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Friday, January 14, 2022

COVID is here for the long haul — we need a variant-proof vaccine

 The pandemic has entered a new phase. The emergence of the highly mutated omicron variant, now spreading like wildfire, underscores the ruthless opportunism of the virus — and the fact that COVID-19 is here to stay. 

While early evidence of reduced severity is welcome, omicron’s phenomenal evolutionary success is a harbinger of a worrying future in which new variants will continue to emerge periodically. Some will have the potential to cause new waves of infection globally — essentially new pandemics — as they progressively evolve away from the strains targeted by existing vaccines. 

This is hardly unprecedented.  We observe similar rapid viral evolution in another common disease, influenza. What is becoming clear is that in the years ahead we will have to contend with two globally circulating viruses — influenza and SARS-CoV-2 — both with the potential to cause pandemics at any time.

That should scare us, but also prompt us into action.  

It is time for scientists and policymakers to double down on research and take advantage of recent advances in vaccinology, with the goal of developing broadly protective or “variant-proof” vaccines against SARS-CoV-2 and, ultimately, other coronaviruses.  

Vaccines that protect against multiple variants would allow us to get ahead of the virus so we are ready for future mutations before they emerge. The alternative is to continually chase the virus, developing vaccines against specific variants only after they have begun to spread. This is not a desirable or sustainable long-term strategy for a world in which COVID-19 is endemic. 

The need for better, more broadly protective, more durable vaccines is clear. But if we want them, we must invest in the research and development to produce them. Making such investments shouldn’t be a hard choice for forward-thinking governments.  

Coronaviruses have proven their deadly potential. We know they circulate widely in animals and have the potential to jump species. What is more, the next disease outbreak could be significantly worse than COVID-19. Its closely related cousins SARS and MERS, for example, are respectively 20 and 70 times more lethal. Fortunately, they are less transmissible than COVID-19, but there is no guarantee the next coronavirus will be. 

Developing broadly protective vaccines will not be easy. While current COVID-19 vaccines work by generating antibodies to neutralize the changeable spike protein that the virus uses to enter human cells, broadly protective vaccines will need to target components of the virus that stimulate the immune system but do not mutate. Ideally, a broadly protective vaccine would provide immunity that endures for years or even a lifetime. Such a vaccine would dramatically reduce and perhaps even eliminate the risk of future coronavirus pandemics. 

The Coalition for Epidemic Preparedness Innovations (CEPI), where I am CEO, is among those pioneering this vital work, along with funders including the National Institutes of Health. Developing variant-proof SARS-CoV-2 vaccines and broadly protective coronavirus vaccines should be pursued as a shared global endeavor, and the more parties that are involved, the faster we’ll make progress. 

Importantly, the effort must go hand in hand with ensuring global access to such products, so that tomorrow’s vaccines protect the world without creating terrible inequalities. This is essential if we are to catch future outbreaks as close to the source as possible and vaccinate people early before such episodes become a global emergency. 

Last year CEPI launched a $200 million program to support the development of vaccines providing broad protection against SARS-CoV-2 and other coronaviruses. Some of that funding is already being put to work across projects with industry and academic groups, and further awards will be announced in the coming weeks. 

These programs are part of CEPI’s ambitious five-year strategy: a $3.5 billion plan to systematically reduce the risk of pandemics. CEPI will host a summit in March to raise funds for this vital work, providing an opportunity for the United States and other governments to support the goal of variant-proofing the world.  

There are grounds for optimism. Throughout the pandemic, good science paired with rapid research and development has been the one element of the global response that has consistently delivered. Vaccines have been deployed at a previously unimaginable scale and speed, with over 9 billion vaccine doses administered around the world in 2021. 

But omicron is a reminder that the pandemic is far from over — and we need new tools as we prepare to live alongside this virus for the long term. The time to invest is now. 

Richard Hatchett, MD, is the CEO of the Coalition for Epidemic Preparedness Innovations (CEPI) and former acting director of the Biomedical Advanced Research and Development Authority (BARDA).

https://thehill.com/opinion/healthcare/589734-covid-is-here-for-the-long-haul-we-need-a-variant-proof-vaccine

Vegas offering teachers up to $2K bonus to remain at work amid COVID-19 surge

 Las Vegas schools are offering full-time employees $2,000 to remain at work amid the ongoing winter surge in COVID-19 cases in the country.

In a statement released Thursday, the Clark County School District Board of School Trustees said it had approved an agreement to provide eligible regular and full-time employees employed as of Jan. 1, 2022 with a $1,000 COVID-19 retention bonus. 

It will also pay an additional $1,000 bonus to eligible regular and full-time employees who are employed on May 25, 2022, bringing the total amount to $2,000.

The Clark County school district, the nation's fifth-largest, added that it has allocated approximately $66 million in Elementary and Secondary School Emergency Relief (ESSER) funds to cover the expected costs of the retention bonuses.

The news of the bonuses comes just days after the Clark County School District was forced to announce a five-day pause due to the extreme staffing shortages based on the high number of positive COVID-19 cases, local station News3LV reported.

According to The Associated Press, around 2,100 of nearly 19,000 licensed staff members in Clark County were absent at one point last week.

In a Twitter thread following the school board's decision to pause classes, Nevada Gov. Steve Sisolak (D) — who is facing reelection in 2022 — said that "he is absolutely committed to keeping schools open for in-person learning" and "keeping our students, educators and staff safe."

"There is no substitute for having kids on our campuses, learning in classrooms with their teachers and peers. And I will use every resource I have as Governor of Nevada to keep schools open for in-person learning. I know the School District leadership shares this same goal," he added on Tuesday.

Teachers unions across the country have said that the Centers for Disease Control and Prevention (CDC) has not been communicating well enough with educators and teachers as COVID-19 hospitalizations hit record numbers across the US, according to Reuters.

COVID-19 rules, whether students should or should not be going to school during the omicron spike and the general health safety of public schools have turned into contentious issues across the country.

https://thehill.com/homenews/state-watch/589802-las-vegas-offering-teachers-up-to-2k-bonus-to-remain-at-work-amid-covid

AbbVie RINVOQ OKd for Atopic Dermatitis

 Approval of two dose strengths (15 mg and 30 mg) supported by efficacy and safety data from one of the largest registrational Phase 3 programs in atopic dermatitis, with more than 2,500 patients evaluated across three studies[1]

- RINVOQ (upadacitinib) monotherapy or with topical corticosteroids met all primary and ranked secondary endpoints in atopic dermatitis pivotal studies[1-3]

- RINVOQ demonstrated significant improvement in itch (Worst Pruritus NRS ≥4) as early as week one, as well as significant improvements in skin clearance (EASI 75 and vIGA-AD 0/1) at 16 weeks, compared to placebo[1-3]

- RINVOQ also demonstrated significantly higher levels of skin clearance (EASI 90 and 100) at 16 weeks, compared to placebo[1-3]

https://finance.yahoo.com/news/u-fda-approves-rinvoq-upadacitinib-181000896.html

Califf advances in FDA chief nomination but committee vote shows he's no slam-dunk choice

 Robert Califf has advanced in his confirmation process to become the FDA commissioner. But the Senate committee vote indicates Califf’s nomination for his second FDA tenure will be anything but a slam dunk.   

The Senate Committee on Health approved Califf's nomination by a 13-8 vote, with some dissenting votes coming from those who have concerns over his handling of the opioid crisis when he served at the FDA during the Obama administration.

He was appointed deputy commissioner in February 2015 and was nominated for the agency's top post seven months later, a role in which he served from February 2016 to January 2017. For that stint, Califf passed the full Senate by a vote of 89-4.

Thursday’s committee nod wasn’t nearly as resounding. Democratic committee member Sen. Maggie Hassan (NH) and independent Sen. Bernie Sanders (VT) voted against Califf, while other non-committee Democrats such as Sen. Joe Manchin (WV) and Sen. Ed Markey (MA) voiced opposition.

Sanders cited Califf’s “revolving door” journey from private industry to the FDA. The nominee was recently employed as a strategist with Alphabet's Verily. Before his time with the FDA, he worked at the Duke University Medical School, leading many clinical trials.

Four Republicans voted for Califf, including Sen. Richard Burr (NC) who urged for Califf’s nomination considering the post has been vacant for nearly a year. Burr also touted Califf’s “unparalleled experience” and his support for medial innovation. He was joined in his support of Califf by committee Republican Sens. Susan Collins (ME), Lisa Murkowski (AK) and Mitt Romney (UT).

One of the Republicans who voted against Califf’s nomination, Sen. Tommy Tuberville (AL), explained that he believed Califf would “continue to advance this administration’s pro-abortion agenda.” Republican Sen. Mike Braun (IN) expressed similar sentiments.

In Califf’s first nomination vote, Markey was one of the four who didn’t approve. On Thursday he explained why in an open letter to acting FDA commissioner Janet Woodcock, which referred to a meeting Markey had last month with the nominee.

“Dr. Califf did not commit to the decisive and comprehensive action necessary to ensure reforms that the FDA, under his leadership, would implement on opioid regulation," Markey wrote. "After years of agency failures and in the midst of a worsening opioid epidemic, we need FDA leadership that is fully committed to utilizing the agency’s full oversight authority to protect public health."

https://www.fiercepharma.com/pharma/califf-advances-fda-nomination-process-but-committee-vote-indicates-he-s-no-slam-dunk-choice

Mainz Biomed Acquires Exclusive Rights to Novel mRNA Biomarkers

 Potential for ColoAlert to Emerge as the Most Robust and Accurate At-home Screening Test for Colorectal Cancer

Biomarkers Demonstrated Unique Ability to Identify Curable Precancerous Colonic Polyps as well as Curable Early-Stage Colorectal Cancer

Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today it has entered into a Technology Rights Agreement with Socpra Sciences Santé Et Humaines S.E.C. (“TTS”) to access a portfolio of novel mRNA biomarkers for potential future integration into ColoAlert, the Company’s highly efficacious, and easy-to-use detection test for colorectal cancer (“CRC”). Mainz is currently marketing ColoAlert in Europe through its unique business model of partnering with third-party laboratories for test kit processing versus the traditional methodology of operating a single facility. The Company is also preparing to initiate ColoAlert’s regulatory pathway for approval in the United States.

Under the terms of the Technology Rights Agreement, the Company has the unilateral option to license the exclusive global rights to five gene expression biomarkers which have demonstrated a high degree of effectiveness in detecting CRC lesions including advanced adenomas (“AA”), a type of pre-cancerous polyp often attributed to this deadly disease. In a study evaluating these biomarkers published in the online peer review journal platform MDPI (March 11, 2021), study results achieved overall sensitivities of 75% for AA and 95% for CRC, respectively, for a 96% specificity outcome. If these statistical results are duplicated when the biomarkers are integrated into ColoAlert, we believe that it will ultimately position the Company’s CRC test to be the most robust and accurate at-home diagnostic screening test on the market. It will not only detect cancerous polyps with a high degree of accuracy but has the potential to prevent CRC through early detection of precancerous adenomas.

“Securing the exclusive rights to license this family of novel biomarkers is a fantastic milestone for the Company as it provides an extraordinary opportunity to potentially upgrade ColoAlert’s technical profile, possibly making it the most effective at-home screening test for CRC that has ever been commercialized,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “The Mainz team is on a mission to develop gold standard molecular diagnostic screening solutions for cancer indications and obtaining the rights to these biomarkers is a testament to our on-going commitment to develop cutting-edge products as they have shown superior sensitivity to even liquid biopsy products in development in terms of identifying advanced adenomas.”

The Company will now commence a clinical study in Europe to evaluate the effectiveness of these biomarkers to enhance ColoAlert’s utility in terms of extending its capability to include the identification of advanced adenomas, while increasing rates of diagnostic sensitivity and specificity. Given ColoAlert in its present form has already been CE-IVD marked (complying with EU safety, health and environmental requirements), the timeline and process to initiate this “add-on” study is expedited, and the Company is targeting the first half of 2022 to launch the clinical study. Furthermore, data generated by the study may potentially be incorporated into the Company’s design of ColoAlert’s U.S. clinical trial for consideration by the FDA.

https://www.globenewswire.com/en/news-release/2022/01/05/2361340/0/en/Mainz-Biomed-Acquires-Exclusive-Rights-to-Novel-mRNA-Biomarkers.html

Texas Sues Planned Parenthood Over $10M in Medicaid Payments

 Texas wants Planned Parenthood to return more than $10 million in payments for low-income patients under a lawsuit filed Thursday, years after Republican leaders moved to cut off Medicaid dollars to the abortion provider.

Planned Parenthood called the lawsuit "another political attack" in Texas, where most abortions have been banned since September under a new law that the U.S. Supreme Court has allowed to remain in effect.

The money Texas is seeking to recoup from Planned Parenthood did not pay for abortion services — which don't receive public funds — but did cover cancer screenings, birth control access and other health services. Planned Parenthood has previously put the number of low-income patients it served in Texas under the program at 11,000.

Republicans across the U.S. launched efforts to defund Planned Parenthood in 2015 over secretly recorded and heavily edited videos taken by anti-abortion activists. Texas health officials accused Planned Parenthood officials of making misrepresentations to investigators and began the process of removing its clinics from the Medicaid program.

Investigations by 13 states into those videos have concluded without criminal charges, and Planned Parenthood officials have denied any wrongdoing.

Planned Parenthood spent years in court fighting its removal from the Medicaid program but ultimately lost. Republican Attorney General Ken Paxton is now arguing to a federal judge in Amarillo that Planned Parenthood was not entitled to keep the more than $10 million it received in reimbursements while fighting the decision.

Planned Parenthood served only a fraction of the 4.3 million people enrolled in Medicaid in Texas.

https://www.medscape.com/viewarticle/966617

NYC Mayor Considering Virtual Learning Plan for Schools

 New York City Mayor Eric Adams is considering allowing the nation's largest school district to return to some form of virtual instruction as the city weathers a wave of coronavirus cases, a reversal from his pledge a week ago to keep children in schools.

Adams said at a news conference Thursday that he still believes the safest place for children to be is in school, "but we do have to be honest that there's a substantial number of children, for whatever reason, parents are not bringing them to school."

Attendance levels since students returned from winter break have been lower than usual, with anywhere from one-quarter to one-third of students not showing up to class most days. As of Wednesday, attendance district-wide was 76%, according to city Department of Education numbers. In a district of nearly a million students, that means about 220,000 were either out sick or otherwise missing school.

More than 100 schools reported attendance of less than 60%, and more than 50 reported less than half of all students attending class Wednesday.

After peaking the first week in January, the average number of new cases in New York City has declined slightly in recent days, raising some hopes among officials that the omicron tide is ebbing.

Adams, a Democrat who took office on the first of the year, has taken a bullish stance on the pandemic, urging New Yorkers to take precautions and get vaccinated but not to let COVID-19 control their lives. He also repeatedly said the city cannot afford more shutdowns of businesses or schools.

Michael Mulgrew, the president of the United Federation of Teachers union representing the city's public school teachers, had asked the mayor to postpone in-person learning as Adams took office.

Adams said Thursday that he's been working closely with Mulgrew and has been willing to entertain temporary remote learning so long as it was a "quality option."

"But my goal: I want children in school," Adams said.

The mayor stressed that the city would not see a dispute like that in Chicago, where the nation's third-largest school district canceled five days of classes because of a disagreement with the teachers' union over COVID-19 safety protocols.

"This is not Chicago," Adams said. "We can resolve this. We can get through these crises and we will find the right way to educate our children in a very safe environment."

He did not offer details about what a remote option might look like. Messages left with the teachers union and the city's Department of Education were not immediately returned.

The city's school system was one of the first to return to in-person instruction after the pandemic hit in 2020 and schools closed in March for the rest of the year. They started a hybrid plan in the fall of 2020, with most students inside school a few days a week and at home learning online the rest of the time.

New York City students returned to full-time in-person instruction this past fall.

https://www.medscape.com/viewarticle/966616