Pfizer says earliest COVID-19 vaccine application to U.S. regulators would be after election

By Manas Mishra and Michael Erman

(Reuters) – Pfizer Inc said on Friday it may file for U.S. authorization of the COVID-19 vaccine it is developing with German partner BioNTech in late November, making it unlikely a vaccine will be available before the U.S. election as President Donald Trump has promised.

Pfizer said that it may say if the vaccine is effective as soon as this month based on its 40,000 person clinical trial but that it also needs safety data that will not be available until November at the earliest.

The Pfizer news, published in a letter from its chief executive on its website, lifted the U.S. stock market and the company’s shares. Shares were up slightly in rival vaccine maker Moderna Inc, which is close to Pfizer in its vaccine development.

“So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the U.S. soon after the safety milestone is achieved in the third week of November,” Pfizer Chief Executive Albert Bourla said.

Trump has said repeatedly that there would be a vaccine available before the election, but health officials and companies had only said that data might be available this month. The possibility of further delays was raised after trials for two rival vaccines were put on hold in the United States this fall.

The president’s rush to a vaccine has also raised concerns that the U.S. Food and Drug Administration, acting in haste, might not conduct an adequate review of the vaccine.

U.S. health officials have sought to assuage those concerns out of fear that not enough Americans would take a vaccine early on. Earlier this month, the FDA formalized a requirement that the vaccine makers collect two months of safety data on one-half of trial participants.

Pfizer’s comments on its time line raise the possibility of U.S. authorization of a coronavirus vaccine this year, a key step in controlling the COVID-19 pandemic, which has killed more than a million people and ravaged the global economy.

Moderna could also apply for an emergency use authorization (EUA) this year. It has said that it may have interim data on its 30,000 person trial as soon as November.

Both companies are also applying for approval in Europe, where they are racing against AstraZeneca PLC. AstraZeneca’s U.S. trial has been on hold since September.

After the FDA announced the two-month requirement on Oct. 6, which was approved by the White House but undercut the likelihood of a vaccine before voters go to polls on Nov. 3., Trump called the move a ‘political hit job.’

In addition to safety and efficacy, the FDA will also examine Pfizer’s manufacturing operations for the vaccine.

Bourla said the filing depended on several other factors, including initial data on effectiveness that may or may not be available by late October.

He said the company plans to share efficacy data with the public as soon as practical. (https://bit.ly/31bWdpP)

A BioNTech spokeswoman confirmed the time frame for the possible EUA application to the FDA.

Pfizer’s shares rose 2.1% in premarket trading, while BioNTech’s U.S-listed shares were up 4% before the opening bell. Moderna was unchanged and U.S. futures were higher.

(Reporting by Manas Mishra, Manojna Maddipatla in Bengaluru and Michael Erman in New Jersey, Patricia Weiss in Frankfurt; writing by Caroline Humer in New York; Editing by Patrick Graham, Saumyadeb Chakrabarty and Steve Orlofsky)

Life upended for Americans as U.S. scrambles to contain coronavirus threat

By Jonathan Allen and Steve Holland

NEW YORK/WASHINGTON (Reuters) – From Disneyland to the U.S. Supreme Court, from Wall Street to Dodgers Stadium, nearly every facet of American life fell into turmoil on Thursday as the coronavirus outbreak caused sweeping closures and economic disruption.

As concern grew over a rapid spread of the sometimes-fatal COVID-19 respiratory illness caused by the virus, the U.S. stock market cratered anew, professional and college sports leagues suspended play, Broadway theaters went dark and many schools from Ohio to Texas shuttered.

The unprecedented cascade of shutdowns reflected growing fears that the outbreak of the highly contagious pathogen, which has already killed at least 40 people in the United States, could race out of control unless authorities squelch large public gatherings.

As companies locked their offices and sent employees to work from home, fears of a recession rose in step with the number of U.S. infections, which jumped to more than 1,300 on Thursday. The concerns were reflected in U.S. stock markets, with major indexes now in bear-market territory – down at least 20% from their recent high.

New York City Mayor Bill de Blasio declared a state of emergency, granting him new powers as the number of confirmed cases rose to 95 in the nation’s most populous city.

“We are getting into a situation where the only analogy is war and a wartime dynamic,” de Blasio said, referring to an expected surge in demand for hospital beds.

From California to New York, officials banned large gatherings and closed museums and other institutions without saying how long the directives would stay in place, compounding the uncertainty.

After the Trump administration imposed sweeping restrictions on air travel between the United States and Europe, Gabriella Ribeiro, a Wayne, New Jersey-based travel consultant, said she was fielding a flood of panicked calls from customers.

“We call it the ‘C’ word,” Ribeiro said of coronavirus. “We’ve been through Ebola and SARS, but I haven’t seen this level of panic among travelers since 9/11.”

CANCELED: MARCH MADNESS AND BASEBALL

With cancellations hitting everything from Little League baseball to school fairs, the rituals of American life started to grind to a halt.

The NCAA canceled its annual “March Madness” college basketball tournament. Professional hockey and basketball seasons were halted indefinitely. Major League Baseball ended spring training and suspended the first two weeks of the season.

“Opening day is religion around here,” said Frank Buscemi, a self-described sports junkie and Detroit Tigers baseball fan. “It makes sense, and you’ve got to err on the side of caution – we get that. It doesn’t make it any easier and it doesn’t make it any more fun.”

Officials in hard-hit areas, including New York and Washington states, sought to balance the need to protect the public without crippling economic activity.

New York state banned gatherings of more than 500 people beginning on Friday, Governor Andrew Cuomo told reporters. California placed the cap at gatherings of 250 people.

Hollywood postponed the release of several movies and theaters around the world closed over the health crisis.

The Walt Disney Company shuttered their large U.S. properties, including Disneyland in California and Disney World in Florida.

In Washington, D.C., officials closed the U.S. Capitol complex to the public after a staffer for a senator from Washington state tested positive for the coronavirus. [L1N2B50S4] The Supreme Court closed to the public indefinitely, and the Kennedy Center canceled all performances.

Oscar-winning actor Tom Hanks and at least one player in the National Basketball Association announced that they had tested positive for the coronavirus.

“WE’RE NOT SET UP”

The patchwork of state and local directives to stem the tide of infections came as U.S. health officials struggled to expand the country’s limited testing capacity.

“The system is not really geared to what we need right now,” Anthony Fauci, the top U.S. official on infectious diseases, said at a congressional hearing. “The idea of anybody getting it (testing) easily the way people in other countries are doing it, we’re not set up for that.”

Two U.S. senators, Rick Scott and Lindsey Graham, opted for self-quarantine after interacting with a delegation led by Brazilian President Jair Bolsonaro in Florida. One of Bolsonaro’s team has tested positive for the virus.

President Donald Trump and Vice President Mike Pence also met the Brazilian delegation, but White House spokeswoman Stephanie Grisham said both of them had “almost no interactions with the individual who tested positive and do not require being tested at this time.”

Republicans initially balked at a sweeping coronavirus economic aid package crafted by Democrats in the House of Representatives. After a day-long negotiating session, House Speaker Nancy Pelosi said late Thursday that they were close to a deal with the administration.

The Senate canceled a scheduled recess and will return next week to work on legislation.

The Trump administration spelled out details of new rules on U.S. citizens and permanent residents’ returning from Europe under restrictions that ban most Europeans from entering the United States.

“Americans coming home will be funneled through 13 different airports, they’ll be screened, and then we’re going to ask every single American and legal resident returning to the United States to self-quarantine for 14 days,” Pence said.

Trump defended his decision, which goes into effect at midnight on Friday and lasts for 30 days. He said the ban could be lengthened or shortened.

The restrictions will heap pressure on airlines already reeling from the pandemic, hitting European carriers the hardest, analysts said.

American Airlines Inc <AAL.O> and Delta Air Lines Inc <DAL.N> said they were capping fares for U.S.-bound flights from Europe amid reports of exorbitant pricing as U.S. citizens flocked to European airports trying to return home.

(Reporting by Jonathan Allen and Steve Holland; Additional reporting by Susan Heavey, Lisa Lambert, Patricia Zengerle, David Morgan and Richard Cowan in Washington and Maria Caspani, Michael Erman and Dan Burns in New York, Steve Gorman in Culver City, California; Writing by Ginger Gibson and Paul Simao; Editing by Sonya Hepinstall, Cynthia Osterman, Leslie Adler and Daniel Wallis)

U.S. Stocks plunge in highly volatile trading: S&P 500 erases 2018’s gains

A trader watches his screens on the floor of the New York Stock Exchange in New York, U.S., February 5, 2018.

By Lewis Krauskopf

(Reuters) – U.S. stocks plunged in highly volatile trading on Monday, with the Dow industrials falling nearly 1,600 points during the session, its biggest intraday decline in history, as investors grappled with rising bond yields and potentially firming inflation.

The benchmark S&P 500 and the Dow suffered their biggest percentage drops since August 2011 as a long-awaited pullback from record highs deepened.

The financial, healthcare and industrial sectors fell the most, but declines were spread broadly as all major 11 S&P groups dropped at least 1.7 percent. All 30 of the blue-chip Dow industrial components finished negative.

With Monday’s declines, the S&P 500 erased its gains for 2018 and is now down 0.9 percent in 2018.

Many investors have been bracing for a pullback for months, as the stock market has minted record high after record high with investors encouraged by solid economic data and corporate earnings prospects, the latter bolstered by recently passed U.S. corporate tax cuts.

Friday’s January jobs report sparked worries over inflation and a surge in bond yields, as well as concerns that the Federal Reserve will raise rates at a faster pace than expected.

“The market has had an incredible run,” said Michael O’Rourke, chief market strategist At JonesTrading In Greenwich, Connecticut.

“We have an environment where interest rates are rising. We have a stronger economy so the Fed should continue to tighten … You’re seeing real changes occur and different investments are adjusting to that,” O’Rourke said.

The Dow Jones Industrial Average fell 1,175.21 points, or 4.6 percent, to 24,345.75, the S&P 500 lost 113.19 points, or 4.10 percent, to 2,648.94 and the Nasdaq Composite dropped 273.42 points, or 3.78 percent, to 6,967.53.

The S&P 500 ended 7.8 percent down from its record high on Jan. 26, with the Dow down 8.5 percent over that time.

Even with the sharp declines, stocks finished above their lows touched during the session. At one point, the Dow fell 6.3 percent or 1,597 points, the biggest one-day points loss ever, as it breached both the 25,000 and 24,000 levels during trading.

The stock market has climbed to record peaks since President Donald Trump’s election and remains up 23.8 percent since his victory. Trump has frequently touted the rise of the stock market during his presidency.

As the stock market fell on Monday, the White House said the fundamentals of the U.S. economy are strong.

The CBOE Volatility index, the closely followed measure of expected near-term stock market volatility, jumped 20 points to 30.71, its highest level since August 2015.

Until recently, gains for stocks have come as the market has been relatively subdued, and any declines were met with buyers looking for bargains.

“People who have been buying the dip are now going to be selling the rip,” said Dennis Dick, a proprietary trader at Bright Trading LLC in Las Vegas. “The psychology of the market changed today. It’ll take a while to get that psychology back.”

About 11.5 billion shares changed hands in U.S. exchanges, well above the 7.6 billion daily average over the last 20 sessions.

Declining issues outnumbered advancing ones on the NYSE by a 8.64-to-1 ratio; on Nasdaq, a 6.92-to-1 ratio favored decliners.

The S&P 500 posted 1 new 52-week highs and 38 new lows; the Nasdaq Composite recorded 17 new highs and 164 new lows. 37.32

(Additional reporting by Megan Davies, Sinead Carew, Caroline Valetkevitch and Chuck Mikolajczak in New York, Noel Randewich in San Francisco and Tanya Agrawal in Bengaluru; Editing by Arun Koyyur and Nick Zieminski)

World stock markets and U.S. dollar retreat before key Trump speech

Men walk past an electronic board showing Japan's Nikkei average outside a brokerage in Tokyo, Japan,

By Sinead Carew

NEW YORK (Reuters) – World stock markets and the U.S. dollar fell on Monday while U.S. Treasury yields rose amid investor caution ahead of a key speech by U.S. President Donald Trump.

The dollar fell ahead of Trump’s State of the Union address, during which he is expected to unveil details on pro-growth policies including infrastructure spending.

“There is setting up for what people expect might be at least a focus on things like fiscal stimulus and infrastructure spending of some kind, that might actually boost risk and cause yields to rise,” said Aaron Kohli, an interest rate strategist at BMO Capital Markets in New York.

U.S. 10-year Treasury notes were last down 7/32 in price to yield 2.342 percent, from a yield of 2.317 percent late Friday. Two-year notes US2YT=RR were last down 1/32 in price to yield 1.169 percent, from a yield of 1.145 percent late Friday.

The dollar was down 0.3 percent against a basket of major currencies after Trump said Monday that tax reform details would not be revealed until after the administration’s proposal on health care.

Investors had hoped for “more clarity around tax reform sooner rather than later” said Bipan Rai, senior macroeconomic strategist at CIBC Capital Markets in Toronto.

At 11:25 a.m. ET, the Dow Jones Industrial Average was down 5.62 points, or 0.03 percent, at 20,816.14, the S&P 500 shed 0.2 points, or 0.01 percent, to 2,367.14, while the Nasdaq Composite added 1.63 points, or 0.03 percent, to 5,846.93.

Europe’s benchmark index of leading 300 shares fell 0.1 percent.

MSCI’s benchmark world stock index slipped 0.03 percent after it hit a record high Thursday.

A proposed 29 billion euro merger between the London Stock Exchange and Deutsche Boerse to create Europe’s biggest stock exchange looked dead in the water due to an inability to meet European antitrust demands. Shares in both companies fell. The London Stock Exchange fell as much as 3 percent while Deutsche Boerse fell as much as 4 percent.

“The regulatory hurdles were always a risk, and with Brexit, there are additional hurdles to clear that seem close to insurmountable now,” said Neil Wilson, senior market analyst at ETX Capital.

MSCI’s broadest index of Asia-Pacific shares outside Japan fell 0.24 percent, while Japan’s Nikkei fell 0.9 percent for its lowest close since Feb. 9 on concerns that a stronger yen would crimp corporate earnings.

The Dow Jones Industrial Average scaled its 11th consecutive record high on Friday, the longest such run since 1987, leading some to suggest it could be prone for a correction.

In Europe, the focus was on France, where the latest polls showed that centrist Emmanuel Macron would score a more convincing victory over far-right and anti-euro Marine Le Pen in the presidential election’s runoff vote.

France’s 10-year bond yield fell to a one-month low of 0.88 percent.

In commodities, Brent crude was up 0.3 percent at $56.14 per barrel while U.S. West Texas Intermediate was up 0.4 percent at $54.20 per barrel as a global supply glut appeared to ease.

(Additional Reporting by Jamie McGeever and Dhara Ranasinghe; Editing by Bernadette Baum)

Rising gasoline, rents push U.S. inflation higher in September

A Shell gas station is shown in Encinitas, California

By Lucia Mutikani

WASHINGTON (Reuters) – U.S. consumer prices recorded their biggest gain in five months in September as the cost of gasoline and rents surged, pointing to a steady pickup of inflation that could keep the Federal Reserve on track to raise interest rates in December.

The Labor Department said on Tuesday its Consumer Price Index increased 0.3 percent last month after rising 0.2 percent in August. In the 12 months through September, the CPI accelerated 1.5 percent, the biggest year-on-year increase since October 2014. The CPI rose 1.1 percent in the year to August.

“The upward creep of prices weakens any argument against a rate increase in December,” said Anthony Karydakis, chief economic strategist at Miller Tabak in New York. “The economy is close to full employment and prices are starting to respond to that reality.”

Last month’s increase in the CPI was in line with economists’ expectations. However, underlying inflation moderated amid a slowdown in the pace of increases in healthcare costs after recent robust gains.

The so-called core CPI, which strips out food and energy costs, gained 0.1 percent last month after climbing 0.3 percent in August. That slowed the year-on-year increase in the core CPI to 2.2 percent following a 2.3 percent rise in August.

But with rents, which account for a larger share of the core CPI, recording their biggest increase in nearly 10 years, and wages pushing higher, economists cautioned against putting too much emphasis on last month’s weak reading.

The U.S. central bank has a 2 percent inflation target and tracks an inflation measure which is at 1.7 percent. Fed Vice Chair Stanley Fischer said on Monday that the U.S. central bank was “very close” to its inflation and employment targets.

“As inflation approaches 2 percent, the argument that the economy has more room to run becomes harder to make and we believe the Fed remains on track for a rate hike in December,” said John Ryding, chief economist at RDQ Economics in New York.

The Fed lifted its short-term interest rate last December and has held it steady since because of persistently low inflation.

The dollar was little changed against a basket of currencies, while prices for longer-dated U.S. Treasuries rose slightly. U.S. stocks rallied, cheered by better-than-expected quarterly earnings from UnitedHealth, Netflix and Goldman Sachs.

FIRMING DEMAND

While the jump in overall inflation was also the result of last year’s lower energy prices dropping out of the calculation, it suggested firming domestic demand.

A 5.8 percent jump in gasoline prices accounted for more than half of the increase in the CPI last month. Americans also paid more for electricity, with prices posting their biggest gain since December 2014.

The price increases are bad news for retirees, with social security recipients only due to get a 0.3 percent cost of living adjustment increase next year. Households, however, got some relief from food prices in September, which were unchanged for a third straight month. The cost of food consumed at home declined for a fifth straight month.

Within the core CPI basket, housing costs rose further in September. Owners’ equivalent rent of primary residence increased 0.4 percent, the largest gain since October 2006, after rising 0.3 percent in August. Rents tend to be sticky and should keep core inflation supported.

Medical care costs rose 0.2 percent last month, the smallest increase since March, after surging 1.0 percent in August. The cost of hospital services was unchanged, while prices for prescription medicine rose 0.8 percent.

The government revised prices for prescription drugs from May through August this year as incorrect data had been used to calculate price changes. Prescription medicine accounts for about 1.4 percent of the CPI basket.

Consumers also paid more for grooming, motor vehicle insurance, tobacco and airline fares. However, prices for communication recorded their largest decline in two years, while heavy discounting by retailers pushed apparel prices down 0.7 percent. Prices for motor vehicles also fell.

“Inflation is moving up, showing this is not an economy that is undergoing serious demand-based weakness,” said Chris Rupkey, chief economist at MUFG Union Bank in New York.

(Reporting by Lucia Mutikani; Editing by Andrea Ricci)