Steenhuysen; Additional reporting by Josephine Mason in London, Deena Beasley in Los Angeles and Manojna Maddipatla in Bengaluru; editing by Caroline Humer and Grant McCool)