Tag Archives: COVID-19 vaccine

Pfizer, U.S. strike 100 million COVID-19 vaccine deal with 70 million due by June

By Ankur Banerjee and Vishwadha Chander

(Reuters) – The U.S. government will pay Pfizer Inc nearly $2 billion for 100 million additional doses of its COVID-19 vaccine to bolster its supply as the country grapples with a nationwide spike in infections.

Under the new agreement, Pfizer will deliver at least 70 million doses by June 30 and the rest no later than July 31, the company said on Wednesday, bringing the total number of doses to 200 million for a total price of about $4 billion.

The purchase price amounts to $19.50 per shot and is slightly higher than the $18.90 per dose that Reuters has reported the European Union has agreed to pay. The shot has been authorized for use in EU and the United States.

The U.S. deal comes after growing concern that the government had not done enough to secure doses of one of the two authorized vaccines, made more pressing amid a COVID-19 surge that has left hospitals struggling to find beds for the sick.

Pfizer’s two-dose vaccine, developed with German partner BioNTech, is being rolled out across the United States after the shot won emergency use authorization earlier this month. The country has also authorized a vaccine from Moderna Inc.

Pfizer and the government have said that they had been negotiating the terms of the agreement, with the company indicating it was trying to work out how to deliver the doses in the second quarter.

Pfizer and BioNTech have said they expect to produce 1.3 billion doses in 2021, but executives at the German biotech have said they were trying to boost manufacturing. Governments around the world are scrambling to get enough supplies of the vaccine to tame the pandemic that has killed about 1.7 million people globally and crushed economies.

“This new federal purchase can give Americans even more confidence that we will have enough supply to vaccinate every American who wants it by June 2021,” U.S. Department of Health and Human Services Secretary Alex Azar said in a statement.

“Securing more doses from Pfizer and BioNTech for delivery in the second quarter of 2021 further expands our supply of doses across the Operation Warp Speed portfolio.”

Pfizer said last week it may need the U.S. government to help it secure some components needed to make the vaccine. While the company halved its 2020 production target due to manufacturing issues, it said last week its manufacturing is running smoothly now.

The government also has the option to acquire up to an additional 400 million doses of the vaccine.

More than 600,000 Americans have received their first COVID-19 vaccine doses as of Monday, according to the Centers for Disease Control and Prevention (CDC).

The first wave of shots have so far gone to healthcare workers and nursing home residents, as well as some top government officials. Americans in “essential” jobs and those over 75 will likely start to receive vaccines in January while general population vaccinations will start in a few months.

(Reporting by Ankur Banerjee and Vishwadha Chander in Bengaluru; Editing by Caroline Humer and Sriraj Kalluvila)

Storm may help U.S. Northeast contain coronavirus but could disrupt vaccine delivery

By Peter Szekely

NEW YORK (Reuters) – A winter storm that has blasted the U.S. Northeast with snow, rain and gusty winds was likely to dump a foot or more of snow on parts of New England before heading out to sea on Thursday.

The first major snowstorm of the season forced much of the population to obey stay-at-home coronavirus orders, but also disrupted travel, possibly including distribution of the new COVID-19 vaccine.

By early Thursday morning, the storm had dumped more snow on New York City than all of last year’s winter storms combined, the National Weather Service said.

It also brought its wintry mix to Washington, parts of Maryland, Virginia, West Virginia and Pennsylvania on Wednesday, affecting an area home to more than 50 million people.

Forecasts showed it would pummel Boston and parts of the New England region before heading out to sea around nightfall.

Before then, many areas could expect 12 to 18 inches of snow.

Wind gusts of up to 50 miles per hour were likely to knock down trees and power lines, the National Weather Service said.

Roads were treacherous. A pileup of 30 to 60 cars on Interstate-80 in Pennsylvania on Wednesday killed two people and injured more, state police said.

At the same time, trucks were delivering the first batches of the COVID-19 vaccine. Healthcare workers around the country started receiving the first inoculations this week.

“We are also watching very carefully the delivery of the vaccine,” New Jersey Governor Phil Murphy told a news conference on Wednesday, noting that some 35 hospitals in his state were expecting deliveries between Wednesday and Friday. “If we didn’t have enough already on our hands, that’s another dimension.”

The New York area’s three major airports reported 20% to 30% of flights were canceled on Wednesday and more cancellations were expected. Amtrak reduced rail service.

New Jersey Transit on Thursday extended its suspension of all rail service, in addition to halting several bus lines including those destined for New York City.

(Reporting by Peter Szekely in New York; Additional reporting by Timothy Garnder in Washington and Brendan O’Brien in Chicago; Writing by Daniel Trotta; Editing by Frances Kerry)

Vaccinations under way, U.S. turns to educating skeptics, economic aid

(Reuters) – The United States extended its rollout of the first authorized COVID-19 vaccine on Tuesday, inoculating healthcare workers with an eye toward convincing skeptical Americans to get their shots and contain a pandemic that has killed more than 300,000 people.

The first Americans outside clinical trials started receiving the vaccine developed by Pfizer Inc and German partner BioNTech SE on Monday, three days after it won U.S. emergency-use authorization.

By day’s end, vaccine shipments had made it to nearly all of the 145 U.S. distribution sites pre-selected to receive the initial batch of doses, with a number of major hospital systems launching immunizations immediately.

The Pfizer vaccine requires two doses three weeks apart, as does the Moderna vaccine that could also receive emergency-use authorization this week.

In one of many made-for-TV injections, New York City intensive care nurse Sandra Lindsay received the first shot in the arm, saying “healing is coming” and that, “I want to instill public confidence that the vaccine is safe.”

But just as large numbers of Americans have called the pandemic a hoax and rejected public health guidelines to wear face masks and avoid crowds, only 61% of respondents in a recent Reuters/Ipsos poll said they were open to getting vaccinated.

“The communication of public health is the No. 1 issue,” Dr. Rob Davidson, an emergency room physician in Michigan and director of the Committee to Protect Medicare, told MSNBC television on Tuesday.

“We’re really hopeful in this next phase that we can all come together with one voice to convince people this is important,” Davidson said.

COVID-19 has killed 301,085 people in the United States and infected 16.5 million, overwhelming the healthcare system with a record 110,163 patients hospitalized as of Monday, according to a Reuters tally of official data.

The pandemic has also inflicted economic pain as states and localities imposed stay-at-home orders and closed businesses, putting millions out of work.

The U.S. Congress on Monday inched toward passing the first COVID-19 relief bill since April, possibly extending aid to the unemployed, small businesses, and vaccine distribution. The COVID-19 aid could be attached to a critical spending measure that must be passed by Friday to avoid a federal government shutdown.

The process of shipping the first 2.9 million doses of vaccine began on Sunday, 11 months after the United States documented its first case of COVID-19.

Moncef Slaoui, top adviser to the U.S. government’s Operation Warp Speed vaccine program, has said the plan is to have about 40 million vaccine doses from Pfizer and Moderna – enough for 20 million people – distributed by year’s end.

It will take months before vaccines become widely available to the public at large.

“This is the most difficult vaccine rollout in history,” U.S. Surgeon General Jerome Adams told Fox News on Monday.

(Reporting by Reuters staff; Editing by Giles Elgood)

New York nurse given COVID-19 vaccine as U.S. rollout begins

By Jonathan Allen and Gabriella Borter

NEW YORK (Reuters) -An intensive care unit nurse became the first person in New York state to receive the Pfizer/BioNTech COVID-19 vaccine on Monday, marking a pivotal turn in the U.S. effort to control the deadly virus.

Sandra Lindsay, who has treated some of the sickest COVID-19 patients for months, was given the vaccine at Long Island Jewish Medical Center in the New York City borough of Queens, an early epicenter of the country’s COVID-19 outbreak, receiving applause on a livestream with New York Governor Andrew Cuomo.

“It didn’t feel any different from taking any other vaccine,” Lindsay said. “I feel hopeful today, relieved. I feel like healing is coming. I hope this marks the beginning of the end of a very painful time in our history. I want to instill public confidence that the vaccine is safe.”

Minutes after Lindsay received the injection, President Donald Trump sent a tweet: “First Vaccine Administered. Congratulations USA! Congratulations WORLD!”

Northwell Health, the largest health system in New York state, operates some of the select hospitals in the United States that were administering the country’s first inoculations of the Pfizer/BioNTech COVID-19 vaccine outside trials on Monday.

The vaccine, developed by Pfizer and its German partner BioNTech, won emergency-use approval from federal regulators on Friday after it was found to be 95% effective in preventing illness in a large clinical trial.

The first 2.9 million doses began to be shipped to distribution centers around the country on Sunday, just 11 months after the United States documented its first COVID-19 infections.

As of Monday, the United States had registered more than 16 million cases and nearly 300,000 deaths from the virus.

Health officials in Texas, Utah, South Dakota, Ohio and Minnesota said they also anticipated the first doses of the vaccine would be received at select hospitals on Monday and be administered right away.

LOGISTICAL CHALLENGE

The first U.S. shipments of coronavirus vaccine departed from Pfizer’s facility in Kalamazoo, Michigan, on Sunday, packed into trucks with dry-ice to maintain the necessary sub-Arctic temperatures, and then were transported to UPS and FedEx planes waiting at air fields in Lansing and Grand Rapids, kicking off a national immunization endeavor of unprecedented complexity.

The jets delivered the shipments to UPS and FedEx cargo hubs in Louisville and Memphis, from where they were loaded onto planes and trucks to be distributed to the first 145 of 636 vaccine-staging areas across the country. Second and third waves of vaccine shipments were due to go out to the remaining sites on Tuesday and Wednesday.

“This is the most difficult vaccine rollout in history. There will be hiccups undoubtedly but we’ve done everything from a federal level and working with partners to make it go as smoothly as possible. Please be patient with us,” U.S. Surgeon General Jerome Adams told Fox News on Monday, adding that he would get the shot as soon as he could.

The logistical effort is further complicated by the need to transport and store the Pfizer/BioNTech vaccine at minus 70 Celsius (minus 94 Fahrenheit), requiring enormous quantities of dry ice or specialized ultra-cold freezers.

Workers clapped and whistled as the first boxes were loaded onto trucks at the Pfizer factory on Sunday.

“We know how much people are hurting,” UPS Healthcare President Wes Wheeler said on Sunday from the company’s command center in Louisville, Kentucky. “It’s not lost on us at all how important this is.”

MORE DOSES ON THE WAY

More than 100 million people, or about 30% of the U.S. population, could be immunized by the end of March, Moncef Slaoui, the chief advisor to the U.S. government’s Operation Warp Speed coronavirus vaccine initiative, said in an interview on Sunday.

Healthcare workers and elderly residents of long-term care homes will be first in line to get the inoculations of a two-dose regimen given about three weeks apart. That would still leave the country far short of the herd immunity that would halt virus transmission, so health officials have warned that masks and social distancing will be needed for months to control the currently rampaging outbreak. Pfizer Chief Executive Officer Albert Bourla told CNN in an interview on Monday that most of the 50 million vaccine doses the company will provide this year have been manufactured, adding that it plans on producing 1.3 billion doses next year. Approximately half will be allocated to the United States, he said. But Bourla said Pfizer is “working very diligently” to increase the amount of doses available because demand is very high. At the same time, he said, the company has not reached an agreement with the U.S. government on when to provide an additional 100 million doses next year. “We can provide them the additional 100 million doses, but right now most of that we can provide in the third quarter,” Bourla said. “The U.S. government wants them in the second quarter so are working very collaboratively with them to make sure that we can find ways to produce more or allocate the doses in the second quarter.” Slaoui said the United States hopes to have about 40 million vaccine doses – enough for 20 million people – distributed by the end of this month. That would include vaccines from both Pfizer and Moderna Inc. An outside U.S. Food and Drug Administration advisory panel is scheduled to consider the Moderna vaccine on Thursday, with emergency use expected to be granted shortly after. On Friday, Moderna announced it had struck a deal with the U.S. government to deliver 100 million additional doses in the second quarter.

(Reporting by Jonathan Allen, Gabriella Borter, Lisa Lambert, Lisa Baertlein and Brendan O’Brien; Editing by Angus MacSwan and Paul Simao)

Explainer: How Canada will vaccinate its population against COVID-19

OTTAWA (Reuters) – Canada on Wednesday approved the first COVID-19 vaccine, jointly developed by Pfizer Inc and its German partner BioNTech SE, and is now preparing to distribute early doses to the most vulnerable groups.

Managing the nationwide rollout will be one of the most complex logistical undertakings in the country’s history, officials say.

WHEN CAN CANADIANS EXPECT TO BE VACCINATED?

Prime Minister Justin Trudeau told the House of Commons on Wednesday that Canada would receive 30,000 doses next week and up to 249,000 by the end of the year.

Only a handful of provinces have so far detailed their immediate plans. Saskatchewan said it expected to receive Pfizer vaccine for 1,950 people by Tuesday, and would use it to inoculate healthcare workers caring directly for COVID-19 patients. Neighboring Manitoba said it expected enough Pfizer vaccine next week to immunize 900 healthcare workers.

General immunization for all 38 million Canadians will begin in April 2021 with a goal of 100% coverage by the end of the third quarter, Health Canada said in a document.

WHO WILL RECEIVE THE FIRST DOSES?

Officials say priority groups such as healthcare workers, employees in long-term care homes, vulnerable members of the elderly population and those living in remote Indigenous communities will receive vaccines first.

HOW WILL VACCINES BE TRANSPORTED AND TO WHERE?

Provincial orders for vaccines will be coordinated through a national operations center with help from the military.

Pfizer’s ultra-low temperature vaccine will be transported by the manufacturer directly to the 14 points of inoculation that Ottawa has set up across the country.

The federal government has contracted FedEx Corp and Innomar Strategies, a Canada-based division of AmerisourceBergen to provide logistical support on vaccine delivery.

Frozen vaccines, like Moderna’s, will be transported by federally contracted logistics service providers from where they are manufactured to set points of delivery.

Canada is now running distribution drills to ensure that critical capability gaps are filled, risks are mitigated, and contingencies are put in place.

WHICH OTHER VACCINES ARE IN THE APPROVAL PROCESS

Canadian officials say the next regulatory decision will be on Moderna Inc’s candidate vaccine. Canada also has agreements to purchase the potential vaccines of Novavax Inc, Johnson & Johnson, Sanofi SA with GlaxoSmithKline Plc, AstraZeneca Plc, and Medicago.

If all were to receive regulatory approval, Canada could buy enough doses to vaccinate the country more than five times over.

Canada expects the first 6 million doses from Pfizer and Moderna Inc to arrive in the first quarter of 2021, enough for 3 million of the 38 million population.

WHO WILL BE IN CHARGE OF ADMINISTERING VACCINES TO PEOPLE?

Health authorities in the provinces and territories are responsible for determining how vaccines will be deployed and on administering them to their populations. Inoculation will be free.

Ontario, Canada’s most populous province, has also set up a task force headed by Canada’s former Chief of the Defence Staff Rick Hillier.

(Reporting by David Ljunggren and Julie Gordon in Ottawa and Rod Nickel in Manitoba; Editing by Steve Scherer, Diane Craft and Denny Thomas)

As U.S. companies push to get workers vaccinated, states disagree on who’s essential

By Tina Bellon and Richa Naidu

NEW YORK/CHICAGO (Reuters) – Companies and industry groups lobbying to get their U.S. workers to the front of the line for COVID vaccination are running into a patchwork of state plans and confusion over who is essential, and who is not.

Inoculation against the disease caused by the novel coronavirus is key to safely reopening large parts of the economy and reducing the risks of illness at crowded meatpacking plants, factories and warehouses.

But before one needle has entered the arm of an American worker, confusion has broken out over who exactly is considered essential during a pandemic.

With initial vaccine doses limited and strong federal guidance lacking, it has fallen to U.S. states to determine who will be first in line to receive a vaccine, and who will have to wait well into next year.

State vaccine distribution plans reviewed by Reuters showed broad discrepancies over who would be considered essential, with some states clearly outlining specific worker groups and others not providing any clarity.

Generally, states have broad discretion when it comes to vaccine distribution and policy and are able to issue vaccination mandates for their residents.

Many states have so far followed federal guidance to give meat and food processing industry workers space in the line, but some are slowly moving away, said Mark Lauritsen, a former hog slaughter worker who now advocates on behalf of about 250,000 meatpacking and food processing workers under the United Food and Commercial Workers union.

“For example, Colorado has not moved meatpacking and meat-processing as high as some other states. So we’ll be directing a lot of our effort towards places like Colorado where we may be moved down the food chain.”

“We’re a union that has members in every state so we will be talking to every state to make our case as to where our place in line should be…Everybody is going to be jockeying for a place in line.”

More than 20 large industries have urged officials to prioritize their workers, including individual companies such as ride-hailing company Uber Technologies Inc and food delivery provider DoorDash Inc and industry groups representing truck drivers, teachers, retail workers and other business sectors.

DoorDash in its letter calling for preferred vaccine access for its delivery workers said the company could also help public health officials communicate vaccine information through its platform.

At least 22 industries, including agricultural companies, cleaning suppliers, dental hygienists, bus drivers and meat packers, also have written to the Advisory Committee on Immunization Practices (ACIP), an independent panel of health experts recommending vaccine distribution guidelines to the U.S. Centers for Disease Control and Prevention.

WHO IS ESSENTIAL?

“We’re hopeful that local health officials start jumping on this quicker rather than later so that there’s some guidance and some better sense of how to be efficient with the essential workforce,” said Bryan Zumwalt, executive vice president of public affairs for the Consumer Brands Association.

The group representing consumer products makers including Procter & Gamble Co and Coca-Cola Co, has sent letters to nearly all 50 U.S. states and federal officials, urging their nearly 1.2 million workers to be prioritized for a vaccine.

ACIP to date has only recommended healthcare personnel and residents of long-term care facilities should receive the vaccine first – a priority not disputed by any industry or state. ACIP members did not respond to a request for comment or declined to comment pending the discussions.

While some states have said they would await the committee’s further recommendations, others went ahead and developed their own vaccine distribution priorities, a review of COVID-19 vaccine distribution plans showed.

In New York, essential frontline workers regularly interacting with the public, such as pharmacists, grocery store workers and transit employees, are slated to receive the vaccine in a second distribution phase, while Florida included all essential workers on a U.S. Homeland Security list.

But that Homeland Security department list, spanning more than 25 major industries, makes up nearly 70% of the U.S. labor force, according to researchers at the National Bureau of Economic Research.

Georgia’s plan said the state was working with various industries, including poultry plants, manufacturers and warehouse distributors.

In North Carolina, which has one of the most detailed distribution plans spanning nearly 150 pages, workers in meatpacking, seafood, poultry and food processing, transportation and retail would be included in an early phase so long as they had at least two chronic conditions that put them at high risk.

Pennsylvania’s distribution plan on the other hand only includes three pages, stating merely that those “contributing to the maintenance of core societal functions” would be prioritized.

(Reporting by Tina Bellon in New York, Richa Naidu in Chicago; Editing to Joe White and Lisa Shumaker)

Moderna to supply four million more doses of COVID-19 vaccine to Israel

(Reuters) – Moderna Inc said on Friday it has extended its contract with the Israeli health ministry to supply an additional 4 million doses of its COVID-19 vaccine candidate.

Israel has now secured access to 6 million doses of Moderna’s mRNA-1273, currently under review in the country.

Financial terms and delivery timelines related to the deal were not disclosed.

In June, Israel signed an agreement with Moderna for its vaccine to protect its people from the new coronavirus. The country, with a population of 9 million, has reported 339,942 cases and 2,890 deaths, according to a Reuters tally.

It has also reached an understanding with AstraZeneca Plc to receive about 10 million doses of its experimental COVID-19 vaccine.

Moderna said it continues to scale up its global manufacturing to boost delivery by about 500 million doses per year, and possibly up to 1 billion doses a year, beginning 2021.

The company has submitted applications seeking emergency use authorization in the United States and EU after full results from a late-stage study showed the vaccine was 94.1% effective with no serious safety concerns.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Shinjini Ganguli)

Fed sees little to no growth in much of U.S. as stress mounts

By Howard Schneider and Ann Saphir

WASHINGTON (Reuters) – Federal Reserve officials saw “little or no growth” in four of their 12 regional districts and only modest growth in the others in recent weeks as a rapidly spreading health crisis and ongoing recession continued to devastate some U.S. businesses and families even as many others thrive.

In the U.S. central bank’s latest “Beige Book” compendium of anecdotes from businesses across the country, Fed officials seemed to signal that the winter slowdown they’ve feared would follow a new coronavirus outbreak is taking root.

Earlier on Wednesday, Fed Chair Jerome Powell repeated his plea for Congress to provide more aid to “get us through the winter” and support businesses and households until a vaccine allows for a broader resumption of commerce. Initial inoculations may begin in the United States this month.

Meanwhile, the pandemic is spreading at a rate of a million new cases a week and around 1,500 deaths a day.

In some places that has led officials to impose new restrictions on businesses and social gatherings. In others, households have pulled back on their own.

But overall it has left little capacity to fix problems that have plagued the economy since the onset of the pandemic last spring, with women sidelined from the workforce due to childcare concerns, leisure and hospitality firms semi-shuttered, and banks concerned their loans books may come under stress soon.

“This is one of the most troubling Beige Books we have seen in a long time,” Jefferies LLC economist Thomas Simon said.

The possibility of growing loan bank stress added a newly worrisome note: The comparative lack of loan defaults so far has prevented the recession from spawning a separate financial crisis.

But “banking contacts in numerous Districts reported some deterioration of loan portfolios, particularly for commercial lending into the retail and leisure and hospitality sectors,” Fed officials reported. “An increase in delinquencies in 2021 is more widely anticipated.”

Commercial real estate – especially in the office and retail sectors – was a weak spot across most districts. The Boston Fed reported that contacts there “estimated daytime office occupancy rates at around 20 percent – bad news for the shops and restaurants that relied on office workers’ business.”

The regional bank also said office tenants nearing the end of leases were renewing only for the short term and that some respondents noted an increase in available subleased space, signaling more trouble ahead in the sector.

Similarly, firms had become tentative about hiring because of the uncertain path of the pandemic.

LABOR MARKET WORRIES

Nearly all districts reported that employment was growing more slowly and that the recovery “remained incomplete.”

Businesses said it was harder to retain workers, especially women, because of challenges finding child care and dealing with school closures caused by the virus. Firms in several districts said they feared “employment levels would fall over the winter” before improving.

In Boston, “a supplier to commercial aviation announced major layoffs over the summer and has not had any reason to revise those plans either up or down,” local Fed officials noted.

Still the latest collection of Fed field reports, compiled on or before Nov. 20, included stories of other firms where managers struggled to find workers to help meet a boom in goods sales.

That divide, among regions and sectors that are doing well and those that are not, has become a hallmark of the current recession and presents the Fed with a difficult decision as it debates whether to provide more support for the economy at its Dec. 15-16 policy meeting.

The economy continues to recover from the deep blow it suffered at the start of the pandemic, and the prospect of a coming COVID-19 vaccine means the recovery could gain steam next year.

In the meantime, the country is 10 million jobs short of where it was in February. Job numbers for November will be released on Friday and are expected to show the pace of improvement is slowing, with some analysts now predicting an outright job loss.

(Reporting by Howard Schneider; Editing by Chizu Nomiyama and Paul Simao)

U.S. plans for first COVID vaccines as pandemic deaths surge again

By Julie Steenhuysen and Doina Chiacu

WASHINGTON (Reuters) – Top U.S. health officials announced plans on Tuesday to begin vaccinating Americans against the coronavirus as early as mid-December, as nationwide deaths hit the highest number for a single day in six months.

Some 20 million people could be inoculated against COVID-19 by the end of 2020 and most Americans will have access to highly effective vaccines by mid-2021, the chief adviser of President Donald Trump’s Operation Warp Speed program said.

“Within 24 hours, maybe at most 36 to 48 hours, from the approval, the vaccine can be in people’s arms,” Moncef Slaoui, a former GlaxoSmithKline executive who is overseeing the vaccine portion of the U.S. program, said at an event conducted by The Washington Post newspaper.

His comments came on the same day that another 2,295 fatalities nationwide were linked to COVID-19, even before California, the most populous U.S. state, reported full results. Officials in several states said numbers were higher in part due to a backlog from the Thanksgiving holiday.

A statement from the public health director for Los Angeles County highlighted the ravages of the surging pandemic. Barbara Ferrer, the public health director, said that while Tuesday was the county’s “worst day thus far” of the pandemic, “…it will likely not remain the worst day of the pandemic in Los Angeles County. That will be tomorrow, and the next day and the next as cases, hospitalizations and deaths increase.”

Health officials pleaded with Americans to stick with coronavirus restrictions even with a vaccine in sight.

The U.S. Centers for Disease Control and Prevention is moving to shorten the length of self-quarantine recommended after potential exposure to the coronavirus to 10 days, or seven days with a negative test, a federal spokesperson said on Tuesday. The CDC currently recommends a 14-day quarantine in order to curb the transmission of the virus.

TIMELINE ON A VACCINE

Some 60 million to 70 million doses of COVID-19 vaccine could be available per month beginning in January, after the expected regulatory approval of products from Pfizer Inc and Moderna Inc, Slaoui said.

A Food and Drug Administration panel of outside advisers will meet on Dec. 10 to discuss whether to recommend emergency use authorization of the Pfizer vaccine, developed with German partner BioNTech SE. Moderna’s vaccine candidate is expected to be reviewed a week later.

The timeline described by Slaoui and Health and Human Services Secretary Alex Azar appeared to assume that the FDA’s authorization of the first vaccine would come within days of the Dec. 10 meeting.

But the head of the FDA’s Center for Biologics Evaluation and Research, Dr. Peter Marks, told patient advocacy groups last week that it might take “a few days to a few weeks.”

FDA Commissioner Stephen Hahn, likewise, has said the process could take longer.

The U.S. Transportation Department said on Tuesday it has made preparations to enable the “immediate mass shipment” of COVID-19 vaccines and completed all necessary regulatory measures.

An estimated 21 million healthcare workers and 3 million residents of long-term care facilities should be first in line to receive a vaccine, according to a recommendation voted on by a CDC panel of advisers on Tuesday.

Nursing homes are experiencing the worst outbreak of weekly coronavirus cases since the spring, according to the American Health Care Association and National Center for Assisted Living.

HOLIDAY TRAVEL SPIKE

State and local officials have returned to imposing restrictions on businesses and activities in response to the latest surge of a pandemic that killed 37,000 people in November.

A record nearly 96,000 COVID-19 patients were reported in U.S. hospitals on Tuesday, according to a Reuters tally.

Hospitalizations and deaths are expected to spike even higher during the holiday travel season, a trend that officials warn could overwhelm already strained healthcare systems.

The monthly death toll from COVID-19 is projected to nearly double in December to a pandemic-high of more than 70,000 and surpass 76,000 in January before ebbing in February, according to a widely cited model from the University of Washington’s Institute for Health Metrics and Evaluation.

Pandemic-related restrictions have ravaged the U.S. economy. A bipartisan group of U.S. lawmakers on Tuesday unveiled a $908 billion COVID-19 relief bill aimed at breaking a deadlock over emergency assistance for small businesses, industries and the unemployed.

(Reporting by Doina Chiacu and Julie Steenhuysen; Additional reporting by Lisa Shumaker, Maria Caspani, Peter Szekely, Jonathan Allen, David Shepardson, Steve Gorman and Dan Whitcomb; Writing by Daniel Trotta and Dan Whitcomb; Editing by Bill Berkrot, Bill Tarrant and Leslie Adler)

In world first, UK approves Pfizer-BioNTech COVID-19 vaccine

By Guy Faulconbridge and Paul Sandle

LONDON (Reuters) – Britain approved Pfizer’s COVID-19 vaccine on Wednesday, jumping ahead of the rest of the world in the race to begin the most crucial mass inoculation program in history with a shot tested in wide-scale clinical trials.

Prime Minister Boris Johnson touted the greenlight from the UK’s medicine authority as a global win and a ray of hope amid a pandemic, though he recognized the logistical challenges of vaccinating an entire country of 67 million.

Britain’s move raised hopes that tide could soon turn against a virus which has killed nearly 1.5 million people, hammered the world economy and upended normal life for billions.

Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) granted emergency use approval to the Pfizer-BioNTech vaccine, which they say is 95% effective in preventing illness, just 23 days since Pfizer published the first data from its final stage clinical trial.

“Fantastic news,” Johnson told parliament, though he cautioned that people should not get too carried away.

“At this stage it is very, very important that people do not get their hopes up too soon about the speed with which we will be able to roll out this vaccine.”

The world’s big powers have been racing for a vaccine for months to begin the long road to recovery, and getting there first may be seen as a coup for Johnson’s government, which has faced criticism over its handling of the crisis.

The approval of a shot for use close to a year since the novel coronavirus emerged in Wuhan, China, is a triumph for science, Pfizer boss Albert Bourla and his German biotechnology partner BioNTech.

Both the United States and the European Union’s regulator are sifting through the same Pfizer vaccine trial data, but have not yet given their approval.

Britain’s breakneck speed drew criticism from Brussels where, in an unusually blunt statement, the EU’s drugs regulator said its longer procedure was more appropriate as it was based on more evidence and required more checks.

British leaders said that, while they would love to get a shot themselves, priority had to be given to those most in need – the elderly, those in care homes and health workers.

Amid the celebratory rhetoric, Germany’s ambassador to Britain Andreas Michaelis publicly scolded a British minister for presenting it as a national triumph.

“I really don’t think this is a national story. In spite of the German company BioNTech having made a crucial contribution, this is European and transatlantic,” Michaelis said.

‘NO CORNERS CUT’

The U.S. drugmaker said Britain’s emergency use authorization marked a historic moment in the fight against COVID-19. Pfizer announced its vaccine breakthrough on Nov. 9 with stage III clinical trial results.

“This authorization is a goal we have been working toward since we first declared that science will win, and we applaud the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the UK,” said CEO Bourla.

Britain’s medicines regulator approved the vaccine in record time by doing a “rolling” concurrent analysis of data and the manufacturing process while Pfizer raced to conclude trials.

“No corners have been cut,” MHRA chief June Raine said in a televised briefing from Downing Street, adding that the first data on the vaccine had been received in June and undergone a rigorous analysis to international standards. “Safety is our watchword.”

“With 450 people dying of COVID-19 infection every day in the UK, the benefits of rapid vaccine approval outweigh the potential risks,” said Andrew Hill, senior visiting research fellow in the Department of Pharmacology at the University of Liverpool.

The U.S. Food and Drug Administration (FDA) will make a decision on emergency use authorization on the Pfizer/BioNTech vaccine in days or weeks after a panel of outside advisors meets on Dec. 10 to discuss whether to recommend it. The FDA often but not always follows the panel’s advice.

The European Medicines Agency (EMA) said it could give emergency approval for the shot by Dec. 29.

“The data submitted to regulatory agencies around the world are the result of a scientifically rigorous and highly ethical research and development program,” said Ugur Sahin, chief executive and co-founder of BioNTech.

BioNTech said it expected FDA and EMA to make a decision in mid-December.

Anti-poverty campaigners, meanwhile, warned against rich countries hoarding vaccines at the expense of poorer ones. “The worst thing we can do at this moment is allow a small number of countries to monopolize access to vaccines like this,” said Romilly Greenhill, UK director of the ONE organization.

FIRST IN LINE?

Britain said it would start vaccinating those most at risk of dying early next week after it gets 800,000 doses from Pfizer’s manufacturing center in Belgium.

“I strongly urge people to take up the vaccine but it is no part of our culture or our ambition in this country to make vaccines mandatory,” Johnson said.

The speed of the rollout depends on how fast Pfizer can manufacture and deliver the vaccine – and the extreme temperature of -70C (-94F) at which the vaccine must be stored.

Britain has ordered 40 million doses of the Pfizer vaccine – enough for just under a third of the population as two shots are needed per person to gain immunity.

Health Secretary Matt Hancock said hospitals were ready to receive the shots and vaccination centers would be set up across the country, but he admitted distribution would be a challenge given storage at temperature typical of an Antarctic winter.

Pfizer has said the shots can be kept in thermal shipping boxes for up to 30 days. Afterwards, the vaccine can be kept at fridge temperatures for up to five days.

Other frontrunners in the vaccine race include U.S. biotech firm Moderna, which has said its shot was 94% successful in late-stage clinical trials, and AstraZeneca, which said last month its COVID-19 shot was 70% effective in pivotal trials and could be up to 90% effective.

(Reporting by Guy Faulconbridge and Paul Sandle; Additional reporting by Kate Kelland, Alistair Smout and Estelle Shirgon; Editing by Kate Holton, Carmel Crimmins, Alex Richardson and Nick Macfie)