Analysis: Wide array of opponents prepare to fight Biden vaccine mandate

By Nandita Bose and Tom Hals

(Reuters) – The country’s first national COVID-19 vaccine mandate, expected to be unveiled by the Biden administration this week, is likely to unleash a frenzied legal battle that will hinge on a rarely used law and questions over federal power and authority over healthcare.

States, companies, trade groups, civil liberty advocates and religious organizations are expected to rush to court with demands to stop the mandate in its tracks. Two dozen Republican state attorneys general have already vowed to use “every legal option” to fight the mandate and 40 Republican lawmakers said on Wednesday they were preparing their own challenge.

Details of the vaccine and testing requirements for private employers remain under wraps. The administration has said that the rule is coming and that it requires certain businesses to “develop, implement and enforce” a mandatory policy that allows employees to either choose to get vaccinated or undergo regular testing and wear a face covering at work.

For opponents, the general principle could not be more clear: the administration’s zeal for fighting the pandemic with vaccinations and testing has trampled the law and the Constitution.

“There will be so much litigation it will never see the light of day,” said Josh Blackman, a professor at South Texas College of Law Houston.

Some legal experts, however, said protecting against a historic public health crisis provides a compelling justification for the mandate against constitutional challenges that claim it infringes on individual or state rights.

COVID-19 vaccine requirements by colleges, cities, states and companies have generally been upheld. The Supreme Court said on Friday that Maine could impose its mandate on healthcare workers, even without the usual religious exemptions.

However, the national vaccine and testing rule, which will likely run hundreds of pages, will differ in important ways from existing vaccine requirements.

It will be issued as an emergency temporary standard (ETS) by the Occupational Safety and Health Administration (OSHA), which regulates workplace dangers. Businesses with at least 100 employees must enforce the rule on their staff or face penalties.

To issue an ETS, OSHA must show there is a “grave danger” in workplaces, and it needs to justify that emergency rule as a necessary response.

A White House spokesperson did not comment for this story. White House Press Secretary Jen Psaki has said a pandemic that has killed over 740,000 Americans qualifies as a “grave risk to workers.” The Department of Labor declined to comment.

An average of 1,100 Americans are still dying daily from COVID-19, according to the latest U.S. data, the vast majority of them unvaccinated.

However, critics expect the OSHA rule to be vulnerable to legal attacks.

COVID-19 infections are trending down, some 70% of U.S. adults are fully vaccinated and treatments for the disease have improved, potentially undermining the grave danger claim.

“I think there’s an issue as to whether they can show that in every business, in every industry, every employer that has more than 100 employees, there is a grave danger from COVID,” said Scott Hecker, an employment attorney with Seyfarth Shaw, which represents businesses.

Or, as the National Retail Federation described it in a letter to Labor Secretary Marty Walsh, “workers face the danger of COVID-19 wherever they go … because they are human beings going about the world, not because they go to work.”

OSHA has convinced courts to uphold emergency standards in the past with evidence that as few as 80 lives would be saved. It will also be able to argue that masking and other COVID-19 safety measures proved no match for the extremely contagious Delta variant, necessitating the current rules.

“The fact that a person can be exposed to the COVID virus outside of the person’s place of employment does not eliminate OSHA’s authority to regulate,” Sidney Shapiro, a law professor at Wake Forest University, told a Congressional hearing last week.

Republican governors and right-wing talk show hosts have waged a political war against vaccine mandates and mask wearing, hoping to galvanize voters against Democratic President Joe Biden.

Vaccine mandates have been effective at shrinking the ranks of the unvaccinated, although they have also touched off protests, and employers worry they could worsen a national labor shortage.

Mandates on individuals have a long history and have been upheld by courts for more than a century, but they have been imposed by local and states governments, not Washington, which is restrained by the U.S. Constitution.

Critics of the mandate will argue it interferes with traditional states’ roles, namely, regulating healthcare within their boundaries.

OSHA is also fighting history. The agency has issued 10 ETS over its 50 years. Of the six that were challenged in court, only one survived entirely intact.

In the meantime, a huge number of U.S. employers will be left dealing with an uncertain outcome of the legal challenges, even as many focus on achieving compliance.

Mike Bennett, the vice president of human resources for Cianbro, a Maine construction company with 4,000 employees, said he is planning to carry out the OSHA rule.

“Unless something comes from the federal government that says ‘pause until further notice,’ we’ll continue to go down the road that this is coming,” he said.

(Reporting by Nandita Bose in Washington and Tom Hals in Wilmington, Delaware, Editing by Chris Sanders, Amy Stevens and Bill Berkrot)

Coronavirus surge pushes Cuba’s healthcare system to brink

By Sarah Marsh

HAVANA (Reuters) – Cuba is bringing back hundreds of doctors working abroad and converting hotels into isolation centers and hospitals in order to battle a COVID-19 crisis that is overwhelming healthcare and mortuary services in parts of the Caribbean island.

The country, which managed to contain infections for most of last year, is now facing one of the worst outbreaks worldwide, fueled by the spread of the more-infectious Delta variant, even as it races to vaccinate its population.

Cuba’s rolling seven-day average of confirmed COVID-19 cases has surged eightfold within two months to 5,639 per million inhabitants, ten times the world average.

One in five tests are positive, four times the benchmark 5% positivity rate cited by the World Health Organization. The seven-day average for confirmed COVID-19 deaths is around 52 per million inhabitants, six times the world average, although the real number could be much higher accounting for potentially undiagnosed cases.

The COVID-19 surge has come amid Cuba’s worst economic crisis in decades that had already resulted in medicine shortages and long queues for scarce goods that made implementing lockdowns tricky.

The predicament has come as a shock to some in the Communist-run country where the right to public healthcare is considered sacrosanct.

“I witnessed queues of more than 20 hours, people dying in the corridors (of the polyclinic),” wrote Ana Iris Diaz, a professor at the university of the central Cuban city of Santa Clara and self-professed “revolutionary”, in a Facebook post that went viral this week.

“I saw an elderly woman die after several hours of waiting and four days without an antigen test or PCR. Simply put, I saw what I would have hoped to never see: the collapse of our health system.”

Cuba’s Communist government did not reply to a request for comment. It has denounced the United States for tightening sanctions, saying this has also slowed down its vaccine rollout due to the difficulty of acquiring inputs. Critics blame more Cuba’s inefficient state-run economy.

“We are at the limit of our capacity for infrastructure, resources, medicine and oxygen,” President Miguel Diaz-Canel told a government meeting on COVID-19 on Monday.

INCINERATOR BREAKS UNDER STRAIN

Cuba was a COVID-19 success story last year, managing to contain the outbreak, dispatching doctors all over the globe to help and even developing its own vaccines, which it started applying in recent months.

Deaths in Cuba since the start of the pandemic are still only a half of the global average, according to official data.

The death toll is rising fast though.

In the eastern province of Guantanamo, artist Daniel Ross said a 30-year-old friend of his who caught COVID-19 had recently died due to a lack of medicines and oxygen.

“Here, we fight COVID-19 with Azitromicina, which costs 16 pesos usually in the pharmacy, but they haven’t had any for months now,” he said, adding that the cost had surged to 3600 pesos, equivalent to $150 on the black market.

Also infected and struggling to breathe, he said he was doing inhalations with yagruma leaves but sometimes could not even heat water because of the power outages that have become more frequent lately.

Ihosvany Fernandez, director of communal services in the province of Guantanamo, said on local television that total deaths there, from any cause, had surged at the start of the month to more than 60 per day from around 12 on average usually.

Official data show no more than 10 COVID-19 death daily in Guantanamo for those days suggesting underreporting in deaths from the respiratory disease.

One of the province’s incinerators had broken down due to overuse, said Fernandez, so they were installing another and using a variety of state vehicles to transport the corpses given insufficient hearses.

So far, a quarter of Cuba’s 11.2 million inhabitants have been inoculated with its two most advanced vaccines that officials say have proven more than 90% effective in phase three trials.

In one bright spot, the case-fatality rate in Havana, where nearly two thirds of the population has now been fully inoculated, was just 0.69 % compared to 0.93% for the rest of the country in the first week of August, according to official data, suggesting the shots are working.

(Reporting by Sarah Marsh in Havana; Additional Reporting by Nelson Acosta in Havana; Editing by Alistair Bell)

Factbox: Healthcare, financial services, agriculture targeted in Biden order

(Reuters) – In an executive order on Friday, U.S. President Joe Biden aims to remove barriers to competition in such industries as healthcare, financial services and agriculture while boosting wages and lowering prices, the White House said.

The order:

* Encourages the leading antitrust agencies to focus enforcement efforts on problems in key markets and coordinates other agencies’ ongoing response to corporate consolidation.

* Calls on the leading antitrust agencies, the Department of Justice (DOJ) and Federal Trade Commission (FTC), to enforce the antitrust laws vigorously and recognizes that the law allows them to challenge bad mergers that past administrations did not previously challenge.

* Announces a policy that enforcement should focus in particular on labor markets, agricultural markets, healthcare markets (which includes prescription drugs, hospital consolidation and insurance), and the tech sector.

* Establishes a White House Competition Council, led by the Director of the National Economic Council, to monitor progress on finalizing the initiatives in the order and to coordinate the federal government’s response to the rising power of large corporations in the economy.

LABOR MARKETS

* Encourages the FTC to ban or limit non-compete agreements.

* Encourages the FTC to ban unnecessary occupational licensing restrictions that impede economic mobility.

* Encourages the FTC and DOJ to strengthen antitrust guidance to prevent employers from collaborating to suppress wages or reduce benefits by sharing wage and benefit information with one another.

HEALTHCARE

* Directs the Food and Drug Administration to work with states and tribes to safely import prescription drugs from Canada, pursuant to the Medicare Modernization Act of 2003.

* Directs the Health and Human Services Administration (HHS) to increase support for generic and biosimilar drugs, which provide low-cost options for patients.

* Directs HHS to issue a comprehensive plan within 45 days to combat high prescription drug prices and price gouging.

* Encourages the FTC to ban “pay for delay” and similar agreements by rule.

Hearing Aids

* Directs HHS to consider issuing proposed rules within 120 days for allowing hearing aids to be sold over the counter.

Hospitals

* Underscores that hospital mergers can be harmful to patients and encourages the Justice Department and FTC to review and revise their merger guidelines to ensure patients are not harmed by such mergers.

* Directs HHS to support existing hospital price transparency rules and to finish implementing bipartisan federal legislation to address surprise hospital billing.

Health Insurance

* Directs HHS to standardize plan options in the National Health Insurance Marketplace so people can comparison shop more easily.

TRANSPORTATION

Airlines

* Directs the Department of Transportation (DOT) to consider issuing clear rules requiring the refund of fees when baggage is delayed or when service isn’t actually provided, such as when a plane’s WiFi or in-flight entertainment system is broken.

* Directs the DOT to consider issuing rules that require baggage, change and cancellation fees to be clearly disclosed to the customer.

Rail

* Encourages the Surface Transportation Board to require railroad track owners to provide rights of way to passenger rail and to strengthen their obligations to treat other freight companies fairly.

Shipping

* Encourages the Federal Maritime Commission to ensure vigorous enforcement against shippers charging American exporters exorbitant charges.

AGRICULTURE

* Directs U.S. Department of Agriculture (USDA) to consider issuing new rules under the Packers and Stockyards Act making it easier for farmers to bring and win claims, stopping chicken processors from exploiting and underpaying chicken farmers, and adopting anti-retaliation protections for farmers who speak out about bad practices.

* Directs USDA to consider issuing new rules defining when meat can bear “Product of USA” labels, so that consumers have accurate, transparent labels that enable them to choose products made in the United States.

* Directs USDA to develop a plan to increase opportunities for farmers to access markets and receive a fair return, including supporting alternative food distribution systems like farmers’ markets and developing standards and labels so that consumers can choose to buy products that treat farmers fairly.

* Encourages the FTC to limit powerful equipment manufacturers from restricting others’ ability to use independent repair shops or do DIY repairs, such as when tractor companies block farmers from repairing their own tractors.

INTERNET SERVICE

* Encourages the Federal Communications Commission (FCC) to prevent ISPs from making deals with landlords that limit tenants’ choices.

* Encourages the FCC to revive the “Broadband Nutrition Label” and require providers to report prices and subscription rates to the FCC.

* Encourages the FCC to limit excessive early termination fees.

* Encourages the FCC to restore Net Neutrality rules undone by the prior administration.

TECHNOLOGY

* Announces an administration policy of greater scrutiny of mergers, especially by dominant internet platforms, with particular attention to the acquisition of nascent competitors, serial mergers, the accumulation of data, competition by “free” products, and the effect on user privacy.

* Encourages the FTC to establish rules on surveillance and the accumulation of data.

* Encourages the FTC to establish rules barring unfair methods of competition on internet marketplaces.

* Encourages the FTC to issue rules against anticompetitive restrictions on using independent repair shops or doing DIY repairs of one’s own devices and equipment.

BANKING AND CONSUMER FINANCE

* Encourages DOJ and the agencies responsible for banking (the Federal Reserve, the Federal Deposit Insurance Corporation, and the Office of the Comptroller of the Currency) to update guidelines on banking mergers to provide more robust scrutiny of mergers.

* Encourages the Consumer Financial Protection Bureau (CFPB) to issue rules allowing customers to download their banking data and take it with them.

(Editing by Howard Goller)

Coronavirus crisis in Latin America made worse by poverty, inequality, U.N. agency says

By Fabian Cambero

SANTIAGO (Reuters) – Latin America and the Caribbean countries in the throes of the coronavirus crisis will only see their problems made worse by festering inequality, poverty and an ailing social safety net, a United Nations agency said on Thursday.

The Economic Commission for Latin America and the Caribbean (ECLAC) said social unrest was on the rise across the region, a sign that immediate action was necessary to aid hard-hit countries struggling long before the pandemic hit.

“The effects of the coronavirus pandemic have spread to all areas of human life, altering the way we interact, paralyzing economies and generating profound changes in societies,” the report said.

Persistently high levels of inequality, the agency said, combined with a sprawling informal labor market that leaves workers without protection and a lack of effective health care coverage have made those problems worse.

Urban slums on the fringes of many of the region’s cities often lack access to basic services, mean many citizens found themselves unable to access food, water and healthcare necessary to confront the crisis.

Poverty meanwhile, has crept upward, while advances in reducing inequality have stagnated, exacerbating trends seen in the five years prior to the crisis.

During that period, Latin America and Caribbean economies grew an average of just 0.3% per year overall, while extreme poverty increased from 7.8% to 11.3% of the population and poverty, from 27.8% to 30.5%.

The report also said the prolonged closure of schools in the region could constitute a “generational catastrophe” that will only deepen inequality.

The pandemic has also brought a rise in mortality that could push down life expectancy in the region depending how long the crisis endures, the agency said.

There have been at least 21,699,000 reported infections and 687,000 reported deaths caused by the novel coronavirus in Latin America and the Caribbean so far.

​ Of every 100 infections last reported around the world, about 24 were reported from countries in Latin America and the Caribbean.

(Reporting by Fabian Cambero; Writing by Dave Sherwood; Editing by Angus MacSwan)

U.S. Congress in sprint to fund government, approve COVID-19 emergency aid

By Richard Cowan

WASHINGTON (Reuters) – The U.S. Congress will try this week to end months of indecision and infighting over the federal government’s budget priorities and coronavirus aid, with more than $2 trillion in funding from Washington potentially at stake.

Lawmakers, facing a midnight Friday deadline, will scurry to put the finishing touches on a $1.4 trillion spending bill for the fiscal year that began Oct. 1.

At stake are funds for federally run programs ranging from healthcare, homeland security and military readiness to foreign aid, national parks and nutrition programs. They have been operating on temporary funding since October.

Without a deal, the government must begin shutting non-emergency programs and furloughing many workers.

Members of the Republican-run Senate and Democratic-led House of Representatives, who fear negotiations could extend through the Christmas holiday, have a second major task: deciding the contours of a coronavirus aid bill that could approach $1 trillion amid a worsening pandemic that has claimed the lives of nearly 300,000 Americans.

Some moderate lawmakers on Sunday dismissed suggestions that a $908 billion bipartisan coronavirus aid proposal was languishing.

“The plan is alive and well and there’s no way, no way that we are going to leave Washington without taking care of the emergency needs of our people,” Democratic Senator Joe Manchin told Fox News, saying the proposal would be introduced formally on Monday.

A person briefed on the matter said the authors now planned to divide the measure into two separate proposals, which could be voted on separately. One would be a $748 billion proposal including small businesses, the jobless and COVID-19 vaccine distribution.

The other would include major sticking points such as coronavirus-related liability protections for business, which are backed by Republicans, and $160 billion for state and local governments, a Democratic priority.

Lawmakers are hoping to attach the aid to the government funding measure.

Local public health agencies worry that without a deal on either of the two bills, they will not have enough money to carry out a massive COVID-19 vaccination program.

The first shipments of Pfizer Inc’s newly approved vaccine were delivered on Sunday.

WHO WINS AND WHO LOSES?

With the twin goals of stimulating the struggling U.S. economy and financing purchases of medical supplies, Democrats and Republicans in Congress are faced with deciding who should receive new help from Washington – beyond over $3 trillion appropriated last spring – and who should not.

Democrats have been pushing hard for aid to state and local governments to insure against laying off more workers, including police, firefighters and emergency medical personnel.

Senate Majority Leader Mitch McConnell, a Republican, dismissed that on Friday as a “preposterous” federal handout for Democratic-leaning states that he says do not need it.

But even some of McConnell’s own Republicans disagreed.

Senator Lisa Murkowski of Alaska told reporters her state’s revenues had seen a 33 percent decline during the pandemic in an economy heavily dependent on summertime tourism.

“We’re a state that is really, really hurting right now,” Murkowski said on Friday, adding that many others are in the same situation.

The House’s No. 2 Democrat, Steny Hoyer, offered a glimmer of hope that a breakthrough might be possible, telling CNN on Sunday that Democrats “are not going to get everything we want. We think state and local (aid) is important. And if we can get that, we want to get it. But we want to get aid out to the people who are really, really struggling and are at grave risk.”

Congress also is divided over whether to do a second round of direct payments to Americans to help stimulate the economy.

“We have a history now of going to the 11th hour and 59th minute on all of this and it’s very unfortunate. That’s where we are,” lamented Republican Senator Pat Roberts, who is retiring at year’s end.

(Reporting by Richard Cowan; Additional reporting by Susan Cornwell and David Shepardson; Editing by Peter Cooney)

U.S. Supreme Court takes up Trump bid to revive Medicaid work requirements

By Lawrence Hurley

WASHINGTON (Reuters) – The U.S. Supreme Court on Friday agreed to hear a bid by President Donald Trump’s administration to revive pilot programs adopted by the states of Arkansas and New Hampshire that allow work requirements to be imposed on people who receive healthcare under the Medicaid program for the poor.

The justices took up the administration’s appeals of rulings by a lower court that found the programs unlawful.  Seventeen other states are pursuing similar policies.

The administration said in court papers that the appeals court rulings cast a legal shadow on the efforts in those other states to adopt work requirements for Medicaid, a state-federal program that provides medical insurance for the poor. New Hampshire and Arkansas filed court papers in support of the administration.

The U.S. Department of Health and Human Services in 2018 approved those projects as part of a push to put a conservative stamp on Medicaid, which was expanded in 37 states and the District of Columbia following the 2010 passage of the Affordable Care Act, also known as Obamacare, to help provide coverage to millions more Americans.

The department gave the go-ahead for states to carry out test projects requiring able-bodied people on Medicaid to work or do volunteer work.

(Reporting by Lawrence Hurley; Additional reporting by Nate Raymond; Editing by Will Dunham)

U.S. death toll from COVID-19 nears quarter million as infection rates soar

By Gabriella Borter and Anurag Maan

(Reuters) – The death toll from COVID-19 in the United States approached 250,000 on Wednesday, the day after the country recorded the highest number of victims in nearly four months, a chilling sign for a healthcare system already struggling to cope.

On Tuesday, the pandemic claimed 1,596 lives in the United States, more than on any single day since July 27, contributing to a total of 248,898 confirmed deaths since the pandemic began, according to a Reuters tally.

For weeks, health officials and healthcare workers have warned that hospitals in all regions could soon become overwhelmed, with widespread community transmission of the virus evident in many places.

“I’m the most concerned I’ve been since this pandemic started,” Dr. Tom Inglesby, director of Johns Hopkins Center for Health Security, told CNN on Wednesday.

Nationwide, the number of patients hospitalized with COVID-19 topped 75,000 on Tuesday, setting a new record. The Midwest has become the epicenter, reporting almost a half-million cases in the week ending on Monday. In Wisconsin, 90.6% of Intensive Care Unit beds were occupied as of Wednesday, state data showed.

Forty-one U.S. states have reported daily record increases in COVID-19 cases in November, 20 have registered new all-time highs in coronavirus-related deaths from day to day, and 26 have reported new peaks in hospitalizations, according to a Reuters tally of public health data.

Government officials in at least 18 states, representing both sides of the U.S. political divide, have issued sweeping new public health mandates this month. These range from stricter limits on social gatherings and non-essential businesses to new requirements for wearing masks in public places.

Even officials who initially bristled at the idea of the government imposing social restrictions have changed tune as the virus has spread.

In South Dakota, about 2% of residents currently have COVID-19, according to state data. The city of Sioux Falls voted to institute a mask mandate on Tuesday night, a week after Mayor Paul TenHaken voted the mandate down. TenHaken shifted to supporting the ordinance after the South Dakota State Medical Association urged the city council to mandate masks. State Governor Kristi Noem, a Republican, has continued to oppose government restrictions to curb COVID-19.

White House spokeswoman Kayleigh McEnany on Wednesday called the wave of new restrictions an overreach by state and local officials.

“The American people know how to protect their health,” she told Fox News in an interview. “We don’t lose our freedom in this country. We make responsible health decisions as individuals.”

(Reporting by Gabriella Borter in New York and Anurag Maan in Bengaluru; additional reporting by Susan Heavey and Maria Caspani; Editing by Rosalba O’Brien)

Pfizer ends vaccine trial with 95% success rate, paving way for a shot this year

By Michael Erman and Ludwig Burger

(Reuters) – Pfizer Inc and BioNTech could secure emergency U.S. and European authorization for their COVID-19 vaccine next month after final trial results showed it had a 95% success rate and no serious side effects, the drugmakers said on Wednesday.

The efficacy of the shot was found to be consistent across different ages and ethnicities – a promising sign given the disease has disproportionately affected the elderly and certain groups including Black people.

The U.S. Food and Drug Administration could grant emergency-use approval towards the end of the first half of December or early in the second half, BioNTech Chief Executive Ugur Sahin told Reuters TV. Conditional approval in the European Union could be secured in the second half of December, he added.

“If all goes well I could imagine that we gain approval in the second half of December and start deliveries before Christmas, but really only if all goes positively,” he said.

The success rate of the vaccine developed by U.S. firm Pfizer and Germany’s BioNTech is the highest of any candidate in late-stage clinical trials so far, and experts said it was a significant achievement in the race to end the pandemic.

Pfizer said 170 volunteers in its trial involving over 43,000 people contracted COVID-19 but 162 of them had only been given a placebo, meaning the vaccine was 95% effective. Of the 10 people who had severe COVID-19, one had received the vaccine.

“A first in the history of mankind: less than a year from the sequence of the virus to the large-scale clinical trial of a vaccine, moreover based on a whole new technique,” said Enrico Bucci, a biologist at Temple University in Philadelphia. “Today is a special day.”

BioNTech’s Sahin said the U.S. emergency authorization would be applied for on Friday.

The FDA committee tentatively plans to meet on Dec. 8-10, a source familiar with the situation said, though the dates could still change. The FDA did not respond to requests for comment.

COVID-19 RUNS RAMPANT

The final trial analysis comes a week after initial results showed the vaccine was more than 90% effective. Moderna Inc <MRNA.O> released preliminary data for its vaccine on Monday, showing 94.5% effectiveness.

The better-than-expected results from the two vaccines, both developed with new messenger RNA (mRNA) technology, have raised hopes for an end to a pandemic that has killed more than 1.3 million people and wreaked havoc upon economies and daily life.

The Pfizer-BioNTech shot was found to have 94% efficacy in people over 65 years, which experts said was crucial at a time when COVID-19 is running rampant around the world with record numbers of new cases and hospitalizations.

“This is the evidence we needed to ensure that the most vulnerable people are protected,” said Andrew Hill, senior visiting research fellow at the University of Liverpool’s department of pharmacology.

Global shares rose as the trial results countered concerns around the stubbornly high global infection rate. Pfizer shares were up 1.6% while BioNTech jumped 3.8% in the United States. By contrast, Moderna dropped 4.2%.

Investors have treated vaccine development as a race between companies, although there is likely to be global demand for as much vaccine as can be produced for the foreseeable future.

DISTRIBUTING SHOTS

Pfizer says it expects to make as many as 50 million vaccine doses this year, enough to protect 25 million people, and then produce up to 1.3 billion doses in 2021.

While some groups such as healthcare workers will be prioritized in the United States and Britain for vaccinations this year, it will be months before large-scale rollouts begin in either country.

Pfizer also has agreements with the European Union, Germany and Japan where distribution could begin next year.

Mike Ryan, the World Health Organization’s top emergency expert, said it would be at least 4-6 months before significant levels of vaccination were taking place around the world.

Distribution of a Pfizer-BioNTech shot is complicated by the need to store it at ultra-cold temperatures of -70 degrees Celsius. It can, however, be kept in a normal fridge for up to five days, or up to 15 days in a thermal shipping box.

Moderna’s vaccine can be stored for up to six months at -20C though it is expected to be stable for 30 days at normal fridge temperatures of 2 to 8 degrees Celsius (36°-46°F).

FATIGUE AND HEADACHES

Pfizer said its two-dose vaccine, called BNT162b2, was well-tolerated and that side effects were mostly mild to moderate, and cleared up quickly.

It said the only severe adverse events experienced by volunteers were fatigue and headaches. Out of 8,000 participants, 2% had headaches after the second dose while 3.8% experienced fatigue. Older adults tended to report fewer and milder adverse events.

“These are extraordinary results, and the safety data look good,” said David Spiegelhalter, a professor and expert in risk and evidence communication at the University of Cambridge.

“It would be interesting to see what adverse reactions were reported by the group getting the placebo, since that gives an idea of how much of the adverse effects are due to the vaccination process, and how much is due to the vaccine itself.”

Of the dozens of drugmakers and research groups racing to develop vaccines against COVID-19, the next data release will likely be from AstraZeneca Plc with the University of Oxford in November or December. Johnson & Johnson says it is on track to deliver data this year.

Authorization of vaccines for children will take longer. Only Pfizer has started vaccinating volunteers under the age of 18 in trials, giving shots to children as young as 12. Moderna and Johnson & Johnson have said they hope to start testing the vaccine in younger patients soon.

(Reporting by Michael Erman in Maplewood, N.J.; Additional reporting by Ankur Banerjee in Bengaluru, Caroline Humer in New York, Dan Levine in San Francisco, Elizabeth Howcroft, Kate Kelland and Josephine Mason in London, Emilio Parodi in Milan and Stephanie Nebehay in Geneva; Writing by David Clarke; Editing by Pravin Char)

Georgia Democrats Ossoff, Warnock challenge Republicans to debate in Senate runoff

By Susan Cornwell and David Morgan

WASHINGTON (Reuters) – Democratic candidates in a pair of U.S. Senate runoff races in Georgia on Monday challenged the two incumbent Republican senators to debates ahead of a Jan. 5 vote that will decide control of the Senate.

Democrat Jon Ossoff said he had accepted invitations from six media outlets to debates, and urged Republican rival Senator David Perdue to join him in the forums. He had already called Perdue a “coward” on Twitter Sunday following media reports that Perdue had declined a chance to debate on Dec. 6 at the Atlanta Press Club.

Likewise, Democrat Raphael Warnock issued a separate challenge to Republican Kelly Loeffler to three televised debates, including one at the Atlanta Press Club, also on Dec. 6.

Georgia laws require a runoff if no candidate reaches 50 percent. The Ossoff-Perdue race and the Warnock-Loeffler matchup will determine whether Republicans or Democrats lead the Senate after Democratic President-elect Joe Biden takes office.

Democrats need to win both seats to split the Senate 50-50 and give Vice President-elect Kamala Harris the tie-breaking vote. Georgia has not elected a Democratic senator since 1996, but Democratic President-elect Joe Biden narrowly leads President Donald Trump there by 49.5% to 49.2% in the recent presidential election. A recount is underway.

Perdue campaign manager Ben Fry said in a statement that there had already been two debates in the Georgia Senate race, before the first round of voting Nov. 3.

“In each (debate), Ossoff lied repeatedly … If Ossoff wants to keep lying to Georgians on TV, he will have to use his out-of-state money to pay for it,” Fry said.

There was no immediate response from Loeffler’s campaign.

Ossoff and Warnock appeared together on Sunday for the first time in the runoff campaign, urging voters to head back to the polls just two months after the presidential election. Both men have sustained attacks from their Republican opponents, and the Democrats are expected to step up their joint campaign efforts.

Their campaigns are emphasizing healthcare, COVID-19 relief and Republicans’ response to the pandemic. Perdue and Loeffler’s campaigns meanwhile accuse Warnock and Ossoff of pursuing “socialist” policies on climate change and healthcare.

At the Sunday event in Marietta, Ossoff called out Perdue for declining the Atlanta Press Club debate. “Imagine being a sitting U.S. Senator, too much of a coward to debate your opponent in public,” Ossoff declared.

Warnock, meanwhile, stressed the importance of voters returning to the polls a second time to support the Democrats, saying he had talked to a woman who voted for him on Nov. 3 and “she had no idea that she had to go back again.”

The Atlanta Press Club said in a statement that Perdue had declined to participate in the Dec. 6 debate, but Ossoff confirmed that, “we will proceed with the debate and Sen. Perdue will be represented by an empty podium.”

(Reporting by Susan Cornwell and David Morgan; Editing by Scott Malone and Aurora Ellis)

Philadelphia bans all indoor gatherings as COVID-19 surges across the United States

By Maria Caspani and Sharon Bernstein

WASHINGTON (Reuters) – The city of Philadelphia will ban indoor gatherings altogether and the nearby state of New Jersey will strictly limit their size as U.S. officials struggle to slow a COVID-19 surge that could overwhelm hospitals and kill thousands.

Philadelphia, the nation’s sixth-largest city, is strongly urging residents to shelter at home and “prohibiting indoor gatherings of any size in any location, public or private,” health commissioner Thomas Farley said at a news conference on Monday.

“We need to keep this virus from jumping from one household to another,” Farley said. If “exponential” growth of cases continues, hospitals will soon become overwhelmed and more than 1,000 people could die in Philadelphia over the next six weeks before the end of the year, he said.

In neighboring New Jersey, Governor Phil Murphy on Monday said a maximum of 10 people will be allowed to gather indoors, down from 25. On Nov. 23, the limit for outdoor gatherings will drop from 500 to 150.

“It’s gotten worse and it’s gonna get worse,” the Northeastern state’s Democratic governor said in an interview with MSNBC.

Total U.S. infections crossed the 11 million mark, just over a week after hitting 10 million, the fastest time it took the country to report an additional 1 million cases since the pandemic began. States across the nation have re-imposed restrictions to stem the resurgent virus straining many healthcare systems.

Dr. Alexander Garza, head of the St. Louis Metropolitan Pandemic Task Force, said hospitals in Missouri could run out of capacity in two weeks as cases there continue to rise.

“If this continues, we’re absolutely going to need more staff, more help, more of everything to deal with the crush of patients that we see coming at us,” Garza told CNN on Monday.

HOSPITALISATIONS ALL-TIME HIGH

Forty U.S. states have reported record increases in COVID-19 cases in November, while 20 have seen a record rise in deaths and 26 reported record hospitalizations, according to a Reuters tally of public health data.

The latest seven-day average shows the United States is reporting more than 148,000 daily cases and 1,120 daily deaths. U.S. COVID-19 hospitalizations hit an all-time high on Sunday.

In Ohio, where total cases have increased by about 17% and total hospitalizations have risen by at least 25% in the past seven days, the state’s health department issued a revised order to limit mass gatherings, which takes effect on Tuesday, Governor Mike DeWine said on Monday.

In what she called the re-enactment of the “most heightened level of statewide” coronavirus restrictions, New Mexico Governor Michelle Lujan Grisham instructed residents to stay home for two weeks beginning on Monday, among other curbs.

“We face a life-or-death situation and we cannot fail to act,” Grisham wrote on Twitter.

Michigan and Washington state on Sunday imposed sweeping new restrictions on gatherings, including halting indoor restaurant service.

MODERNA VACCINE 95% EFFECTIVE

The slew of grim records and news was partly offset by Monday’s announcement by drugmaker Moderna that its experimental vaccine was 94.5% effective in preventing COVID-19, based on interim data from a late-stage trial.

Together with Pfizer Inc’s vaccine, which is also more than 90% effective, and pending more safety data and regulatory review, the United States could have two vaccines authorized for emergency use in December with as many as 60 million doses available this year.

Dr. Anthony Fauci, a top U.S. health official, said the Moderna vaccine results were impressive but cautioned the United States could still go through a “dark winter” as COVID-19 fatigue sets in and people grow tired of restrictions.

“It’s a very serious situation,” Fauci said on NBC’s “Today” program. “But the fact that help is on the way should spur us even more to double down on some of the public health measures. … We can do it.”

(Reporting by Maria Caspani in New York and Doina Chiacu in Washington; additional reporting by Anurag Maan in Bengaluru, David Shepardson and David Lawder in Washington; Writing by Maria Caspani; Editing by Jonathan Oatis, Bill Tarrant and Aurora Ellis)