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Thursday, January 6, 2022

Reimbursement for At-Home COVID Tests to Start Next Week

 Starting next week, Americans struggling to get tested for COVID-19 will be able to get reimbursed for the cost of rapid at-home tests, according to The New York Times.

In upcoming weeks, people should also be able to order free tests online, White House officials said.

"We know this remains frustrating for people getting tested in many parts of the country," Jeff Zients, the White House coronavirus response coordinator, said during a news briefing on Wednesday. "So we are working to do all we can."

Two weeks ago, President Joe Biden said his administration would buy 500 million rapid tests to distribute to the public for free and that insurance companies would begin reimbursing people for the tests they buy on their own. At the time, Biden said the new initiatives would start "in the coming weeks."

So far, the Biden administration hasn't released specifics for people to order the free tests online. With a massive surge in COVID-19 cases due to the Omicron variant, the demand for at-home tests has outpaced supply, and most retail stores have run out of stock.

Zients said Wednesday that test makers will begin delivering rapid test kits to the federal government next week and that Americans will start receiving free tests "in the coming weeks." The Biden administration will set up a "free and easy system, including a website" where people can order them, he said.

In the meantime, new federal testing sites are opening this week in Philadelphia and Washington, DC, Jen Psaki, the White House press secretary, told reporters on Wednesday. Other testing sites will also open soon in Delaware, Maine, Maryland, Nevada, Texas, and Washington, Zients said, and mobile testing sites are now available in New York City and New Jersey.

Last week, the CDC removed a testing requirement from its new isolation guidelines, which shortened the isolation period from 10 days to 5 days. Public health experts criticized the change, saying that a negative test should be required before people end their isolation.

On Tuesday, the CDC amended its guidance, adding that people who want to end isolation after 5 days can choose to take a test if they have access to one. If the test result is positive, they should stay home for another 5 days. But if the test is negative and they no longer have symptoms, they can end isolation and should wear masks in public for another 5 days.

The CDC took out the testing requirement because rapid tests aren't authorized by the FDA to determine whether someone is infectious, Rochelle Walensky, MD, the CDC director, said during the news briefing on Wednesday. Instead, the tests are authorized to detect infection and are meant to be used back-to-back, as in schools, to confirm that people continue to test negative, she said.

But the CDC amended its guidance this week because "it became very clear that people were interested in using the rapid tests," Walensky said, and she wanted to "provide guidance on how they should be used."

SOURCES:

The New York Times: "Reimbursement for rapid at-home tests will start next week, a White House official says."

C-SPAN: "White House COVID-19 Response Team Briefing," Jan. 5, 2022.

CDC: "COVID-19: Quarantine and Isolation, Updated Jan. 4, 2022."

https://www.medscape.com/viewarticle/966176

Every US Cruise With Passengers Has COVID Cases

 Coronavirus cases have been reported on every cruise ship sailing with passengers in U.S. waters.

All 92 ships have met the threshold for investigation, according to the CDC, which has either started an investigation or has already investigated and is observing each ship.

The number of ships under investigation has increased rapidly in recent days, The Washington Post reported. The CDC's update on Tuesday used data from the cruise lines submitted Monday, showing that every ship reached the threshold of .1% of passengers testing positive.

Last week, the CDC warned all travelers, including vaccinated people, to avoid cruise ships after COVID-19 cases jumped from 162 during the first 2 weeks of December to more than 5,000 cases during the last 2 weeks of December. The CDC moved cruise ship travel to Level 4, the highest level of risk.

"The virus that causes COVID-19 spreads easily between people in close quarters on board ships, and the chance of getting COVID-19 on cruise ships is very high, even if you are fully vaccinated and have received a COVID-19 vaccine booster dose," the CDC said in updated guidance.

Cruise lines are requiring all crew and most ― if not all ― passengers to be fully vaccinated to board, the newspaper reported. Passengers also need proof of a recent negative test.

In addition to the 92 ships with passengers, 18 ships with only crew members are in U.S. waters, the CDC reported Tuesday. Among those, two have met the threshold for investigation, while three have reported cases but not enough to pass the threshold.

"As part of investigating cruise ships that meet the investigation threshold, CDC will obtain additional information from the cruise ship, such as case exposure histories, details about close contacts, traveler vaccination rates, and medical capacities," Caitlin Shockey, a CDC spokeswoman, told the newspaper in an email.

The CDC will "consider multiple factors" and work with the cruise lines before moving ships from the current "yellow" status to the more serious "red" status that requires ships to return to port or delay sailing, Shockey told the Post. To reach the red status, a ship must have ongoing COVID-19 transmission and the potential for cases to overwhelm medical resources on the ship.

Several cruise ships have been turned away from ports since late December due to passengers or crew members testing positive, the newspaper reported. Most continued their trips but skipped the stops where they were turned away.

On Wednesday, Norwegian Cruise Line announced that it would cancel Norwegian Getaway's 9-day Caribbean trip that was scheduled to leave Miami that day, citing "COVID related circumstances."

The cruise line gave the same reason on Tuesday for bringing the Norwegian Pearl back to Miami after it departed for an 11-night Panama Canal trip on Monday. Passengers were told that the trip was ending after many crew members tested positive, the Post reported, though the specifics weren't disclosed. The ship is scheduled to return to Miami on Thursday.

The cruise line also announced on Wednesday that voyages will be canceled for Norwegian Pearl cruises through Jan. 14, Norwegian Sky cruises through Feb. 25, Pride of America cruises through Feb. 26, Norwegian Jade cruises through March 3, Norwegian Star cruises through March 19, Norwegian Sun cruises through April 19, and Norwegian Spirit cruises through April 23. All guests will receive an automatic full refund, the cruise line said.

"We will never compromise on health and safety and we will of course, continue to take all appropriate action to ensure everyone's well-being and to protect public health," the company said in a statement.

Also on Wednesday, Royal Caribbean Cruises canceled its Spectrum of the Seas cruise for Thursday after nine passengers on its Jan. 2 trip were identified as close contacts of a local COVID-19 case in Hong Kong, according to Reuters. They have tested negative so far, but the cruise ship will return to Hong Kong for more testing.

Sources

The Washington Post: "Every U.S. cruise with passengers has coronavirus cases on board."

CDC: "Travel Notices: COVID-19 and Cruise Ship Travel," updated Dec. 30, 2021.

Norwegian Cruise Line: "Media Statements: Jan. 5 and Jan. 4 announcements."

Reuters: "Royal Caribbean, Norwegian Cruise cancel voyages amid Omicron scare."

https://www.medscape.com/viewarticle/966175

Tough Time for Parents With Kids Under 5

 Katelyn Jetelina, PhD, MPH, flew out to California from Texas to be with family for the holidays. She and her family played it as safe as possible, since her two girls -- ages 14 months and 2.5 years -- can't be vaccinated against COVID-19 yet.

Everyone got a PCR test before they flew. They did rapid antigen tests daily while quarantining in California ahead of gathering with family for Christmas.

On the morning of Christmas Eve, her 14-month-old tested positive.

"We were all very shocked," Jetelina told MedPage Today. "There was too much time between the flight and the positive test, so she didn't get it there. We have no idea where she got it. We haven't been doing much besides going to the beach."

Jetelina, an epidemiologist at UT Health Science Center at Houston, is among the many parents with children too young to be vaccinated.

It's a challenging time for these parents. The data show that most children fight off a COVID-19 infection without any problem -- but many parents are risk-averse, as small as that risk may be.

"It's a really tough balance for parents right now," Jetelina said. "You don't want to take this lightly, but don't want to paralyze your life, either."

A Difficult Line to Walk

Nicole Baldwin, MD, a pediatrician in private practice in Cincinnati, emphasized that kids without underlying risk factors fare very well with COVID.

"The hospitalization rate is still low in kids, and the death rate is very, very low," she said. "While it's important that parents stay vigilant, it's a fine line to walk figuring out, 'What do I still need to be afraid of, and where can I let my guard down and allow more normalcy back into my life?'"

Like Jetelina, Leana Wen, MD, of George Washington University in Washington, D.C., also has two children under 5 who can't be vaccinated.

"It's a difficult time for us," she said. "There's just so much virus around. It's an extremely challenging time to try to protect our children."

One of the hardest parts is that there are so many different interpretations as to how to move forward, and they're all very reasonable, Wen noted.

"We're at a point in the pandemic where people have different realities based on individual circumstances. A family that's healthy, vaccinated, and boosted could very reasonably decide they're going to be exposed if they haven't already, and the risk to their unvaccinated young child is low," she said.

"At the same time, a family with a child who has an underlying medical condition or is immunocompromised wants to take many additional precautions," she added. "That's a reasonable decision based on those circumstances."

By the Numbers

Pediatric COVID-19 cases in the U.S. are at an all-time high. According to the latest report from the American Academy of Pediatrics (AAP), there were 325,340 pediatric cases in the week ending Dec. 30, 2021 -- topping the fall Delta surge peak of 251,781 cases for the week ending September 2.

Pediatric hospitalizations are also the highest they've ever been, with a current 7-day average of 574 daily admissions in kids under 18 -- up from the previous week's 7-day average of 294, according to the latest CDC data.

That translates to about 0.8 new admissions per 100,000 population ages 0 to 17.

Pediatric mortality from COVID-19 also remains very low, with 735 deaths since May 2020, according to the AAP data. Pediatric deaths make up just 0.1% of total COVID-19 deaths, and only 0.01% of pediatric cases have resulted in death, according to the AAP.

Still, Wen noted that COVID in kids is not something to take lightly: "It's so disturbing that COVID came out of nowhere to become one of the leading causes of death among children," she said. "The risk to an individual child of severe illness is thankfully very low. However, children do become ill, and some become severely ill. This is not a trivial illness."

Baldwin pointed out that "with so many more cases, we're definitely going to have more children hospitalized." While the Omicron variant is likely leading to less severe illness for both adults and children, the sheer number of children infected is leading to an expected uptick in hospitalizations.

Indeed, some children's hospitals are busier than they've ever been. CNN reported that Texas Children's Hospital is currently treating 70 patients, a more than four-fold rise in the last 2 weeks alone.

Baldwin said that with other respiratory illnesses going around among kids, in addition to illness among hospital staff, "there's huge stress on children's hospitals right now, and whatever we can do to keep the family healthy and out of the hospital is a good idea."

Other worries for parents of kids under 5 include long COVID and the inflammatory condition MIS-C.

When it comes to long COVID in kids, the picture in the U.S. isn't clear, Jetelina said. She noted that the U.K. has estimated around 7% of kids with COVID will develop long COVID, and the Swiss estimate puts that figure at just 3%.

Either way, the estimates are "much lower than the 10% to 30% we're seeing in adults, which is very reassuring," she noted.

Finally, when it comes to MIS-C, the CDC reports that there have been about 6,000 cases in the U.S., and most children have recovered, though there have been 52 deaths.

In the Meantime

Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, has previously said that data on a three-dose vaccine series from Pfizer for kids under 5 aren't expected until the end of the first quarter of 2022, meaning vaccines for this population won't be available until "a few months into 2022."

In the meantime, Baldwin said parents of kids under 5 who can't be vaccinated "have to control what we can control. ... We can't forget about masking, ventilation, and testing. We have to do what we can with what's available."

She also said that everyone around those children should be vaccinated and boosted, including teachers and daycare professionals, who should also be wearing masks.

Wen added that all siblings ages 5 and up should be vaccinated as well. But vaccination rates remain abysmally low among eligible kids. According to CNN, only 9% of kids ages 5 to 12 are fully vaccinated, and among those ages 12 to 15, only 51% are fully vaccinated.

Baldwin was just getting over COVID-19 when she spoke with MedPage Today on Monday. She had only mild symptoms -- a sore throat and a runny nose for a few days -- which she attributes to being boosted.

She was feeling back to normal 5 days after her symptoms started and was eager to get back to her pediatric practice to help out other staffers, many of whom "have kids home with COVID right now."

"What's so hard about this now is that it's happening to everybody," she said. "But we'll get through it."

Jetelina's youngest daughter developed symptoms after her positive rapid test -- a low-grade fever, "a lot of snot," and a lot of crankiness. It all lasted about 7 days, Jetelina said.

Jetelina and her 2.5-year-old both developed very mild symptoms, and Jetelina's husband remained symptom-free, which she attributes to both of them being boosted: "We may be proof that boosters are working," she said.

One of the most important things to remember during this Omicron surge, she noted, is that "even if your family gets infected, it doesn't mean you failed as a parent. It's more an indication of how transmissible Omicron is, and how much community transmission we have now."

https://www.medpagetoday.com/special-reports/exclusives/96510

Metabolomic Biomarkers in Blood Samples ID Cancers in Mixed Population with Nonspecific Symptoms

 James R. Larkin, Susan Anthony, Vanessa A. Johanssen, Tianrong Yeo, Megan Sealey, Abi G. Yates, Claire Friedemann Smith, Timothy D.W. Claridge, Brian D. Nicholson, Julie-Ann Moreland, Fergus Gleeson, Nicola R. Sibson, Daniel C. Anthony and Fay Probert

COVID-19 Vaccination and Breakthrough Infections in Patients with Cancer

 A.L.Schmidt1C.Labaki1C.-Y.Hsu2Z.Bakouny1N.Balanchivadze3S.A.Berg4S.Blau56A.Daher7T.El Zarif1C.R.Friese8E.A.Griffiths9J.E.Hawley1010bB.Hayes-Lattin11V.Karivedu12T.Latif13B.H.Mavromatis14R.R.McKay15G.Nagaraj16T.K.Choueiri1

DOI: https://doi.org/10.1016/j.annonc.2021.12.006

PDF: https://www.sciencedirect.com/science/article/pii/S2667036421000029/pdfft?md5=fc7a3b82123aa153b8e27bda89a9cc62&pid=1-s2.0-S2667036421000029-main.pdf

Highlights

Patients with cancer who develop breakthrough COVID-19 following full vaccination remain susceptible to severe outcomes.

Hematologic malignancies are over-represented among vaccinated patients with cancer who develop breakthrough COVID-19.

Vaccination of close contacts, masking, boosters, and social distancing are needed to protect patients with cancer.

Abstract

Background

Vaccination is an important preventive health measure to protect against symptomatic and severe COVID-19. Impaired immunity secondary to an underlying malignancy or recent receipt of anti-neoplastic systemic therapies can result in less robust antibody titres following vaccination and possible risk of breakthrough infection. As clinical trials evaluating COVID-19 vaccines largely excluded patients with a history of cancer and those on active immunosuppression (including chemotherapy), limited evidence is available to inform the clinical efficacy of COVID-19 vaccination across the spectrum of patients with cancer.

Patients and methods

We describe the clinical features of patients with cancer who developed symptomatic COVID-19 following vaccination and compare weighted outcomes to those of contemporary unvaccinated patients, after adjustment for confounders, using data from the multi-institutional COVID-19 and Cancer Consortium (CCC19; ClinicalTrials.gov number, NCT04354701).

Results

Patients with cancer who develop COVID-19 following vaccination have substantial comorbidities and can present with severe and even lethal infection. Patients harboring hematologic malignancies are over-represented among vaccinated patients with cancer who develop symptomatic COVID-19.

Conclusions

Vaccination against COVID-19 remains an essential strategy in protecting vulnerable populations, including patients with cancer. However, patients with cancer who develop breakthrough infection despite full vaccination remain at risk of severe outcomes. A multilayered public health mitigation approach that includes vaccination of close contacts, boosters, social distancing, and mask-wearing should be continued for the foreseeable future.

https://www.sciencedirect.com/science/article/pii/S0923753421048808

Chile to Become First Country in Latin America to Offer Fourth COVID Shot

 Chile will begin offering a fourth shot of the coronavirus vaccine next week to immunocompromised citizens, the government said on Thursday, the first country in Latin America and one of the first in the world to offer the extra dose.

"Starting next Monday, January 10, we are going to start a new mass vaccination process with a fourth dose or a second booster dose," said Pinera in a press conference.

Chile has one of the world's highest vaccination rates and has been hailed as a model for its response to the pandemic, having administered two doses to over 85% of the population. About 57% have received a third booster shot, according to Our World in Data.

Chile's announcement comes as the highly contagious Omicron variant is spreading worldwide, with several countries reporting all-time high COVID-19 case loads even among vaccinated populations. Cases in Mexico have more than doubled in the past week, while Peru imposed new restrictions this week.

"The success that Chile has had in the vaccination process (...) puts us among the best countries in the world in the way we have managed to combat this pandemic," Pinera added. "And with this fourth dose we seek to maintain this leadership position and protect the health and lives of our compatriots."

The vaccines for the fourth dose will be a combination of the same shots that have been used so far in Chile, including Pfizer-BioNTech, Sinovac and AstraZeneca, said Health Minister Enrique Paris.

This combination of different vaccines between the first and fourth doses should allow "an improvement in the immune response," Paris explained.

Chile reported its first case of the Omicron variant at the beginning of December and has confirmed 698 cases of this variant have been reported, the vast majority corresponding to people who traveled outside the country.

https://www.usnews.com/news/world/articles/2022-01-06/chile-to-become-first-country-in-latin-america-to-offer-fourth-covid-shot