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)

Russia says its Sputnik V COVID-19 vaccine is 92% effective

By Polina Ivanova

MOSCOW (Reuters) – Russia’s Sputnik V vaccine is 92% effective at protecting people from COVID-19 according to interim trial results, the country’s sovereign wealth fund said on Wednesday, as Moscow rushes to keep pace with Western drugmakers in the race for a shot.

Russia’s results are only the second from a late-stage human trial, following on swiftly from data released on Monday by Pfizer Inc. and BioNTech, which said their shot was also more than 90% effective.

While experts said the Russian data was encouraging and reinforced the idea the pandemic could be halted by vaccines, they warned that the results were only based on a small number of trial volunteers who had contracted COVID-19.

The analysis was conducted after 20 participants developed the virus and examined how many had received the vaccine versus a placebo. That is significantly lower than the 94 infections in the trial of the vaccine being developed by Pfizer and BioNTech.

“I assume there was political pressure after the press release from Pfizer and BioNTech earlier in the week to now draw level with their own data,” said Bodo Plachter, deputy director of the Institute of Virology at the Mainz University. “What is missing for now is an analysis of statistical significance.”

To confirm the efficacy rate of its vaccine, Pfizer said it would continue its trial until there were 164 COVID-19 cases.

The Russian Direct Investment Fund (RDIF), which has been backing Sputnik V’s development, said the Russian trial would continue for six months.

Alexander Gintsburg, director of the Gamaleya Institute which developed the vaccine, said the interim results demonstrated that Sputnik V was effective and mass vaccinations would be rolled out in Russia in the coming weeks.

European stocks and U.S. stock futures extended their gains slightly after Russia’s announcement though the reaction was far more muted than after Pfizer’s results.

China’s Sinopharm, which is running large-scale late-stage clinical trials for two COVID-19 vaccine candidates, said on Wednesday that its data was better than expected, though it did not give further details.

‘NOT A COMPETITION’

Successful vaccines are seen as crucial to restoring daily life around the world by helping end the pandemic that has killed more than 1.26 million people, shuttered businesses and put millions out of work.

However, experts said knowledge about the Russian trial’s design was sparse, making it hard to interpret the data.

Scientists have raised concerns about the speed at which Moscow has worked, giving the regulatory go-ahead for the shot and launching mass vaccinations before full trials to test its safety and efficacy had been completed.

“This is not a competition. We need all trials to be carried out to the highest possible standards and it is particularly important that the pre-set criteria for un-blinding the trial data are adhered to avoid cherry picking the data,” said Eleanor Riley, a professor of immunology and infectious disease at the University of Edinburgh.

“Anything less than this risks a public loss of trust in all vaccines, which would be a disaster.”

The results are based on data from the first 16,000 trial participants to receive both shots of the two-dose vaccine.

“We are showing, based on the data, that we have a very effective vaccine,” said RDIF head Kirill Dmitriev, adding that it was the sort of news that the vaccine’s developers would talk about one day with their grandchildren.

The so-called Phase III trial of the shot is taking place in 29 clinics across Moscow and will involve 40,000 volunteers in total, with a quarter receiving a placebo shot.

The chances of contracting COVID-19 were 92% lower among people vaccinated with Sputnik V than those who received the placebo, the RDIF said.

That’s well above the 50% effectiveness threshold for COVID-19 vaccines set by the U.S. Food and Drug Administration.

The RDIF said data from the study would be published in a leading medical journal following a peer review. The results of the early-stage Russian trials were peer reviewed and published in September in The Lancet medical journal.

Experts said that as with the Pfizer results, it was not yet clear how long immunity would last after taking the Russian vaccine, nor how efficient it would be for different age groups.

“We certainly need longer-term observations to draw valid conclusions about efficacy and side effects. The same goes for Pfizer’s and BioNTech’s numbers,” said Plachter in Mainz.

As Moscow seeks partners abroad to boost output, China’s Tibet Rhodiola Pharmaceutical Holding announced a deal soon after the results to released to make, sell and test the shot in China.

SPUTNIK V

The Russian drug is named Sputnik V after the Soviet-era satellite that triggered the space race, a nod to the project’s geopolitical importance for Russian President Vladimir Putin.

Russia registered the vaccine for public use in August, the first country to do so, ahead of the start of the large-scale trial in September.

So far, it has inoculated 10,000 members of the public considered at high risk of contracting COVID-19 such as doctors and teachers, outside of the trial.

The vaccine is designed to trigger a response from two shots administered 21 days apart, each based on different viral vectors that normally cause the common cold: human adenoviruses Ad5 and Ad26.

The Pfizer and BioNTech vaccine uses messenger RNA (mRNA) technology and is designed to trigger an immune response without using pathogens, such as actual virus particles.

Russia is also testing a different vaccine, produced by the Vector Institute in Siberia, and is on the cusp of registering a third, Putin said on Tuesday, adding that all of the country’s vaccines were effective.

RDIF said as of Nov. 11 no serious side effects had been reported during the Sputnik V Phase III trial.

Some volunteers had short-term minor adverse events such as pain at the injection site, flu-like syndrome including fever, weakness, fatigue, and headache, it said.

In late October, the vaccination of new volunteers was temporarily paused due to high demand and a shortage of doses.

Russia’s deputy prime minister said on Wednesday that the Vector Institute vaccine was expected to start post-registration trials on Nov. 15.

She also said that Russia would produce 500,000 doses of Sputnik V in November, lower than a previous forecast of 800,000 doses given by Trade and Industry Minister Denis Manturov.

Russia reported 19,851 new coronavirus infections in the past 24 hours and a record high of 432 deaths. At 1,836,960, its overall case tally is the fifth largest in the world, behind the United States, India, Brazil and France.

(Reporting by Polina Ivanova; Additional reporting by Kate Kelland, Ludwig Burger, Josephine Mason and Thyagaraju Adinarayan; Editing by David Clarke)

In blow to WHO, EU seeks powers to declare health emergencies

By Francesco Guarascio

BRUSSELS (Reuters) – The European Commission on Wednesday proposed rules which would give the EU the power to declare a health emergency and stress test national plans to tackle pandemics, in a potential blow to the World Health Organization.

The move follows an often uncoordinated reaction by the 27 EU governments to the COVID-19 pandemic, which at the beginning of the crisis led to competition on vital medical gear and export bans on medicines.

It also comes after the WHO was criticized for having declared the pandemic, which first emerged in China at the end of last year, too late. The U.N. agency has repeatedly denied the accusation.

Under the proposals, the EU would be able to declare an EU-level public health emergency, which would in turn trigger more coordination among EU states.

Currently, the EU relies on the WHO to declare such an emergency.

“The new rules will enable the activation of EU emergency response mechanisms (..) without making it contingent upon the WHO’s own declaration of a Public Health Emergency of International Concern,” an EU document says, adding that such a move would be coordinated with the WHO.

If adopted, the overhaul would partly take away a major power from the WHO, as EU states call for reform of the organization to address shortfalls in emergencies.

“We relied too much on the WHO for the COVID-19 pandemic,” Peter Liese, a top EU lawmaker from German Chancellor Angela Merkel’s party, said.

“Under pressure from China, the WHO declared the health emergency too late. It is therefore very important to have the possibility to act at European level in future similar situations.”

The WHO, which the Trump administration has labelled a puppet of China, was not immediately available to comment.

COORDINATION ON VACCINES

Under the commission’s proposals, the EU would help governments prepare pandemic plans and would audit and stress test them, an EU document says.

EU states have traditionally been reluctant to give more powers to Brussels on the matter.

During the pandemic, they have applied different national measures on a series of issues, including testing policies for COVID-19 cases, quarantine rules and travel restrictions.

But they have shown good coordination on procuring vaccines.

If approved by EU governments and EU lawmakers, the commission said the proposals would be immediately applicable and could strengthen EU powers to tackle the current pandemic, in which most European countries are seeing a surge in cases.

Brussels wants to strengthen the EU public health agency, the European Centre for Disease Prevention and Control, whose non-binding advice, such as on the length of quarantine after contact with an infected person, has often been ignored.

It also wants more power for the EU Medicines Agency to prevent risks of shortages of medicines and medical devices.

Brussels also said it would unveil by the end of next year plans for a new health authority modelled after the U.S. Biomedical Advanced Research and Development Authority, which has played a vital role in procuring experimental dugs and vaccines.

(Reporting by Francesco Guarascio @fraguarascio; Editing by Alison Williams and 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)

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)