COVID-19 Transmitted to Babies in Utero

Strong evidence of vertical transmission of the novel coronavirus from mother to child during pregnancy was reported at an offshoot of the virtual International AIDS Conference devoted to COVID-19.

Of 31 pregnant women infected with the SARS-CoV-2 coronavirus, two of their infants were born with the infection, reported Claudio Fenizia, MD, of the University of Milan in Italy.

“Our study shows that vertical transmission in utero from mother to child of COVID-19 is indeed possible,” Fenizia said at a virtual press conference at the online AIDS 2020 meeting.

The women were recruited for the study in March and April 2020 from three hospitals in Northern Italy – one of the regions hardest hit when the pandemic swept across Europe. “All the women we enrolled were towards the end of their pregnancies, in the late third trimesters,” Fenizia said.

The researchers collected numerous specimens from the women and their newborns, including the placenta, umbilical cord biopsies, maternal and umbilical cord blood, vaginal swabs, nasopharyngeal swabs of the newborns, the mother’s milk, and amniotic fluid. “We tested all of these specimens looking for the presence of the virus, and our results strongly suggest and support that vertical transmission in two cases,” Fenizia said.

In both cases of infection in infants, placenta specimens were positive for SARS-CoV-2, the virus that causes COVID-19. Fenizia noted that the initial tests did not find the virus, but further sampling of the placenta showed virus-positive results.

“The two babies were found to be positive through nasal swabs taken immediately upon delivery. One of the babies had IgM [immunoglobulin M] in the umbilical cord blood. Keep in mind that IgM is not usually transferred in the blood from the mother to the child, so the appearance of IgM is due to direct exposure of the fetus to the virus,” Fenizia said.

Caveats, he said, included that the number of women enrolled was too small to draw any firm conclusions. “This should be considered a preliminary study, and this is basically a picture of women in Italy at the beginning of the infection. There is a question mark as to what will happen if women get infected earlier on in their pregnancy,” Fenizia said. “Further studies should be performed on a wider sample of pregnant women.”

He and his colleagues also examined the inflammatory processes in the mothers and the children, covering different gestational ages, analyzing the placenta and umbilical cord blood looking for expression and release of inflammatory molecules.

“Indeed, we found quite strong enhanced inflammatory status in infected women compared with negative controls,” Fenizia said. “This is not really a surprise, but the placenta was extremely inflamed and the fetal blood showed higher expression of inflammatory molecules, and that could be more detrimental than even the infection itself during the pregnancy.”

Fenizia said both babies are doing well. One continued to test positive for a week after birth, and the other appeared to have just a transient infection that was not seen in subsequent tests.

He added that since the babies were infected within 2 weeks of delivery, he would not expect that the coronavirus infection would have long-lasting impact on their development. “So far, we are not aware of any consequences of infection in these babies, but it is just two cases so it is too early to determine any long-term risk for putative infected babies,” he said.

This preliminary work “should be considered a ringing bell that should drive awareness about a topic that has not been really well studied,” Fenizia said.

He noted that in one case, the breast milk of one women in the study was positive for evidence of the virus, but “it is far too early to determine if that was an infectious virus. I don’t think we can draw any conclusions about this unique sample.”

Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, who participated in the press briefing, commented: “Generally, children have much less of a chance of having an adverse outcome, except maybe for newborns.”

To answer the question of whether children can easily transmit the disease, he said, a 6,000-family study is underway in the U.S. “Are they really poor transmitters or not? That has obvious implications when one thinks in terms of opening schools,” Fauci said.

Disclosures

Fenizia and Fauci disclosed no relevant relationships with industry.

Primary Source

International AIDS COVID Conference

Source Reference: Fenizia C, et al “In-utero mother-to-child SARS-CoV-2 transmission — viral detection and fetal immune response” IAC 2020; Abstract 11384.

https://www.medpagetoday.com/infectiousdisease/covid19/87511

Investors keep pushing Qiagen to seek better offer

Union Investments and Davidson Kempner both continue to say Qiagen (NYSE:QGEN) should push Thermo Fisher Scientific (NYSE:TMO) even harder for a higher bid, despite the new €43 per share offer that just arrived last Thursday.

The strong sales results forecast from Qiagen due to pandemic demand has investors thinking an offer in the €48 to €52 per share range would be more appropriate.

Qiagen closed at €42.07 on Friday vs. the 52-week range of €22.54 to €42.50. The company is due to post full results on August 4, but preliminary numbers may arrive earlier. Meanwhile, Thermo Fisher Scientific is due to post Q2 numbers on July 22 (consensus estimates).

https://seekingalpha.com/news/3592419-investors-keep-pushing-qiagen-to-seek-better-offer

Call for COVID-19 ‘challenge trial’ ahead of AstraZeneca vaccine readout

Press reports suggest that there is good news about AstraZeneca and Oxford University’s COVID-19 vaccine due from an early stage trial in the coming days – but the focus is moving on how to get the in-depth safety and efficacy results needed to get the jab formally approved. 

According to the press reports, the phase 1 trial results suggest the vaccine produces an immune response including both antibodies and T-cells with few side-effects.

Further details are due to be published in The Lancet, according to the journalist Robert Peston, who broke the story. 

This twin effect could be the key to lasting immunity against the virus, with the T-cells able to attack the virus even if the body has stopped producing antibodies that neutralise it. 

AZ’s vaccine is one of the front-runners in a growing list of vaccines that have been rushed into clinical trials, when development began almost immediately after Chinese scientists published the virus’s genetic details in January. 

The vaccine is already in phase 3 development and the company is busy recruiting tens of thousands of people in the UK, Brazil, South Africa, and the US. 

According to The Guardian, the next step is to begin a controversial “challenge trial” where healthy subjects are given the vaccine and then exposed to the virus to test to test the levels of protection it confers. 

These trials are conducted in a lab and can be completed in a few weeks, requiring far fewer people. 

This is important because in countries where lockdown measures have been successful in controlling the spread of the SARS-CoV-2 virus, it is becoming difficult to gather the data showing whether the vaccine is effective or not. 

Professor Adrian Hill, director of Oxford University’s Jenner Institute, told The Guardian that scientists are already preparing the trial and aim to get it up and running by the end of the year. 

He said: “This might be in parallel or might be after the phase three trial is completed. They’re not competing options, they’re complementary.” 

The Oxford team is among a growing group of scientists who argue that human challenge is justified given the low risk of serious complications or death for healthy people in their twenties. 

The World Health Organization has already produced guidance on challenge trials that suggests that risk of death from COVID-19 is approximately one in 3,000, around the same for live kidney donation. 

Hill said the risk is “so low that it’s very difficult to measure” and is among the signatories of an open letter from US-based campaign group 1Day Sooner, which is promoting challenge trials to accelerate development of a COVID-19 vaccine. 

Other signatories include the Nobel laureate and biologist Sir Richard Roberts, the renowned surgeon and former health minister Lord Darzi. 

Call for COVID-19 ‘challenge trial’ ahead of AstraZeneca vaccine readout

Orexo launches digital therapies for depression, alcohol misuse early in US

Sweden’s Orexo has launched two digital therapies in the US earlier than expected, following changes to US regulations that allow early access during the COVID-19 crisis.

The two therapies – deprexis to help people with depression manage their symptoms and vorvida for alcohol use disorder – launched on 1 July and 15 July, respectively. They are both licensed from digital health specialist GAIA.

The early roll-out takes advantage of an accelerated access pathway for digital therapies used for psychiatric disorders, introduced to help people struggling to access face-to-face care and support during the lockdowns introduced to tackle the coronavirus pandemic.

Orexo has also brought forward the development timeline for another digital therapeutic originated by GAIA – OXD01 – that is intended to treat people misusing opioid painkillers.

Testing is now slated to start before the end of the year with a launch now scheduled for the second quarter of 2021, a year earlier than planned.

Orexo submitted vorvida for approval by the FDA in March, before the pandemic gathered pace in the US, and had been hoping for a third-quarter approval before the new pathway came into effect.

It combines cognitive behavioural therapy coupled with machine learning and is designed to guide heavy drinkers through a series of steps to reach the target of reduced alcohol intake.

Meanwhile, deprexis had already been certified by the FDA when Orexo licensed US rights to the therapeutic from its developer GAIA in May, and had been heading for a launch by the end of the summer.

“The COVID-19 pandemic, with society lockdowns and social distancing is expected to lead to a significant increase in mental health issues and substance use disorders,” said Orexo.

That adds to what is already a heavy burden on society from these health issues, with more than 16 million heavy drinkers, 10 million opioid misusers and 21 million people with depression in the US before the crisis, according to the company.

It is expecting to generate the first sales from its digital therapies in the third quarter, and is now focusing on getting access and reimbursement sorted out with insurers and other healthcare payers in the US.

Orexo estimates that sales of all three digital therapies could reach between $420 million and $650 million five years after launch, propelled by the upsurge in the adoption of remote healthcare tools and telehealth during the outbreak.

The Swedish company will have to spend more to accelerate its plans, and it is now predicting an investment of up to SEK 800 million (around $88 million) this year from its earlier estimate of up to SEK 600 million ($66 million).

Orexo launches digital therapies for depression, alcohol misuse early in US

85 infants under age 1 tested positive for coronavirus in one Texas county

Eighty-five infants under age 1 have tested positive for coronavirus in one county in Texas — with local officials imploring residents to help stop its spread as the state becomes one of the newest hotspots.

Since January, health authorities have identified more than 3.6 million COVID-19 cases throughout the United States. Nearly 140,000 people have died, according to Johns Hopkins University.

In Texas’ Nueces County, where Corpus Christi is located, the number of new coronavirus cases skyrocketed in July after a flattening trend. The virus has infected dozens of babies and local officials are urging people to wear masks and practice social distancing.

“We currently have 85 babies under the age of one year in Nueces County that have all tested positive for COVID-19,” said Annette Rodriguez, director of public health for Corpus Christi Nueces County.

“These babies have not even had their first birthday yet. Please help us stop the spread of this disease.”

Nueces County has the fastest growth in new cases on the seven-day average than any other metropolitan county in the state,” said Peter Zanoni, the Corpus Christi city manager.

“You can see the trend line is relatively flat until July, and this is where we have had that huge spike in cases, and this is why it’s turned into a major problem for Nueces County,” he said.

Corpus Christi has about 8,100 coronavirus cases and 82 deaths linked to the virus, local officials said.

https://www.wcvb.com/article/85-infants-under-age-1-tested-positive-for-coronavirus-in-one-texas-county-1/33354995

Fauci: ‘months to a year or more’ to know if Covid symptoms in young are chronic

• Dr. Anthony Fauci highlighted the range of coronavirus symptoms among young people in an interview with Mark Zuckerberg on Friday.
• Some young coronavirus patients “can be knocked on their back and brought to their knees pretty quickly,” Fauci said.
• He added that it could take “months to a year or more” to determine whether these patients suffer from chronic illnesses.

Most young people infected with the coronavirus won’t become seriously ill, but a growing number of young patients report being sick for weeks on end. The nation’s top disease expert, Dr. Anthony Fauci, said it may take a while to understand whether these people suffer from long-term illnesses.

“It’s the people who really get knocked out badly, particularly those who require hospitalization, that it’s going to take months to a year or more to determine if there are any long-lasting, deleterious consequences of the infection,” Fauci said during a conversation with Facebook CEO Mark Zuckerberg on Thursday. “We just don’t know that now. We haven’t had enough time.”

Fauci’s comments follow a drastic rise in coronavirus infections among young adults in the US. People in their 20s, 30s, and 40s represent roughly half of cases in coronavirus hotspots like Arizona and Texas, while people ages 18 to 34 represent more than a third of cases in Florida and California.

“If you look at what’s going on with the new infections, the median age is about a decade and a half younger than it was a few months ago,” Fauci said.

This could have dangerous effects on transmission, he added.

“My message to young people is consider your responsibility to yourself, but also the societal responsibility,” Fauci said. “By allowing yourself to get infected, you are propagating the pandemic.”

As coronavirus cases rise, doctors have started to identify a wider range of symptoms among patients in their 20s, 30s, and 40s.

“I’ve never seen an infection with this broad range of manifestations,” Fauci said. Some young people, he added, “can be knocked on their back and brought to their knees pretty quickly.”

People ages 18 to 29 make up more than four times as many coronavirus hospitalizations as they did a few months ago: around 38 hospitalizations out of every 100,000 people as of July 4, compared to nine hospitalizations out of every 100,000 people on April 18.

A new study from researchers at the University of California, San Francisco determined that one in three young adults ages 18 to 25 are vulnerable to severe COVID-19 cases due to factors like smoking habits or preexisting illnesses. But even young, healthy non-smokers have reported feeling sick for several months, with lasting symptoms like chest pain and shortness of breath.

Fauci said some patients may suffer from “post-infection syndromes” that resemble chronic fatigue syndrome — a disease often characterized by cognitive impairment, muscle pain, and a debilitating lack of energy. UK doctors also warned of post-viral syndromes among coronavirus patients in June.

“You have to separate the damage from the disease,” Dr. Ramzi Asfour, an infectious-disease doctor in Marin County, California, previously told Business Insider. “The symptoms are probably coming from an immune reaction.”

Asfour said he has seen college-aged patients with mononucleosis who have had severe fatigue for two years, or viral infections that trigger a lifelong autoimmune disease like lupus or rheumatoid arthritis. The coronavirus could have similar effects on patients, he said.

“It’s different for different people,” he added. “Usually time heals. But not necessarily always.”

https://www.msn.com/en-us/health/medical/dr-fauci-says-it-will-take-months-to-a-year-or-more-to-know-whether-lingering-covid-19-symptoms-in-young-people-could-be-chronic-illnesses/ar-BB16QfzY