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Tuesday, February 1, 2022

All-out effort to keep Biden COVID-free; no ‘normal’ yet

 When President Joe Biden met with U.S. governors at the White House on Monday, he was the only one given a glass of water — lest anyone else remove their mask to take a drink.

The president was seated more than 10 feet from everyone, including Vice President Kamala Harris and members of his Cabinet.

A White House staffer who was wearing a surgical mask when Biden entered the room was quickly handed an N95 version.

These are just some of the extraordinary efforts on the part of the White House to keep the president from getting COVID-19, even though he’s gotten both of his regular vaccinations and his booster.

It’s no surprise that unusual steps are taken to protect any president. But the strict precautions could also threaten to undercut the Biden administration’s own efforts to tell Americans — especially those who are vaccinated and boosted — that they can get on with something closer to their normal lives in the face of the omicron wave.

And it’s emblematic of the messaging challenges surrounding the administration’s approach to COVID-19 as the virus becomes endemic, familiar and somewhat controlled but still menacing, with hard-to-follow guidelines often unevenly implemented.

For months, Biden aides have fretted that the people who are most protected against COVID-19 remain the most cautious, a dynamic they view as a drag on the nation’s economic and psychological recovery.

When the highly transmissible omicron variant hit, Biden said it was a “cause for concern, not cause for panic.”

In recent weeks, his aides and science advisers have highlighted study after study showing the strong protection offered by the COVID vaccines against the variant and reassuring vaccinated people they can go about their daily lives. At a Jan. 19 press conference, Biden declared: “We have the tools — vaccines, boosters, masks, tests, pills — to save lives and keep businesses and schools open” and rejected the notion that still-widespread restrictions reflect a “’new normal.”

“It will get better,” he promised.

Since even before Biden was elected, his aides have gone all-out to protect the now-79-year-old president from potential infection. He spent much of the 2020 campaign season holding remote events from a studio in the basement of his home, venturing out for travel in a bubble of frequently tested aides subject to an array of restrictions.

That caution continued well after he was fully vaccinated and living at the White House. The president has held up his administration’s fidelity to Centers for Disease Control and Prevention guidelines as a virtue, after they were regularly flouted by former President Donald Trump, who became seriously ill after contracting the virus.

As the nation’s virus response and vaccination campaign has become increasingly politicized, White House officials have expressed both political and policy concerns over a possible Biden infection. Though the vaccines are highly effective, a breakthrough case could erode public confidence in the shots and be used as a political cudgel against a president who was elected to bring an end to the pandemic.

Biden himself has at times taken a more relaxed approach to restrictions.

When the CDC last May surprised the White House by easing its guidelines on indoor mask-wearing by fully vaccinated individuals, Biden sought to publicly model the policy for the rest of the nation. He was meeting with vaccinated Republican lawmakers when the change was announced and led the group in removing their masks.

But that CDC guidance proved to be premature and was reversed over the summer, because vaccinated people could still transmit the virus, potentially endangering the tens of millions of Americans who are still unvaccinated.

When the delta strain surged last fall, the White House strengthened its testing protocols for everyone close to Biden — restrictions that had been lessened once aides were fully vaccinated and case counts began to fall nationally. In-person meetings were once again curtailed. Aides began increasing the distance between Biden and even vaccinated-and-tested individuals as a precaution, reminiscent of his earliest days in office.

In early January, as the nation’s capital led the country in per capita COVID-19 cases, White House press secretary Jen Psaki highlighted the “very strict precautions” taken to keep Biden and Harris safe, including mandatory mask-wearing and daily testing for those coming in contact with them.

She also said the White House had taken to limiting gatherings “to under 30 people.” But there were nearly 40 participants named by the administration — as well as two dozen members of the press — at Biden’s Monday meeting with the governors.

Psaki said the administration takes extra precautions any time the president removes his mask to speak to a group. She noted that the nation continues to set records in reported cases and hospital admissions.

“The president’s view is that right now we still need to keep our heads down and stay at it to fight what is still surging in parts of the country,” she said. “But we do have the tools to get to a point where it does not disrupt our daily lives.”

Biden, aides say, has relished opportunities outside the White House when he can engage in the sort of political glad-handing that has been suppressed by the pandemic. And in public, he’s chafed at some of the precautions, saying that the first thing he aims to do differently in his second year in the White House is “I’m going to get out of this place more often.”

He’s hardly alone in his impatience.

On Monday, seated across a large gap from Biden in the East Room, Arkansas Gov. Asa Hutchinson, the chair of the governors’ association, appealed for the government to more clearly define a pathway out of the pandemic.

“We need the CDC to help us to have the right standards to end this pandemic and move to more endemic status,” he said. “We want to go from today to more normal.”

The night before, the president and first lady Jill Biden did attend the black-tie National Governors Association dinner at Mount Vernon. Biden spoke, but he didn’t stay for dinner.

https://apnews.com/article/coronavirus-pandemic-joe-biden-health-pandemics-kamala-harris-648f64eafd0b4f58e05f75e236b65e00

US urges Pfizer to apply for under-5 COVID shots

  U.S. regulators are urging drugmaker Pfizer to apply for emergency authorization for a two-dose regimen of its COVID-19 vaccine for children 6 months to 5 years old while awaiting data on a three-dose course, aiming to clear the way for the shots as soon as late February, a person familiar with the matter told The Associated Press Monday.

The company’s application was expected to be submitted as soon as Tuesday.

Early Pfizer data has shown the vaccine — which is administered to younger kids at one-tenth the strength of the adult shot — is safe and produces an immune response. But last year Pfizer announced the two-dose shot proved to be less effective at preventing COVID-19 in kids ages 2-5, and regulators encouraged the company to add a third dose to the study on the belief that another dose would boost the vaccine’s effectiveness much like booster doses do in adults.

Now, the Food and Drug Administration is pushing the company to submit its application based on the two-dose data for potential approval in February, and then to return for additional authorization once it has the data from the third dose study, which is expected in March, the person familiar with the matter said. The two-step authorization process could mean that young children could be vaccinated more than a month earlier than previous estimates, assuming the FDA and the Centers for Disease Control and Prevention greenlight the shots.

The person spoke on the condition of anonymity to discuss sensitive regulatory issues. The person said the decreased effectiveness of the two-dose vaccine was not unexpected given the emergence of the highly transmissible omicron variant of COVID-19. Allowing young kids to be vaccinated with a two-dose shot earlier would ultimately accelerate when they could get the expected stronger protection from a third dose.

That would be welcome news for parents of young children, the last remaining age group without approval of COVID-19 shots.

Young children are far less likely than adults to develop serious complications or to die from COVID-19, but incidences of illness among the age group have risen amid the nationwide spike in cases from the omicron variant. Most cases and deaths occur among older people, especially those who are unvaccinated.

Speeding the authorization of pediatric vaccines against COVID-19 has been a priority for more than a year of the Biden administration, which believes them critical to reopening and keeping open schools and day care centers — and for freeing up parents occupied by childcare responsibilities to return to the workforce.

Vaccines for kids ages 5-12 were approved by U.S. regulators in November, though uptake of shots has been slower than U.S. officials hoped.

Pfizer’s primary series is administered three weeks apart. The third dose for young kids is being studied for administration at least two months after the second dose.


https://apnews.com/article/coronavirus-pandemic-business-health-0ec7437a181ddbade75dea90884a6b8f

ImmunityBio: Promising Study Results for Strategy to Reduce HIV Viral Load

 

  • Data from the Phase 1 "HIV Cure" Study as published in Nature Medicine showed that Anktiva (N-803) stimulates latent HIV replication in CD4+ cells (the kick) and increases immune cell activation (the kill)

  • Activated CD4, CD8, and NK immune cells are necessary for finding and killing HIV-infected cells

  • No treatment-related serious adverse events were reported

  • Multiple Phase 1 and 2 trials with Anktiva in patients with HIV are ongoing

  • The need for this therapeutic approach is significant: Globally there are an estimated 38 million people living with HIV; in the US, with 1.2 million people living with HIV, the average annual cost of antiretrovirals is $36,000, while nearly $2 billion is spent on those therapies in developing countries

MaxCyte, Intima Bioscience to Advance Tumor Infiltrating Lymphocytes Programs

 MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT, MXCN), a leading provider of enabling platform technologies for ex-vivo cell engineering, today announces the signing of a strategic platform license (SPL) with Intima Bioscience, Inc., a clinical stage biotechnology company developing genetically engineered cell therapies for solid tumor cancer. Intima joins a group of 15 other leading cell therapy companies who have partnered with MaxCyte.

Under the terms of the agreement, Intima obtains non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform. In return, MaxCyte is entitled to receive platform licensing fees and program-related milestone payments.

Intima is currently running a Phase 1/2 clinical study (NCT04426669) of its lead checkpoint cell therapy candidate, which targets the immune checkpoint CISH in patients with gastrointestinal and colon cancers.

https://finance.yahoo.com/news/maxcyte-signs-strategic-platform-license-070000857.html

Monday, January 31, 2022

Trial tests strategy to augment response to COVID-19 vaccines in transplant recipients

 A study has begun to assess the antibody response to an additional dose of a COVID-19 mRNA vaccine in kidney and liver transplant recipients, either alone or with a concurrent reduction in immunosuppressive medication. The clinical trial will enroll people for whom two to four doses of a COVID-19 mRNA vaccine did not elicit a detectable antibody response. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is sponsoring and funding the Phase 2 trial, called COVID Protection After Transplant–Immunosuppression Reduction, or CPAT-ISR.

“Eliciting a protective immune response to COVID-19 vaccines in some organ transplant recipients continues to be a challenge,” said NIAID Director Anthony S. Fauci, M.D. “We are concerned about protecting everyone from COVID-19 and therefore continue to develop and test new approaches to make vaccination effective for all organ transplant recipients.”

Organ transplant recipients must take lifelong immunosuppressive therapy to prevent organ rejection, and this therapy blunts their immune responses to pathogens and vaccines. Research has shown that many organ transplant recipients do not develop antibodies against SARS-CoV-2, the virus that causes COVID-19, after receiving a primary COVID-19 vaccine regimen. Even after receiving a third dose of a COVID-19 mRNA vaccine, many transplant recipients still fail to produce an antibody response. Those who do develop antibodies tend to have much weaker responses than immunocompetent people. The lack of robust antibody responses, along with a high prevalence of risk factors such as obesity and diabetes, leaves kidney and liver transplant recipients at high risk for SARS-CoV-2 infection and severe COVID-19.

The purpose of the new study is to determine if temporarily reducing immunosuppressive medication taken during the days before and after an additional dose of an mRNA COVID-19 vaccine safely allows for better antibody responses to vaccination in kidney and liver transplant recipients. Research has shown that pausing immunosuppressive medication in people with autoimmune disease can safely improve their antibody responses to vaccinations for both COVID-19 and influenza, suggesting that this approach might also work for some transplant recipients.

The new trial builds on NIAID’s CPAT pilot study, which is assessing the antibody response to a third dose of a COVID-19 mRNA vaccine in kidney transplant recipients. Dorry L. Segev, M.D., Ph.D., leads both trials. Dr. Segev is the associate vice chair for research and the Marjory K. and Thomas Pozefsky professor of surgery and epidemiology at Johns Hopkins University in Baltimore.

The CPAT-ISR trial will take place at approximately 15 transplant centers across the United States. The study team will enroll up to 400 adults ages 18 years or older who received a kidney or liver transplant a year or more prior to enrollment. All participants will have received two to four doses of either the Moderna COVID-19 vaccine or the Pfizer-BioNTech COVID-19 vaccine at least 30 days before enrollment and will have a negative or indeterminate antibody response 30 days or more after the most recent dose. Participants must be taking one of two specific tacrolimus-based immunosuppressive medication regimens and have no recent transplant rejection or change in immunosuppression.

The study team will assign participants at random to one of two groups. One group will receive an additional dose of a COVID-19 mRNA vaccine with no further intervention. The other group will take a reduced dose of their immunosuppressive therapy for five days before and two weeks after receiving an additional dose of a COVID-19 mRNA vaccine. Investigators will measure each participant’s antibody response to vaccination 30 days after the additional vaccine dose. The goal is to determine the proportion of participants who achieve a predefined antibody response at the 30-day mark. The study team will follow participants for one year after enrollment.

More information about the trial, including study site locations and contacts, is available at ClinicalTrials.gov under study identifier NCT05077254.

https://www.nih.gov/news-events/news-releases/trial-tests-strategy-augment-response-covid-19-vaccines-transplant-recipients

CCP May Collect Top American Athletes’ DNA At Beijing Olympics

 by Dorothy Li and Joshua Philipp via The Epoch Times (emphasis ours),

Sealed from the rest of Beijing in a “closed-loop” bubble, over 200 American athletes are receiving daily COVID screening for the Winter Olympics. But some experts worry that U.S. Olympians’ DNA might be collected by the Chinese Communist Party (CCP).

Patricia Adams, executive director of Canada-based non-profit Probe International, said “it’s a very likely possibility” that the CCP will be collecting top-performing athletes’ DNA at the Games.

They [CCP] are doing the testing every day … and [there’s] absolutely no oversight over the use of the products that they’re getting,” Adams said during a Jan. 26 webinar on EpochTV’s “Unmasking Communist China” program.

In the online event, Stephen Yates, chief executive of consultancy firm DC International Advisory, spoke of the threat posed by the Chinese regime’s mass collection of personal information and health data. U.S. officials and experts have previously sounded the alarm that Beijing is amassing a large database that includes Americans’ personal and health information, which could be used to enhance artificial intelligence systems and fields of medicine, as well as assist in espionage and military operations.

The danger, Yates said, lies in the CCP using the mass data set for unethical purposes.

“China has weaponized artificial intelligence and a lot of other studies of the human process in ways that civilized countries wouldn’t even allow, so we don’t have any way to really know what this dark window of the future might be,” he said.

According to Yates, CCP may use the massive data set to give their athletes a competitive advantage or increase opportunities for psychological warfare.

The Winter Olympics is set to open in Beijing on Feb 4. The diplomatic boycotts announced by the United States and a spate of other countries, which is meant to hold the communist regime accountable for its human rights violations in Xinjiang, don’t keep athletes from competing at the Games.

The U.S. athletes arrived in Beijing on the evening of Jan. 28, and were sent straight to hotels situated in a closed-loop system surrounded by wire fences. Everyone in the bubble can only leave via special vehicles, and staff in full protective suits carry out mouth swabs on them every day.

A security guard stands guard at a hotel parking in Beijing on January 29, 2022. (KIRILL KUDRYAVTSEV/AFP via Getty Images)

In the online event, Adams suggested that the CCP may “get rid of an American who’s the likely winner of the gold” through what she described as “nefarious means using false positive COVID test.”

Beijing’s Olympic organizers on Jan. 29 denied reports that they may potentially manipulate COVID test results, saying that the tests are up to international standards, according to state media China Daily.

Adams said that “at the end of the day, it’s all being done by the Chinese government, and nobody really knows what’s going to happen to the data.”

She noted the problem is “nobody trusts the Chinese government.”

“The Chinese government has demonstrated to the world over and over and over again that they don’t follow rules. They follow their own rules. They don’t follow international rules. They don’t follow treaties that they’ve signed.”

The CCP’s known record of cyber espionage has led several countries, including the United States, UK, and Canada to tell their athletes to bring a burner phone for the Games. Cyber security experts warned that Beijing 2022, a compulsory health app for the Games, may spy on users through encryption flaws.

“I think that athletes are very, very nervous. And they’re not happy,” said Adams.

https://www.zerohedge.com/geopolitical/ccp-may-collect-top-american-athletes-dna-beijing-olympics-experts-say

Did NYC Testing Numbers Drop Due To COVID Fatigue Or At-Home Tests?

 Everyone has their pandemic pastime. What’s Francine Ricchi’s? Tracking the lengths of COVID testing lines.

For more than a year, the Boerum Hill resident has done laps around her Brooklyn neighborhood almost daily, tallying the number of people waiting to get their noses swabbed and then posting to her Twitter account.

On her most recent trips, though, Ricchi has seen a change in the testing sites along her route. During past waves, she has watched lines grow and dwindle, as community transmission rises and falls. And sure enough, as cases skyrocketed in December, she documented queues of more than 100 people waiting to get tested.

But even though the daily number of New York City cases has still been enormously high — day after day larger than the peak once recorded in April 2020 – Ricchi said testing lines have become ghost towns.

“It was mostly documenting different locations showing there was no line at opening time,” she said. On January 26th, when the daily average case rate was 5,054, “there was really nobody. At one location, there were two people. We’re definitely in this period where demand for tests has dropped off.”

City data supports Ricchi’s findings. As COVID cases have come down from their omicron summit, so too have tests, which is to be expected.

But official PCR testing numbers have been cut nearly in half over two weeks. Last year, a similar drop took six months. It’s the sharpest drop over the shortest time ever recorded during the pandemic.

 PCR testing numbers have been cut nearly in half over two weeks. Last year, a similar drop took six months. 

In the most recent week for which complete data is available, about 86,700 New Yorkers got a PCR COVID test each day. That’s down from an early-January apex of almost 133,300 such tests per day. Antigen tests are trending in much the same way.

For comparison, during the winter wave a year ago, daily testing doubled from October to January, peaking at an average of 69,000 PCR tests. This tally didn’t shrink back to its original level until June.

City-run COVID sites are doing less than half as much testing now as they were in early January, said Dr. Ted Long, a primary care physician and executive director of the New York City Test & Trace Corps.

“​​As omicron was under better control and people started to see cases were no longer sharply rising, the impetus to get tested also went down a bit across the city,” Long said. He added that record numbers of New Yorkers sought to get tested before traveling to see family over the last winter holiday, as recommended by city health officials. After the break, that demand cooled off.

CityMD, a local urgent care chain, is administering 40% fewer COVID tests than at the height of the omicron testing crush, said Matt Gove, a spokesperson for the private health care provider.

Did Official Numbers Drop Due To COVID Fatigue Or At-Home Tests?

Frustrations over slow turnaround times might also be dissuading people from seeking tests.

Turnaround times took a hit around the start of the holiday season, and the issues persisted for some providers through the first half of January. In the run-up to Christmas, CityMD needed five-plus days on average to return test results. The urgent care chain shuttered 19 of its approximately 150 offices in December, citing staffing challenges. All have since reopened.

Other private health providers faltered, too. Jessica Benmen, a 27-year-old East Village resident, got results on January 27th from a COVID test she’d taken at a Labworq location on December 31st — a whopping 28 days earlier.

New York State Attorney General Letitia James sent the Brooklyn-based testing company a warning letter in December demanding that it report accurate turnaround times for its COVID-19 tests. Labworq is one of a half dozen companies to receive such warnings, the others being ClearMD HealthLabQSameday HealthEZ Test NY and Keep Health Safe,

“I’d forgotten that I even did it,” Benmen said, “It’s almost worse that they sent it to me this late.”

Citywide, turnaround times haven’t yet fully returned to their pre-omicron speed, but they have rebounded from early January, when less than 60% of tests came back within two days. Now, more than three-quarters of tests return results within 48 hours, according to data compiled by the New York City health department.

CityMD is now returning PCR tests in two or three days, Gove said, and turnaround times are even quicker at municipal-run sites. More than 80% of tests come back within 24 hours, Long said. He chalked the speed up to their pandemic response lab, which processes tests conducted at city sites.

Benmen, who gets tested before seeing friends and family, has experienced the improvement firsthand. Most tests she takes come back quickly, but she also says she's now using rapid tests more often. The holiday season's long lines and waits made rapid tests a more convenient option for New Yorkers who could get their hands on the limited supplies.

But home tests aren't counted in the city's official records, so it's hard to tell whether New Yorkers are actually getting tested less frequently — or simply switching over to rapid tests taken at home. When asked why the city hadn't incorporated at-home tests into its recordkeeping, a spokesperson told WNYC/Gothamist to contact the New York State Department of Health for an answer.

The New York State Department of Health said the decision was up to New York City officials.

"Local health departments have launched their own portals for at-home test tracking and approval by the Department is not required," state health department spokesperson Erin Silk wrote in an email, citing the examples of Warren and Tompkins counties.

Long said the city has distributed more than 8 million at-home test kits, 6.6 million of which went to New York City schools. The city began handing out the kits in mid-December. Assuming the free at-home kits have experienced the same average positivity rate as the city’s PCR testing since then, at least 1.7 million cases could have been potentially missed by recordbooks.

Francine Ricchi said that while short lines are less likely to make a splash with her Twitter followers, she'll keep documenting her local testing sites.

"Documenting zero people on line is just as important as documenting 50 or 60 waiting at open," she said. She also enjoys the excuse to go outside.

"It's a good morning routine for me to get up and get moving," Ricchi added. "Little bit of exercise. It's not a bad way to start your day."


https://gothamist.com/news/nycs-covid-testing-numbers-are-shrinking-faster-ever