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)

FDA’s emergency approval of blood plasma as COVID-19 treatment on hold: NYT

(Reuters) – The emergency approval of blood plasma as a potential COVID-19 treatment by the U.S. Food and Drug Administration has now been put on hold, the New York Times reported on Wednesday, citing two senior administration officials.

A group of top federal health officials including Anthony Fauci have argued that the emerging data on the treatment was too weak, the report said, adding that an emergency approval could still be granted in the near future.

The authorization is on hold for now as more data is reviewed, the NYT reported, citing Clifford Lane, the clinical director at the National Institute of Allergy and Infectious Diseases, part of the National Institute of Health.

The FDA and NIH did not immediately respond to Reuters’ requests for comment.

People who survive an infectious disease like COVID-19 are left with blood plasma containing antibodies, or proteins the body’s immune system created, to fight off a virus. This can be transfused into newly infected patients to try to aid recovery.

An FDA emergency-use authorization could allow faster access to a therapy for the pandemic.

(Reporting by Trisha Roy in Bengaluru; Editing by Saumyadeb Chakrabarty)

State attorneys general urge U.S. government to increase supply, lower price of remdesivir

(Reuters) – A bipartisan coalition of attorneys general on Tuesday urged the U.S. government to use its legal authority to increase the availability and lower the price of Gilead Sciences’ COVID-19 treatment, remdesivir.

Gilead has priced remdesivir, the antiviral drug at the forefront of the battle against the pandemic, at $2,340 per patient for wealthier nations and said will charge U.S. patients with commercial insurance, $3,120 per course, or $520 per vial.

The United States signed a deal with Gilead in June for more than 500,000 courses of the treatment, which shortened hospital recovery time in a U.S. trial, making up most of the company’s output through September.

In a letter sent to the U.S. health agencies, the coalition led by Louisiana Attorney General Jeff Landry and California Attorney General Xavier Becerra urged the federal government to ensure Americans can afford and have reasonable access to sufficient supply of remdesivir during this pandemic.

Under the Bayh-Dole Act, the National Institutes of Health and the U.S. Food and Drug Administration have the authority to license remdesivir to third-party manufacturers to scale up production and distribution and ensure its availability at a reasonable price, according to the letter.

Gilead was not immediately available for comment.

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

U.S. Supreme Court’s Ginsburg undergoing treatment for cancer recurrence

By Andrew Chung

(Reuters) – Justice Ruth Bader Ginsburg, at 87 the U.S. Supreme Court’s oldest member, said on Friday she is receiving chemotherapy treatment for a recurrence of cancer – the latest in a series of health issues – but indicated no intention to retire.

In a statement released by the court, Ginsburg said that a periodic scan in February, followed by a biopsy, revealed lesions on her liver. She said she is tolerating the chemotherapy treatment well and that it is yielding positive results. She said she began her chemotherapy on May 19.

“I have often said I would remain a member of the Court as long as I can do the job full steam. I remain fully able to do that,” Ginsburg said.

The health of Ginsburg, the court’s senior liberal member, is closely watched because a Supreme Court vacancy could give Republican President Donald Trump the opportunity to appoint a third justice to the nine-member court and move it further to the right. The court currently has a 5-4 conservative majority including two justices appointed by Trump – Brett Kavanaugh in 2018 and Neil Gorsuch in 2017.

On Wednesday, Ginsburg was released from a hospital in Baltimore after treatment for a possible infection. She underwent a procedure at Johns Hopkins Hospital to clean a bile duct stent that was inserted last August. Ginsburg said recent hospitalizations to remove gall stones and treat an infection were unrelated to this cancer recurrence.

Ginsburg experienced a bout with lung cancer in 2018 and pancreatic cancer in 2019. She had previously been treated for pancreatic cancer in 2009 and colon cancer in 1999. In May, she underwent non-surgical treatment for a gallstone that had caused an infection.

In this latest cancer fight, Ginsburg said, immunotherapy proved unsuccessful, but with chemotherapy her most recent scan on July 7 indicated “significant reduction of the liver lesions” and no new disease.

“Satisfied that my treatment course is now clear, I am providing this information,” Ginsburg added.

Ginsburg said she has been able to keep up with her work at the court, including writing opinions in cases, throughout the treatment course. “I will continue bi-weekly chemotherapy to keep my cancer at bay, and am able to maintain an active daily routine,” she added.

Ginsburg is the second-longest serving among the current nine justices behind Clarence Thomas, having been appointed to a lifetime post on the court by President Bill Clinton in 1993. She was the second woman ever named to the court, after Justice Sandra Day O’Connor was appointed 12 years earlier.

A trail-blazing lawyer who won gender equality cases at the Supreme Court in the 1970’s, as a justice she has provided key votes in landmark rulings securing equal rights for women, expanding gay rights and safeguarding abortion rights.

(Reporting by Andrew Chung; Editing by Will Dunham)

U.S. signs $450 million contract with Regeneron for COVID-19 therapy

By Manojna Maddipatla

(Reuters) – The U.S. government signed a $450 million contract with Regeneron Pharmaceuticals Inc for its potential COVID-19 antibody cocktail, the drug maker said on Tuesday.

The agreement, the first by the Trump administration to support a therapy, comes under the government’s “Operation Warp Speed” program that is aimed at faster distribution of vaccines and treatments to fight the new coronavirus when trials are successful.

The United States is also funding manufacturing and several trials for potential vaccines and has rushed to secure billions of doses of the vaccines being tested by companies around the world.

Earlier in the day, Novavax Inc received a $1.6 billion grant, the biggest award yet from Operation Warp Speed, to cover testing, manufacturing and sale of a potential coronavirus vaccine.

Under the contract with Regeneron, signed with the HHS’ Biomedical Advanced Research and Development Authority and the Department of Defense, the doses manufactured under the project will be owned by the federal government.

Regeneron’s cocktail, REGN-COV2, contains an antibody made by the company and another isolated from recovered COVID-19 patients. Rivals Eli Lilly and AbbVie are also pursuing antibody therapies for the respiratory illness.

REGN-COV2 is being tested separately for both preventing and treating COVID-19, with a late-stage prevention trial being run jointly with the National Institutes of Health.

The agreement covers a fixed number of bulk lots intended to be completed in the fall of 2020, Regeneron said.

A range of 70,000 to 300,000 potential treatment doses or 420,000 to 1,300,000 prevention doses are expected to be available from these lots, with initial doses to be ready as early as end of summer.

The U.S. government would make the doses available to Americans at no cost, if EUA or product approval is granted, Regeneron said.

Shares of Regeneron were up 1.4% at $636.11. They have risen 67% so far this year.

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

Florida moves to ease coronavirus lockdown as promising treatment emerges

By Zachary Fagenson and Jessica Resnick-Ault

MIAMI (Reuters) – The governor of Florida, among the last to lock down his state against the U.S. coronavirus outbreak, announced on Wednesday he would permit a limited economic reopening next week while leaving restraints intact for the dense greater-Miami area.

Florida became the latest, and one of the two largest, of about a dozen states forging ahead to ease crippling restrictions on business activity without vastly expanded virus testing and other safeguards that medical experts recommend should be in place first.

“There is a light at the end of the tunnel,” Governor Ron DeSantis said as he unveiled his “phase-one” plan for relaxing mandatory workplace closures and stay-at-home orders imposed four weeks ago.

Earlier in the week his counterpart in Texas, Greg Abbott, another governor closely aligned with fellow Republican President Donald Trump, announced a similar economic reopening strategy due to go into effect on Friday.

As questions lingered over when and how to loosen social-distancing rules employed as the chief weapon against a highly contagious virus with no vaccine, word emerged from Washington on Wednesday of a promising new treatment for the disease.

The U.S. government’s top infectious-disease official, Dr. Anthony Fauci, said the experimental antiviral drug remdesivir, from pharmaceutical maker Gilead Sciences Inc, had proven effective in a key clinical trial.

With preliminary results showing patients recovering 31% faster with the drug than with a placebo, remdesivir will become the standard of care for treating COVID-19, the potentially deadly lung disease caused by the novel coronavirus, Fauci told reporters at the White House.

He called the development “highly significant.” The U.S. Food and Drug Administration said it was in talks with Gilead about making the drug available to patients as quickly as possible.

MIXED NEWS

At the same time, a senior Trump administration official confirmed reports of an escalated campaign by federal agencies to speed development of a coronavirus vaccine, with the goal of securing 100 million doses by the end of this year.

The encouraging news on the medical front contrasted with ominous new Commerce Department data showing the nation’s gross domestic product contracted at an annualized rate of nearly 5% in the first quarter – its sharpest such drop since the 2007-2009 collapse – to end the longest expansion in U.S. history.

With millions of Americans out of jobs since the lockdowns went into effect and no overall federal plan beyond general guidelines issued by the White House on April 16, states and cities have come under mounting pressure to ease restrictions on as the outbreak appeared to be waning.

Public health experts have urged caution, saying that a curtailment of social distancing without large-scale virus testing or the means to trace close contacts of infected individuals could trigger a second wave of infections.

U.S. deaths from the novel coronavirus topped 60,000 on Wednesday – eclipsing the number of American lives lost during the Vietnam war – and the outbreak will soon be deadlier than any influenza season since 1967, according to a Reuters tally.

The toll has given many business owners pause about reopening, but others are ready.

“I want my business to open, but I want a healthy balance,” said Holly Smith, 48, whose Designer Dawgs restaurant in Hunterdon County, New Jersey, currently offers only takeout. But she added: “I feel like we’ve gone about this the wrong way. We’ve sheltered in place too long.”

New Jersey Governor Phil Murphy said he would reopen state parks and golf courses to recreation starting Saturday. In Michigan, Governor Gretchen Whitmer said she would allow construction work to resume on May 7.

FLORIDA’S LIMITED REOPENING

Under the reopening plan in Florida, where COVID-19 has killed over 1,200 people, DeSantis said retail merchants and restaurants could open on Monday, with indoor patronage limited to 25% of capacity.

Eateries may also reopen outdoor seating with appropriate social distancing, and medical practices can resume elective surgeries and procedures. But movie theaters, bars and fitness clubs will remain shuttered for the time being, he said.

The governor left existing restrictions in place across Miami-Dade, Broward and Palm Beach counties – the three most highly populated in the state.

DeSantis had drawn criticism for waiting until April 2 to clamp down on commerce – after most other states had already done so – in part because of Florida’s high proportion of elderly residents – more than a fifth are age 65 and over – who are especially vulnerable to the virus.

But Florida, a key swing electoral swing state, has avoided the worst of the health crisis seen in other states such as New York and New Jersey, and DeSantis said he would take a measured approach to further reopening.

“Part of our strategy in phase one is to expand testing,” DeSantis said.

But Florida Democratic Party Chair Terrie Rizzo criticized the governor’s plan as lacking details on how he would quickly increase the state’s virus screening, which Rizzo said ranked 22nd in COVID-19 tests per capita among all 50 U.S. states.

Other Florida Democrats questioned why the governor made no mention of the state’s beleaguered unemployment system that collapsed as hundreds of thousands of residents sought benefits in the early days of the pandemic lockdown.

(Reporting by Zach Fagenson in Miami; Additional reporting by Maria Caspani, Barbara Goldberg and Jessica Resnick-Ault in New York and Susan Heavey and Doina Chiacu in Washington; Writing by Sonya Hepinstall and Steve Gorman; Editing by Bill Tarrant and Cynthia Osterman)

Ebola fight has new science but faces old hurdles in restive Congo

A doctor cares for a patient inside an isolate cube at The Alliance for International Medical Action (ALIMA) treatment center in Beni, North Kivu province of the Democratic Republic of Congo September 6, 2018. REUTERS/Fiston Mahamba

By Fiston Mahamba

BENI, Democratic Republic of Congo (Reuters) – When Esperance Nzavaki heard she was cured of Ebola after three weeks of cutting-edge care at a medical center in eastern Democratic Republic of Congo, she raised her arms to the sky with joy and praised the Lord.

Her recovery is testament to the effectiveness of a new treatment, which isolates patients in futuristic cube-shaped mobile units with transparent walls and gloved access, so health workers no longer need to don cumbersome protective gear.

“I started to feel sick, with a fever and pain all over my body. I thought it was typhoid. I took medicine but it didn’t work,” Nzavaki told Reuters in Beni, a city of several hundred thousand, where officials are racing to contain the virus.

“Then an ambulance came and brought me to hospital for Ebola treatment. Now I praise God I’m healed.”

The fight against Ebola has advanced more in recent years than in any since it was discovered near the Congo River in 1976. When the worst outbreak killed 11,300 people in West Africa in 2013-2016, there was no vaccine and treatment amounted to little more than keeping patients comfortable and hydrated.

Now there’s an experimental vaccine manufactured by Merck which already this year helped quash an earlier outbreak of this strain of the virus on the other side of the country in under three months. And there are the cube treatment centers, pioneered by the Senegalese medical charity, ALIMA.

“With this system … where there are not people donning masks, the patients feel reassured and perceive that there is life here,” said Claude Mahoudeau, the coordinator of ALIMA’s treatment center in Beni.

In addition, three experimental treatments have been rolled out for the first time, offering patients additional reason to hope that their diagnosis is not a death sentence.

Yet even the smartest science can do little about the marauding rebel groups and widespread fear and mistrust that could yet scupper efforts to contain Congo’s tenth outbreak of the deadly haemorrhagic fever.

The latest outbreak is so far believed to have killed 90 people since July and infected another 40.

The stakes are high, not just for health reasons. Ebola could complicate Congo’s first democratic change of power, the holding of a Dec. 23 election to replace President Joseph Kabila that is already two years late.

FILE PHOTO: Congolese officials and the World Health Organization officials wear protective suits as they participate in a training against the Ebola virus near the town of Beni in North Kivu province of the Democratic Republic of Congo, August 11, 2018. REUTERS/Samuel Mambo

FILE PHOTO: Congolese officials and the World Health Organization officials wear protective suits as they participate in a training against the Ebola virus near the town of Beni in North Kivu province of the Democratic Republic of Congo, August 11, 2018. REUTERS/Samuel Mambo

REBELLION, FEAR, MISTRUST

The affected North Kivu and Ituri provinces have been a tinder box of armed rebellion and ethnic killing since two civil wars in the late 1990s. Some areas near the epicenter require armed escorts to reach because of insecurity. Two South African peacekeepers there were wounded in a rebel ambush last week.

And last week, authorities confirmed the first death from Ebola in the major trading hub of Butembo, a city of almost a million near the border with Uganda, dampening hopes that the virus was being brought under control.

Insecurity aside, the biggest challenges the government faces could be panic and downright denial, as they were during the catastrophic West Africa outbreak.

“Ebola does not exist in Beni,” resident Tresor Malala said, shaking his head. “For a long time, people got sick with fever, diarrhea, vomiting and they healed. Now someone gets a fever, they get sent to the Ebola treatment center and then they die.”

Taxi driver Mosaste Kala was equally skeptical: “The only people dying are the ones going to the … treatment center.”

Tackling these perceptions will be crucial if authorities are to halt the epidemic.

At a news conference on Saturday, Health Minister Oly Ilunga Kalenga admitted that “community resistance is the first challenge to the response to the epidemic”.

In the district of Ndindi, in Beni, Ebola is spreading due to the community’s reluctance to cooperate with health workers, the ministry says. Some locals have hidden sick relatives or refused to be vaccinated.

The problem, says school teacher Alain Mulonda, many of whose pupils were being kept at home by anxious parents, is that locals have little understanding of Ebola.

“If the population of Beni continues to show this distrust,” he said, “this disease will consume the whole town.”

(Additional reporting by Amedee Mwarabu in Kinshasa and Aaron Ross in Dakar; Writing by Alessandra Prentice; Editing by Tim Cocks, David Evans and Peter Graff)

More than 18 million on AIDS treatment a million more than 2015

A nurse (L) hands out a red ribbon to a woman, to mark World Aids Day, at the entrance of Emilio Ribas Hospital, in Sao Paulo

By Kate Kelland

LONDON, Nov 21 – More than 18 million people now have access to life-saving AIDS treatment, 1.2 million more than at the end of last year, the United Nations said on Monday.

In a report on the AIDS pandemic, which has infected 78 million people and killed 35 million since it began in the 1980s, UNAIDS said the consistently strong scale-up of treatment has seen annual AIDS-related deaths drop by 45 percent to 1.1 million in 2015 from a peak of about 2 million in 2005.

But, as more HIV-positive people live longer, the challenges of caring for them as they get older, of preventing the virus spreading and of reducing new infections are tough, UNAIDS said, even though drugs can reduce virus levels in a patient’s blood to near zero and significantly reduce the risk of passing it on.

“The progress we have made is remarkable, particularly around treatment, but it is also incredibly fragile,” UNAIDS’ executive director Michel Sidibe said as the report was published.

With detailed data showing some of the many complexities of the HIV epidemic, the report found that people are particularly vulnerable to HIV at certain points in their lives.

It called for “life-cycle” approach to offer help and prevention measures for everyone at every stage of life.

As people with HIV grow older, they are at risk of developing long-term side-effects from HIV treatment, developing drug resistance and requiring treatment for other illnesses such as tuberculosis and hepatitis C.

The report also cited data from South Africa showing that young women who become infected with HIV often catch the virus from older men. It said prevention is vital to ending the epidemic in young women and the cycle of HIV infection needs to be broken.

“Young women are facing a triple threat,” said Sidibe. “They are at high risk of HIV infection, have low rates of HIV testing, and have poor adherence to treatment.”

The report, saying the number of people with HIV getting life-saving drugs was 18.2 million, also showed that the rapid progress in getting AIDS drugs to those who need them is having a significant life-extending impact.

In 2015, there were 5.8 million people aged over 50 living with HIV – more than ever before.

UNAIDS said that if treatment targets are reached – the U.N. is aiming to have 30 million HIV positive people on treatment by 2020 – that number will soar.

(Editing by Louise Ireland)