Fauci to testify before U.S. House COVID-19 panel after being blocked by White House

By David Morgan

WASHINGTON (Reuters) – Dr. Anthony Fauci, the top U.S. infectious disease expert, will testify on Friday before a coronavirus subcommittee in Congress, weeks after President Donald Trump’s administration first refused to let him address the panel.

Fauci’s testimony comes at the end of a week when the pandemic’s tragic toll on the country has become far clearer. The United States on Wednesday experienced its 150,000th death from the disease — more than any other country — and data on Thursday showing a deep economic plunge.

Democrats said the Trump administration initially prevented Fauci from testifying to the panel by saying he was unavailable for the entire month of July and relented only after House Majority Whip James Clyburn wrote to Vice President Mike Pence.

A veteran of six Republican and Democratic administrations, Fauci has become the most familiar face of the administration’s coronavirus task force.

This week, Trump, who has often bristled against scientists’ advice on responding to the pandemic, bemoaned the degree to which Fauci is admired, saying “nobody likes me. It can only be my personality.”

U.S. Centers for Disease Control and Prevention Director Dr. Robert Redfield and Admiral Brett Giroir, assistant secretary at the Department of Health and Human Services, are also scheduled to testify before the Select Subcommittee on the Coronavirus Crisis.

Headed by Clyburn, the subcommittee was created this year to monitor the trillions of dollars approved by Congress to help the United States weather the health and economic impacts of the COVID-19 pandemic.

Earlier this week, Trump retweeted a post accusing Fauci and Democrats of suppressing the use of the drug hydroxychloroquine to treat the new coronavirus that included a link to a video of a group discounting the need for face masks amid the pandemic. The tweet was removed by social media companies.

(Reporting by David Morgan; Editing by Scott Malone and David Gregorio)

Lung radiation shows promise for COVID-19 pneumonia; smoking raises risks

By Nancy Lapid

(Reuters) – The following is a brief 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.

Lung radiation may hasten COVID-19 pneumonia recovery

A low dose of radiation to the lungs of COVID-19 pneumonia patients can help them recover more quickly, a small study suggests. Doctors at Emory University in Atlanta treated 10 such patients with lung radiation and compared them to 10 patients of similar ages who received usual care, without radiation. With radiation, the average time to significant improvement was three days, compared to 12 days in the control group.

Other potential effects included a shorter average time to hospital discharge (12 days with radiation versus 20 days without it) and a lower risk of mechanical ventilation (10% with radiation versus 40% without it). But those two differences were too small to rule out the possibility they were due to chance, the researchers found.

The radiation group was “a little older, a little sicker, and their lungs were a little more damaged … but despite that we saw a strong signal of efficacy,” Emory’s Dr. Mohammad Khan told Reuters.

Khan noted that in the radiation group, COVID-19 medications were withheld before and after the treatment, so the results reflect the effect of the radiation alone.

“Radiotherapy,” Khan said, “can reduce the inflammation in the lungs of COVID-19 patients and reduce the cytokines that are causing the inflammation.” Cytokines are proteins made by the immune system. The results on the first five patients have been accepted for publication by the journal Cancer.

The results on all 10 were posted on Tuesday ahead of peer review on the website medRxiv. The researchers have launched a randomized controlled trial of the treatment and expect to eventually include multiple centers.

Smoking may boost severe COVID-19 risk among young adults

Close to one third of young U.S. adults appear to have an elevated risk for severe COVID-19, with smoking their strongest risk factor, according to survey data.

Researchers looked at data from more than 8,000 participants, ages 18 to 25, in the nationally representative National Health Interview Survey for 2016 to 2018. They also looked at participants’ medical conditions identified by the U.S. Centers for Disease Control and Prevention as making people of any age “medically vulnerable” to severe illness from the coronavirus.

Among these are diabetes, heart disease, immune problems, smoking, poorly controlled HIV or AIDS, and respiratory diseases. Overall, 32% of the young adults surveyed were seen as medically vulnerable to severe COVID-19. Among non-smoking young adults, however, only 16% were seen as medically vulnerable.

“Efforts to reduce smoking and e-cigarette use among young adults would likely reduce their medical vulnerability to severe illness,” the researchers said on Monday in the study published in the Journal of Adolescent Health. “Our analysis suggests that risk from smoking and e-cigarette use is highest among young adults who are male, white, and lower income and who are fully or partially uninsured.”

Coronavirus may rarely pass through placenta

It is unclear whether the coronavirus can pass through the womb from mother to fetus.

On Tuesday, doctors in France reported a very rare case that suggests transmission through the placenta may be possible. In the journal Nature Communications, they described a baby born prematurely to a mother with COVID-19. They found the virus in placental tissue as well as in the mother’s and baby’s blood, which suggests that trans-placental transmission of the novel coronavirus virus may be possible, although further studies are needed. Both mother and baby recovered well.

Marian Knight, a professor of maternal and child population health at Oxford University, said the case should not be a major worry for pregnant women. Among the many thousands of babies born to mothers infected with the virus, only around 1% to 2% have been reported to also have had a positive test, Knight said.

Promising results from early trial of new vaccine

Moderna Inc’s experimental vaccine for COVID-19, mRNA-1273, was safe and provoked immune responses in all 45 healthy volunteers in a first-in-humans phase 1 study, researchers reported on Tuesday in the New England Journal of Medicine. Volunteers who got two doses of the vaccine had levels of virus-killing antibodies that exceeded the average levels seen in recovered COVID-19 patients.

Dr. Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, whose researchers developed Moderna’s vaccine candidate, called the results good news. Fauci noted that the study found no serious adverse events and the vaccine produced “reasonably high” levels of virus-killing or neutralizing antibodies.

“If your vaccine can induce a response comparable with natural infection, that’s a winner,” Fauci told Reuters. “That’s why we’re very pleased by the results.” A phase 2 trial testing the vaccine’s efficacy in a larger group started in May.

A much larger phase 3 trial to confirm efficacy and identify rare side effects will begin this month, ultimately including 30,000 participants. Separately, early-stage human trial data on a vaccine being developed by AstraZeneca and Oxford University will be published on July 20, the Lancet medical journal said on Wednesday.

(Reporting by Nancy Lapid, Kate Kelland and Julie Steenhuysen; Editing by Will Dunham)

Trump rebukes aide Navarro for attacking popular Fauci

By Steve Holland

WASHINGTON (Reuters) – President Donald Trump issued a rare rebuke of his senior adviser Peter Navarro on Tuesday, saying Navarro should not have written a scathing opinion piece about Anthony Fauci, a top government coronavirus expert who is hugely popular.

Navarro, a trade adviser who at times has expanded his reach within the Trump White House, launched an attack on Fauci in an article for USA Today.

“Dr. Anthony Fauci has a good bedside manner with the public, but he has been wrong about everything I have interacted with him on,” Navarro wrote.

The initial lack of a push-back from the White House for the article fed a belief that Navarro’s article was supported at the top levels of the White House.

But departing for a trip to Atlanta, Trump was asked whether Navarro had gone rogue.

“Well he made a statement representing himself. He shouldn’t be doing that. No, I have a very good relationship with Anthony,” Trump said.

A White House official said Trump did not endorse Navarro’s op-ed and that Navarro was told “explicitly in recent days to de-escalate the situation.” The official said that White House chief of staff Mark Meadows is “fully engaged” on the matter and that Meadows thought Navarro’s article was “unacceptable.”

Fauci is a member of the government’s coronavirus task force led by Vice President Mike Pence. The 79-year-old infectious diseases expert aided the search to treat the HIV disease in the 1980’s and is a revered figure for not letting politics intrude on his judgment.

“We’re all on the same team, including Dr. Fauci,” Trump said. “We all want to get rid of this mess.”

Tensions between Trump and Fauci have emerged at times with the president focused on getting Americans back to work and school while Fauci has urged caution to prevent the spread of infection.

Fauci, in an interview with The Atlantic, said the White House’s recent attacks have been a “major mistake on their part.”

“I can’t explain Peter Navarro. He’s in a world by himself,” Fauci said.

He said he had not spoken with Trump “in a while,” but had been working with Pence on the U.S. struggle to gain control of the virus.

(Reporting by Steve Holland; Editing by Howard Goller)

Moderna Phase 1 results show coronavirus vaccine safe, induces immune response

By Julie Steenhuysen

CHICAGO (Reuters) – Moderna Inc’s experimental vaccine for COVID-19 showed it was safe and provoked immune responses in all 45 healthy volunteers in an ongoing early-stage study, U.S. researchers reported on Tuesday.

Volunteers who got two doses of the vaccine had high levels of virus-killing antibodies that exceeded the average levels seen in people who had recovered from COVID-19, the team reported in the New England Journal of Medicine.

No study volunteers experienced a serious side effect, but more than half reported mild or moderate reactions such as fatigue, headache, chills, muscle aches or pain at the injection site. These were more likely to occur after the second dose and in people who got the highest dose.

Experts say a vaccine is needed to put an end to the coronavirus pandemic that has sickened millions and caused nearly 575,000 deaths worldwide.

Moderna was the first to start human testing of a vaccine for the novel coronavirus on March 16, 66 days after the genetic sequence of the virus was released.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, whose researchers developed Moderna’s vaccine candidate, called the results “good news,” noting that the study found no serious adverse events and the vaccine produced “reasonably high” levels of virus-killing or neutralizing antibodies.

“If your vaccine can induce a response comparable with natural infection, that’s a winner,” Fauci said in a telephone interview. “That’s why we’re very pleased by the results.”

Moderna shares jumped more than 15% in after-hours trading on Tuesday.

The U.S. government is supporting Moderna’s vaccine with nearly half a billion dollars and has chosen it as one of the first to enter large-scale human trials. A successful vaccine could be a turning point for Cambridge, Massachusetts-based Moderna, which has never had a licensed product.

Moderna’s shot, mRNA-1273, uses ribonucleic acid (RNA) – a chemical messenger that contains instructions for making proteins. When injected into people, the vaccine instructs cells to make proteins that mimic the outer surface of the coronavirus, which the body recognizes as a foreign invader, and mounts an immune response against.

The results released Tuesday involved three doses of the vaccine, tested in groups of 15 volunteers aged 18-55 who got two shots, 28 days apart. The groups tested 25, 100 or 250 micro grams of the vaccine.

Adverse events after the second dose occurred in seven of the 13 volunteers who got the 25-micro gram dose, all 15 participants who received the 100 micro gram dose and all 14 who got the 250 micro gram dose. In the highest-dose group, three patients had severe reactions such as fever, chills, headache or nausea. One of these had a fever of 103.28 Fahrenheit (39.6 C).

“We didn’t see any events that are characterized as serious adverse events,” said lead author Dr Lisa Jackson of Kaiser Permanente Washington Health Research Institute in Seattle, referring to reactions that require hospitalization or result in death.

In June, Moderna said it selected the 100-micro gram dose for its late-stage study to minimize adverse reactions.

At that dose, Moderna said the company is on track to deliver about 500 million doses per year, and possibly up to 1 billion doses per year, starting in 2021, from the company’s internal U.S. manufacturing site and strategic collaboration with Swiss drug-maker Lonza.

“It’s a good first step,” said Dr William Schaffner, a vaccine expert at Vanderbilt University Medical Center who was not involved in the study.

“There’s nothing here that would inhibit one from going ahead to the Phase 2/Phase 3 trials,” he said.

In April, Moderna expanded the Phase 1 trial to include adults over 55, who are more at risk of serious disease, with the aim of enrolling 120 volunteers. Moderna said it will follow study volunteers for a year to look for side effects and check how long immunity lasts.

Moderna started its phase 2 trial in May and expects to start a phase 3 trial on July 27.

Phase 1 trials aim to ensure a treatment is safe and help determine an effective dose. Phase 2 trials test a treatment in a larger group and get an early read on effectiveness. Phase 3 trials are conducted in a large group of individuals to confirm efficacy and identify rare side effects. Moderna’s Phase 3 trial will be conducted in 30,000 volunteers.

(Reporting by Julie Steenhuysen in Chicago; Editing by Matthew Lewis and Richard Pullin)

Fauci says leak concerns fueled his White House revelation of Gilead drug results

By Julie Steenhuysen

CHICAGO (Reuters) – Concerns over leaks compelled the top U.S. infectious disease official to reveal data on Gilead Sciences Inc’s experimental drug remdesivir, the first in a scientifically rigorous clinical trial to show benefit in treating COVID-19.

The dramatic announcement by Dr Anthony Fauci in the Oval Office on Wednesday prompted concerns among scientists that the Trump administration was raising hopes about a coronavirus treatment before sharing the full data with researchers.

As a cautionary example of inflating the potential value of a therapy, some pointed to President Donald Trump’s repeated endorsements of malaria drug hydroxychloroquine as a treatment, with no evidence that it works.

Newer data suggests the malaria treatments may carry significant risks for some sufferers of the respiratory disease caused by the virus.

Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), which is running the trial, said he took the first opportunity to get the word out that patients taking a dummy treatment or placebo should be switched to remdesivir in hopes of benefiting from it.

He expressed concern that leaks of partial information would lead to confusion. Since the White House was not planning a daily virus briefing, Fauci said he was invited to release the news at a news conference with Louisiana Gov. John Bel Edwards(D). “It was purely driven by ethical concerns,” Fauci told Reuters in a telephone interview.

“I would love to wait to present it at a scientific meeting, but it’s just not in the cards when you have a situation where the ethical concern about getting the drug to people on placebo dominates the conversation.”

An independent data safety and monitoring board, which had looked at the preliminary results of the NIAID trial, determined it had met its primary goal of reducing hospital stays.

On Tuesday evening, that information was conveyed in a conference call to scientists studying the drug globally.

“There are literally dozens and dozens of investigators around the world,” Fauci said. “People were starting to leak it.” But he did not give details of where the unreported data was being shared.

Several scientists interviewed by Reuters felt the White House setting seemed inappropriate for the release of highly anticipated government-funded trial data on the Gilead therapy.

They had expected it to be presented simultaneously in a detailed news release, a briefing at a medical meeting or in a scientific journal, allowing researchers to review the data.

Information from various trials of remdesivir has been leaked to media in recent weeks. In a statement on Wednesday, Gilead said the NIAID’s much anticipated trial had met its primary goal, but gave no details.

Data in a separate NIAID statement after Fauci spoke detailed preliminary results showing that patients who got the drug had a 31 percent faster time to recovery than those who got a placebo, cutting hospital stays by four days.

The trial also came close to showing the drug helped people survive the disease, but the data fell just short of statistical significance.

“I want to see the full data. I want to understand the statistics. I want to understand the benefit and risk. I want to understand the structure of the study, and all of it,” said Dr. Steven Nissen, the chief academic officer at the Cleveland Clinic.

“Am I encouraged from what I’ve heard? Yes, I’m encouraged. But I want to get a full understanding of what happened here, and not get it via a photo opportunity from the Oval Office.”

Data Gilead released on its own trial of remdesivir drew less attention, as it did not compare outcomes between those receiving therapy and those who did not.

Results from a third study in China suggesting remdesivir failed to help COVID-19 patients were released in the British medical journal the Lancet after review by a peer group of scientists.

“That’s the only thing I’ll hang my hat on, and that was negative,” said Dr. Eric Topol, director and founder of the Scripps Research Translational Institute in La Jolla, California.

He was unimpressed by remdesivir’s modest benefit.

“It was expected to be a whopping effect,” Topol added. “It clearly does not have that.”

At the Oval Office news conference, Fauci compared the study findings to AZT, the first drug to show any benefit against HIV, decades ago.

“We know that was an imperfect drug. It was the first step,” Fauci said in the interview.

“Similar to AZT, it’s (remdesivir) the first baby step towards what hopefully will be a number of better drugs that will come in and be able to treat people with COVID-19.”

(This story has been refiled to correct spelling of “clinical” in paragraph one)

(Reporting by Julie Steenhuysen; Editing by Michele Gershberg and Clarence Fernandez)