Fears of COVID-19 resurgence spread to East Coast as grim U.S. records mount

By Maria Caspani and Anurag Maan

NEW YORK (Reuters) – As COVID-19 infections, hospitalizations and deaths surge across the United States, more signs emerged that a second wave could engulf areas of the Northeast, which managed to bring the pandemic under control after being battered last spring.

In New Jersey, one of the early U.S. hotspots, a spike in cases in Newark, the state’s largest city, prompted Mayor Ras Baraka to implement aggressive measures, including a mandatory curfew for certain areas, to contain the spread of the virus.

New York state and city officials also reported a worrying rise in the seven-day average infection rate that raised the specter of stricter mitigation measures adopted at the height of the pandemic.

“This is our LAST chance to stop a second wave,” New York City Mayor Bill de Blasio wrote on Twitter on Wednesday as he announced the seven-day average positivity rate citywide was 2.52%. The city’s public school system, the largest in the country, would have to shut down if that figure reached 3%.

“We can do it, but we have to act NOW,” he said.

The United States as a whole reported more than 1,450 deaths on Tuesday, the highest single-day count since mid-August, according to a Reuters analysis.

U.S. COVID-19 cases climbed for seven days straight to reach more than 136,000 as of late Tuesday while hospitalizations, a key metric of the pandemic, crossed 60,000 for the first time since the pandemic began.

In Newark, the positivity rate hovered at 19%, more than double the state’s 7.74% seven-day average, Baraka said in a statement released on Tuesday.

“Stricter measures are required in the city’s hotspots in order to contain the virus and limit the spread,” he said.

New Jersey Governor Phil Murphy announced some restrictions on Monday in response to a rise in COVID-19 cases in the state, and outbreaks among bartenders.

New York Governor Andrew Cuomo said in a press release on Tuesday that New York’s positivity rate had climbed above 3% for the first time in weeks.

In Maryland, where the positivity rate stood at 5.6% on Wednesday, officials warned about rising COVID-19 hospitalizations. More than 800 people were being treated for the coronavirus at state hospitals as of Wednesday, according to Mike Ricci, the communications director of Governor Larry Hogan, the highest daily count since April, a Reuters tally showed.

A record number of people died of coronavirus in several Midwest and western states on Tuesday, including in Alaska, Indiana, Missouri, North Dakota, Wisconsin and Wyoming.

Officials in states hardest-hit by the virus pleaded with residents to stay home as much as possible and heed the advice of experts by wearing masks, washing their hands and social distancing.

“It’s not safe to go out, it’s not safe to have others over — it’s just not safe. And it might not be safe for a while yet,” Wisconsin Governor Tony Evers said during a primetime address on Tuesday. “So, please, cancel the happy hours, dinner parties, sleepovers and playdates at your home.”

(Reporting by Maria Caspani in New York and Anurag Maan in Bengaluru, Editing by Nick Macfie)

Moderna on track to report COVID-19 vaccine data later this month

By Manas Mishra and Dania Nadeem

(Reuters) – Moderna Inc. said on Wednesday it was on track to report early data from a late-stage trial of its experimental coronavirus vaccine later this month, and could file for U.S. emergency use authorization in early December.

The company may have to wait for a two-month follow up safety data to apply for U.S. emergency use authorization, even after reporting positive interim data on the vaccine’s effectiveness.

Moderna said it expects the safety data in the second half of this month.

Hopes of the world soon getting an effective vaccine against the virus that has killed over a million people were raised on Monday after Pfizer Inc. said its COVID-19 vaccine was more than 90% effective based on interim trial results.

There are no vaccines that have gained global approval yet, although a handful, including Moderna’s, are in late-stage studies.

It was too early to guess how effective Moderna’s vaccine could be, Chief Executive Officer Stephane Bancel said at a Credit Suisse conference.

The world would have to wait for more data to understand whether use of a particular vaccine would be more widespread, Bancel said.

Moderna, which uses a technology similar to Pfizer’s, finished enrolling 30,000 volunteers in its late-stage study last month.

Public health experts have said it is likely that more than one vaccine would be needed to control the pandemic.

(Reporting by Manas Mishra and Dania Nadeem in Bengaluru; Editing by Krishna Chandra Eluri, Saumyadeb Chakrabarty and Sriraj Kalluvila)

Q&A: Where are we in the COVID-19 vaccine race?

(Reuters) – Drugmakers and research centers around the world are working on COVID-19 vaccines, with large global trials of several of the candidates involving tens of thousands of participants well underway.

The following is what we know about the race to deliver vaccines to help end the coronavirus pandemic that has claimed over 1.26 million lives worldwide:

Who is furthest along?

U.S. drugmaker Pfizer Inc and German partner BioNTech SE were the first to release data showing on Monday that their vaccine worked in a large, late-stage clinical trial.

Russia’s sovereign wealth fund published interim late-stage trial results for its Sputnik V vaccine on Wednesday showing the shot is 92% effective at protecting people from COVID-19.

The next data releases will likely be from U.S. biotech firm Moderna Inc, possibly in November, and from Britain-based AstraZeneca Plc with the University of Oxford in November or December. Johnson & Johnson says it is on track to deliver data this year.

What happens in these trials?

The companies are testing their vaccines against a placebo – typically saline solution – in healthy volunteers to see if the rate of COVID-19 infection among those who got the vaccine is significantly lower than in those who received the dummy shot.

Why is Pfizer ahead with its data?

The trials rely on subjects becoming naturally infected with the coronavirus, so how long it takes to generate results largely depends on how pervasive the virus is where trials are being conducted. Each drugmaker has targeted a specific number of infections to trigger a first analysis of their data.

Pfizer said its interim analysis was conducted after 94 participants in the trial developed COVID-19 while Russia’s examination was conducted after 20 participants in the trial developed the disease.

AstraZeneca said last week a slowdown in infections during the summer is delaying data analysis for its UK trial.

COVID-19 cases, however, soared in October and early November, setting daily records in the United States and Europe.

How well are the vaccines supposed to work?

The World Health Organization has recommended a minimum standard for effectiveness of at least 50%. The United States and some other regulators are following that guideline – which means there must be at least twice as many infections among volunteers who received a placebo as among those in the vaccine group. The European Medicines Agency has said it may accept a lower efficacy level.

Pfizer and Russia both said their vaccines are more than 90% effective against COVID-19.

When will regulators rule on safety and efficacy?

Regulators review vaccines after companies submit applications seeking either emergency use authorization (EUA) or formal approval.

The earliest the U.S. Food and Drug Administration could make a decision is in December because Pfizer/BioNTech and Moderna do not expect to have enough safety data until the second half of November. The FDA has asked companies to watch trial participants for side effects for two months after receiving a final vaccine dose.

Regulators for Europe, the United Kingdom and Canada are considering data on a rolling basis, as it becomes available. They expect to conduct expedited reviews as well. It is not clear when companies will submit efficacy data to these agencies or when the agencies would make a decision.

Could these be the first widely available coronavirus vaccines?

Yes, although China is on a similar timeline. The country launched an emergency use program in July aimed at essential workers and others at high risk of infection that has vaccinated hundreds of thousands of people.

At least four vaccines are far along including those from China National Biotec Group (CNBG), CanSino Biologics and Sinovac. Sinovac and CNBG have said to expect early trial data as soon as November.

Russia has also given the Sputnik V vaccine developed by the Gamaleya Institute to 10,000 members of the general population considered at high risk of contracting the virus.

In late October, the director of the Gamaleya Institute, Alexander Gintsburg, said 20,000 volunteers had received the first shot so far and 9,000 the second.

(Reporting by Carl O’Donnell in New York; Additional reporting by Julie Steenhuysen in Chicago, Michael Erman in New York, Ludwig Burger in Frankfurt, Alistair Smout in London and Polina Ivanova in Moscow; Editing by Caroline Humer, Bill Berkrot, Edwina Gibbs, David Clarke and Josephine Mason)

Alarmed by soaring COVID-19 hospitalizations, some U.S. states tighten curbs

By Sharon Bernstein and Maria Caspani

SACRAMENTO (Reuters) – Several U.S. states on Tuesday imposed restrictions to curb the spread of the coronavirus as hospitalizations soared, straining hospitals and medical resources across much of the country.

The number of patients hospitalized with COVID-19 in California has risen by 32% over the past two weeks, and intensive-care admissions have spiked by 30%, Dr. Mark Ghaly, the state’s health and human services secretary, told reporters.

As a result, Ghaly announced that three counties that are home to about 5.5 million people – San Diego, Sacramento and Stanislaus – must reverse their reopening plans and go back to the most restrictive category of regulations under which indoor dining in restaurants is not allowed and gyms and religious institutions are also not permitted to hold indoor activities.

“We anticipate if things stay they way they are … over half of California counties will have moved into a more restrictive tier” by next week, Ghaly said.

In Minnesota, Governor Tim Walz announced new restrictions as the Midwestern state reported a fresh record high in daily COVID-19 hospitalizations, and medical systems in Minnesota expressed concerns about their ability to cope with the surge.

The state reported 1,224 coronavirus hospitalizations on Tuesday, up from 1,084 the previous day and a new daily record, according to a Reuters tally.

Beginning Friday, restaurants and bars in Minnesota must close dine-in services between 10 p.m. and 4 a.m., and keep the number of patrons below 50% of capacity. The governor’s order also includes private social gatherings, which must be limited to 10 people from three households or less.

“We’ve turned our dials, we’re going to have to turn them back a little bit today,” Walz told a briefing.

In Illinois, which recorded its highest number of daily cases on Tuesday with 12,626 new infections, Governor J.B. Pritzker told reporters the majority of the state’s regions were seeing higher hospitalization rates than last spring.

Faced with rampant coronavirus infections and a strained healthcare system, Iowa Governor Kim Reynolds also took steps to curb the disease’s spread by limiting the size of social gatherings and imposing a targeted mask-wearing requirement for certain situations.

U.S. Health Secretary Alex Azar expressed concern about rising hospitalizations that were straining medical facilities in areas hardest hit by the surge, and said health officials will work to set up temporary medical facilities where they might be needed.

“As you get more cases, you get more hospitalizations,” Azar said in an interview with MSNBC. “It’s just simple math.”

There were just over 59,000 COVID-19 patients in hospitals across the United States on Monday, the country’s highest number ever of in-patients being treated for the disease. Daily new infections exceeded 100,000 for the sixth consecutive day.

Hospitalizations are a key metric of how the pandemic is progressing because, unlike case counts, they are not influenced by the number of tests performed.

The harsh statistics tallied by Reuters cemented the United States’ position as the country worst affected by the coronavirus pandemic, even as drugmaker Pfizer Inc. on Monday provided some hope: successful late-stage tests of its vaccine.

U.S. infectious disease expert Anthony Fauci welcomed the Pfizer vaccine announcement but warned the winter months promise to bring more infections as people stay indoors.

Fauci said health officials were reporting more infections from small gatherings, an indication the virus is being spread by asymptomatic people.

“There are people out there, innocently and unwittingly, who are infected, don’t have any symptoms, who are infecting others,” he told MSNBC on Tuesday. “So, much more widespread testing of asymptomatic individuals is going to be very important as we enter, and go into, these months of indoor-type gathering.”

The American Health Care Association and National Center for Assisted Living warned about a spike in COVID-19 cases in nursing homes.

“As we feared, the sheer volume of rising cases in communities across the U.S., combined with the asymptomatic and pre-symptomatic spread of this virus, has unfortunately led to an increase in new COVID cases in nursing homes,” Mark Parkinson, president and chief executive of the American Health Care Association and National Center for Assisted Living, said in a statement.

Nursing homes in the hard-hit Midwest saw a 120% increase in weekly COVID-19 cases since mid-September, the group said.

(Reporting by Doina Chiacu in Washington, Anurag Maan in Bengaluru, Sharon Bernstein in Sacramento, California; additional reporting by Maria Caspani, Peter Szekely and Gabriella Borter in New York; writing by Maria Caspani; editing by Jonathan Oatis)

Europe COVID death toll tops 300,000 as winter looms and infections surge

By Shaina Ahluwalia, Anurag Maan and Roshan Abraham

(Reuters) – More than 300,000 people have died of COVID-19 across Europe, according to a Reuters tally on Tuesday, and authorities fear that fatalities and infections will continue to rise as the region heads into winter despite hopes for a new vaccine.

With just 10% of the world’s population, Europe accounts for almost a quarter of the 1.2 million deaths globally, and even its well-equipped hospitals are feeling the strain.

After achieving a measure of control over the pandemic with broad lockdowns earlier this year, case numbers have surged since the summer and governments have ordered a second series of restrictions to limit social contacts.

In all, Europe has reported some 12.8 million cases and about 300,114 deaths. Over the past week, it has seen 280,000 cases a day, up 10% from the week earlier, representing just over half of all new infections reported globally.

Hopes have been raised by Pfizer Inc’s announcement of a potentially effective new vaccine, but it is not expected to be generally available before 2021 and health systems will have to cope with the winter months unaided.

Britain, which has imposed a fresh lockdown in England, has the highest death toll in Europe at around 49,000, and health experts have warned that with a current average of more than 20,000 cases daily, the country will exceed its “worst case” scenario of 80,000 deaths.

France, Spain, Italy and Russia have also reported hundreds of deaths a day and together, the five countries account for almost three quarters of the total fatalities.

Already facing the prospect of a wave of job losses and business failures, governments across the region have been forced to order control measures including local curfews, closing non-essential shops and restricting movement.

France, the worst-affected country in the EU, has registered more than 48,700 infections per day over the past week and the Paris region’s health authority said last week that 92% of its ICU capacity was occupied.

Facing similar pressures, Belgian and Dutch hospitals have been forced to send some severely ill patients to Germany.

In Italy, which became a global symbol of the crisis when army trucks were used to transport the dead during the early months of the pandemic, daily average new cases are at a peak at more than 32,500. Deaths have been rising by more than 320 per day over the past three weeks.

While the new vaccine being developed by Pfizer and German partner BioNTech will take time to arrive, authorities are hoping that once winter is passed, it will stem further outbreaks next year.

Citi Private Bank analysts described the news as “the first major advance toward a Post-COVID world economy”.

“More than any fiscal spending package or central bank lending program, a healthcare solution to COVID has the greatest potential to restore economic activity to its full potential…” it said in a note.

European Commission President Ursula von der Leyen on Monday said the European Union would soon sign a contract for 300 million doses of the vaccine, just hours after the drugmaker announced promising late-stage trials.

Yet health experts cautioned that the vaccine, should it be approved, was no silver bullet – not least because the genetic material it’s made from needs to be stored at temperatures of minus 70 degrees Celsius (-94 F) or below.

Such requirements pose a challenge for countries in Asia, as well as Africa and Latin America, where intense heat is often compounded by poor infrastructure.

(Reporting by Anurag Maan, Shaina Ahluwalia, Chaithra J and Roshan Abraham in Bengaluru, Sujata Rao-Coverley in London; editing by Jane Wardell, James Mackenzie, Nick Macfie and Mike Collett-White)

Fed’s Kaplan concerned about next six months as virus surges

By Ann Saphir

(Reuters) – Dallas Federal Reserve President Robert Kaplan said on Tuesday he was “cautious and concerned” about downside economic risks in the short run because of the resurgence of the coronavirus, but more optimistic in the longer term.

“The next two quarters are going to be very challenging, very difficult,” Kaplan told Bloomberg’s Future of Finance virtual conference. “Downside risks are growing with this resurgence.”

Still, he said, the U.S. economy will likely rebound strongly in the second half of next year, after a vaccine is widely available, adding that his business contacts have told him they are gearing up for exactly that.

The United States is experiencing a rise in cases, hospitalizations and deaths from COVID-19, with some state and local governments re-imposing restrictions to slow the spread.

With millions of out-of-work Americans dipping into savings built with government aid distributed earlier this year, Kaplan said, household income and spending will drop off “at some point” unless more fiscal aid is forthcoming.

Aid to small businesses in the form of a renewed Paycheck Protection Program would be particularly helpful, he said, because while financial conditions are broadly fairly loose, that is not the case for smaller businesses that rely on banks for credit.

“While we are in the teeth of the pandemic I believe we need to do what we need to do to fight the pandemic,” Kaplan said in a separate event sponsored by UT Dallas.

As long as the pandemic is ongoing, the U.S. central bank should not back away from its programs supporting economic growth, which include bond purchases totaling $120 billion a month and lending programs to corporate America, he said.

Once it subsides, he said, the U.S. will need to moderate government debt.

(Reporting by Ann Saphir; Editing by Paul Simao and Chizu Nomiyama)

U.S. has a plan to start Pfizer vaccine shots in December: Health Secretary Azar

By Doina Chiacu and Deena Beasley

WASHINGTON (Reuters) – If Pfizer Inc. submits the positive initial data from its COVID-19 vaccine trial to health regulators as quickly as expected, the U.S. government plans to begin vaccinating Americans in December, Health Secretary Alex Azar said on Tuesday.

Pfizer on Monday said the vaccine it has been developing with German partner BioNTech SE was 90% effective against COVID-19, based on an early look at results from its large, late-stage trial.

The U.S. drugmaker said it expects to have safety data as soon as next week that it needs to apply for emergency use authorization (EUA) with the U.S. Food and Drug Administration.

Upon FDA authorization, the United States would receive about 20 million doses of the Pfizer vaccine per month, Azar said on a call with reporters, noting that HHS could being procuring supplies at the end of this month.

The United States has a $1.95 billion contract for 100 million doses of the Pfizer vaccine – enough to inoculate 50 million people – with an option to acquire 500 million more.

Earlier on Tuesday, Azar said on CNBC that final decisions are subject to a close look at the vaccine efficacy data.

Based on recommendations to the government, it will likely start with inoculations of the elderly in nursing homes and assisted living facilities, healthcare workers and first responders, with a goal to complete those shots by the end of January.

Top U.S. infectious disease expert Anthony Fauci also said in an interview with MSNBC that he expects the doses of the vaccine to be available for certain high priority groups in December.

Azar said he anticipates there will soon be more vaccines to protect against COVID-19 from other companies, including Moderna Inc <MRNA.O>, which is expected to announce interim results of a large trial of its experimental vaccine at the end of the month.

“By the end of March, early April, we expect to have enough for every American who would like to be vaccinated,” Azar told CBNC.

ANTIBODY DRUG DISTRIBUTION

Azar also said the U.S. government would begin distribution of Eli Lilly and Co’s antibody treatment this week, starting first in areas with the highest numbers of hospitalized COVID-19 patients and overall cases.

The treatment, which is administered by infusion, received an EUA on Monday.

“We’ll ensure equitable distribution, and we’ll work tightly with our governors,” Azar said. He said the government will use the same process employed to distribute remdesivir, an antiviral drug from Gilead Sciences Inc used to treat people hospitalized with COVID-19.

According to the Health and Human Services website, the agency will ship more than 79,000 doses of the antibody therapy this week, with the largest number going to Wisconsin, Texas, California, and Illinois.

The United States has purchased 300,000 doses of the treatment for this year and has an option to buy an additional 650,000 doses next year.

Azar said health officials and Eli Lilly were exploring ways to provide the treatment outside of hospitals, including through outpatient infusion centers.

Fauci described the Lilly treatment as “an important first step in the development and distribution of interventions that are given early in the course of disease.”

(Reporting by Doina Chiacu in Washington, Caroline Humer and Carl O’Donnell in New York, Deena Beasley in Los Angeles and Manojna Maddipatla in Bengaluru; Editing by Andrew Heavens, Alexandra Hudson and Bill Berkrot)

One in five COVID-19 patients develop mental illness within 90 days: study

By Kate Kelland

LONDON (Reuters) – Many COVID-19 survivors are likely to be at greater risk of developing mental illness, psychiatrists said on Monday, after a large study found 20% of those infected with the coronavirus are diagnosed with a psychiatric disorder within 90 days.

Anxiety, depression and insomnia were most common among recovered COVID-19 patients in the study who developed mental health problems. The researchers from Britain’s Oxford University also found significantly higher risks of dementia, a brain impairment condition.

“People have been worried that COVID-19 survivors will be at greater risk of mental health problems, and our findings … show this to be likely,” said Paul Harrison, a professor of psychiatry at Oxford.

Doctors and scientists around the world urgently need to investigate the causes and identify new treatments for mental illness after COVID-19, Harrison said.

“(Health) services need to be ready to provide care, especially since our results are likely to be underestimates (of the number of psychiatric patients),” he added.

The study, published in The Lancet Psychiatry journal, analyzed electronic health records of 69 million people in the United States, including more than 62,000 cases of COVID-19. The findings are likely to be the same for those afflicted by COVID-19 worldwide, the researchers said

In the three months following testing positive for COVID-19, 1 in 5 survivors were recorded as having a first time diagnosis of anxiety, depression or insomnia. This was about twice as likely as for other groups of patients in the same period, the researchers said.

The study also found that people with a pre-existing mental illness were 65% more likely to be diagnosed with COVID-19 than those without.

Mental health specialists not directly involved with the study said its findings add to growing evidence that COVID-19 can affect the brain and mind, increasing the risk of a range of psychiatric illnesses.

“This is likely due to a combination of the psychological stressors associated with this particular pandemic and the physical effects of the illness,” said Michael Bloomfield, a consultant psychiatrist at University College London.

Simon Wessely, regius professor of psychiatry at King’s College London, said the finding that those with mental health disorders are also at higher risk of getting COVID-19 echoed similar findings in previous infectious disease outbreaks.

“COVID-19 affects the central nervous system, and so might directly increase subsequent disorders. But this research confirms that is not the whole story, and that this risk is increased by previous ill health,” he said.

Marjorie Wallace, chief executive of the UK mental health charity SANE, said the study echoed her charity’s experience during the pandemic.

“Our helpline is dealing with an increasing number of first-time callers who are being triggered into mental health problems, as well as those who are relapsing because their fear and anxiety have become intolerable,” she said.

(Reporting by Kate Kelland; Editing by Bill Berkrot and Angus MacSwan)

Highly effective vaccine, new warning signs, disrupted heart rhythm

By Nancy Lapid

(Reuters) – The following is a roundup of some of the latest scientific studies on the novel coronavirus and efforts to find treatments and vaccines for COVID-19, the illness caused by the virus.

Pfizer vaccine appears highly effective

An experimental COVID-19 vaccine from Pfizer Inc and BioNTech SA appears to be more than 90% effective, based on data analyzed midway through a gold-standard clinical trial, the companies announced on Monday. The trial has enrolled 43,538 participants so far, including many from racially and ethnically diverse backgrounds. Pfizer said researchers had analyzed 94 confirmed cases of COVID-19 in trial participants and found the vast majority of the infections were in volunteers in the placebo group. The trial is expected to continue until 164 confirmed cases of COVID-19 are available for analysis. BioNTech’s co-founder and chief executive said he was optimistic that the protective effect of the experimental COVID-19 vaccine would last for at least a year.

New study adds to COVID-19 symptom list

Fever, coughing, and shortness of breath are known symptoms of COVID-19, but other warning signs can include weakness, poor blood sugar control and gastrointestinal complaints, according to a new study published on Saturday in the American Journal of Emergency Medicine. Researchers analyzed nearly 12,000 visits by adult patients to emergency departments at five New York City hospitals. They found COVID-19 in 57.5% of patients who went to the hospital because of weakness, falls, or altered mental status, in 55.5% of those who came in because their blood sugar was out of control, and in 51.4% of patients whose chief complaint was a gastrointestinal problem. Patients over the age of 65 tended to have more atypical complaints such as diarrhea, fatigue and weakness. Patients with dehydration, altered mental status, falls and high blood sugar were at higher risk for death in the study. The new findings can help hospitals provide better care and are “also important for family members and people that work with the elderly to better identify possible warning signs of COVID-19 infection,” coauthor Dr. Christopher Clifford of the Icahn School of Medicine at Mount Sinai told Reuters.

COVID-19 can fuse heart cells, disrupt rhythm

COVID-19 can disrupt the heart’s electric system, according to a report undergoing peer review at a Nature Research journal. The heart pumps blood by sending electrical signals through its “conducting cells” to tell “muscle cells” to contract. Normally, each conducting cell activates the one next to it in a domino effect to ensure smooth contractions. An autopsy of a COVID-19 patient found the virus had infected her heart in an unusual patchy pattern, “with small islands of infected cells here and there,” Dr. Jay Schneider of the Mayo Clinic in Rochester, Minnesota told Reuters. Upon further study in the laboratory, his team realized the spike protein on the surface of the new coronavirus can create holes between neighboring cells, causing them to fuse together. So instead of orderly electrical signal transmission and a steady heart rhythm, the signals flow like “a tsunami tidal wave” through the fused cells.

(Reporting by Nancy Lapid; Editing by Tiffany Wu)

New U.S. COVID-19 cases up 34% last week, set fresh records

By Michael Erman and Julie Steenhuysen

(Reuters) – Pfizer Inc’s experimental COVID-19 vaccine is more than 90% effective based on initial trial results, the drugmaker said on Monday, a major victory in the war against a virus that has killed over a million people and battered the world’s economy.

Experts welcomed the first successful interim data from a large-scale clinical test as a watershed moment that showed vaccines could help halt the pandemic, although mass roll-outs, which needs regulatory approval, will not happen this year.

Pfizer and German partner BioNTech SE said they had found no serious safety concerns yet and expected to seek U.S. authorization this month for emergency use of the vaccine, raising the chance of a regulatory decision as soon as December.

If granted, the companies estimate they can roll out up to 50 million doses this year, enough to protect 25 million people, and then produce up to 1.3 billion doses in 2021.

“Today is a great day for science and humanity,” said Pfizer Chief Executive Albert Bourla.

“We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen,” he said.

Experts said they still wanted to see the full trial data, which have yet to be peer-reviewed or published in a medical journal, but the preliminary results looked encouraging.

“This news made me smile from ear to ear. It is a relief to see such positive results on this vaccine and bodes well for COVID-19 vaccines in general,” said Peter Horby, professor of emerging infectious diseases at the University of Oxford.

There are still many questions, such as how effective the vaccine is by ethnicity or age, and how long it will provide immunity, with the “new normal” of social distancing and face covering set to remain for the foreseeable future.

Pfizer expects to seek U.S. emergency use authorization for people aged 16 to 85. To do so, it will need two months of safety data from about half the study’s 44,000 participants, which is expected in the third week of November.

U.S. Health and Human Services Secretary Alex Azar said it would take several weeks for U.S. regulators to receive and process data on the vaccine before the government could potentially approve it.

MARKETS SURGE

The prospect of a vaccine electrified world markets with the S&P 500 and Dow hitting record highs as shares of banks, oil companies and travel companies soared. Shares in companies that have thrived during lockdowns, such as conferencing platform Zoom Video and online retailers, tumbled.

Pfizer shares jumped more than 11% to their highest since July last year, while BioNTech’s stock hit a record high.

Shares of other vaccine developers in the final stage of testing also rose with Johnson & Johnson up 4% and Moderna Inc, whose vaccine uses a similar technology as the Pfizer shot, up 8%. Britain’s AstraZeneca, however, fell 2%. Moderna is expected to report results from its large-scale trial later this month.

“The efficacy data are really impressive. This is better than most of us anticipated,” said William Schaffner, infectious diseases expert at Vanderbilt University School of Medicine in Nashville, Tennessee. “The study isn’t completed yet, but nonetheless the data look very solid.”

U.S. President Donald Trump welcomed the test results, and the market boost: “STOCK MARKET UP BIG, VACCINE COMING SOON. REPORT 90% EFFECTIVE. SUCH GREAT NEWS!” he tweeted.

President-elect Joe Biden said the news was excellent but did not change the fact that face masks, social distancing and other health measures would be needed well into next year.

The World Health Organization said the results were very positive, but warned there was a funding gap of $4.5 billion that could slow access to tests, medicines and vaccines in low- and middle-income countries.

‘NEAR ECSTATIC’

“I’m near ecstatic,” Bill Gruber, one of Pfizer’s top vaccine scientists, said in an interview. “This is a great day for public health and for the potential to get us all out of the circumstances we’re now in.”

Between 55% and 65% of the population will need to be vaccinated to break the dynamic of the spread of COVID-19, said Germany’s health minister Jens Spahn, adding that he did not expect a shot to be available before the first quarter of 2021.

The European Union said on Monday it would soon sign a contract for up to 300 million doses of the Pfizer and BioNTech COVID-19 vaccine.

The companies have a $1.95 billion contract with the U.S. government to deliver 100 million vaccine doses beginning this year. They did not receive research funding from the Trump administration’s Operation Warp Speed vaccine program.

The drugmakers have also reached supply agreements with the United Kingdom, Canada and Japan.

Pfizer said the interim analysis, conducted after 94 participants in the trial developed COVID-19, examined how many had received the vaccine versus a placebo.

Pfizer did not break down how many of those who fell ill received the vaccine. Still, over 90% effectiveness implies that no more than 8 of the 94 had been given the vaccine, which was administered in two shots about three weeks apart.

The efficacy rate, which could drop once full results are available, is well above the 50% effectiveness required by the U.S. Food and Drug Administration for a coronavirus vaccine.

Shortly after Pfizer’s announcement, Russia said its Sputnik V vaccine was also more than 90% effective, based on data collated from inoculations of the public. Its preliminary Phase III trial data is due to be published this month.

MORE DATA NEEDED

To confirm the efficacy rate, Pfizer said it would continue its trial until there were 164 COVID-19 cases among volunteers. Bourla told CNBC on Monday that based on rising infection rates, the trial could be completed before the end of November.

Pfizer said its data would be peer reviewed once it has results from the entire trial.

“These are interesting first signals, but again they are only communicated in press releases,” said Marylyn Addo, head of tropical medicine at the University Medical Center Hamburg-Eppendorf in Germany.

Dozens of drugmakers and research groups around the globe have been racing to develop vaccines against COVID-19, which on Sunday exceeded 50 million cases since the new coronavirus first emerged late last year in China.

The Pfizer and BioNTech vaccine uses messenger RNA (mRNA) technology, which relies on synthetic genes that can be generated and manufactured in weeks, and produced at scale more rapidly than conventional vaccines. The technology is designed to trigger an immune response without using pathogens, such as actual virus particles.

The Trump administration has said it will have enough vaccine doses for all of the 330 million U.S. residents who want it by the middle of 2021.

(Reporting by Michael Erman and Julie Steenhuysen; Additional reporting by Michele Gershberg in New York, Ludwig Burger and Patricia Weiss in Frankfurt and Kate Kelland in London; Editing by Bill Berkrot, Caroline Humer, Edwina Gibbs and David Clarke)